PHARMACEUTICAL AND BIOTECHNOLOGY

UPDATE

 

November 2008

 

McIlvaine Company

www.mcilvainecompany.com

 

TABLE OF CONTENTS

 

Amerilab Achieves GMP Registration

Walker Barrier to Produce Booths for Extract Technology

Catalent Expands Bioreactor Capacity

HollisterStier Completes Small-Volume Parenterals Line

Encap Adds New Facilities

GlaxoSmithKline Closing UK Plant

Syracuse University Completes $107-million Life Sciences Complex

Rowan University Dedicates Samuel H. Jones Innovation Center, First Building Planned for Mantua, NJ, Tech Park

Lonza completes $300 Million Expansion of Bioreactor at Portsmouth, NH, Tradeport; 350 New Jobs Planned

Indiana EDC Offers $1.5M+ in Incentives for Schwarz Pharma Manufacturing, Subsidiary Tied to $12M Expansion, 150 New Jobs

Charles River Laboratories Fetches a Reported $9 Million for Worcester, MA Office-Lab Building

SpectraCell Doubles Size of Facility at Houston’s Westchase Business Center

Gene 24 Takes Full Building at San Diego’s Sorrento Science Park

Monsanto Completes $3M Expansion of Jerseyville Ill., Site with New Office Building, Seed Processing Facility

Accelerator/Research Facility Planned for Owensboro, Ky.’s Carnegie Village

Siemens Healthcare Unit Signs Lease for Full Floor at Cambridge, MA Discovery Park

BioEnergy International Expands at Woburn, MA, Light Manufacturing Site

NorthMarq Enters Facilities Management Accord with Minneapolis-based Techne

Synexus to Double Clinical Capacity in South Africa

The Indian State of Orissa and a Biotech Company Enter a Public-Private Partnership (PPP) to Construct a $20 Million Technology Park

Charles River Opens New Facility in Shanghai, China

Tepnel Life Sciences Expand Pharmaceutical Offerings

Merck Begins Validation for Vaccine Manufacturing in North Carolina

Wyeth to Cut Jobs at Irish Subsidiary

Schwartz Pharma Manufacturing Expands Indiana Plant

Artel's Services Driving Expansion in Canada

Ferro Sells Fine Chemicals Arm to Private Equity

Ohio’s Cardiovascular Innovation Center Awards $496K to Arteriocyte

Four Wisconsin Institutions Launch Collaborative Genomics Research Project

Texas Consortium Commits $100 Million to Sweeten San Antonio NBAF Biolab Bid

Pherecydes Pharma Moves into Paris Life Science Park Biocitech

Invitrogen Shells Out $1.2 Million for Five More Acres Near West Eugene, OR, Campus

Millipore Opens New $83 Million Membrane Casting Manufacturing Plant in Ireland’s County Cork

Pharmatech Associates Leads Design for China’s First FDA-licensed Biomanufacturing Facility

Construction Begins on Binghamton University’s New Engineering and Science Facility

Pierre Fabre “Most Improved Facility”

Patheon has New API Manufacturing Capabilities

QbD — Scientific Quality at Every Stage

DeWolff Gets Project for Jordan’s King Hussein Institute of Biotechnology and Cancer

Niagara U. Lands $10 Million Donation for Science, Bioinformatics Center

National Institute of Allergy and Infectious Disease Gives Grant to UT in Galveston, Texas

New Life for Older Building at UC Davis in Sacramento

UC Davis received $20.1 Million from CIRM.

UCLA Receives $19.9 Million CIRM Grant

Sanford Consortium for Regenerative Medicine Plans to Break Ground

UC Merced Plans a $7.5 million, 5,420-square-foot Stem Cell Instrumentation Foundry

UC Santa Barbara Planning $6.35 Million Biological Sciences Building

CIRM Awarded $7.2 Million toward  $12.9 Million Biomedical  Building at UC Santa Cruz

Five London-based centers Forge £2 Billion Research Cluster

NIAID Awards $68.7 Million in Contracts for Microbial Systems Biology Studies

Millipore Opens Membrane Casting Manufacturing Facility in Cork, Ireland

Encap Completes £3 Million (€3.9m) Expansion of Production Facility for High Potency Drugs

CMO Demand Still Outstrips Production Capacity Including Patheon in Puerto Rico

Piramal Healthcare Extends Development and Manufacturing at Morpeth, UK Facility

Piramal Expansion into Contract Research

Alcan Has New Indian Packaging Facility

Pharmatech Associates Chosen by Pacific Biopharma Group (PBG) for Design of First FDA- and EMEA-approved Biotechnology Manufacturing Facility in China

Honeywell Agrees to Supply Moisture-Barrier to Shanghai Haishun Packaging Material

U.S. Irvine Pharmaceutical Services Launches Subsidiary for Fill-and-Finish Services

Merck Serono Plans Expansion of its Swiss Biotech Facility

Niagara U. Lands $10 Million Donation for Science, Bioinformatics Center

National Institute of Allergy and Infectious Disease Gives Grant to UT in Galveston, Texas

Pfizer Puts Terre Haute, IN Manufacturing Plant on the Block

Kraft Group Planning Biotech Park for Foxboro, MA

AIDS Vaccine Lab Opens at Brooklyn Army Terminal

UTMB Opens New Biodefense Lab

Pfizer Launches Global Stem Cell Research Unit; Will Invest $60 Million in UK Facility

Utah Offers Medical Testing Lab $2M in Tax Credits for Expansion

Regeneron Signs NJ Sublease with Sanofi-Aventis

Abilene, Texas, Officials Approve $5.3 Million Biomedical Research Center

North East UK Economic Development Agency Opens Proteomics Center

Galveston National Laboratory Opens at University of Texas Medical Branch

Cleveland Community College Opens Bailey Allied Health and Science Center

Novo Nordisk Plans to Build an Insulin Plant in China, Tapping into a Major New Market

Nestles Invests in China

Pfizer’s NEWCON Facility Wins 2008 Facility Of The Year Award

NEWCON Benefits From Global Expertise

Catalent Pharma Solutions First FDA Product Approval for Brussels Syringe Facility

Metrics Inc. Opens Larger Scale Manufacturing Facility

Actavis Research & Development Labs in Florida

Scripps Research Institute Begins Move to Permanent Home on FAU Campus in Jupiter, FL

Mass. Life Sciences Center Board OKs $5.2 Million Grant for Genzyme Expansion in Framingham, MA

Univ. of Rochester Medical Center Breaks Ground for $76.4 Million Translational Research Institute

University of South Alabama Opens Mitchell Cancer Institute in Mobile, AL

Roche Reveals Plan to Add 250 Jobs at Ventana Medical Systems in Arizona’s Oro Valley

Duke University to Open Biomarker Factory at NC Research Campus

European Medicines Agency OKs Bayer Facility in Berkeley, CA

DuPont and Delaware Unveil $80 Million Innovation Center Partnership

Mississauga, Ont., Officials Welcome Therapure Biopharma

Bolder BioTechnology Moves Headquarters, R&D Operations, to Boulder, CO

Mass. Medical Device Concept Manufacturer Opens Sales/Support Office in Boulder, CO

AMRI Expands Manufacturing Capabilities in India; Adds Non-GMP Plant Capacity

University of Colorado Alumni Couple from Boulder, CO, Pledges $2 Million for Bioscience Initiative

Orissa, India, Joins Bharat Biotech International in Partnership to Build $20 Million Tech Park

Menomonee Falls Tool and Die Maker Launches Biomed Division

Construction Begins on Merck Sharp Vaccine Plant in Ireland

Inauguration of Italy-based Stevanato’s Packaging Production Facility in Cienega de Flores, Mexico

Swiss Centre for Applied Ecotoxicology Opens and Available for Contract Research

Synexus to Double Clinical Trial Capacity in South Africa

AMRI Expands in India

University of California Berkeley Opens BioPharm Center

Merck to Shutter Rosetta Research Center in Seattle, Two Overseas Sites

$250 Million Expansion Plan for Salk Institute Approved by San Diego City Council

PacificGMP Drops Plans for 200,000-Sq. Ft. Lab Facility in China

UC Irvine Breaks Ground on $66.6 Million Stem Cell Building, to House Sue and Bill Gross Stem Cell Research Center

Gilead Buys Foster City, CA, Building, Land for $137.5 Million from Digital Printing Concern

DHS Dedicates $160 Million National Biodefense Analysis and Countermeasures Center at Maryland’s Fort Detrick

Gilead, Novo Nordisk Subsidiary Sign Lease Deals within Seattle’s South Lake Union

Sanofi-Aventis Expanding China Presence with Enlarged R&D Facility, New Biometrics Center, SIBS Accord

Neurotech Opens GMP Manufacturing Facility in Cumberland, RI

Bioscience Center Planned for MinnWest Campus in Willmar, MN, Wins $1.3M State Grant

Patheon Opens New Drug Development Suite

Genetics Lab Opens New Bangor Maine Facility

DuPont and State of Delaware Unveil $80 Million Innovation Center Partnership

Covidien Expands in Missouri and Dublin, Ireland

William Beaumont Hospital Updates / Expands

Eisai Plans to Open Indian API Plant by 2011

NC Research Campus at Kannapolis Opens Doors

Singapore Opens Fusionopolis R&D Hub

University of Illinois Opens Advanced Digital Sciences Center

Merck Hints at Further Growth for Durham, NC, Vaccine Plant

Yale Begins Move to Science Park

Affymetrix Opts to Keep USB Subsidiary in Ohio

MedImmune Opens Cambridge, UK, R&D Facility

Meridian Life Sciences Expands Building to Meet Antibody Production Growth

Lancaster, PA, Developer Says Biotech Firm Interested in Proposed Business Park

Pharma Manufacturer to Hire 150 in Indiana

Niagara U. Lands $10 Million Donation to Construct Science, Bioinformatics Center

Idexx to Expand Memphis Distribution Facility

Intel Opens Work-site Medical Clinics

 

 

 

 

Amerilab Achieves GMP Registration

Amerilab Technologies (Plymouth, MN) achieved Good Manufacturing Practices Registration through NSF International's Dietary Supplement Certification program.

Amerilab Technologies specializes in the development, manufacture, and packaging of effervescent tablets and powders. With extensive experience in formulation of various pharmaceuticals, dietary supplements, nutraceuticals, and other specialty applications, Amerilab Technologies is a leader in effervescent dosage forms.

Walker Barrier to Produce Booths for Extract Technology

Walker Barrier Systems (New Lisbon, WI) will manufacture Extract Technology (Huddersfield, UK) downflow booths and products for the North American and Puerto Rican markets at its recently expanded New Lisbon facility.

Walker produces high-quality stainless steel isolators for containment and aseptic applications. Customers will continue to receive technical support from the Extract team in the US.

Catalent Expands Bioreactor Capacity

Catalent Pharma Solutions (Somerset, NJ) will add a 1000-L bioreactor train in its Middleton, Wisconsin, facility by 2009. The expansion will more than double Catalent's bioreactor capacity. The expansion will meet increased demand for production to support clinical trials in Asia, Australia, Europe, and the United States.

Catalent supplied two biotechnology companies with proteins produced with its proprietary "GPEx" technology. The technology is designed to aid the development of new biopharmaceuticals in a compliant, timely and cost-effective manner. The GPEx system produces stable, high-yielding mammalian cell lines for protein production.

HollisterStier Completes Small-Volume Parenterals Line

HollisterStier Laboratories (Spokane, WA) added a small-volume parenterals (SVP) line to its 172,000-ft2 state-of-the-art facility. The new line aseptically fills 2–200-mL vials with liquid and lyophilized pharmaceutical products in batch sizes of 20–3000 L.

The 25,500-ft2 vial-filling complex includes a vial filler equipped with a nondestructive automatic check-weigh system, and diaphragm filling pumps. The line offers compounding options such as aseptic compounding, portable compounding vessels, and large fixed compounding tanks. The vial inspection and packaging area includes inspection, labeling, ink-jet coding and secondary packaging.

Encap Adds New Facilities

After moving to a new location, Encap Drug Delivery (Livingston, UK), in partnership with Thermal Transfer (Derbyshire, UK), completed the first phase of its new expansion by opening a major new 200-m2 (2,152 sq. ft.) laboratory suite dedicated to formulation, production, and analytical development.

The second phase of Encap's expansion, a 450-m2 (4,842 sq. ft.) manufacturing facility was scheduled for completion in July 2008. This new facility will include two separate suites for large-scale pharmaceutical processing. One suite will be dedicated to the manufacture of products requiring special handling (e.g., high-potency and anticancer products).

GlaxoSmithKline Closing UK Plant

British drug maker GlaxoSmithKline PLC said it is planning to close one of its English plants, which employs 620 people, by 2013 because the majority of drugs made at the plant are losing their patent protection and facing generic competition within a year.

The world's second-largest pharmaceutical company by revenue said that 60 percent of the production at its Dartford plant is of two drugs: Lamictal, which is used to treat epilepsy and bipolar disorder, and Valtrex, which is used to treat herpes.

Lamictal's patent expired earlier this year and generic competition for the drug will hit U.S. pharmacies in July. Valtrex's patent will expire next year.

As a result, GlaxoSmithKline's sales of the two drugs are set to dry up over the next several years, and so the company said it makes economic sense to shut the plant down by 2013.

The announcement comes less than a week after the drug maker announced that it is reducing its U.S. sales force by 1,000 to cut costs amid growing competition from generic drugs, as increasing numbers of the company's profitable patents expire.

GlaxoSmithKline, the maker of antidepressant Wellbutrin and Requip for Parkinson's disease, currently employs around 100,000 people worldwide.

U.S.-traded shares of GlaxoSmithKline rose 25 cents to $37.85.

Syracuse University Completes $107-million Life Sciences Complex

Syracuse University last week completed construction of its $107 million Life Sciences Complex, which the school hopes will promote more interdisciplinary biology and chemistry research, and consolidate its growing science programs, in particular biology, where the number of undergraduate majors has jumped 30 percent over the past two to three years.

The school also expects the new facility to help it recruit “10 or so faculty over the next five years” in areas such as stem-cell research, renewable energy, and  genetics, according to John Russell, chair of SU’s Department of Biology.

The Life Sciences Complex, actually a single, 230,000-square-foot building, is the largest construction project in SU history. The six-story facility, designed by Ellenzweig Associates of Cambridge, Mass., features a pair of wings in an “L”-shaped configuration: A research wing that houses biology research laboratories, conference rooms, and faculty offices; and a teaching wing that includes lecture halls, research greenhouses, and biochemistry, biology, and chemistry teaching labs.

The new building places under one roof the university’s biology, biochemistry, and chemistry programs.

During fiscal 2007, SU won around $6.1 million in grants from the National Institutes of Health. By comparison Columbia University was awarded $340.2 million, Cornell University and its Weill Medical College won $177.2 million, and the State University of New York system brought in nearly $133.5 million.

The Life Sciences Complex replaces separate biology and chemistry buildings that totaled 95,000 square feet. Biology had been taught in two buildings, one opened in 1905, the other 1964, while the Chemistry Department held classes in a building that opened in 1906.

The older buildings will be renovated for new uses, with a biomaterials group set to occupy the chemistry building.

The new facility has been designed to allow construction of an expansion wing, though that is not likely to happen for at least a decade. 

SU is funding the Life Sciences Complex through $90 million in bonds and donations from various sources. Donations have included $6 million from husband-and-wife alumni Jack and Laura Milton, both members of SU’s Class of 1951, for the atrium that connects the Life Sciences Complex to the Center for Science and Technology.

That center houses the university’s chemistry research labs and the SU Center for Advanced Systems and Engineering, or CASE, which includes incubator space for biotech and other startups.

The complex also benefited from a $5 million state grant secured by Assemblyman William Magnarelli (D-Syracuse) through the Assembly’s Rebuilding the Empire State Through Opportunities in Regional Economies program, also known as RESTORE.

RESTORE aims to encourage collaborations between academic institutions and local biotech and pharma companies. Using funding from the program, they expect to offer tutorials, short classes, in the use of various modern equipment, and to make available to small firms our expertise, even to having them have a little lab space if they needed to push forward some product, and needed some technical advice by scientists.”

Funding from RESTORE was also used for the new facility’s RESTORE Center for Environmental Biotechnology, designed to advance research into how organisms interact with their environments, promote collaborations between researchers and professionals from Central New York biotech and biopharma industries, and develop graduates with the skills needed to fill positions with the region’s life-sci employers.

At present, the university’s collaboration partners include Welch Allyn, which in September joined with SU to open on campus the 4,000-square-foot “Blue Highway” incubator, which is focused on accelerating commercialization of biomedical devices. The incubator is named for a 40-year Welch Allyn employee, Richard W. Newman.

Welch Allyn is one of the largest employers in Syracuse’s county of Onondaga, with 1,100 employees at a plant in Skaneateles Falls, according to data from the Greater Syracuse Economic Growth Council compiled earlier this year.

Another major regional life-sci employer, Bristol-Myers Squibb, maintains a drug-manufacturing plant in East Syracuse that employs 820, according to the growth council. BMS generates more than $2.6 million in taxes annually with a local payroll exceeding $50 million, the company states on its web site.

The university is also a partner in the Central New York Biotechnology Research Center, formed to help commercialize technologies developed at the university and other centers, including the State University of New York’s Upstate Medical University and College of Environmental Science and Forestry.

SU is also a member of MedTech, a not-for-profit regional trade association that promotes commercialization of medical technologies in Central New York.

Rowan University Dedicates Samuel H. Jones Innovation Center, First Building Planned for Mantua, NJ, Tech Park

Rowan University last week dedicated its Samuel H. Jones Innovation Center, the 45,000-square-foot first building in what is planned as a 25-building, 1.5-million-square-foot campus called South Jersey Technology Park in Mantua Township, NJ.

The innovation center is located about a mile from Rowan's Glassboro campus, within the 200-acre SJTP, part of the proposed 580-acre Rowan University West Campus that would straddle Mantua, Glassboro, NJ, and Harrison, NJ.

SJTP is a public/private partnership that has received support from numerous organizations and individuals, including:

The innovation center is a mixed-use facility that houses laboratories and laboratory/office space for research sponsored by private life-sci employers as well as by Rowan’s College of Engineering. The building is the home of the Center for Innovation and Entrepreneurship, and the Rohrer College of Business Incubator, operated by the Rohrer College of Business at Rowan University.

Lonza completes $300 Million Expansion of Bioreactor at Portsmouth, NH, Tradeport; 350 New Jobs Planned

 Lonza Biologics, a subsidiary of Swiss-owned Lonza Group, has completed a $300 million, 330,000-square-foot expansion of its bioreactor at Pease International Tradeport in Portsmouth, NH

The expansion, the largest in the company's history, will increase Lonza’s bioreactor capacity to 93,000 liters, as well as add up to 30 new jobs to its current workforce of 650 people.

Unused space at the Tradeport could be developed into a mid-scale plant, a vaccine facility or a large-scale mammalian plant. The manufacturer of life science-based custom antibodies continues to add employees, but acknowledged it has been slower to do so than planned, something it blamed in part on slower-than-expected growth in the biotech industry.

Lonza came to Portsmouth in 1996 through its acquisition of Celltech Biologics, obtaining a 56,000-square-foot space at Pease International. It completed a 300,000-square-foot expansion with three added 20,000-liter bioreactors in 2004, and announced the recently completed expansion in 2006.

Indiana EDC Offers $1.5M+ in Incentives for Schwarz Pharma Manufacturing, Subsidiary Tied to $12M Expansion, 150 New Jobs

Schwarz Pharma Manufacturing and its generic-drug subsidiary Kremers Urban have announced plans for a $12 million expansion of their Seymour, Ind., manufacturing operations projected to create 150 new jobs for the drug makers by 2011 — a project for which the Indiana Economic Development Corp. has offered the companies more than $1.5 million in incentives.

Schwarz and Kremers will upgrade the manufacturing, information technology systems, and logistics equipment at their 280,000-square-foot pharmaceutical manufacturing and distribution center, located some 65 miles south of Indianapolis.

The drug makers employ 366 at their Indiana manufacturing facility. They plan to begin hiring managers, business associates and production staff later this month.

The Indiana Economic Development Corporation offered Schwarz Pharma Manufacturing and Kremers Urban up to $1.25 million in performance-based tax credits and up to $310,000 in training grants based on the company's job creation plans. The city of Seymour will provide property tax abatement at the request of the Jackson County Industrial Development Corporation.

Charles River Laboratories Fetches a Reported $9 Million for Worcester, MA, Office-Lab Building

The vacant five-story, 160,000-square-foot 55-57 Union St. in Worcester, Mass., has been sold by Charles River Laboratories for $9.1 million to a buyer that plans to renovate the office/lab building for life science tenants.

The buyer, TDG Union Street LLC, will seek assistance from the city of Worcester and the state of Massachusetts to market the single-tenant building to multiple life-sci tenant prospects. Renovations will include the building's lobby, installation of a new café and tenant fit-ups.

The building, which has been renamed the Redstone Center,  has more than 20,000 square feet of wet labs. Constructed in 1929, the building has been converted over the years to lab uses by past owners and tenants, including TSI, PerkinElmer and Charles River Laboratories.

The reposition should draw companies seeking to escape historically high rents in Boston and neighboring Cambridge, MA.

SpectraCell Doubles Size of Facility at Houston’s Westchase Business Center

SpectraCell Laboratories, a provider of advanced clinical testing services to healthcare providers,   has doubled the size of its facilities by adding a second 20,000-square-foot building on its campus in the Westchase Business District.

The new $3.5 million facility, completed in late October, houses SpectraCell’s clinical laboratory operations. An existing building, designed in 2005, retains the company’s corporate, financial, marketing and administrative functions.

SpectraCell has more than doubled its number of employees since 2005, and now serves more than 3,000 physician clients in 38 states.

Gene 24 Takes Full Building at San Diego’s Sorrento Science Park

Biotech research company Gene 24 has signed a lease to occupy the entire 10,571-square-foot office/wet lab building 4045 Sorrento Valley Blvd. in San Diego, one of three buildings within Sorrento Science Park, developed in 1973.

The three-year lease is valued at $982,000, which equates to about $2.58 per square foot per month.

Monsanto Completes $3M Expansion of Jerseyville Ill., Site with New Office Building, Seed Processing Facility

Monsanto has completed a $3 million expansion project at its Jerseyville, Ill., location, consisting of roughly 22,000 square feet of new building or renovation that includes a new office building and a seed processing facility. The new facilities join the site’s existing 16 greenhouses, and nearly 300 acres of land for field trial.

Jerseyville is where Monsanto manages biotechnology field trials for projects in its research-and-development pipeline like dicamba-tolerant soybeans, water use efficiency cotton, nitrogen use efficiency corn, Roundup Ready 2 Yield soybeans, and drought tolerant corn. The site also processes seed for further field trials in other Midwestern states.

Next summer, Monsanto intends to plant at Jerseyville roughly 120,000 field plots, with about 90,000 of those to corn trials and the remainder to soybean trials.

Jerseyville conducted the world’s very first biotechnology field trial in 1987 – first with tomatoes and later that year with Roundup Ready soybeans.

Accelerator/Research Facility Planned for Owensboro, Ky.’s Carnegie Village

The city of Owensboro, Ky., and the Greater Owensboro Economic Development Corp. have announced plans for a new Centre for Business and Research in the Carnegie Village development.

The center will consist of a 37,000-square-foot accelerator and research site designed to accommodate early-stage life sciences companies and other tech startups, as well as cultivate high technology companies through the Emerging Ventures Center for Innovation. According to the city, the current growth of plant biotech companies associated with Kentucky BioProcessing has created a demand for biotech lab space.

The Daviess County Fiscal Court will assist the project by providing funding.

The center, at 9th and Allen streets, is part of an overall proposed urban village development called Carnegie Village, a project intended to help redevelop the city’s adjacent downtown.

Siemens Healthcare Unit Signs Lease for Full Floor at Cambridge, MA Discovery Park

A division of Siemens Healthcare Diagnostics has signed a lease for the entire sixth floor in the Smithsonian Astrophysical Institute Observatory, within Cambridge (Mass.) Discovery Park. Oncogene Science Biomarker Group, a division of Siemens, will occupy the floor’s 22,442 square feet of office space.

Oncogene is a maker of ready-to-use cancer reagent systems for commercial and clinical research customers. Cambridge Discovery Park is a 27-acre campus that can accommodate an additional 700,000 square feet in office, laboratory, and research and development buildings certified as meeting Leadership in Energy Environmental Design standards.

BioEnergy International Expands at Woburn, MA, Light Manufacturing Site

BioEnergy International, a developer of multi-product biorefineries that produce biofuels and bio-based specialty chemicals, has expanded to 17,760 square feet at 42 West Cummings Park in Woburn, Mass., a single-story, 142,000-square-foot light-manufacturing building. 

NorthMarq Enters Facilities Management Accord with Minneapolis-based Techne

Techne, a Minneapolis-based specialty manufacturer of biological products, has entered into a five-year deal with NorthMarq Corp. Solutions for real estate services, project management and facilities management — including for an 800,000-square-foot, 11 building campus in northeast Minneapolis.

Techne is a holding company whose Research and Diagnostic Systems division employs 640 employees at the campus, operating the company's laboratory research, manufacturing, administration, sales and marketing departments.

Synexus to Double Clinical Capacity in South Africa

The increased capacity will come from the building of two purpose designed sites in Mamelodi and Soshanguwe, as well as an expansion of the existing facilities in Pretoria.

Synexus expanded in the South African market in 2006 through the acquisition of CRC SA and now regards the country as one of its most successful sites.

They are able to carry out a wide variety of clinical studies involving both outpatients and inpatients through their own hub sites, 36 bed unit as well as affiliated general practitioner and hospital based sites.

The Pretoria facility is being expanded into the adjoining building, creating a 562 sq. m. (6,047 sq. ft.) outpatient site for clinical trials. Negations are underway to establish the locations of the new sites, with Synexus hoping to have the facilities completed by March 2009.

Synexus’ current operations in South Africa cover paediatric vaccines, osteoporosis, women's health and post operative pain, across Phases II and III. Upon completion of the expansion Synexus will employ 25 clinically trained staff in South Africa.

From these facilities Synexus will continue to recruit for and run clinical trials on behalf of pharmaceutical and biotech companies.

Synexus has operations in the UK, Poland, Hungary, Bulgaria, India and South Africa, holding the latter in particularly high regard. Michael Fort, Synexus’ CEO, attributed this to the high number of patients it has recruited in the country and the quality of clinical trials performed.

Recruiting in South Africa is relatively quick as the population is genetically diverse and treatment naïve. The country also has a stringent regulatory process to ensure patient safety.

The Indian State of Orissa and a Biotech Company Enter a Public-Private Partnership (PPP) to Construct a $20 Million Technology Park

Orissa, which is located on India’s east coast, has selected Bharat Biotech International (BBIL) as its partner in the venture to create a hub for pharmaceutical and biotechnology companies.

The venture is the first of its kind in Orissa, which is attempting to establish the infrastructure needed to benefit from India’s growing pharmaceutical and biotech sectors.

Dr Krishna Ella, chairman and managing director of BBIL, said: “We are delighted that the Government of Orissa has acknowledged our competence and awarded this prestigious project to BBIL.

Our task is to focus on rapid development of this park by developing core infrastructure and technology to enable establishment of new companies whereby new local entrepreneurs in the biotechnology field will be created.”

BBIL specialises in the R&D and manufacture of vaccines and biotherapeutics but also has experience in the development and commercialisation of technology parks in India.

The company is to develop the 55 acre site that has been allocated by Orissa’s government, with completion of the project expected to take eight years.

A ten acre section of the site has been earmarked for the Biotechnology Incubation Centre, which will be used by researchers, entrepreneurs and students. Funding for the Centre has been received from the Department of Biotechnology, Government of India.

Indian state governments have been keen to encourage pharmaceutical and biotech companies to establish in their region, with various PPP and incentives initiated to achieve this.

The state if Himachal Pradesh implemented a five year ‘tax holiday’ for pharmaceutical units set up in the state, while the Gujarat’s PPP website lists 295 large scale projects that are underway, with a total investment of $533 million.

These governmental investments in initiatives and infrastructure have assisted India’s rise to prominence in the global pharmaceutical market.

Charles River Opens New Facility in Shanghai, China

Charles River Laboratories has opened a new preclinical development facility in Shanghai, China which, the firm says, will act as a centre of excellence and help strengthen its position in the global outsourcing market.

The new 60,000 square foot site is designed to serve both the emerging Chinese and global drug sectors and is compliant with rules laid down by the US Food and Drug Administration (FDA), the Chinese state regulators (SFDA) and the Organization for Economic Cooperation and Development (OECD).

The US Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) and the Canadian Council of Animal Care (CCAC) has also approved operations at the site, enabling it to carry out the full range of preclinical development work.

The Shanghai site is expected to begin providing good laboratory practice (GLP) accredited development services in the first quarter, 2009.

There is considerable and growing demand for preclinical services in the country. Further evidence for this is indicated by WuXi Pharmaceuticals decision to press ahead with the development of a preclinical facility despite the withdrawal of partner Covance.

Tepnel Life Sciences Expand Pharmaceutical Offerings

Tepnel Life Sciences has expanded its pharmaceutical services offering by becoming the UK’s first genetic analysis services provider to use Illumina’s next-generation iScan system.

The new iScan platform will enable the firm to provide its pharmaceutical customers with higher-throughput genetic analysis services using Illumina’s BeadChip-based microarrays.

Genetic analysis has become an important part of many drug discovery programmes, especially as the genetic data can not only help determine the causes of fatal conditions, but can also explain variations in patient response to drug candidates.

At the core of Illumina’s iScan system is the iScan Reader, which offers rapid, sensitive and accurate sub-micron imaging of Illumina’s BeadChip-based genetic analysis assay systems.

In combination with the Illumina’s LIMS (laboratory information management system) and automation offerings, the iScan system can analyse 225m genotypes per day.

The addition of the iScan platform marks the first anniversary of the opening of Tepnel’s £5m (€6.4m) pharmaceutical services facility in Livingston, Scotland, which was partly funded by Scottish Enterprise, Edinburgh and Lothian.

Merck Begins Validation for Vaccine Manufacturing in North Carolina

Merck & Co has completed start-up activities at its vaccine manufacturing plant in Durham, North Carolina, which is intended to further the company’s ambitions in the sector.

The validation of production processes has also commenced at the facility, which represents one aspect of Merck’s efforts to expand its share of the vaccine market.

Merck has named the facility The Maurice R Hilleman Center for Vaccine Manufacturing, after a member of staff who in 30 years at Merck developed vaccines for eight significant diseases, including measles, mumps and rubella.

The company states that “The startup of this new site in Durham, new investments in vaccine facilities at West Point, Pennsylvania, and their intent to build a new vaccine plant in Carlow, Ireland, are all testimony that Merck intends to continue building on the legacy of Dr Hilleman in providing high quality vaccines that prevent diseases and enhance health care for millions around the world."

Since the project to build a vaccine facility in Durham was undertaken in 2004 Merck has initiated two expansions. These have taken total investment to $750m, with the plant predicted to create 400 jobs upon its completion in 2011.

At the Durham site Merck will manufacture childhood vaccines for measles, mumps, rubella and chickenpox, as well as a vaccine for shingles in adults.

Wyeth to Cut Jobs at Irish Subsidiary

Wyeth Medica, an Irish subsidiary of U.S. drugmaker Wyeth, plans to cut 250 jobs at its manufacturing plant in Newbridge, County Kildare, according to media reports.

The 1,000,000 square foot facility, which was established in 1992, currently employs 1,300 people in the production of over 140 drug formulations for the European, African, and Australian and Latin American markets.

The news was largely unexpected, particularly given Wyeth’s €5m ($6.7m) expansion of its Irish pharmaceuticals division in January when it created 24 new jobs and new medical, regulatory, corporate affairs departments at its base in Ballycoolin, Dublin.

Schwartz Pharma Manufacturing Expands Indiana Plant

Schwarz Pharma Manufacturing, Inc., a unit of Schwarz Pharma AG of Monheim, Germany, announced a $12 million expansion of its Seymour, IN manufacturing plant and distribution center. As a result of this expansion, the company expects to add 150 employees for a total of 516 by 2011. The company plans to begin hiring managers, business associates and production staff later this month.

The 280,000-sq.-ft. facility handles manufacturing for all of the company's products sold in the U.S., including blood pressure medication Univasc.

Artel's Services Driving Expansion in Canada

With big pharma and biopharma looking to cut costs and increase efficiency, liquid handling experts Artel have found that their services are in greater need than ever before.

This growing need for liquid handling quality assurance (QA) and quality control (QC) products and services has led to Artel opening a new office in Montreal, Canada, so that the company can provide technical support and training to help laboratories optimize their liquid handling operations and improve the quality of their data.

Artel made its name with the introduction of instruments that enable researchers to check the accuracy of handheld and automated liquid handling devices, the PCS (Pipette Calibration System) and MVS (Multichannel Verification System).

The PCS and MVS instruments use a ratiometric photometry approach to measure the amount of liquid dispensed, rather than the more laborious gravimetric weighing techniques.

Inaccurate pipetting can lead to inaccurate data generation, expensive QA/QC issues and problems with regulatory bodies if the errors remain undetected until after products have been released.

If a pharmaceutical company is audited by the FDA [US Food and Drug Administration] and a facility is shut down for QA/QC reasons, a new product introduction is delayed, staff members are let go and then the share price goes down the cost of those errors are huge; on the other hand for a simple handling error the cost could be as small as having to redo one morning’s work, which while costing time, effort and materials is relatively minor.

With regulatory requirements constantly changing, Artel has found that its customers want more than just a company to provide an instrument and service it; they want a partner that will ensure they have the correct systems and procedures in place to avoid being exposed to the cost of error.

The company has recently introduced a Pipette Quality Management System that helps laboratories implement an in-house pipette calibration process and integrate it into existing workflows.

The company’s service offering helps ensure traceability throughout laboratory workflow while making sure regulations are adhered to.

Ferro Sells Fine Chemicals Arm to Private Equity

U.S. company Ferro has said it will sell off its fine chemicals division to private equity firm Arsenal Capital Partners, which will rename the business as Novolyte Technologies, for $66 million.

Although best known for its electrolytes business which serves the battery industry, Ferro sells a broad range of fine chemicals and intermediates to the pharmaceutical, agricultural and electronics industries, amongst others. It also offers custom synthesis of fine chemicals.

Ferro's pharmaceuticals and fine chemicals business - spanning high-potency active pharmaceutical ingredients, low-endotoxin carbohydrates, large-volume parenterals, food additives, dietary supplements, electrolytes, glymes and phosphine derivatives - have to date been incorporated in the firm's 'other businesses' segment when reporting financial results.

The acquisition will include the electrolyte business Ferro Suzhou, as well as Ferro’s facilities in Posnick, Walton Hills and Independence Woods, Ohio, Ferro Japan KK, and most of the assets held at the firm’s Baton Rouge location in Louisiana.

Not included in the sale is Ferro’s pharmaceutical contract manufacturing business, Ferro Pfahnstiehl, which is headquartered north of Chicago in Waukegan, Illinois.

The divested businesses had sales of around $55m in 2007 and employ around 140 staff, who will transfer to Novolyte. The sale is expected to close in the fourth quarter.

Earlier this year, Arsenal announced plans to acquire DSM Special Products, a business unit of Royal DSM N. that manufactures specialty ingredients used in food, pharma, and animal feed.

The private equity firm has also invested in Velsicol Chemical, a manufacturer of high performance specialty chemicals including benzoic acid and derivatives used in applications such as agrochemicals, food and beverage preservatives and non-phthalate plasticizers.

Last December, Arsenal sold specialty chemicals firm Vertellus Specialties, a supplier to the agriculture, nutrition, pharmaceutical, personal care, and performance materials markets, after increasing annual sales to more than $450 million.

Vertellus was formed by Arsenal in 2006 through the merger of its portfolio companies Reilly Industries and Rutherford Chemicals.

Ohio’s Cardiovascular Innovation Center Awards $496K to Arteriocyte

Arteriocyte, a clinical stage biotechnology company with facilities in Cleveland, Ohio, and Hopkinton, Mass., has been awarded $496,000 through the Global Cardiovascular Innovation Center to continue clinical research on its lead stem cell therapy (ACY001) for use in chronic coronary ischemia. This funding is in addition to the first year GCIC support received in 2007, to accelerate the company's cardiac stem cell therapy development. Under the GCIC project, Arteriocyte participates as one of a number of companies working as research partners with the Cleveland Clinic.

GCIC is a $250 million research and product development consortium created through a $60 million grant from Ohio's $1.6 billion, 10-year Third Frontier Project. Founded in 2007, the consortium is led by the Cleveland Clinic and is comprised of Case Western Reserve University, Ohio State University, the University of Cincinnati, the University of Toledo and University Hospitals of Cleveland along with leading industry and economic development partners. GCIC is focused on developing, incubating, and commercializing cardiovascular technologies

Four Wisconsin Institutions Launch Collaborative Genomics Research Project

Four Wisconsin-based research institutions have banded together to form the Wisconsin Genomics Initiative with a focus on personalized healthcare research.

The collaborators include the Marshfield Clinic, the Medical College of Wisconsin, the University of Wisconsin, School of Medicine and Public Health, and the University of Wisconsin-Milwaukee. The institutions will combine resources to conduct research on predicting individual susceptibility to disease, targeting personalized treatments, determining how patients respond to specific treatments, and disease prevention.

The public-private collaborative was the result of a challenge issued by Doyle in 2006 at the groundbreaking for Marshfield Clinic's Laird Center for Medical Research expansion. He challenged the four institutions to combine and leverage resources to create a Wisconsin Medical Research Triangle.

One of the participants, Marshfield Clinic, is home to the Personalized Medicine Research Project, a population-based genetic research project that has collected DNA and medical records from around 20,000 people thus far.

"[The Oct. 10] historic announcement by Gov. Doyle solidifies Wisconsin's global leadership in personalized health care research. The collective strength of the four participating Wisconsin institutions, each a research leader in its own right, will move transformational DNA-based research from lab bench to bedside more quickly than ever,” Jim Leonhart, executive director of the Wisconsin Biotechnology & Medical Device Association, said in a statement.

Texas Consortium Commits $100 Million to Sweeten San Antonio NBAF Biolab Bid

The consortium of political, academic, and business leaders working to attract the US Department of Homeland Security’s proposed National Bio and Agro-Defense Facility to San Antonio is promising to set aside $100 million in state funds for the project.

More than half the money — $56 million — will come from state funds that Gov. Rick Perry, Lt. Gov David Dewhurst, and Texas House of Representatives Speaker Tom Craddick have pledged to secure during the state legislature’s upcoming session. Additional funds have been committed by the Texas Enterprise Fund, Texas Emerging Technology Fund, Texas Workforce Commission, City of San Antonio, Bexar County, San Antonio City Public Service, San Antonio Economic Development Foundation, and AT&T, which is headquartered in Dallas.

 “San Antonio provides unique advantages, including its skilled workforce, scientific community and transportation infrastructure that will provide the facility the resources it needs to fulfill its vital role in our national defense,” Perry said in a press release announcing the funding.

NBAF’s Texas site consists of 100 acres within the 1,236-acre Texas Research Park, straddling Bexar and Medina Counties. The research park site is part of a former working ranch that was donated to the Texas Research & Technology Foundation in 1986, and is located about four miles west of the city of San Antonio.

Members of the Texas Biological and Agro-Defense Consortium hope the biolab will help grow San Antonio’s budding commercial life sciences industry, which includes companies like Genzyme and DPT Laboratories, as well as add to the region’s number of government and other research facilities.

Texas is one of five states whose proposals to host the $451 million biolab remain under DHS consideration. The other four states are Georgia, Kansas, Mississippi, and North Carolina. DHS is also weighing a sixth option, retaining the existing Plum Island Animal Disease Center in New York.

The homeland security department is expected to reach a final decision by the end of the year. Construction is set to start in 2010 and stretch four years.

DHS has projected its biolab would generate between 1,300 and 1,614 construction jobs over four years and create between $138.2 million and $183.9 million in labor income. When completed, the facility would have between 250 and 350 permanent jobs that together would yield between $26.8 million and $30.4 million in annual salaries.

The NBAF would consist of 500,000 to 520,000 square feet housed in two laboratory buildings and four outbuildings. One building would serve as the primary research facility containing biosafety laboratories rated 2, 3E, 3A, and the highest rating of 4, plus support spaces. The second building would serve as a laboratory for small-scale vaccine and reagent production.

Pherecydes Pharma Moves into Paris Life Science Park Biocitech

Pherecydes Pharma has moved into Biocitech, becoming the 22nd company within the Paris life sciences technology park, and raising the park's occupancy rate to 93 percent.

Pherecydes is a biopharmaceutical company focused on biosecurity and biodefense. The company offers biosensors for the real time identification of bacteria and solutions for surface decontamination. The company is a spin-off from the research activities of Bio-Modeling Systems SAS, a predictive integrative biology specialist.

Invitrogen Shells Out $1.2 Million for Five More Acres Near West Eugene, OR, Campus

Invitrogen has acquired almost five additional acres near its campus in West Eugene, Ore., for $1.15 million. The Oct. 2 purchase came at a time when Invitrogen has been looking at expanding its Eugene site, which has about 300 employees.

Based in Carlsbad, Calif., Invitrogen, announced in June that it planned to buy Applera’s Applied Biosystems Group for $6.7 billion in cash and stock. Shareholders of both companies are scheduled to vote on the proposed merger, with the deal expected to close early next month.

Millipore Opens New $83 Million Membrane Casting Manufacturing Plant in Ireland’s County Cork

Millipore has opened a new $83 million membrane casting manufacturing facility in Carrigtwohill, County Cork, Ireland. The 30,000-square-foot facility almost doubles the company's membrane production capabilities in County Cork, where it employs 580 people and has maintained operations for 20 years.

The facility is expected to produce most of the company's membranes, used in various Millipore products requiring precise filtration and purification. Millipore's products are used to sterilize drug solutions, test beverages for purity, filter IV fluids in patient care and to support hundreds of other applications in life sciences sectors that include Medical Devices, Pharmaceutical and Biotechnology.

Headquartered in Billerica, Mass., Millipore employs more than 6,000 people in 47 countries.

Pharmatech Associates Leads Design for China’s First FDA-licensed Biomanufacturing Facility

 Pharmatech Associates, a Hayward, Calif., consultancy in the life sciences industry, has been chosen by Pacific Biopharma Group to provide the Basis of Design — the first reference document reviewed as part of any licensure activity in China — for the first biotechnology manufacturing facility to be built in China that has attained approvals from the US Food and Drug Administration and European Medicines Agency.

The new 181,000-square-foot facility will be a cGMP laboratory that uses single-use technology throughout the biomanufacturing process. It will be located in Taizhou, Jiangsu Province, in the emerging biomedical science park known as China Medical City.

The project is a joint venture between PBG and CMC. In addition to manufacturing biotechnology products for late-stage clinical supplies, the facility will be used for development projects originating at the California Institute for Quantitative Biosciences or QB3 — the collaboration of the University of California’s Berkeley, Santa Cruz, and San Francisco schools based at known UCSF’s Mission Bay campus

Construction Begins on Binghamton University’s New Engineering and Science Facility

Binghamton University, State University of New York, launched construction of its new Engineering and Science building. The facility will be located next to the Biotechnology Building, which is part of the University’s Innovative Technologies Complex (ITC).

The $66 million, two-story glass, metal and stone building will accommodate the expansion of the Thomas J. Watson School of Engineering and Applied Science. Adding about 125,000 square feet to the ITC, the new building will feature state-of-the-art, flexible research laboratory space, as well as suites for new business start-ups and offices that support the University’s ongoing and expanding industry partnerships.

 

Working through the SUNY Construction Fund and drawing from the expertise of our Physical Facilities department, the unique features of this state-of-the-art building will greatly strengthen and enhance our partnerships throughout the region and state.

 

It is estimated that the building will provide $112 million in economic impact and support over 1,500 jobs in the region during its construction.

 

The new building will house the Department of Electrical and Computer Engineering, the Department of Mechanical Engineering, and the Integrated Electronics Engineering Center (IEEC). A large rotunda feature will connect the two ITC buildings, offering access to laboratories and fostering closer interactions between departments and the research centers currently housed in the Biotechnology facility.

 

“With one of the fastest growing programs in New York State, Binghamton is committed to providing high-quality education and research in the engineering and computer science fields," said Seshu Desu, dean of the Watson School. “By adding to the instructional and research infrastructure, this new building will greatly enhance the Watson School’s efforts to attract and retain outstanding faculty, staff and students in order to further advance our national reputation.”

 

Through in-house design, planning and construction management, the University has achieved savings that have been redirected to building construction and needed equipment. The building has been designed to meet LEED (Leadership in Energy and Environmental Design) standards, incorporating passive solar energy for heating, geothermal technology for heating and cooling the rotunda, energy-efficient windows and skylights to allow for maximum use of daylight and the latest technology for heat recovery and humidity control.

Several unique features will be incorporated so that some building systems, such as the mechanical systems driving the building’s heating and cooling equipment, will remain accessible to serve as a teaching tool for engineering students. The design has also taken into consideration the nature of research to be conducted in the building. As a result, its mechanical equipment will be located in a tower structurally separated from the

Pierre Fabre “Most Improved Facility”

French contract drugmaker Pierre Fabre received the “Most Improved Facility” award for a plant run by its subsidiary Aquitaine Pharm International. The 10,760 square foot (1,000 sq. meter) unit, which was set up in 2007 with an investment of €30m ($41m) manufactures drug vials from 1ml to 80ml.

Medelis Expands into Europe

US-based contract research organisation Medelis has founded a European division, Medelis Europe, to bring its expertise in oncology clinical trials design and management to customers wanting to launch drugs in Europe.

The new branch of the CRO (contract research organisation), Medelis Europe aims to deliver a complete preclinical and clinical oncology drug development service offering that will help European, US and Asian sponsors bring anticancer drugs to both the US and European markets.

The firm’s preclinical offering will include programme design, management and execution, as well as electronic data capture (EDC), preclinical reviews and gap analysis to ensure alignment of the preclinical, regulatory and clinical teams.

For those compounds that pass through preclinical testing successfully, the company will offer a complete oncology clinical trial management and design service package, which includes strategic planning for regulatory approval from Phase I through to NDA (new drug applications).

The company pride’s itself on bringing its pharmaceutical customers clinical answers more quickly by finding the right patients for targeted therapeutic candidates and speed successful drugs to market.

Patheon has New API Manufacturing Capabilities

Contracting giant Patheon hopes that new intermediate scale, QbD compatible API manufacturing capabilities will broaden its offering to the drug industry and enable it to cement its market position.

The new intermediate scale processing suite (ISPS), which has been constructed at its facility in Cincinnati in the US, will focus on helping drugmakers to scale-up processes according to US Food and Drug Administration (FDA) quality by design (QbD) principles.

The additional capacity will be a further boost for Patheon’s reputation for the successful development of commercial scale manufacturing processes. Earlier this month the Canadian firm and partner Procter & Gamble received the “most effective scale-up and technology transfer” prize at this year’s European Outsourcing Awards.

The centre piece of the new ISPS facility is an intermediate scale Diosna-P300 high shear granulation unit that is coupled with a Niro-MP4 fluid bed dryer that has solvent and high potency compound handling capabilities.

The unit can output active pharmaceutical ingredient (API) batches in the 35 to 115kg range that are sufficient for regulatory registration, validation and early-stage clinical trials.

Such quantities are also ideal for final product process development and will allow firms to strike a balance between creating sufficient quantities for multiple design iterations and the cost of producing the API in question.

QbD — Scientific Quality at Every Stage

The FDA’s QbD guidelines are intended to provide a scientifically robust, statistically sound approach to drug development from initial concept to commercial launch.

A key aspect of the agency’s plan is that drugmakers and contract manufacturers build up a detailed understanding of how a product’s attributes relate to its commercial performance. Such expertise will then serve as the basis for a more generalised development approach across the industry.

As a leading contract manufacturer Patheon’s adoption of the approach QbD, which was first announced by the FDA in 2002 and is still under industry consultation, suggests that the guidelines are compatible with current trends and developments in the contract manufacturing sector.

DeWolff Gets Project for Jordan’s King Hussein Institute of Biotechnology and Cancer

The King Hussein Institute of Biotechnology and Cancer will sit on a mountaintop about halfway between the Dead Sea and the city of Amman, Jordan.

 

The 900,000-square-foot facility will include 358 beds — 60 of them for children — and space for 3,500 employees. And construction is supposed to start in December, as DeWolff Partnership Architects is finishing up the blueprints.

 

For the Rochester-based architectural firm, with 30 employees locally, being prime consultant "is the project of a lifetime," said James H. Newton, business development manager.

 

The DeWolff firm — which has done such work in health care as an expansion of Ontario County's Geneva General Hospital and numerous projects for University Hospitals of Cleveland — landed the job of prime contractor in 2005 after having worked with Johns Hopkins University Hospital to create plans for a cancer center. Former Johns Hopkins CEO James A. Block also does health consulting work for the Jordanian government and recommended the firm to King Abdullah II, said senior partner Carlton E. DeWolff.

 

The hospital will include a hotel and research building. At the center of the design is an oblong, open-air agora that is to serve as the central hub of activity. And all the patient rooms are arranged with a view of the surrounding scenery.

 

With Rochester and Amman 5,700 miles apart, the design work was done using a variety of digital technology allowing for real-time review of drawings and schematics from offices around the globe. The firm also used a number of Jordanian firms and an associate architect, Khaled Azzam, with an office in Cairo, Egypt.

 

A similar facility being built in the United States would cost roughly $450 million, DeWolff said. The firm's fee will be $10 million to $12 million, he said, though most of that will pay 16 other design consultants.

 

Cultural issues played a sizable role in the design, Newton said. The exterior of the concrete building will be faced with local stone and had to have an Arabic feel to it, DeWolff said. In addition, the toilets in the building could not be placed so they were facing the Muslim holy city of Mecca, while the morgue had to be big enough to accommodate the Arab tradition of people washing the corpse of a deceased family member, he said.

Representatives of DeWolff will meet in Cairo with a number of consultants and the Turkish contractor, Korey, to finalize some design details. The hospital is to be completed by 2011.

Niagara U. Lands $10 Million Donation for Science, Bioinformatics Center

Niagara University has received a pledge for $10 million to support construction of a new science building that, when built, will house a research and interdisciplinary biology center that will focus on bioinformatics and computational biology.

The $10 million from businessman and philanthropist B. Thomas Golisano, who is founder and chairman of payroll services firm Paychex and owner of the Buffalo Sabres hockey team, will be part of the university’s $80 million capital campaign, called “The Promise of Niagara.” The gift to the university will be presented in five installments of $2 million.

The funds from Golisano will help support construction of the 44,000 sq. ft. center, which will house academic and clinical partnerships with the Buffalo Medical Complex, the State University at Buffalo, Roswell Park Cancer Institute, and the Heart Center of Niagara.

The current capital campaign is seeking to raise $16.5 million toward the total cost of the $25 million science center.

National Institute of Allergy and Infectious Disease Gives Grant to UT in Galveston, Texas

The National Institute of Allergy and Infectious Diseases will grant up to $10.9 million to the University of Texas Medical Branch, Galveston, to seek biomarkers for infectious diseases.

UTMB will use the five-year contract to establish the Clinical Proteomics Center for Infectious Disease and Biodefense, one of two such centers funded by NIAID.  Caprion Proteomics will receive as much as $12.9 million from NIAID to establish its center and fund research.

UTMB researchers will search for proteins that are created by pathogens, or made by the human body in response to infection. These proteins could be used as indicators of disease to develop diagnostics, therapies, or vaccines, Maureen Beanan, NIAID program officer in microbiology and infectious diseases, said in a statement.

The first two diseases the centers will study include dengue fever and brucellosis. Any candidate biomarkers will be made publicly available for free to the research community for further development.

These centers also will assess samples submitted from outside institutions for protein biomarkers, Beanan added.

California Stem-Cell Facilities Growing Include Buck Institute, Stanford, and University of California Facilities

 

Though approved for a $20.5 million grant from California’s stem-cell agency to start building a new 65,708-square-foot facility, a private research institution in the state is blaming the troubled US credit markets for its failure to raise the balance of capital it needs to develop the $41 million project.

 

 The Buck Institute for Age Research in Novato, Calif., emerged last week as the first of the 12 major facility grant recipients named in May by the California Institute for Regenerative Medicine to disclose difficulty in financing its project.

 

On the other end of the spectrum, six California schools among the 12 CIRM grant recipients have begun constructing their facilities, while another three said they plan to do so by next spring, according to a review conducted by BRN last week.

 

CIRM announced on May 7 that it would dole out $271 million to help 12 institutions build out their labs, a move that reflects up to half the cost of the 800,000 square feet of stem-cell facility projects.

 

In return for the money, the 12 agreed to speed their construction schedules to ensure their facilities would open within two years with researchers and equipment in place.

 

CIRM spokesman Don Gibbons told BRN on Oct. 3 it was too early for CIRM and its 29-member Independent Citizens Oversight Commission to assess whether the two-year deadline should be extended because of the credit squeeze.

 

In June, Buck Institute President and COO James Kovach told BRN that the institute planned to break ground on the four-story building in September and complete it in July 2010. The project would be an addition to Buck’s existing 185,000-square-foot research facility.

 

In its application, Buck sought a grant of $25 million, saying an award that high “is likely to be a catalyst for development of” the final two buildings in its master plan, both of 60,000 square feet. That, in turn, would bring on-site enough researchers and others to justify construction of 128 units of affordable housing also planned by the institute, it told CIRM.

 

While endowments have topped $17 billion at Stanford and $7 billion at the University of California system — which accounted for nine of the 12 stem-cell grant recipients.

 

Buck Trust donations account for up to 20 percent of the Buck Institute’s total annual budget. Half of its total revenues come from National Institutes of Health research grants, 14 percent comes from individual and foundation contributions; 8 percent comes from other grants; 6 percent from corporate-sponsored agreements and licensing deals; and 2 percent comes from interest and other income.

 

As of Oct. 6, three California academic centers have either begun building or are in the pre-construction phase of their own stem-cell facilities: Stanford University; USC; and UC’s San Francisco, Los Angeles, Davis, and Irvine campuses.

 

UC Irvine became the latest school to start work on a stem-cell facility when it launched its effort Oct. 6 to build its $66.6 million Sue and Bill Gross Stem Cell Research Center.

 

At 100,636 square feet, the new facility will be 10 times the size of the 10,000-square-foot current core stem-cell laboratory, at UC Irvine, school spokeswoman Jennifer Fitzenberger told BRN via e-mail. UC Irvine plans to break ground on the facility Oct. 24, she said.

 

UC Irvine also demonstrates one complication for the schools as they translate their stem-cell facility plans into bricks and mortar: rapid escalation of construction costs. Since CIRM approved its grants in May, the agency and UCI have seen those costs grow about 10 percent over the $60.5 million projection the school furnished to the stem-cell agency.

 

New Life for Older Building at UC Davis in Sacramento

At the Health System campus of UC Davis in Sacramento, groundbreaking ceremony was held for its $62 million, 92,000-square-foot UC Davis Institute for Regenerative Cures.

The new facility will occupy most of a 109,000-square-foot building dating back more than a half-century to when the health system campus was the site of the California State Fairgrounds. When the fairgrounds moved out in the late 1960s, and UC Davis took over the 140-acre site, the school used the building as a bulk-mailing site and a warehouse before renovating 17,000 square feet for its Clinical and Translational Science Center, which opened in 2006 through a $24.8 million NIH clinical and translational science award.

The new stem-cell facility would occupy the remainder of the old fairgrounds building.

“We ran all new mechanical [infrastructure] in there from our power plant, and new water and new electrical and new communications systems to update the site. The facility itself required specialized plumbing and electrical supplies, and we’ve done that over more than a year,” said UC Davis spokesman Charles Casey. 

Casey said the facility will benefit UC Davis by allowing it to consolidate separate locations now in use by the more than 100 scientists and researchers who now carry out stem cell research at the school’s Davis and Sacramento campuses.

Another highlight of the stem-cell building will be a 5,500-square-foot good manufacturing practice facility, as well as numerous labs, conference rooms, and support spaces.

UC Davis received $20.1 Million from CIRM. 

At UC San Francisco, project manager David Bendet told BRN his school broke ground in early September on its $119 million, 74,832-square-foot facility, to be located on the school’s Parnassus campus. The building will consist of four split-level floors with terraced grass roofs and solar orientation, with open labs that flow into each other, and office/interaction areas on the pedestrian circulation routes between the labs.

UCSF expects to move into the new building, designed by New York architect Rafael Viñoly, by the end of October or early November 2010.

Plans to grow its stem cell research corps to 25 researchers by the time the building opens in 2010, and between five and eight additional principal investigators once the building opens.

UCSF won $34.9 million from CIRM and agreed to raise another $59.7 million from institutional and donor funds. The school’s fundraising effort for the building was jumpstarted in 2006, when Ray and Dagmar Dolby donated $16 million.

USC on Sept. 3 broke ground on its $80 million Eli and Edythe Broad CIRM Center for Regenerative Medicine and Stem Cell Research. The building is named for the husband-and-wife benefactors who established a Los Angeles-based national philanthropy focused on advancing entrepreneurship for the public good in education, science, and the arts. The Broads donated $25 million toward the project in 2006.

The 80,000-square-foot center is one of three anchors envisioned in a “research triangle” within the Health Sciences campus, along with the Zilkha Neurogenetic Institute and the Harlyne J. Norris Cancer Research Tower.

USC received $26.97 million from CIRM toward the facility. In return for the CIRM grant, USC committed itself to raising $55.6 million in institutional and donor funds.

USC was the first of three stem-cell facilities partially funded by the Broads. At UCLA, construction is nearly half-completed on the $42.8 million, 21,000-square-foot UCLA CIRM Institute, under the direction and management of UCLA Broad Stem Cell Research Center Director Owen Witte. UCLA received $20 million last year from the Broads — funding specifically restricted from being used for construction of the building itself, though part of the money was among several funding sources for equipment being used in the facility.

UCLA Receives $19.9 Million CIRM Grant

UCLA received a $19.9 million CIRM grant toward construction, and has agreed to raise $22.8 million on its own. UCLA, which currently has around 150 stem cell researchers on staff, said it plans to double its new stem cell faculty to 12 members by the time the facility opens. The facility will feature 15 stem-cell laboratories and access to six core facilities including advanced mouse genetics and microfluidics.

Close to breaking ground is Stanford, which has begun excavating the site of its planned $200 million, 130,000-square-foot stem-cell building on the south side of the university’s medical school.

The four-story stem-cell building, to be called Stanford Institutes of Medicine 1, will include a microfluidics facility, allowing researchers to narrow their analysis to a few hundred cells, rather than the millions typically needed.

Stanford’s new building is designed to house, under one roof, some 25 faculty members working with adult, embryonic, cancer and reprogrammed stem cells. The faculty members — 12 of them current, the rest to arrive by the time the facility opens — are now scattered between several on-campus buildings and an off-campus satellite lab.

Also in the new facility will be about 60 benches reserved for collaborating scientists from Stanford or neighboring institutions. Those visiting scholars will be mentored by two faculty members, a basic scientist and a clinical researcher. The building is being constructed using a $43.58 million grant the university’s School of Medicine received from CIRM — the largest of its 12 stem-cell facility grants.

Stanford is one of three schools planning to hold formal groundbreaking ceremonies for new stem-cell facilities.

Sanford Consortium for Regenerative Medicine Plans to Break Ground

San Diego’s newly-renamed Sanford Consortium for Regenerative Medicine plans to break ground early next year on a new $115.2 million, 23,740-square-foot stem cell research venue.

They hope to begin construction during the first quarter of 2009. Completion is set for the summer of 2010.

Lab space in the new four-story facility will accommodate 300 scientists, but won’t be large enough to accommodate all stem cell research in the consortium’s four component institutions. In addition, the institutions have some equipment too large to be moved safely into the new building.

“This is really going to be the hub for the four institutions, but there still will be the spokes of the four,” consortium spokesman Ian Stone said. “The scientists who do occupy the new building can then go and work in colleagues’ labs at any of the four institutions. And those colleagues could come to work at the consortium itself.”

Created in 2005, the consortium combines UC San Diego in a research effort with three institutions — the Burnham Institute for Medical Research, the Salk Institute for Biological Studies, and the Scripps Research Institute. The consortium received $43 million from CIRM, and agreed to raise another $72.2 million in institutional and donor funds. 

The project’s price tag include the $15 million cost of land to be leased back from UCSD under a long-term lease.

UC Merced Plans a $7.5 million, 5,420-square-foot Stem Cell Instrumentation Foundry

Also planning to break ground on a stem cell building in January is UC Merced, which plans to construct a $7.5 million, 5,420-square-foot Stem Cell Instrumentation Foundry focused on the development of stem cell technologies at the university's outpost on the former Castle Air Force Base.

UC Merced was awarded $4.36 million from CIRM, and will raise another $3.1 million on its own for the facility; Shaw could not say how much has been raised to date. It will include two cleanrooms, specialized spaces for cell imaging and culture work, and support and office space.

UC Santa Barbara Planning $6.35 Million Biological Sciences Building

UC Santa Barbara is in the planning process for its $6.35 million renovation of 10,337 square feet on parts of three floors in the seven-story Biological Sciences 2 building. The project received $3.2 million from CIRM.

“Currently we have about 25 faculty that are engaged in stem cell projects, with 1-2 individuals per lab. Renovation will create space for 3 new Endowed Chair positions, with capacity for 50 new stem cell researchers at the bench,” Dennis Clegg, professor and chair of the school’s Department of Molecular, Cellular and Developmental Biology.

“We are adhering to the original proposed schedule, which calls for construction to begin next spring,” Clegg added. “We have raised over $3M in support of the Stem Cell Center, but this is not earmarked for construction. Additional fundraising is underway that will include the construction project.”

CIRM Awarded $7.2 Million toward  $12.9 Million Biomedical  Building at UC Santa Cruz

CIRM has also awarded $7.2 million toward the $12.9 million facility to be built on the fourth floor of a planned Biomedical Sciences Building at UC Santa Cruz; and $20.18 million to UC Berkeley, toward the $78 million construction of two floors of stem cell research labs and shared equipment in the planned Li Ka Shing Center for Biomedical and Health Sciences. The Berkeley Building, slated for completion in 2010, has benefited from a $40 million lead gift from Hong Kong philanthropist and entrepreneur Li Ka-Shing.

Five London-based centers Forge £2 Billion Research Cluster

Five London-based medical research centers have partnered to become Europe's largest Academic Health Science Centre (AHSC). Uniting University College London (UCL) with four of the capital's most renowned hospitals—Great Ormond Street, Moorfields Eye Hospital, the Royal Free and University College Hospital—this venture aims to position London internationally as a hub of biomedical innovation. The new partnership, called UCL Partners, began life last month with a combined annual budget of around £2 billion. Together, the partners will treat 1.5 million patients a year and employ 3,500 scientists, senior researchers and medical consultants. UCL Partners is based on a model well established in North America, and in Europe, deepening the ties between universities and hospitals to inform academic and clinical research, improve professional education and enhance patient care. Such collaborations give rise to spin-off companies that create new treatments, The first AHSC was established in October 2007 when Imperial College London joined forces with Hammersmith and St. Mary's hospitals.

 

NIAID Awards $68.7 Million in Contracts for Microbial Systems Biology Studies

The National Institute of Allergy and Infectious Diseases awarded four five-year contracts worth a total of up to $68.7 million to support systems biology research for infectious disease.

The four projects aim to identify molecular features that distinguish bacterial and viral species and strains that may be targets for medical interventions for diseases such as severe acute respiratory syndrome, tuberculosis, and influenza.

Researchers will use a combination of computational and experimental methods to analyze, quantify, model, and predict the overall dynamics of the network of molecular components within microbes and the interactions of those components with human cells, NIAID said.

The institute said that these projects will expand upon data, technologies, and other resources that have already been generated through NIAID’s microbial genomics program.

The following institutions received the awards:

Millipore Opens Membrane Casting Manufacturing Facility in Cork, Ireland

Millipore Corp. opened a new membrane casting manufacturing facility in Carrigtwohill, County Cork, Ireland. The 30,000-sq.-ft. facility nearly doubles the company’s membrane production capabilities in Ireland.

Since 1988, our Cork operation has grown from the ground up into a Millipore Manufacturing Center of Excellence employing more than 580 people.

The new $83 million membrane casting facility is expected to produce a majority of the company’s membrane. These membranes are used in a range of Millipore products requiring filtration and purification. The company’s products are used to sterilize drug solutions, test beverages for purity, filter IV fluids in patient care and to support other applications in the medical device, pharmaceutical and biotechnology industries.

Encap Completes £3 Million (€3.9m) Expansion of Production Facility for High Potency Drugs

Drug delivery specialist Encap hopes that a recently completed £3m (€3.9m) expansion of its production facility, which allows it make high potency drugs, will help it attract a broader range of manufacturing contracts.

Encap specializes in filling two-piece solid and semi solid liquid capsules, which it says is one of the fastest growing sectors of the market, increasing at a rate of 30 per cent a year.

The firm’s plant, which is located in Livingston, Scotland, already produces a range of pharmaceutical products based on its oral drug delivery technology for pharmaceutical and biotechnology firms and academic institutions.

The expansion, which will double production capacity when it becomes fully operational in November, is designed to serve pharmaceutical companies developing highly potent drugs, particularly the new generation of oral anti-cancer agents.

CMO Demand Still Outstrips Production Capacity Including Patheon in Puerto Rico

An increasing number of contract manufacturing organisations (CMOs) and chemicals firms are installing high potency drug handling capacity, notably major players like SAFC and Pharmatek which have recently unveiled new purpose built facilities.

In addition, CMO giant Patheon has announced plans to invest around $3 million to add a dedicated high-potency manufacturing unit at its facility in Manati, Puerto Rico, significantly boosting its contract production capacity.

Despite this, the anticipated demand for high potency drugs such as those used to treat cancer for example, sales of which are expected to grow between 12 and 15 per cent to 2012 according to IMS health, suggest that there is still room in the market for smaller operations.

Piramal Healthcare Extends Development and Manufacturing at Morpeth, UK Facility

India-based Piramal Healthcare has extended the range of early phase drug product development and manufacturing offered at its Morpeth, UK facility.

Piramal’s Morpeth facility was acquired from Pfizer in 2006, with the 13,000 sq. ft. facility being re-equipped with primary and secondary packaging capabilities. The company could double packaging capacity in the future.

Morpeth is also an active pharmaceutical ingredient (API) formulation and small-scale manufacturing facility, equipping it to provide a range of clinical trial supplies (CTS) services.

The new CTS offerings from Piramal include label design and printing, comparator drug procurement, product blinding, global storage and distribution and drug destruction.

Piramal’s in-house developed tracking system, TrakPack, is being used to barcode patient kits through labelling, assembly and distribution. Using this system allows customers to track the project’s progress in real time, providing reassurance to the client.

The new services have been launched as part of a series of business developments undertaken since the company re-branded in March.

Piramal Expansion into Contract Research

Included in the realignment of Piramal is the acquisition of Tangent Data, a Romanian contract research organisation (CRO) specialising in the central nervous system (CNS).

Acquiring Tangent gives Piramal a presence in the growth sectors of Eastern Europe and CNS research. However, the company is planning on expanding further over the next three years, setting up operations in Western and Eastern Europe, South Asia and North America.

This geographic expansion will also see the company broaden its research scope to cover dermatology, oncology and metabolic diseases.

Alcan Has New Indian Packaging Facility

Alcan says that its new Indian facility further strengthens its position “in pharmaceutical flexibles through growth in emerging markets,” which contributed about 20 per cent of its revenue last year.

Located in Chakan in India’s Northern Maharashtra state, the facility will be run by Alcan Global Pharmaceutical Packaging (AGPP), which itself is in the process of being divested by parent firm Rio Tinto.

Rio is selling AGPP as part of a $15bn programme to repay debt, finance its 2007 Alcan acquisition and maintain its focus on the mining and metals industries.

Acquisition of the Chakan site is a further step in AGPP’s expansion in the Indian flexible packaging market following its inauguration of a $10m production plant in Haridwar, Northern India in June.

Last year, packaging produced by the existing 100-strong manufacturing workforce at the 27,976 square foot plant generated revenue of $3.6m for previous owners Associated Capsules.

While the new facility and Haridwar plant clearly indicate AGPP’s interest in and commitment to India’s $8.2bn a year drug market, expansion of its manufacturing capacity is also likely to further the firm’s position in the global market.

One of the key targets for Alcan’s flexible packaging range is likely to be the emerging Chinese pharmaceutical sector. A recent Freedonia report suggested that while Europe and the US will continue to account for 75 per cent of drug packaging sales, in a market expected to be worth $45bn by 2016, China will provide some of the strongest growth opportunities.

Pharmatech Associates Chosen by Pacific Biopharma Group (PBG) for Design of First FDA- and EMEA-approved Biotechnology Manufacturing Facility in China

Pharmatech Associates, a leading consultancy in the regulated life sciences industry, has been chosen by Pacific Biopharma Group (PBG) to provide the Basis of Design for the first FDA- and EMEA-approved biotechnology manufacturing facility ever built in China.

The Basis of Design for the 181,000 square foot facility will be the first reference document reviewed by the FDA as part of any licensure activity in China.

The new facility is a showcase cGMP laboratory that uses state-of-the-art "single-use" technology throughout the biomanufacturing process. It is located in Taizhou, Jiangsu Province, in the emerging biomedical science park known as China Medical City (CMC).

CMC is considered to be one of the largest and most ambitious undertakings by any nation to establish biomedical capabilities for the development of novel therapies for the world marketplace. 

The project is a joint venture between PBG and CMC. In addition to manufacturing biotechnology products for late-stage clinical supplies, the facility will be used for development projects borne at the California Institute for Quantitative Biosciences (QB3) whose lead campus is at University of California, San Francisco.

Honeywell Agrees to Supply Moisture-Barrier to Shanghai Haishun Packaging Material

The deal grants Honeywell increased access to the rapidly expanding packaging market, which was worth $2.4bn in 2007.

 

In turn Haishun gains access to Aclar to improve the quality of its products and will also receive technical services and training from Honeywell.

 

Honeywell promotes Aclar as being clear, chemical-resistant, non-flammable, biochemically inert and free from plasticisers and stabilisers. These traits are coupled to its effectiveness as a moisture barrier.

 

Aclar has been used in a range of applications from blister packaging to overwraps and pouches, with the products flexible variant proving particular suitable for the latter uses.

 

Like many other companies Honeywell has been trying to establish a presence in China and Asia-Pacific, with the opening of its technology centre in Shanghai intended to achieve this.

 

However, Haishun will receive Aclar that has been manufactured at Honeywell’s plant in Pottsville, Pennsylvania.

 

U.S. Irvine Pharmaceutical Services Launches Subsidiary for Fill-and-Finish Services

The new business, called Avrio Biopharmaceuticals, is due to start operations in January next year, and is an integral part of Irvine’s growth strategy.  Irvine has been operating since 1988, initially serving as an independent contract testing laboratory. Since then it has gradually extended its portfolio to include a broad range of drug development services including method development and validation, analytical chemistry, stability storage and testing, comprehensive microbiological support, preformulation and formulation, drug delivery testing, as well as inhalation and nasal testing.

 

The Californian company said that it has been active in biopharmaceutical services for some time, focusing on API manufacturing, cell line development, manufacture of peptides and proteins, and the development of dosage forms.

 

Avrio Biopharma expands its offerings in the biopharmaceutical sector, providing a “full range” of formulation development and aseptic fill-and-finish services.

The new company will focus on developing production processes and providing filling, lyophilisation and packaging services for early phase clinical trial materials.

 

Merck Serono Plans Expansion of its Swiss Biotech Facility

The $374m expansion of the manufacturing facility in Corsier-sur-Vevey, Switzerland has also been earmarked for the production of treatments for autoimmune and inflammatory diseases, which are currently in clinical development.

 

When completed in 2010 the facility will have two new dedicated production suites with 120,000 litres of bioreactor capacity and an additional wastewater treatment station and logistic centre. Erbitux production is due to commence in 2012 following inspections from regulators.

 

Since opening in 1999 the facility has produced the active pharmaceutical ingredient for Rebif (interferon beta-1a) and therapeutic proteins for clinical trials. It currently has two production suites and employs 250 people.

 

The need for capacity to manufacture other biologics in the pipeline, has led to Merck initiating the expansion.

 

Niagara U. Lands $10 Million Donation for Science, Bioinformatics Center

Niagara University has received a pledge for $10 million to support construction of a new science building that, when built, will house a research and interdisciplinary biology center that will focus on bioinformatics and computational biology.

 

The $10 million from businessman and philanthropist B. Thomas Golisano, who is founder and chairman of payroll services firm Paychex and owner of the Buffalo Sabres hockey team, will be part of the university’s $80 million capital campaign, called “The Promise of Niagara.” The gift to the university will be presented in five installments of $2 million.

 

The funds from Golisano will help support construction of the 44,000 sq. ft. center, which will house academic and clinical partnerships with the Buffalo Medical Complex, the State University at Buffalo, Roswell Park Cancer Institute, and the Heart Center of Niagara.

 

The current capital campaign is seeking to raise $16.5 million toward the total cost of the $25 million science center.

 

National Institute of Allergy and Infectious Disease Gives Grant to UT in Galveston, Texas

The National Institute of Allergy and Infectious Diseases will grant up to $10.9 million to the University of Texas Medical Branch, Galveston, to seek biomarkers for infectious diseases.

 

UTMB will use the five-year contract to establish the Clinical Proteomics Center for Infectious Disease and Biodefense, one of two such centers funded by NIAID. Caprion Proteomics will receive as much as $12.9 million from NIAID to establish its center and fund research.

 

UTMB researchers will search for proteins that are created by pathogens, or made by the human body in response to infection. These proteins could be used as indicators of disease to develop diagnostics, therapies, or vaccines.

 

The first two diseases the centers will study include dengue fever and brucellosis. Any candidate biomarkers will be made publicly available for free to the research community for further development.

 

These centers also will assess samples submitted from outside institutions for protein biomarkers.

 

Pfizer Puts Terre Haute, IN Manufacturing Plant on the Block

Pfizer’s manufacturing facility in Terre Haute, Ind., went up for sale for reuse or redevelopment last Monday, the Tribune-Star of Terre Haute, Ind., reported.

 

The facility at one time employed around 800 workers, and still houses 140 employees who will continue to produce two antibiotics through the first half of 2009, a Pfizer spokesman told the paper. The 935-acre property is being marketed by the real estate brokerage firm CB Richard Ellis, from its Indianapolis office. The site includes 23 manufacturing and warehouse facilities totaling around 580,000 square feet and about 762 acres of vacant land. The plant site has undergone $300 million in upgrades since 1999. Pfizer has had a manufacturing facility on the site since 1948.

 

K-State Plans to Break Ground on Olathe Innovation Campus in 2009 or 2010

 Kansas State University is moving ahead with plans for its Olathe Innovation Campus in the wake of a local vote in favor of the Johnson County Education Research Triangle, which increased sales tax in the county to one-eighth of a cent.

 

Kansas State plans to break ground in late 2009 or early 2010 for the first building on the campus, which will include around 103,000 square feet of educational space.

 

The increase in sales tax is expected to generate about $15 million a year to support the KU-Edwards Campus, the KU Medical School, and the K-State Olathe Innovation Campus. Each campus will receive $5 million in the base in perpetuity.

 

The economic impact of the park has been projected to include $150 million in public and private investment and 3,000 new jobs.

 

The Olathe Innovation Campus will include space for biotechnology incubators and space for start-up and established biotech industries. The city of Olathe will offer tax abatements to incoming bioscience businesses.

 

Kraft Group Planning Biotech Park for Foxboro, MA

The Kraft Group is planning to build a 1.6 million-square-foot biotech office park in Foxboro, Mass.  Kraft is "in the process of marketing for a tenant for this biotech office campus," Building Commissioner William Casbarra said, adding that the timing of the project would depend on how soon a major tenant is found.

 

Foxboro has deemed the site an “Economic Overlay District,” which may help it qualify for a piece of a $55 million state grant fund. Officials said the town would use the money for project-related infrastructure under the state program.

 

AIDS Vaccine Lab Opens at Brooklyn Army Terminal

The International AIDS Vaccine Initiative hosted a ribbon-cutting ceremony for its new AIDS Vaccine Design and Development Laboratory — a 36,000 square foot facility and the first occupant within a planned new bioscience center at the Brooklyn Army Terminal.

 

The lab “is the only facility in the world to be dedicated exclusively to the design and development of an AIDS vaccine,” IAVI said in a statement. 

 

The New York City Economic Development Corporation provided $12 million for the construction of IAVI's space at the Brooklyn Army Terminal, and IAVI raised an additional $5 million in funds through federal tax programs to cover the costs of renovating the new facility.

 

UTMB Opens New Biodefense Lab

The University of Texas Medical Branch at Galveston held formal dedication ceremonies to mark the completion of the Galveston National Laboratory, a $174 million biodefense lab.

 

While much of Galveston was devastated by Hurricane Ike in September, the GNL “emerged unscathed from the storm due to its multiple redundant safety and engineering features,” UTMB said in a statement.

 

The 186,267-square-foot Biosafety Level 4 lab will employ around 300 people when it is fully staffed. Researchers at the lab will study a range of pathogens of interest to biodefense, including organisms that cause anthrax, avian flu, bubonic plague, typhus, West Nile virus, influenza, drug-resistant tuberculosis, and hemorrhagic fevers such as Ebola.

 

Officials expect the lab to contribute around $1.4 billion to the state’s economy over the next 20 years.

 

Pfizer Launches Global Stem Cell Research Unit; Will Invest $60 Million in UK Facility

Pfizer last week launched a new research unit called Pfizer Regenerative Medicine, which will focus on using stem cells as therapeutics.

 

Pfizer Regenerative Medicine will be co-located in Cambridge, UK, and Cambridge, Mass., and it is expected to expand to employ around 70 researchers.

 

The Cambridge, UK, site is based at Granta Park and will focus on neural and sensory disorders, while the Cambridge, Mass., site is based at Pfizer’s Research Technology Center and will focus on endocrine and cardiac research.

 

The UK’s Financial Times reported that the company plans to spend up to $60 million on the Cambridge, UK, center.

 

Utah Offers Medical Testing Lab $2M in Tax Credits for Expansion

Utah’s Governor’s Office of Economic Development has offered a tax incentive of $1,996,600 to medical testing firm Nelson Laboratories to support a $13 million expansion for the company’s Salt Lake City facilities.

 

The project is expected to generate more than 350 new full-time positions at an average of 125 percent of the Salt Lake County average wage.

 

Over the ten-year project, these new positions will generate wages in excess of $157 million and new state tax revenue of more than $9.9 million.

 

Regeneron Signs NJ Sublease with Sanofi-Aventis

Regeneron Pharmaceuticals of Tarrytown, NY, said that it has entered into a sublease with Sanofi-Aventis for 14,000 square feet of office space in the Somerset Corporate Center in Bridgewater, NJ.

 

Regeneron said that it will initially employ 35 people at the New Jersey site. These employees will primarily work on the company’s clinical drug development programs and are expected to begin working at the new offices in January 2009.  

 

Abilene, Texas, Officials Approve $5.3 Million Biomedical Research Center

The Development Corporation of Abilene approved $5.3 million for a new biomedical research center.

 

The 20,000-square-foot facility is expected to house six to eight biotech companies and bring 140 to 190 jobs to Abilene with an average yearly salary of $70,000.

 

Richard Burdine, DCOA’s chief executive officer, said that these workers will likely come primarily from outside Abilene, but added that he’d also like to see local workers benefit. 

The DCOA already allocated $335,000 for the building's completed architectural design and spent more than $325,000 to purchase and demolish the property, readying the lots for construction.

 

North East UK Economic Development Agency Opens Proteomics Center

The Centre of Excellence for Life Sciences, or CELS, an economic development effort in North East England, opened a new proteomics facility in Newcastle, UK.

 

The North East Proteome Analysis Facility, or NEPAF, will work with a wide range of R&D groups and healthcare companies in the private and public sector in the UK and internationally and will provide then with access to leading expertise and equipment for the study of proteins.

 

In addition to CELS, which raised £4 million ($6 million) in 2007 to develop the facility, the regional development agency One North East and the European Regional Development Fund also supported NEPAF.

 

Galveston National Laboratory Opens at University of Texas Medical Branch

A dedication of the $180 million Galveston National Laboratory at the University of Texas Medical Branch was held. Six years out from its initial concept, the 170,000-square-foot building is the first of its size and scope to be located on a university campus and will target both naturally occurring diseases and biological threats posed by terrorists.

 

Cleveland Community College Opens Bailey Allied Health and Science Center

A tangible result of the way Cleveland Community College can turn visions into realities is the Bailey Allied Health and Science Center, now in the final stages of construction. The Bailey Center - a 50,000 square foot, three-story complex - contains a concentration of allied health and science classes as well as space for numerous programs.

 

Besides the expected classrooms and faculty offices, the building contains the John O. Harris Television Studio for broadcasting students and has science labs for biotechnology, biology, chemistry and physics classes and labs for nursing students. It will also offer hands-on training experiences in the form of X-ray labs, an operating room, a simulated hospital room and a clean room for biotechnology experiments.

 

The first two floors are mainly dedicated to broadcasting and nursing students and the third floor is designated for science labs and classrooms.

 

Named after Hoyt Q. Bailey, chairman of the CCC board of trustees, the center cost $8.2 million and was funded by N.C. State Bond Funds, N.C. Appropriations, Economic Development Administration, and private contributions from individuals, businesses and foundations.

CCC hopes to have students in the building in the spring semester.

 

Novo Nordisk Plans to Build an Insulin Plant in China, Tapping into a Major New Market

Danish Drugmaker, Novo Nordisk will invest a whopping $400m in the insulin production plant, based in Tianjin, China. It will serve as the company’s primary production base in the Asia Pacific region and will supply both local and export markets.

 

China’s relentless industrialisation is changing the health profile of the nation, with the result that it is fast-becoming a global hot spot for diabetes.

 

The number of cases of type 2 diabetes in China, for example, is among the highest in the world with 62.5 million cases in 2007, higher than the US, Europe and Japan combined with 48.5 million cases.

 

Growth in diabetes medicines such as insulin will be fuelled by increased access to health insurance, greater patient spending power and more aggressive treatment practice, including the widespread adoption of guidelines published by the American Diabetes Association, the World Health Organization and the Chinese Society of Diabetes, according to market research firm Decision Resources. That in turn will lead to increased usage of newer treatments for diabetes, such as insulin analogues. Novo Nordisk is active in this sector with Levemir (insulin detemir), a long-acting analogue which will be formulated and filled at the new plant, along with other insulin products such as NovoMix 30 and NovoRapid.

 

The Tianjin investment is one of the largest investments in Novo Nordisk’s history, and the largest single investment outside Denmark.

 

The 22,500 sq. m. plant will take around two years to build, and after validation should become operational in 2012. It is on a site adjacent to the Danish company’s existing facility in Tianjin, which opened in 1996. The firm also operates an R&D centre in China which opened in 2002 and provides molecular biology, protein chemistry and cell biology services.

 

Meanwhile, Novo Nordisk is reaching deep into its pockets to ride through the current economic storm, and has set up a war chest of $1-$2bn to be spent over the next year or so on mergers and acquisitions.

 

The fall in equity value of biotech companies may provide some opportunities for acquisitions as well as in-licensing deals, said Sørensen in a conference call to discuss the firm’s third-quarter results.

 

Nestles Invests in China

Nestle is investing CHF 11.5 million (€7.8 million) in a new research and development centre in Beijing to focus on health and wellness.

 

The centre, which employs 80 people, will target three main categories, including growth and development, healthy ageing and weight management.

 

The centre brings the company’s total R&D investment in China to CHF 18 million (€12.3 million). The company’s other R&D centre in the country is based in Shanghai and focuses on culinary products and ice cream, said Backes.

 

The company will strengthen existing collaborations with Chinese scientists in universities as well as in other research organisations in China.

The company currently has 24 R&D centres around the globe

 

Beyond the health and wellness focus, the company said that safety and quality will also be a major focus, with these issues being addressed at every stage of product development - from the selection of ingredients to the choice of packaging material.

 

Pfizer’s NEWCON Facility Wins 2008 Facility Of The Year Award

The judges have conferred and cast their ballots - Pfizer’s NEWCON (New Containment Facility for Oral Solid Dosage) facility in Illertissen, Germany has been named the 2008 Facility of the Year award winner.

 

The annual Facility of the Year Awards (FOYA) competition, sponsored by the International Society for Pharmaceutical Engineering (ISPE), INTERPHEX, and Pharmaceutical Processing magazine is designed to recognize and reward the facilities and people behind the industry’s most advanced manufacturing plants.

 

Looking back it’s apparent that Pfizer knew they had an award winning facility on their hands. By just reviewing the information they provided in their submission material you get a sense of the pride and accomplishment that they have in their new facility. The top five reasons why the facility was worthy of the overall prize:

 

1. Facility Design

The new facility was built under an extremely aggressive timeline to support market demand. Equipment installations utilize containment technology. All such contained equipment is combined in a single High Containment Module with a high degree of automation and without manual operator intervention.

 

2. Systems

The degree of automation is completely novel: MES layer system triggers all process sequences from dispensing to coating, in the automation layer. Transporting of goods and materials is carried out automatically by Automated (laser-) Guided Vehicles without any operator control. The processing is executed at equipment level. The batch data are collected automatically into the MES. Raw data are archived in data historian.

 

3. Operational Excellence

From design of robust process (as part of FDA`s pilot program) from facility concept to ramp up of production, the project comprises all elements of modern manufacturing: Process robustness, facility design and throughput simulation for lean manufacturing was applied to accommodate synchronized operations to maximize capacity with “semi continuous flow”.

 

4. PAT

PAT applications are installed across the manufacturing process to support the vision of continuous quality verification. Raw material NIR identification and evaluation, online NIR blend monitoring, online NIR core testing and NIR testing of film coated tablets are in place to support the vision of adaptive process control and/or to replace conventional release testing. NIR water content is filed; filing of online NIR core testing is foreseen.

 

5. Safety

No operator attendance is required, substantially enhancing health and safety aspects for the employees.

 

In The Beginning

When the Pfizer team first conceptualized the NEWCON facility in April 2004, the main, practical purpose was to create a manufacturing plant for oral solid dosage forms including high potency compounds with a high degree of integrated automation to produce the smoking cessation drug varenicline (Chantix®, Champix®).

 

Upon completion, the US $48.8 million (US $59 million with soft costs), single floor, single containment module facility features a total production floor area of 7,800 m2 that consists of 3,000 m2 of production space, including the currently idle areas for potential expansion. Construction ended in September 2007 and production began in October 2007, when the German inspection license (PIC) was granted to the facility. The plant currently uses a production area of 1,600 m2 and has a production capacity of 1 billion tablets per year.

 

PAT Leads the Way

“What we have accomplished in terms of automation, process integration and process analytical technology (PAT) is groundbreaking - these are the features that really stand out,” says Holger Weyhers, Head of Production. He also points out that all unit operations at the Illertissen facility are within a single containment module, supported by automated systems without any manual handling.

 

The facility includes an automation layer for process sequencing, automated transport systems and a manufacturing execution system (MES) layer for electronic batch records (EBR) and data archiving. Zeroing in on the accomplishments of the Illertissen team, Weyhers says, “This facility is unprecedented in the entire pharmaceutical industry. We have nothing like this in the Pfizer network, and I strongly believe at this stage that there is nothing comparable in the entire pharmaceutical industry when it comes to the manufacture of solid dosage forms and the containment philosophy.”

 

“The PAT applications are front running and innovative,” says George Bernhard, Director of Right First Time at Pfizer. Right First Time, which was launched in 2003, uses Six Sigma tools and includes PAT, which is included in the FDA framework for quality assurance (QA) in the pharmaceutical industry.

 

Bernhard explains that operationally, the instruments in the facility, which are quite sensitive, have already attained 95% robustness. “Our goal, however, is to get to 100% robustness, which will allow us to have full process control,” he says. This is a part of the integrated process control strategy in which the process will be fully automated from beginning to end. “The vision is that you push a button and get tablets out at the end that won’t need to be tested,” he says.

 

“This is the first facility with such a high degree of integration with IT automation. You will not find another facility in the world with a similar technical approach,” says Ernst Sander, Managing Director, PhC Pharma Consult, a Heidelberg-based engineering firm that provided design and engineering services at the facility, and which has a long-standing relationship with Pfizer, Illertissen.

 

Keeping It All Contained

“The issue with this product (varenicline ) is that it falls into Pfizer’s occupational exposure band (OEB) 4. This means that from an operator safety perspective, this product cannot be handled in a conventional, open manner. We were required to design and build a containment facility for this purpose,” Weyher stated.

 

Weyhers holds responsibility for production at the facility and sets and manages output targets as well as ensures that all GMP requirements are satisfied.

 

Weyhers continued by explaining that Pfizer Illertissen used its pilot facility, which has the capability to handle high potency drugs, to support the initial launch phase of Chantix in 2006. “But based on the demand forecast for Chantix, it became quite obvious that the capacity of the pilot facility would not be sufficient to support the demand. This, in essence, is the background for the design phase, the planning and the building of NEWCON.

 

“It is also the reason we moved the project forward by six months. Initially the plan was to have the facility fully commissioned and available for production during 2008, but we managed to have the plant ready by November 2007,” says Weyhers.

 

NEWCON Benefits From Global Expertise

“We had the support of Pfizer Global Engineering, which was kept in the loop and apprised of all progress. They did not come up with solutions for us - these were essentially formulated on site, and we managed to come up with our own solutions throughout the project,” says Weyhers.

 

Tracing the early development of the project, Sander says, “Pfizer Illertissen has a very strong internal team, which has considerable knowledge of process technologies. The internal team was involved in the selection of engineering and design companies, and they picked PhC Pharma Consult, which has a strong relationship with Pfizer in Illertissen.”

 

“We were involved in the pilot project plant before NEWCON. We worked on an integrated design, which integrated process, equipment specification, building services, architecture and automation of the facility as part of our general contract for engineering and design with Pfizer.”

 

Weyhers noted that the Pfizer team, the PhC Pharma Consult team and all the suppliers and subcontractors worked very successfully together during the entire project - driven by a solid team spirit and a success oriented philosophy.

 

Sander explains, “This was one of the strongest teams we have ever put together. The team members were working closely together with a strong focus on being successful. The leaders of Pfizer Illertissen placed a great deal of trust in us, which allowed for the building of a team on a very friendly basis, and where everybody supported each other.”

 

High Capacity, Flexibility and Complete Control – All under One Roof

The Illertissen site sits on 510,000 square meters of land, and the production and testing facilities occupy some 23,450 square meters. The site has a total of 598 employees and currently produces approximately 80 MM packs per year. The Illertissen plant supplies 82 countries worldwide, including the United States.

 

As mentioned earlier, the NEWCON facility is a single floor, single containment module (“cell concept layout”), which can house up to 3 productions trains. Currently, only 1 train is being used for the production of the high potent drug product Chantix®, according to Weyhers.

 

“The equipment train, however, could be used to accommodate various other products so that we could operate under a multipurpose mode if needed. We also have the flexibility and the space already available to expand the operation and add other unit operations if needed,” says Weyhers. At the moment, PhC Pharma Consult is engaged in ongoing work in capacity enhancement at the facility, he adds.

 

Weyhers believes that the automation and process integration aspects may have been decisive factors that swayed the FOYA judges. He explains that the degree of automation in the facility is completely novel. The MES layer system triggers all process sequences from dispensing to coating, in the automation layer. Transporting of goods and materials is carried out automatically by automated laser-guided vehicles without any operator control. Processing is executed at the equipment level. The batch data are collected automatically into the MES and raw data are archived.

 

“This means that the automation layer takes care of the entire process flow, performs plausibility checks, and uses the results of the checks as a trigger for the initiation of the next unit operation. This degree of automation and process integration is unique and absolutely impressive,” he says.

The Pfizer Illertissen teams points out that the facility incorporates all the elements of modern manufacturing. PAT applications are installed across the manufacturing process to support the vision of continuous quality verification. With respect to safety, no operator attendance is required, which substantially enhances workers’ health and safety.

 

“Apart from the automation levels, we minimized the changeover times by using washing in place systems and cleaning in place systems, all of which helped to minimize the changeover times from one step to another. It is also integrated in the process and in the automation layer,” says Sander.

One Facility – Two Awards – A Very Good Year

In addition to the overall Facility of the Year Award recognition, the NEWCON facility also snagged the Facility of the Year award for Process Innovation earlier this year.

 

Turning to the question of what the (Process Innovation) award meant for his organization, Weyhers says, “It is a big honor to be the Facility of the Year category winner in Process Innovation. This is the first time that Pfizer has received an award for process innovation - and this is the result of our hard work and innovative thinking.”

 

“From the PhC Pharma Consult perspective, this is great honor for us because this is the first time that one of our client’s projects has received this award. I think that the biggest benefit for us is the knowledge and the know-how we have gained together with the Pfizer team for the next step.

 

Catalent Pharma Solutions First FDA Product Approval for Brussels Syringe Facility

Catalent Pharma Solutions, Inc., a provider of advance technologies and outsourced services to the global pharmaceutical, biotechnology and consumer health industry, has received notice that the FDA has approved the sale of a prescription product manufactured in Catalent's recently opened, state-of-the-art pre-filled syringe facility in Brussels, Belgium. Syringes from Catalent's Brussels facility will likely be dispensed to patients in the United States in upcoming months.

 

Metrics Inc. Opens Larger Scale Manufacturing Facility

Metrics Inc. has opened a new larger scale manufacturing facility with a production capability of 1 billion tablets per year.

 

As part of its recent facility expansion, the company has brought online two packaging lines, two granulating rooms and three compressing rooms including a double-sided, 45-station tablet press. Because of this growth, Metrics now can handle batch sizes up to 500 kilograms with a blending capacity of 46 cubic feet and a total capacity of 1 billion tablets per year.

 

The new manufacturing space comes as a result of the company’s recently completed $18-million, 47,000-square-foot expansion that doubled its overall facility size and dramatically grew service offerings to clients.

 

Metrics Inc., headquartered in Greenville, N.C., provides quality pharmaceutical formulation development, clinical trial material (Phase I, II and III) and commercial manufacturing, and analytical development / validation services to the pharmaceutical industry.

 

The manufacturing suites are fully qualified and reflect Metrics’ excellent regulatory track record. While Metrics’ manufacturing suites usually produce solid dosage tablets and capsules, the company also can accommodate topical powders and oral liquids. Metrics now can handle on a development-, clinical- and commercial-scale controlled substances Schedule II through V.

 

The $18-million, 47,000-square-foot facility addition at Metrics also includes:

Four new analytical laboratories. The labs are fully operational, validated and ready for projects.

 

Stability storage. Metrics provides state-of-the-art ESI chambers with redundant mechanical systems. For chambers without redundancy, Metrics maintains empty back-up chambers preset to condition. Access is strictly limited to authorized personnel.

 

A dedicated cytotoxic and potent laboratory.

 

A new microbiology laboratory.

 

Metrics has brought antibiotic assay and sterility testing online, enhancing its ability to offer full microbiological support of sterile products. The company routinely performs bacterial endotoxin and particulate matter testing on parenterals.

 

As part of its growth, Metrics is increasing staff, adding at least 50 pharmaceutical scientists and technicians, among them industry veterans with the experience to oversee projects from conception through completion.

 

Actavis Opens Research and Development Labs in Florida

Actavis South Atlantic (ASA), a United States division of the international generic pharmaceutical company Actavis, has opened new analytical and R&D laboratories to expand the Company’s research and development efforts for controlled release (CR) and other technically difficult generic pharmaceutical products.

 

The new analytical labs have been expanded by 3,000 sq. ft. and the new R&D labs have been expanded by 1,500 sq ft. As part of the Sunrise, FL expansion, appropriate office space was also added to support both of the lab expansions.

Actavis is one of the leading companies in the U.S. market in the development of CR products, with more than EUR 50 million (USD 74 million) expected to be invested in CR development in 2008 and 200 employees dedicated in the development of CR products. Actavis has 13 pending ANDAs for CR products with the FDA.

 

Scripps Research Institute Begins Move to Permanent Home on FAU Campus in Jupiter, FL

The Scripps Research Institute has begun moving the first of its 290 employees into its new permanent home in Florida, a three-building, 364,000-square-foot campus within the campus of Florida Atlantic University in Jupiter.

 

The chemistry and molecular biology labs will be the first to relocate.

 

The first group of scientists and researchers, and their equipment, began relocating out of the institute’s temporary quarters at the university. Several such groups are expected to move into the new space each week through mid-December — a series of arrivals made possible with more than $600 million in tax breaks and other subsidies by the state and Palm Beach County.

 

County officials later this month plan to unveil a development proposal for 4 million square feet of additional space to accommodate biotech-related businesses that they hope will be drawn to the area by the presence of Scripps.

 

Scripps is one of two research institutes headed for Palm Beach County. Earlier this year, the state and county finalized a $194 million package of economic incentives for Germany’s Max Planck Society to open a new $60 million, 100,000-square-foot permanent facility within six acres at FAU’s MacArthur campus in Jupiter.

 

Mass. Life Sciences Center Board OKs $5.2 Million Grant for Genzyme Expansion in Framingham, MA

The Massachusetts Life Sciences Center Board of Directors last week approved a $5.2 million grant to the town of Framingham allowing it to begin upgrading its wastewater collection system in conjunction with a large-scale manufacturing expansion project by Genzyme.

 

The first phase of the project includes the replacement of a wastewater pump station along with ancillary pipe work. Genzyme had sought the infrastructure work as part of the expansion, which it projects will create 300 new manufacturing jobs within the next year. The project is designed to improve Framingham’s overall water and sewer systems, as well as benefit other employers in the area.

 

The grant is part of a $12.9 million funding earmark contained within the $1 billion, 10-year Massachusetts Life Sciences Initiative, signed into law in June by Gov. Deval Patrick.

Framingham’s new wastewater pumping station must be completed and accepting wastewater no later than September 2009 for Genzyme to meet its schedule for expansion.

 

Univ. of Rochester Medical Center Breaks Ground for $76.4 Million Translational Research Institute

The University of Rochester [NY] Medical Center broke ground last week on a $76.4 million Clinical and Translational Science Building, a facility designed to help accelerate scientific discoveries into new treatments for diseases.

 

The 200,000-square-foot, four-story building will be home to more than 600 scientists, physicians, nurses, statisticians, research administrators, and support staff. The building will contain several clinical research programs and resources that are currently scattered throughout the medical center.

 

LeChase Construction of Rochester is the construction manager for the building is scheduled to be completed in the summer of 2010.  Donald Blair & Partners Architects provided preliminary space programming and site planning, along with Mark Chen Architect, who has served as a consultant for the medical center.

 

The building will be connected to the adjacent School of Nursing's Helen Wood Hall. The two buildings will share an atrium designed to form both a physical and symbolic connection between the School of Medicine and Dentistry and the School of Nursing.

 

The building includes conference rooms on the ground floor for meetings, education programs, and community events. One room will allow the arrangement of chairs in a circle — a configuration which, coupled with a wall color that provides contrast, is designed to accommodate people with hearing disabilities, allowing all participants to see each other in order to read sign language. The CTSB is home to the University's National Center for Deaf Health Research.

 

The ground floor will also contain a clinical research suite that is a satellite of a larger Clinical Research Center located across the street from the CTSB. This suite of exam rooms will enable researchers to see study participants on site.

 

The upper floors will contain a number of research programs, including neurological disorders, cancer, pediatrics, biostatistics and bioinformatics, and cardiovascular disease. The building will also house the Department of Community and Preventive Medicine and the Clinical Trials Coordination Center — a division of the Department of Neurology that oversees an international network of clinical research sites.

 

New York state officials agreed earlier this year to provide $50 million toward the construction of the building, part of a $300 million, multi-year effort by the medical center to upgrade its research, educational, and clinical care facilities.

 

The building will also serve as a hub for the Upstate New York Translational Research Network — a consortium of nine institutions that have promised to develop and share clinical research resources — as well as a home for the institute's education programs, including several training and graduate degree programs in clinical and translational research.

 

The CTSB was designed by Philadelphia-based architect Francis Cauffman along with local engineer Bergmann Associates and BR&A Engineers from Boston. LeChase Construction of Rochester is the construction manager for the building. Donald Blair & Partners Architects provided preliminary space programming and site planning, along with Mark Chen Architect who has served as a consultant for the med center.

 

The medical center said it will seek to be the first building on UR’s campus that will be certified as adhering to standards of the Leadership in Energy and Environmental Design, or LEED, program.

 

UR has projected the new CTSB project will generate $30 million in economic activity annually, as well as create 830 construction-related jobs, to be supported during the multi-year construction phase.

 

University of South Alabama Opens Mitchell Cancer Institute in Mobile, AL

The University of South Alabama has opened its Mitchell Cancer Institute. The new 125,000-square-foot facility will house labs for cancer research intended to be translated into clinical care, as well as for research into cancer metastasis and stem cells. The center will focus on breast, ovarian, and melanoma cancers.

 

The center is pursuing a Comprehensive Cancer Center designation from the National Cancer Institute, a designation held now by 40 research centers nationwide. The nearest such center to the Mitchell facility is about 250 miles northeast of Mobile, at University of Alabama Birmingham.

 

Among design features of the new facility is a “window of hope,” or glass wall in the main lobby that allows patients to peek into the research area. CLA Architecture of Birmingham, Ala., served as architects of record, while RMJM Hillier was the project’s design architect.

 

Roche Reveals Plan to Add 250 Jobs at Ventana Medical Systems in Arizona’s Oro Valley

Ventana Medical Systems, based in Arizona’s Oro Valley, plans to add 250 employees and expand its research-and-development facilities over the next year, as part of a $100 million expansion tied to the pharma giant’s focus on personalized medicine.

 

Roche plans to expand its workforce at Ventana from about 750 to more than 1,000.

 

Eager to tap into its leadership in tissue diagnostics, Swiss-based Roche bought Ventana in a $3.4 billion deal completed in February. Since then, Ventana has purchased 17.1 acres for $8.9 million to expand its campus.

 

Duke University to Open Biomarker Factory at NC Research Campus

Duke University will open a business incubator called the Biomarker Factory at the North Carolina Research Campus., the $1.5 billion campus being developed by David Murdock — the billionaire real estate and food magnate who owns Dole Food Company.

 

The biomarker center — set to occupy some 30,000 square feet of a 100,000-square-foot future multi-tenant building in Kannapolis — will raise funds for the Measurement to Understand Reclassification of Disease of Cabarrus/Kannapolis Study — also known as MURDOCK. Launched with $35 million from its namesake benefactor, the study is designed to develop new, and more effective, ways to fight cancer, liver disease, aging/arthritis, brain disorders, and heart disease.

 

The center will also do fee-for-service work for outside firms, and will break ground soon, Victoria Christian, the chief operating officer for the study and the Duke Translational Research Institute, told attendees at the Charlotte Biotechnology Conference.

 

The Biomarker Factory will include a nonprofit institute, a for-profit contract research organization and several commercial partners.  LabCorp was a potential partner. LabCorp is already collaborating with Duke to operate a 45,000-square-foot biorepository capable of holding more than 10 million specimens to be brought in by pharmaceutical companies.

 

European Medicines Agency OKs Bayer Facility in Berkeley, CA

The European Medicines Agency has granted license approval to Bayer HealthCare for a new $100 million, 44,000-square-foot sterile filling facility on its Berkeley, Calif., campus.

 

The facility — which won authorization in August by the US Food and Drug Administration — will be used by Bayer for late-stage filling and freeze drying of its hemophilia treatment Kogenate FS in the US and European Union.

 

Bayer said in a statement the facility will “significantly” increase its capacity and support larger lot sizes. It also features an automated loading and unloading system, reducing the risk of external contamination and requiring fewer employees.

 

Regulatory agencies from Canada and other countries are in the final stages of inspections and application reviews. Pending those approvals Kogenate products will continue to be made at the existing approved filling and freeze-drying facility on Bayer’s Berkeley campus.

 

DuPont and Delaware Unveil $80 Million Innovation Center Partnership

DuPont and Delaware state officials have announced an $80 million Innovation Center partnership. The collaboration includes opening the DuPont Innovation Center business incubator within the DuPont Experimental Station in Wilmington, Del., at the company's global research and development facility; as well as donating 250 DuPont patents to the Delaware Economic Development Office; and delivering 24 biotechnology seminars for Delaware high school teachers and students.

 

Since the partnership was launched in 2005, more than 800 teachers and students have undergone training and education in new biotechnology developments. Two of the patents donated to the DEDO Intellectual Property Business Creation Program have been used to create Streamline Industries, a new Delaware company that plans to produce environmentally friendly automotive coatings and finishes. And DuPont has added 250 employees at the Experimental Station, the company's largest global R&D site.

 

The Innovation Center, a new business incubator building, will be a home base for DuPont Applied Biosciences staffers working with scientists that are creating DuPont’s new pipeline of biomaterials, biofuels, and other renewables. The state provided a $6 million grant that was matched by a commitment from DuPont to invest $80 million in capital projects at the Experimental Station by 2010.

 

DuPont has teamed up with the Delaware Department of Education to conduct 24 biotechnology seminars for high school students, providing six programs per year, beginning in 2006 at the Experimental Station or other “appropriate” sites throughout Delaware.

 

Mississauga, Ont., Officials Welcome Therapure Biopharma

Therapure Biopharma celebrated completion of its 130,000-square-foot Canadian biopharmaceutical facility, at 2585 Meadowpine Blvd. The facility specializes in developing, manufacturing, purifying, and packaging biological protein therapeutics.

 

Therapure acquired its Canadian-built and -conceived facility in 2007 from Hemosol Corp., which used the site to manufacture a blood-substitute product called hemolink. Therapure is privately owned by Catalyst Capital Group, a Toronto-based private equity group that specializes in asset turnarounds.

 

Bolder BioTechnology Moves Headquarters, R&D Operations, to Boulder, CO

Bolder BioTechnology, a biopharmaceutical company, has relocated its research operations and corporate headquarters to 2425 55th St., Suite 210, in the Flatiron Park West Business Park in Boulder, Colo.

 

The new facility includes about 8,600 square feet of laboratory and office space.

 

Mass. Medical Device Concept Manufacturer Opens Sales/Support Office in Boulder, CO

TDC Medical, a medical device concept manufacturer based in Marlborough, Mass., has opened a new sales and support office in Boulder, Colo., where it has signed a lease for 1,915 square feet of space at 5446 Conestoga Court. The office is intended to support TDC clients in Colorado and the central United States.

 

TDC Medical provides concept brainstorming, design development, manufacturing and quality and regulatory control services to help companies create and produce innovative disposable and reusable therapeutic medical devices.

 

AMRI Expands Manufacturing Capabilities in India; Adds Non-GMP Plant Capacity

AMRI announced the expansion of multipurpose pilot plant facilities in Aurangabad, India providing non-GMP manufacturing services up to a 1,000 liter scale.

 

The new facility will serve as an extension to AMRI’s kilo lab capabilities in Hyderabad, which operates to 100 liters in scale. The plant was recently commissioned and its first production run is underway. Besides the creation of another customer product offering, certain plant production will be dedicated to making starting materials for AMRI’s U.S. manufacturing facilities, significantly diminishing that plant’s reliance on external resource providers.

 

University of Colorado Alumni Couple from Boulder, CO, Pledges $2 Million for Bioscience Initiative

Jack and Jeannie Thompson of Boulder, Colo., husband-and-wife alumni of the University of Colorado, have pledged $2 million toward a new Vaccine Development Laboratory in CU-Boulder's Systems Biotechnology Building, slated for groundbreaking in 2009, the University of Colorado Foundation said.

 

The gift will boost the ability of the Colorado Initiative in Molecular Biotechnology, or CIMB, to spearhead scientific and medical advances.

 

Jeannie Thompson's 12 years of working in research labs, including at the National Institutes of Health and the University of Colorado Hospital, sparked the couple's interest in donating to the research lab. In addition, her position as incoming chair of the University of Colorado's fundraising arm motivated the couple to make a leadership gift, according to CU.

 

Orissa, India, Joins Bharat Biotech International in Partnership to Build $20 Million Tech Park

The government of Orissa, India, has joined the biotechnology company Bharat Biotech International in a public-private partnership formed to construct an Rs 100 crores ($20 million) technology park. The venture is the first of its kind for Orissa, which is attempting to attract pharmaceutical and biotech companies, as well as information technology businesses sectors.

 

The 55-acre park will be located at Mouza-Andharua, Bhubaneswar, and is projected to take eight years to construct. A 10-acre section of the site has been earmarked for the Biotechnology Incubation Centre, to be funded by the Department of Biotechnology of India’s national government.

 

BBI specializes in the R&D and manufacture of vaccines and biotherapeutics, but has also helped develop technology parks in India.

 

Menomonee Falls Tool and Die Maker Launches Biomed Division

Reich Tool & Design Inc., a Menomonee Falls Wisconsin-based designer and manufacturer of tools and dies, recently launched Trinity Biomedical Inc., a new biomedical division.

 

In July 2007, Reich Tool & Design moved into a new 52,000-square-foot building in Menomonee Falls, WI. The building included a 2,500 square foot medical-grade cleanroom, where Trinity's first orders will be fulfilled.

 

Trinity's clean room was recently certified, but each potential customer needs to inspect it before the company can become a supplier.

 

Reich Tool and Design has about 50 workers, but Trinity Biomedical only has one. When the company begins receiving orders, it will start hiring production workers.

They will be hiring five to 10 employees within the next year or so.

 

Although its building is less than two years old, Reich Tool and Design has a 30,000-square-foot expansion plan ready once Trinity's orders kick off.

At the same time, Reich's business is growing. The company is now looking for three new employees, and its shop floor is booked through January.

 

Construction Begins on Merck Sharp Vaccine Plant in Ireland

The construction commenced on the previously announced  Merck Sharp & Dohme’s new €200 million "state-of-the-art" drugs vaccine facility in Carlow, which is supported by Government through IDA Ireland, and will create 170 new "high quality" jobs by 2011. The investment was announced in November 2007, following Merck Sharp & Dohme’s acquisition of the 65 acre IDA Carlow Business and Technology Park.  The benefits of this investment and the boost for the region’s economy will begin to flow immediately, initially through the 300 hundred jobs in the construction phase and long-term through the high quality employment of 170 people in the facility’s operation. In addition, the impact of the facility’s need for numerous specialist services and purchases of support activities, combined with the overall ripple effect, will be substantial. This investment represents a very significant consolidation of Ireland’s leadership position as a successful location for substantial biotechnology global investments.

 

Recruitment for MSD Ireland (Biologics) Carlow will be advanced next year.  The company will be seeking a full range of skills and qualities in its Carlow workforce including experts in science, engineering, pharmacy, microbiology, technology, IT, management, quality control, production, administration, maintenance, safety and environment. 

 

MSD Ireland (Biologics) Carlow joins MSD Ireland (Human Health) Dublin and MSD Ireland (Manufacturing) Tipperary as Merck Sharp & Dohme’s third Irish facility.  The company’s Irish operations are involved in the research, development, manufacturing and marketing of vaccines and medicines that address worldwide medical needs.  In 2006, Merck Sharp & Dohme announced an €85 million investment for a 70,000 sq. ft. facility at its Tipperary site. The Carlow facility’s employment of 170 people, combined with current employee numbers and ongoing expansion in Tipperary, will bring the company’s total Irish workforce to over 700 people within the next four years.

 

Inauguration of Italy-based Stevanato’s Packaging Production Facility in Cienega de Flores, Mexico

Stevanato claims the facilities is one of the most advanced for production of glass tube containers for pharmaceutical applications.

 

Mexico was selected as a location owing to the nation’s tradition in industrial glass, excellent technical universities and proximity to the American market, which Stevanato has targeted for growth.

 

Stevanato has stated its desire to develop highly technological products for the US and overcome the logistical barriers erected by manufacturing solely in Europe.

 

Swiss Centre for Applied Ecotoxicology Opens and Available for Contract Research

A federal mandate to strengthen independent research, consulting and training in the ecotoxicology field has been granted to the facility, which will offer some contract services but is not allowed to compete with the private sector.

 

The facility was established to provide an independent institute to identify, assess and minimize the environmental risks posed by chemicals.

 

National Councillor Maya Graf said: "Increasingly, and at an ever accelerating pace, chemicals are being used whose effects in the environment are largely or completely unknown. Here, the Ecotoxicology Centre is filling a gap."

 

Nanotechnology is one specific area that the facility will be used to investigate, with researchers investigating the potential environmental effects of products. This will entail closely following other research and performing additional studies.

 

The institute has already launched a number of in-house investigations, which demonstrate the capabilities possessed at the facility. These include research into how effectively endocrines can be removed from water and the toxicity of substances released by epoxy resins.

 

In addition to performing studies Swiss authorities are viewing the facility as a hub for the transfer of knowledge between researchers and manufacturers.

 

The facility will receive CHF 2m in funding each year, as well as money generated by conducting contract research.

 

Synexus to Double Clinical Trial Capacity in South Africa

The increased capacity will come from the building of two purpose designed sites in Mamelodi and Soshanguwe, as well as an expansion of the existing facilities in Pretoria.

 

Synexus expanded in the South African market in 2006 through the acquisition of CRC SA and now regards the country as one of its most successful sites.

The Pretoria facility is being expanded into the adjoining building, creating a 6,047 sq. ft. (562 sq. m.) outpatient site for clinical trials. Negations are underway to establish the locations of the new sites, with Synexus hoping to have the facilities completed by March 2009.

 

Synexus’ current operations in South Africa cover pediatric vaccines, osteoporosis, women's health and post operative pain, across Phases II and III. Upon completion of the expansion Synexus will employ 25 clinically trained staff in South Africa.

 

From these facilities Synexus will continue to recruit for and run clinical trials on behalf of pharmaceutical and biotech companies.

 

Synexus has operations in the UK, Poland, Hungary, Bulgaria, India and South Africa, holding the latter in particularly high regard. Michael Fort, Synexus’ CEO, attributed this to the high number of patients it has recruited in the country and the quality of clinical trials performed.

 

Recruiting in South Africa is relatively quick as the population is genetically diverse and treatment naïve. The country also has a stringent regulatory process to ensure patient safety.

 

AMRI Expands in India

AMRI reports that is has expanded the multipurpose pilot plants in Aurangabad, India, providing non-GMP manufacturing services up to a 1,000-liters scale.

The move increases AMRI’s ability to provide customized pilot-scale materials for customers. In addition to being a stand-alone provider, the new facility will serve as an extension to AMRI's kilo-lab capabilities in Hyderabad, India, which operates to 100 liters in scale.

Certain plant production will be dedicated to making starting materials for AMRI's U.S. manufacturing facilities, significantly diminishing that plant’s reliance on external resource providers, the firm notes.

 

University of California Berkeley Opens BioPharm Center

Researchers are getting ready to open a new biopharmaceutical center at UC Berkeley in mid-2009, uniting academic researchers with industry leaders in an effort to improve biotech drug production.

 

At UC Berkeley's Center for Biopharmaceutical Operations, professors and students will work together with biopharmaceutical companies in devising a more efficient method to supply drugs to consumers, both domestically and abroad.

 

The center's directors said they hope to locate their offices in the new Center for Information Technology Research in the Interest of Society building, a larger partnership of students and faculty members working to devise solutions in the information technology sector. The building is currently under construction on Hearst Avenue.

 

While the center has not been officially established, students and academic researchers have already started working on projects with Bayer HealthCare, Genentech and other biopharmaceutical companies that have pledged up to $100,000 to help fund the center's infrastructure.

 

Plans to officially start the center began two years ago, but the original impetus came years before when professors from the industrial engineering and operations research department saw that many of the common life-saving drugs being advertised, like flu vaccines, were not being produced to meet the demands of all consumers.

 

Undergraduate students from a new research course on campus will also have the chance to collaborate with the center by participating in a competition to win a $1,000 cash prize, as they conduct a presentation at the center's annual industry conference about the current state of a biotech industry as well as the problems it faces.

 

Merck to Shutter Rosetta Research Center in Seattle, Two Overseas Sites

Merck disclosed plans last week to shut down three basic research sites worldwide by the end of 2009 — labs in Seattle; Pomezia, Italy; and Tsukuba, Japan — as part of a consolidation of research operations into four locations.

 

The consolidation is among a series of cost-cutting moves through which the pharma giant plans to eliminate about 7,200 jobs — 6,800 active employees and 400 vacancies — at a projected cumulative pretax savings of $3.8 billion to $4.2 billion through 2013. Merck, which is headquartered in Whitehouse Station, NJ, will account for between $250 million and $450 million in restructuring costs in the fourth quarter.

 

In Seattle, Merck will shut down the Rosetta Inpharmatics research site in the city’s South Lake Union community, eliminating 300 jobs. Founded in 1996, Rosetta was acquired by Merck in 2001 for more than $620 million. The following year, Merck relocated the company from Kirkland, Wash., to South Lake Union, where it occupies 133,000 square feet under a long-term lease.

 

Merck opted to close the Seattle facility because it lacked the full sweep of chemistry, animal testing, and clinical research capabilities that the company already has at a cancer research center in Boston, said Douglas Bassett, Merck’s executive director of molecular profiling, and the head of the Merck Seattle site.

 

As part of its cutbacks, Merck said it will also reduce its total number of senior and mid-level executives by approximately 25 percent, in addition to the 10,400 positions eliminated in a 2005 restructuring completed last month. As of Sept. 30, Merck has approximately 56,700 employees.

 

$250 Million Expansion Plan for Salk Institute Approved by San Diego City Council

 The San Diego City Council approved a $250 million expansion plan for the Salk Institute for Biological Studies that will add a “Torrey East” laboratory building, community center, greenhouses and underground parking garages to the 26.3-acre site overlooking the Pacific Ocean.

 

The Salk Institute, within Torrey Pines Mesa, will expand to 476,000 square feet, up from 289,800 square feet. Construction would be phased over several years, but no start date has been set, pending fundraising.

 

Salk employs about 1,000 people; has an annual budget of about $100 million, much of it in federal research grants; and has helped launch 22 startup companies and generate 250 patents.

 

The expansion plan was revised to address objections from neighbors and preservation advocates. In one change, Torrey East will preserve a longtime view through an open courtyard with a linear artificial stream by creating a glass atrium through which the iconic courtyard will be visible from North Torrey Pines Road. In another change, Salk Institute will preserve 7.1 acres of the South Mesa as open space, rather than expand there as originally planned.

 

PacificGMP Drops Plans for 200,000-Sq. Ft. Lab Facility in China

Contract manufacturer Pacific¬GMP, based in San Diego’s Sorrento Mesa, has dropped earlier plans to create an offshoot in China, citing concern about the plan’s effect on its domestic business.

 

PacificGMP employs 17 full-time staff in its 8,000-square-foot facility, at 8810 Rehco Road. The company would have expanded into a 200,000-square-foot facility in Taizhou, China, under a collaboration that also involved the Chinese government and the California Institute for Quantitative Biosciences — a joint effort of University of California’s Berkeley, Santa Cruz, and San Francisco campuses also known as QB3.

 

UC Irvine Breaks Ground on $66.6 Million Stem Cell Building, to House Sue and Bill Gross Stem Cell Research Center

The University of California, Irvine, broke ground on a $66.6 million, 100,636-square-foot stem cell research building that will house the UCI Sue and Bill Gross Stem Cell Research Center, dozens of laboratory-based and clinical researchers, a stem cell techniques course, a master’s program in biotechnology with an emphasis on stem cell research, and programs for patients that include public education. The building is set for completion in July 2010.

 

The California Institute for Regenerative Medicine, the state’s stem cell research agency, awarded a $27.2 million grant toward construction of the building, to be named Sue and Bill Gross Hall: A CIRM Institute. The billionaire investor and his wife donated $10 million in July 2006 to support stem cell research at UCI.

 

UCI has raised additional money through donations, equipment grants and external funding for Gross Hall, to be located within the heart of UCI’s Biomedical Research Center in the Health Sciences Complex. The university has also committed about $17.5 million over the next 10 years toward recruiting new faculty members to expand its stem cell research and regenerative medicine programs.

 

Gross Hall will include the core stem cell laboratory and equipment for human embryonic stem cell line derivation, cell culture, differentiation and purification, and cell and tissue imaging. It also will include clinical space with resources for patient care. The fourth floor and basement will be constructed as shell space, to be built out as additional funding becomes available.

 

Gilead Buys Foster City, CA, Building, Land for $137.5 Million from Digital Printing Concern

Gilead Sciences has entered into an agreement to buy the 163,000-square-foot 301 Velocity Way in Foster City, Calif., as well as some 30 adjacent acres designed to accommodate up to an additional 542,000 square feet of office space, for $137.5 million.

 

The biopharmaceutical company said that it expects to close on the transaction with seller Electronics For Imaging, a digital printing company, in January 2009. Gilead has until Dec. 12 to complete a “due diligence” review of the property. The building and adjacent land border Gilead’s Foster City campus; where the company has based its headquarters since 1988.

 

Under the agreement, EFI will lease a portion of 301 Velocity Way from Gilead to assist with the transition and relocation of its employees and labs, from the date of closing through April 15, 2009. EFI will also retain ownership of an approximately 295,000-square-foot building it currently occupies along with surrounding land.

 

DHS Dedicates $160 Million National Biodefense Analysis and Countermeasures Center at Maryland’s Fort Detrick

The Department of Homeland Security has dedicated the $143 million, 160,000-square-foot National Biodefense Analysis and Countermeasures Center, a biodefense laboratory at Fort Detrick in Frederick, Md., with the facility set to formally open in March.

 

The new lab will employ about 150 scientists focused on protecting against bioterrorist attacks, as well as quickly tracing the sources of biological agents such as viruses and bacteria. Till now, many of those scientists have been working in leased space at Fort Detrick.

 

Construction began in June 2006 on the facility. The building is designed in the shape of a ship, and will include a forensic testing center designed to identify the culprits in biological attacks; and the Biothreat Characterization Center, which seeks to predict the extent of such attacks as well as help develop countermeasures.

 

The new center is also designed to provide the FBI with forensic capabilities it lacked after the 2001 anthrax mailings, which killed five people. In August, the FBI revealed its conclusion that the anthrax episode was the sole work of a mentally ill Army biodefense researcher working at Fort Detrick, Bruce Ivins, who died of an apparent suicide in July.

 

The 2001 attacks helped stoke fears by some nearby residents that the facility would become a target for terrorists. Internal-security measures for the new facility are still being developed, Patrick Fitch, laboratory director and president of Battelle National Biodefense Institute, told the Associated Press. BNBI, a unit of Columbus, Ohio-based Battelle Memorial Institute, has a $250 million, five-year contract to run the lab.

 

Gilead, Novo Nordisk Subsidiary Sign Lease Deals within Seattle’s South Lake Union

Gilead Sciences has signed a long-term lease for 106,000 square feet of an 115,000-square-foot office and laboratory building under construction at 199 E. Blaine St., in Seattle's South Lake Union neighborhood.

 

The space — to be occupied by Gilead’s research and development division — represents nearly all of the building’s 110,000 square feet of life-sci space. Gilead has “a commitment” to that remaining space, the remaining 5,000 square feet consists of retail space.

 

The building, across Fairview Avenue East from Lake Union, is scheduled to be completed in 2010. Alexandria is a publicly-traded real estate investment trust headquartered in Pasadena, Calif.

 

In a separate South Lake Union deal, a wholly owned subsidiary of Novo Nordisk has signed a lease for 36,900 square feet at 530 Fairview Ave. in Seattle, a recently-constructed five-story, 94,000-square-foot building at Fairview Avenue North and Mercer Street. The building is owned by BioMed Realty Trust, a REIT based in San Diego.

 

Sanofi-Aventis Expanding China Presence with Enlarged R&D Facility, New Biometrics Center, SIBS Accord

Sanofi-Aventis said it will strengthen its presence in China by expanding an R&D facility in Shanghai, completing a Biometrics Center in Beijing, and signing a partnership agreement with the Shanghai Institutes for Biological Sciences to develop drugs for cancer, diabetes, and neurological diseases.

 

Sanofi has expanded its China Clinical Research Unit, which opened in June 2005 in Shanghai with the goal of carrying out clinical trials; and is completing a Biometrics Center to support global and local trials in both pharmaceuticals and vaccines development. The center, set be fully operational by year’s end, will be devoted to the study design, data management and statistical analysis of global and local phase I-IV clinical trials.

 

Sanofi’s partnership with SIBS, a subsidiary of the Chinese Academy of Sciences, is part of the company’s China Discovery platform designed to establish long-term relationships with top Chinese academic institutions. "A comprehensive development program for vaccines is already ongoing in China and we are looking forward to its expansion in the near future," Michel DeWilde, a senior vice president with Sanofi Pasteur R&D, the vaccines division of Sanofi-Aventis, said in a statement.

 

Neurotech Opens GMP Manufacturing Facility in Cumberland, RI

Neurotech Pharmaceuticals, a biotechnology company focused on developing therapeutics for chronic retinal diseases, has opened a new 27,000-square-foot GMP manufacturing facility in Cumberland, RI, in a ceremony headed by Gov. Donald Carcieri and company officials.

 

The company now employs 27, but that number will “significantly increase” when the company receives approvals and ramps up for production.

 

Neurotech has been approved for $4 million financing to help pay for equipping the facility from the Rhode Island Industrial Facilities Corporation and Rhode Island Industrial-Recreational Building Authority, the financing programs of the Rhode Island Economic Development Corp.

 

Until now, Neurotech has operated from a pilot facility in Lincoln, RI, as it undergoes Phase 1 and Phase 2 clinical trials of its NT-501 protein capsule for the treatment of retinitis pigmentosa and the dry form of age-related macular degeneration.

 

The new facility includes 8,000 square feet of cleanrooms.

 

Bioscience Center Planned for MinnWest Campus in Willmar, MN, Wins $1.3M State Grant

Minnesota’s Department of Employment and Economic Development has awarded a $1.25 million Bioscience Business Development Public Infrastructure grant toward half the planned $2.5 million cost of converting an existing building on the 100-acre MinnWest Technology Campus in Willmar, Minn., to life sciences use.

 

MinnWest will provide another $1.25 million to purchase equipment for the building, which will be renamed Mid-Central Biosciences Center. The research laboratory and business development center is a collaboration between the University of Minnesota, the Minnesota State Colleges and Universities system, the city of Willmar —the technical recipient of the grant and owner of the building — and MinnWest, a private venture that provides facilities for new and expanding businesses in biosciences.

 

The U of M will operate the laboratory and provide faculty and graduate students that will oversee the research. St. Cloud State University will take the lead for MnSCU. Research and development conducted at the lab will be paid for by biotechnology businesses.

 

Renovation of the three-story building will begin this fall and will be operational by the fall of 2009 or the spring of 2010, Salzer told the newspaper. MinnWest opened about three years ago on the site of the former Willmar Regional Treatment Center.

 

Patheon Opens New Drug Development Suite

Patheon hopes that a new pharmaceutical development services (PDS) suite at its facility in Whitby, Ontario will complete its “Quick to Clinic” offering and provide a rapid-response means of making solid dosage forms for trials.

 

The 2,500 square foot unit will house good manufacturing practice (GMP) compliant production lines capable of making drug supplies for Phase I and II clinical trials. The facility will also provide early-phase manufacturing capacity in the 1kg to 10kg range.

 

The PDS also houses multiple laboratory units capable of carrying out small scale dosage testing, powder-in-bottle manufacture, as well as tablet, capsule, oral dosage and nasal spray development.

 

Further evidence of Patheon’s efforts to develop its offering emerged earlier this month when the firm opened a new intermediate scale processing suite (ISPS) at its plant in Cincinnati, U.S.

 

In contrast with the PDS, the ISPS will focus on helping drugmakers to scale-up processes according to US Food and Drug Administration (FDA) quality by design (QbD) principles.

 

Genetics Lab Opens New Bangor Maine Facility

Nearly four years after it was introduced to the public, the Maine Institute for Human Genetics and Health has a home of its own. Officials cut the ribbon to a newly refurbished facility at the end of Sylvan Road that will serve as the research institute’s home for the near future.

 

Announced in January 2005 as a collaboration among Eastern Maine Healthcare Systems, the University of Maine and The Jackson Laboratory in Bar Harbor, the institute promises to bring scientists together with clinicians to provide research-based treatments to patients with cancer, diabetes, heart disease and other conditions. This so-called “translational” scientific environment is key to attracting research funding from primary sources such as the National Institutes of Health.

 

The Maine Institute for Human Genetics and Health is an affiliate of Brewer-based Eastern Maine Healthcare Systems. For the past four years, scientists associated with the research institute have been working at laboratories in Orono, Bar Harbor, Bangor and elsewhere, waiting for the completion of the new lab to bring them together.

 

The Maine Institute of Human Genetics and Health is already attracting international attention, she said, and, in concert with its partners, is making a name for itself in the areas of cancer, brain and bone research.

 

The institute is providing research opportunities to under-graduate students from Husson University and UMaine, and partnering on projects with several other university-based programs in this country and Canada.

To date, the institute has attracted six full-time scientists, along with a small cadre of technicians and assistants.

 

The Sylvan Road laboratory will house the Maine Institute for Human Genetics and Health for three to five years, until its permanent home in Brewer becomes available. Eastern Maine Medical Center’s new Cancer Care of Maine building is under construction on Whiting Hill and is expected to house patient care services by the end of 2009. It will take longer, however, before the top floor of that building will be ready for the genetics lab to move in.

 

The Maine Institute for Human Genetics and Health is expected to stimulate the regional economy by attracting biomedical and biotechnology-related businesses to eastern Maine. One such business, Trillium Diagnostics, is now located in the new Sylvan Road facility.

 

DuPont and State of Delaware Unveil $80 Million Innovation Center Partnership

DuPont and Delaware government leaders unveiled their $80 million Innovation Center partnership, the latest program in strengthening market-driven science and technology capabilities in Delaware. The partnership includes opening of the DuPont Innovation Center business incubator at the company’s global research and development facility here, donating 250 DuPont patents to the Delaware Economic Development Office (DEDO) and delivering 24 biotechnology seminars for Delaware high school teachers and students.

 

The DuPont Innovation Center partnership has helped science and technology to grow in Delaware. Since its inception, the partnership has resulted in the training and education of more than 800 teachers and students in new developments in the field of biotechnology. Two of the patents donated to the DEDO Intellectual Property Business Creation Program have been used to create Streamline Industries, a new Delaware company that will produce eco-friendly automotive coatings and finishes. DuPont has added 250 employees at the Experimental Station, the company’s largest global research and development center, since the partnership was created in 2005.

 

A critical component of the partnership was the construction of the DuPont Innovation Center, a new business incubator building which co-locates Applied BioSciences business people next to the scientists creating the company’s new pipeline of renewably sourced products, including biomaterials and biofuels. A $6 million grant was provided by the state and matched by a commitment from DuPont to invest $80 million in capital projects at the Experimental Station by 2010.

 

The Innovation Center includes state-of-the-art features for energy efficiency and environmental stewardship and will apply for Leadership in Energy and Environmental Design (LEED) certification next year. Design elements incorporated in the building include more than 30 DuPont materials such as DuPont™ Tyvek® CommercialWrap® and Mohawk SmartStrand® with DuPont Sorona®

(http://mohawkflooring.com/carpeting/smartstrand/default.aspx) renewably sourced polymer carpeting. Tyvek® Weatherization Systems

 

DuPont has collaborated with the Delaware Department of Education to conduct 24 biotechnology seminars for high school students, providing six programs per year, beginning in 2006 at the Experimental Station or at appropriate sites throughout Delaware. As part of today’s event, nearly 20 Delaware high school teachers attended a workshop in the Innovation Center on microbiology evolution conducted by DuPont scientists and Department of Education personnel while nearly 120 high school students and teachers from public and charter schools across Delaware attended a biotechnology career path seminar.

 

DuPont is a science-based products and services company. Founded in 1802, DuPont puts science to work by creating sustainable solutions essential to a better, safer, healthier life for people everywhere. Operating in more than 70 countries, DuPont offers a wide range of innovative products and services for markets including agriculture and food; building and construction; communications; and transportation.

 

Covidien Expands in Missouri and Dublin, Ireland

Covidien hopes that a $100m (€74m) expansion of facilities at its production hub in St Louis, Missouri, US will boost efficiency and cut the time it takes to bring products to market.

 

The firm, which is headquartered in Bermuda, will invest in its R&D centre in Webster Groves creating around 30 new jobs and increasing capacity at its Maryland Heights manufacturing facility.

 

Covidien explained that around $72m would be spent at the 364,000 square foot Maryland Heights plant to add a further 12,000 feet of manufacturing space. Construction is scheduled to begin early next year and is anticipated take around five years to complete.

 

The investment move is in keeping with comments made by Covidien in late September when it announced a wide ranging restructuring programme through which hopes to generate savings of between $50m to $75m a year.

 

Prior to today’s news, Covidien announced the opening of a €15m expansion at its Blanchardstown plant in Dublin. The development, which increases production capacity by 30 per cent, will create 13 new manufacturing jobs and bring the total workforce to 103 employees.

 

One key aspect of the Maryland Heights investment plan is the addition of 5,000 square feet to its radiopharmaceuticals manufacturing capacity to improve standards and expand the supply of products to its medical imaging division.

 

Earlier this year the US Food and Drug Administration (FDA) issued Covidien with a warning letter following the identification of several manufacturing problems at the Maryland Heights facility.

 

An agency inspection in March uncovered violations related to the production of Covidien’s Ultra-TechneKow DTE Generator, specifically that the firm had failed to establish appropriate standards and test procedures.

 

William Beaumont Hospital Updates / Expands

Southfield, Mich.-based Skanska USA Building Inc. and joint venture partner Barton Malow have been named construction manager and design-builder for the William Beaumont Hospital project in Troy, Mich. The project—which started in June 2007 and is expected to wrap in October 2010--includes a 223,000-sq-ft emergency center and critical care tower, and a three-story ambulatory care center. The project also involves vertical expansion of the West Tower, loading dock and powerhouse expansion, a 5,400-sq-ft MRI addition and a connector bridge linking the existing main campus to the new ambulatory center on the hospital’s east campus. Skanska’s share comprises 51% of the program’s $213 total price tag.

 

Eisai Plans to Open Indian API Plant by 2011

India’s reputation as a base for quality, low-cost drug manufacture has proved irresistible for yet another big pharma company with Japan’s Eisai unveiling plans for a new production and R&D facility.

 

Eisai has chosen the Southern port city of Visakhapatnam, Andhra Pradesh as the location for its new plant, which will formulate finished drugs and active pharmaceutical ingredients (API).

 

Construction of the $125m (€97m) facility, which began earlier this year, is expected to be completed early in 2011.

 

The Japanese drugmaker first entered the Indian drug sector in 2004 when it set up a marketing subsidiary. Eisai hopes that the additional capacity provided by the new Visahapatam plant will allow it to access emerging drug markets in Asia, Africa and Russia.

 

The move is part of Eisai’s “Dramatic Leap” plan to focus on selecting prime locations for its global operations. The company is paying particular attention to India, building what it describes as “strategic information dissemination bases” to create a manufacturing hub.

 

India’s outsourcing sector, the country’s other strong suit in drug industry terms, has also attracted Eisai interest. In March this year the firm signed a deal to farm out clinical data management to an Accenture site in Chennai, Tamil Nadu.

 

In addition to ramping up its Indian operations Eisai has ploughed considerable funds into developing and diversifying its presence in China, Asia’s other drug production hub.

 

In May, the firm set up its Eisai Machinery Shanghai (EMS) subsidiary to produce a range of pharmaceutical manufacturing platforms for the country’s emerging pharmaceuticals industry.

 

NC Research Campus at Kannapolis Opens Doors

The NC Research Campus in Kannapolis, NC, held a grand opening and dedication to mark the official opening of three buildings.

 

On Oct. 20, officials dedicated three buildings on the $1.5 billion, 350-acre campus developed by Dole Food owner David Murdock and Castle & Cooke North Carolina.

 

The campus is expected to have up to 50 buildings when finished, including a medical office building, a branch of Rowan-Cabarrus Community College, a biorepository to store blood samples for a Duke University study, and a greenhouse for NC State University.

 

Singapore Opens Fusionopolis R&D Hub

Singapore last week opened Fusionopolis, a 30-hectare R&D center focused on research in the physical sciences, engineering, and technology.

 

Fusionopolis joins the country’s first R&D hub, Biopolis, which opened five years ago. 

 

Fusionopolis has been “specially designed” to encourage multidisciplinary research, according to a statement from Singapore’s Agency for Science, Technology and Research, or A*STAR.

 

Two of A*STAR’s science and engineering research institutes have moved into phase 1 of the development, and another four will move into Fusionopolis by 2011. These groups will be joined by at least 13 corporate laboratories located in phase 1 of the development, including wind turbine company Vestas; game publisher Ubisoft; Linden Lab, the creator of Second Life; and Nitto Denko, an electronics and advanced materials company.

 

University of Illinois Opens Advanced Digital Sciences Center

The University of Illinois at Urbana-Champaign will also open a research center at Fusionopolis called the Advanced Digital Sciences Centre.

 

In total, 800 scientists, engineers, and game developers will join phase 1 of Fusionopolis, and this number will increase to 2,400 by 2012 when phase 2 of the development is ready, A*STAR said.

 

Researchers at Fusionopolis are expected to “draw on the biomedical research expertise” at Biopolis, which is located half a mile away and is home to A*STAR’s 13 biomedical research institutes, consortia, and centers.

 

A*STAR said it has been “actively encouraging collaborations between its 1,500 physical sciences researchers and engineers, and 1,000 biomedical researchers.”

 

Merck Hints at Further Growth for Durham, NC, Vaccine Plant

Merck officials last week told reporters at a dedication ceremony for a new vaccine-manufacturing plant in Durham, NC, that the firm may expand the facility beyond its current commitment of $750 million and 400 jobs by 2011.

 

The paper reported that Merck has yet to decide where to manufacture two new vaccines it is still testing: a combination pediatric vaccine and a vaccine to protect against staph infections. The Durham plant, called the Maurice R. Hilleman Center for Vaccine Manufacturing, will compete with Merck vaccine production plants in Elkton, Va., and West Point, Penn., for that work.

 

Further expansions would be required if the Durham plant is chosen as the production site for additional vaccines, Willie Deese, the head of Merck's manufacturing division, told the paper.

 

Merck is slated to receive up to $45 million in state and local tax breaks and other incentives to build the vaccine facility.

 

Merck began building the facility on a 262-acre site in 2004. It currently employs 150 people who make childhood vaccines for measles, mumps, and chickenpox, and a shingles vaccine for adults.

 

Yale Begins Move to Science Park

Yale University has begun moving employees into the 165,000 square feet it is leasing at 25 Science Park. The moving process will last until the first week of December. About 650 staffers from Yale’s information technology services, finance, budget, business services, and other departments will move from their current offices in 155 and 175 Whitney Ave. to the space at Science Park.

 

The four-acre plot of land between 155 and 175 Whitney Ave., meantime, will become the new campus of the Yale School of Management.

 

Affymetrix Opts to Keep USB Subsidiary in Ohio

Microarray manufacturer Affymetrix has decided to expand and renovate the Warrensfille Heights, Ohio, facility for its subsidiary USB rather than move those operations to California.

 

Affymetrix acquired USB, which develops molecular and biochemical reagents, in January.

 

MedImmune Opens Cambridge, UK, R&D Facility

MedImmune opened a new biologics R&D facility in Cambridge, UK.

 

The Aaron Klug building, named after the 1982 Nobel Prize winner for chemistry, is a 92,000-square-foot facility that offers the firm the capacity to “significantly increase the number of candidate drugs that it can develop each year,” MedImmune said in a statement.

 

MedImmune, headquartered in Gaithersburg, Md., was acquired by AstraZeneca in June 2007 and now serves as the pharma firm’s global biologics unit.

 

The opening of the Aaron Klug Building follows the recent renovation and expansion of MedImmune’s production site in Nijmegen, the Netherlands, where it makes products such as Synagis (palivizumab) and Ethyol (amifostine).

 

Meridian Life Sciences Expands Building to Meet Antibody Production Growth

Meridian Life Science said last week that it has completed a building expansion at its Saco, Maine, location in order to meet the rapid growth in its antibody production business. 

 

The company broke ground on the 13,000-square-foot expansion in late 2007. The addition “more than doubles” Meridian’s current footprint.

 

Meridian said in a statement that its staff has doubled in size since 1999 and production volumes of goat anti-human immunoglobulin G, mouse IgG, and sheep IgG have doubled in the past 12 months.

 

The new space will allow the company to expand shipping and receiving, customer service, sales, technical service, data entry, R&D, production, and administration. 

 

Lancaster, PA, Developer Says Biotech Firm Interested in Proposed Business Park

An undisclosed biotech firm has expressed interest in being the anchor tenant for a business park proposed for a former stockyards property in Lancaster, PA, according to the site’s developer.

 

Lancaster’s Intelligencer Journal reported last week that developer Tim Harrison is seeking to begin construction on the site by January because the biotech firm needs to be operational by mid-2009.

 

The proposed 40,000-square-foot structure would create about 100 jobs over the next five years, Harrison told the Lancaster city planning commission.

 

The single-story biotech building would be the first phase of a project that would also include several smaller professional buildings, a plaza with a fountain, and two commercial sites that Harrison said could house a bank and a microbrewery.

 

City planners granted Harrison a waiver permitting him to file a combined preliminary/final land development plan in order to accelerate the first phase of the project, the paper reported.

 

Pharma Manufacturer to Hire 150 in Indiana

A subsidiary of German drugmaker Schwarz Pharma Manufacturing plans to upgrade its manufacturing and distribution facility in Seymour, Ind., and add 150 jobs over the next three years.

 

The Schwarz subsidiary, Kremers Urban, currently employs 366 workers at the site.

 

The company will spend more than $12 million on the upgrades and will begin hiring managers, business associates, and production staff later this month.

 

IEDC has offered Schwarz and Kremers up to $1.25 million in performance-based tax credits and up to $310,000 in training grants based on the company's job creation plans, according to a news release.

 

Niagara U. Lands $10 Million Donation to Construct Science, Bioinformatics Center

Niagara University has received a pledge for $10 million to support construction of a new science building that, when built, will house a research and interdisciplinary biology center that will focus on bioinformatics and computational biology.

 

The $10 million from businessman and philanthropist B. Thomas Golisano, founder and chairman of payroll services firm Paychex and owner of the Buffalo Sabres hockey team, will be part of the university’s $80 million capital campaign, called “The Promise of Niagara.” The gift to the university will be presented in five installments of $2 million.

 

The funds from Golisano will help support construction of the 44,000-square-foot center, which will house academic and clinical partnerships with the Buffalo Medical Complex, the State University at Buffalo, Roswell Park Cancer Institute, and the Heart Center of Niagara.

The current capital campaign is seeking to raise $16.5 million toward the total cost of the $25 million science center, the university said in a statement.

 

Idexx to Expand Memphis Distribution Facility

Idexx Laboratories plans to expand its distribution facility in Memphis, TN.

 

The Westbrook, Maine-based veterinary health company is building an 8,000-square-foot lab next to its existing Memphis distribution facility that is expected to create 50 new jobs.

 

Idexx currently employs 42 at the 100,000-square-foot Memphis distribution facility.

The new lab should be completed by January 2009.

 

Intel Opens Work-site Medical Clinics

Two of the most extensive worksite medical clinics opened their doors at Intel Corp.'s two Chandler locations. The facility will serve 10,000 employees.

 

The new Intel Health for Life Centers at the company's major complexes at 5000 W. Chandler Blvd. and 4500 S. Dobson Road underscore the growing number of on-site employee medical treatment facilities opening in the Valley and the nation.

 

The giant semiconductor company, with more than 10,000 employees at the two campuses, hired Take Care Health Systems to administer and manage the clinics.

 

Take Care, owned by Walgreen Co. and based in Philadelphia, has 180 corporate clients and has established more than 400 clinics at work sites in the United States. It is the largest operator of U.S. work-site medical clinics.

 

Intel's new centers will provide primary and urgent care, laboratory services, physical therapy, occupational health care, fitness training, a pharmacy, and wellness and prevention programs. Costs are comparatively low or, in some cases, free.

 

The Intel centers each have a full-time primary care physician, seven registered nurses, two nurse practitioners, a physical therapist and six other employees. They will be open Mondays through Fridays.

 

The movement toward worksite centers began about 30 years ago, but fell out of favor amid questions about cost-effectiveness and the desire of workers to visit their regular physicians. However, as medical insurance and health care costs climbed in recent years, the number of on-site centers grew because employers found them a less expensive way to deliver care.

 

In the Valley, several other corporations provide the service including Boeing Corp., which has clinics at its Mesa and Chandler facilities. The firm said the clinics are convenient for employees and reduces time away from work.

 

 

McIlvaine Company,

Northfield, IL 60093-2743

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