PHARMACEUTICAL & BIOTECHNOLOGY

UPDATE

 

February 2010

 

McIlvaine Company

www.mcilvainecompany.com

 

TABLE OF CONTENTS

 

UNITED STATES

QualTex Labs Promises New Lab Jobs for Georgia

QB3 Expands its Roster of Incubator Tenants, adds LP to Fund

New Cancer Center in Gilbert Arizona

Pharmarama Builds in U.S. Market

Epeius Biotechnologies Completes Construction for Genetic Medicines

GenVec Announces Contract with the Department of Homeland Security

Pharmatek Receives DEA Registration for Handling Controlled Substances

CDC to Fund Genomics Knowledge Center

Duke University Opens Clinical Research Facility for Molecular Medicine

Life Technologies to Close Camarillo Facility

Avrio Manufacturing Plant Cleared for Biologics

Berlin Packaging Acquires All-Pak

Colorado University Applies for Federal Grants to Help Finish Biotechnology

Watson Buys Eden Biodesign

Nelson Labs Adding As Many as 300 New Utah Jobs

Mocon Unveils 'One Stop' Food and Packaging Testing System

Mocon Buys into Irish Bioscience Firm

Mackenzie Medical Plaza and New Surgery Center

NIGMS Awards Contract to Coriell Institute for Medical Research

US Oncology, Baylor, Starting PGx-Focused Lab

Dell Children's Medical Center First Healthcare Facility to Achieve LEED Platinum Certification

Yakult Honsha to Commence U.S. Production in 2012

SurModics Opens Facility in Alabama

University Research and Funding Examples

Progenitor Cell Therapy Expands Manufacturing Operations

$54 million Upgrade at Hudson Valley Community College

University of Florida Receives $15 Million, and Berkeley Lab Obtains $12.8 Million in ARRA Funding

Catalent and Compass Boost Blister Capacity

REST OF WORLD

WuXi PharmaTech Passes EMEA Inspection of Facilities in Shanghai

Parexel Opens another Early Phase Unit in South Africa

Helvoet to Build Parenteral Component Plant in India

Perkin/Elmer Opens New Lab in Chennai, India

Caleco Pharma Signs Lab Facilities and Service Agreement with Natac Research

Singapore Biotech Sector Churns On

Haupt Pharma Completes FDA Inspection

Quintiles Launches New Testing Services in China

Thermo’s New UK Facility to Manufacture Chrom Products

PPD Singapore Lab Okayed by CAP

Elder’s New Plant Will Boost Sales

Symrise and International Flavors & Fragrances Invest in Russia and Singapore

SCM Gets Grant for Expansion Plans

HST Global Identifies Global Partner for Panamanian Treatment Facility

Perfecseal's Puerto Rico Facility Registered to ISO 13485

Watson Buys Eden Biodesign

Canadian CMO Patheon Will Consolidate its Puerto Rican Facilities

Gorbec Pharmaceutical Announces GMP Laboratory in China

Esco Adds Manufacturing Floor Space

Catalent Expands Capabilities at German Facility

Sanofi-Aventis Enters Joint Venture in China

Roche Invests in Singapore-Based Center for Translational Medicine

Romaco and CRO Ankur Complete Upgrade

SPMC Seeks Loan to Meet Sri Lanka’s Medical Needs

Crospon Spins out Transdermal Patch

BBSRC, UK Partners Launch Start-up

Gemabank Opens New Laboratory

Human Stem Cell Institute Expands

Schott Russian Plant Operational by Year End

Mocon Buys into Irish Luxcel Biosciences

LANXESS Building Chemical Plant in Bitterfeld, Germany

Patheon Building State-of-the-Art Development Center in France

Roche Expands Manufacturing Sites to Produce Self-Administration Device for Herceptin

Quotient and GE Deal Secures Supply Ahead of Move

DSM to Close Intermediates Business

 

 

 

 

UNITED STATES

 

QualTex Labs Promises New Lab Jobs for Georgia

QualTex Laboratories, a blood-testing lab based in San Antonio, is expanding to Norcross, Ga., where it is expected to create 125 jobs and invest nearly $12 million over five years, according to a statement.

 

QualTex, which also perform genetic testing, was founded in 2007 as an independent affiliate of the South Texas Blood & Tissue Center and is currently the largest independent testing lab in the US for blood and plasma products.

 

The Norcross facility will screen whole blood and plasma donations and, once fully operational, it will be expected to test "more than 8 million biological samples" annually, or double its current throughput.

 

The new hires will include clinical lab scientists, certified lab techs, quality specialists, materials management personnel, and general management personnel, according to the statement.

 

QB3 Expands its Roster of Incubator Tenants, adds LP to Fund

The California Institute for Quantitative Biosciences, or QB3, continues to grow its family of startups housed at its incubators within San Francisco's Mission Bay campus, said Douglas Crawford, QB3's director of industry alliances and associate executive director.

 

The total number of tenants has risen from the 16 reported at the end of 2009, to the current 18. Of those, five are within the 2,500-square-foot incubator space known as "The Garage," while 13 are within 8,000 square feet of a 10,000-square-foot space one block east — a section of FibroGen's headquarters at 409 Illinois St., the 239,000-square-foot building to which the developer of recombinant collagen and gelatin for medical device and pharmaceutical uses, relocated its headquarters more than a year ago.

 

"We continue to see one to two new companies a month move into that [Fibrogen] space, which is just extraordinary to see that kind of vitality at the entry level of the biotech industry. We're very happy to see that," Crawford said in an interview.

 

In addition, QB3 said that Zcube, the research corporate venture of Italian pharmaceutical firm Zambon, has joined the Mission Bay Capital Fund — QB3's first venture fund — with a $1 million investment. Zcube is the only European company to contribute to the Mission Bay Capital Fund to date, QB3 said in a statement.

 

New Cancer Center in Gilbert Arizona

A new cancer center is slated to open in fall 2011 at Banner Gateway Medical Center, Gilbert, Ariz. The three-story, 120,000-sf, $107 million cancer center will contain physician clinics, medical imaging, radiation oncology, infusion therapy, and support services. A/E firm Cannon Design has created a visually open, column-free interior to increase patient comfort and care. Punctuating the exterior of the building is a tall, open-air lantern tower with color-changing LED lighting and organic leaf patterns.

 

Pharmarama Builds in U.S. Market

U.S. Pharma firms can benefit from the sourcing, storage and distribution efficiencies offered by comparator drug sourcing and distribution specialist Pharmarama says managing director Rosemary Bensley.

 

Bensley said that the firm, which gained a wholesale distributor’s license (WDL) for its facility in Boston, Massachusetts, last month, sees plenty of opportunities in the US market.

 

“The increasing demand for evidence-based medicine, particularly in today’s economic climate, is resulting in a greater focus on clinical studies comparing investigational drugs against an established standard of care.

Bensley explained that: “Comparator sourcing is a time-intensive process,“ adding that “because we have an established global infrastructure, we can do it far more efficiently and cost effectively than a pharmaceutical company on its own.”

 

She went on to say that the Boston site which, like Pharmarama’s facility in the UK, houses temperature-controlled storage and distribution capacity, “will enable us to attract more clients.”

 

However, while the focus of operations at Boston is the US, like Pharmarama sites worldwide the new facility will also serve other regions, including rapidly expanding markets in South and Central America.

 

The firm also provides comparator pharmaceutical drug sourcing services in the Chinese clinical trials sector through a partnership it set up in 2007 with a firm in Shenzhen.

 

The increasing global spread of the clinical trials industry and pressure from regulators to prove a drug is more effective than those that are already available is likely to increase demand for comparator medications of the next few years.

 

Epeius Biotechnologies Completes Construction for Genetic Medicines

Epeius Biotechnologies announces the completion of the design engineering and construction phase of a state-of-the-art Vector Production Unit (VPU) for the commercial manufacturing of its advanced targeted genetic medicines. In accordance with an FDA Critical Path initiative, which encourages innovation and the implementation of new technological advances in GMP, CMC, aseptic processing, and quality control, the Epeius VPU is poised to launch the large-scale production of targeted genetic medicine into the 21st century. By combining the most advanced modular clean-room engineering specifications with space-age materials, aseptic processes, and robotic operations, the stunning new facility exemplifies a new level of cleanliness, efficiency, productivity, and cost-effectiveness, as well as product quality control, all by design.

 

Housed in a spacious NASA-style hangar and seated onto an expansive seamless epoxy floor, the elegant stainless steel and glass facility is pleasing to the eye, both inside and out, as large windows and walls of plate glass rise to form corridors with twelve-foot ceilings. Equipped with clean-room air handling systems derived from the high-tech industry, the impeccable cleanliness of the enveloped interior is further maintained by batteries of UV-lights embedded within the integral ductwork. The outstanding level of high-tech innovation embodied in the Epeius VPU is hardly surprising, considering that systems engineers from Terra Universal critical environment solutions worked closely with Epeius scientists on the plant's design features.

 

By streamlining material flow, personnel tasks, and bioprocessing operations, while reducing overall footprint and manual labor, the modular, robotic VPU provides an optimization of single-use technologies and the decoupling of solution preparation from the process, thereby providing increased operating efficiencies, large economies-of-scale, and enhanced quality assurance.

 

This modular, robotic VPU serves as a flagship facility that meets and exceeds the challenges of operating economy, process optimization, and operational excellence, as it extends these concepts to the bio-manufacturing industry of the 21st century. From its inception as an academic startup enterprise -- incubated at The University of Southern California School of Medicine -- to its emergence as a global leader in the field of targeted genetic medicine, Epeius Biotechnologies has advanced the science of molecular genetics from the bench to the bedside in a manner that is unprecedented in modern times. By working closely with acknowledged leaders in the fields of molecular biotechnology, biopharmaceutical manufacturing, and clean-room fabrication, Epeius Biotechnologies is striving to make the promise and potential of targeted genetic medicine more abundant and affordable for cancer patients worldwide.

 

GenVec Announces Contract with the Department of Homeland Security

GenVec, Inc. has announced a new contract with the Department of Homeland Security (DHS) to continue the development of adenovector-based vaccines against foot-and-mouth disease (FMD) based on research and development done in collaboration with USDA-ARS and DHS S&T scientists at the Plum Island Animal Disease Center. Under this new agreement, GenVec will receive $3.8 million in program funding the first year and an additional $0.7 million if DHS exercises its renewal option under the contract.

 

Under this contract, GenVec will use its adenovector technology to develop additional FMD-serotype candidate vaccines. GenVec will also explore methods to increase the potency and simplify the production process of FMD vaccines developed under this contract as well as its previous contract with the DHS announced in 2007.

 

"This contract expands our ongoing efforts to develop adenovector-based FMD vaccines," said Dr. Paul Fischer, GenVec's President and Chief Executive Officer. "This new contract with the DHS will support new vaccine discovery and technology improvement for this important threat."

 

Pharmatek Receives DEA Registration for Handling Controlled Substances

Pharmatek Laboratories, Inc., a contract development and manufacturing organization supporting the pharmaceutical industry, announced that it has successfully met Drug Enforcement Agency (DEA) requirements to be registered for the development and manufacture of Schedule IV and V controlled substances.

 

"Based on the needs of our clients, Pharmatek has put significant systems in place for the handling, inventory, development and manufacture of controlled substances," said Kevin Rosenthal, Director of Manufacturing. "Being registered by the DEA validates our facility design, security systems, and procedures for manufacturing, handling, storage and disposal meet the stringent requirements of the DEA."

 

Controlled substances are designated as Schedule I-V according to their medical use, potential for abuse and safety or dependence liability. In order to research, manufacture or distribute a controlled substance, a person or entity must be audited and registered by the DEA.

 

"Our goal is to continue to strive to meet the needs of our existing and prospective clients by adding to our capabilities in pharmaceutical chemistry development and manufacturing," said Timothy Scott, President at Pharmatek. "As a client-centric organization, our success is predicated on our ability to serve our clients. We are happy to bring this additional capability to Pharmatek in order to serve that purpose."

 

CDC to Fund Genomics Knowledge Center

The Office of Public Health Genomics at the US Centers for Disease Control and Prevention will grant $1.5 million to fund the creation of a center that will help plan and develop systematic evidence reviews on genomics applications, among other efforts.

 

The OPHG grant will give up to $500,000 in the first year of the three-year project to start a Genomics Knowledge Synthesis Center.

 

In addition to developing the systematic evidence reviews, the center also will develop topic briefs on genomic applications and methods to enhance the efficiency and quality of systematic evidence reviews.

 

The evidence reviews will examine the validity and utility of various health-related genomic and proteomic tests, family health history tools, other health-related genomic services, and information on contextual factors and ethical, legal, and social issues. These reviews will be conducted using methods developed by the Evaluation of Genomic Applications in Practice and Prevention Working Group and by CDC.

 

The center also will collaborate with CDC to develop evidence summaries on the validity and utility of selected genomic applications, and these reviews and recommendations will be made publicly available in an online repository.

 

The repository is being developed by the OPHG, the National Cancer Institute, the National Center for Biotechnology Information, and the National Library of Medicine.

Applications for the funding opportunity are due by April 7, with an anticipated start date on the project of Sep. 15.

 

Duke University Opens Clinical Research Facility for Molecular Medicine

Duke University Medical Center has opened a $5.3 million facility designed to apply systems biology and molecular medicine approaches to early-phase studies of new drug or medical device candidates, especially at the proof-of-concept or "first-in-human" clinical stages.

 

The new Duke Clinical Research Unit said it will work with other research centers, as well as drug and device makers, to apply 'omics and other advanced technologies in a variety of early-phase studies. That research, according to the DCRU, would include studies aimed at identifying and validating disease biomarkers, as well as studies into the biological processes involved in everyday activities, or behaviors linked to disease.

 

The DCRU is designed to carry out research studies by the roughly 800 faculty members within the Duke Clinical Research Institute, an academic clinical research.

 

"The unit is looking and working in over 20 different therapeutic areas now," John McHutchison, program director of the DCRU and associate director of the Duke Clinical research Institute, told GenomeWeb Daily News. "We have a lot of work in immunology. We have a lot of work in rheumatology, asthma and lung disease, hepatitis and liver disease, cardiovascular disease, diabetes, and metabolic diseases. And then in children, we're looking at a lot of different drugs that are given to children in different ways."

 

Among the unit's researchers, he added, will be Wesley Burke, chief of the medical center's division of pediatric allergy and immunology, and an expert in peanut and other food allergies in children. DCRU researchers can access the institute's technology cores in cell therapy, clinical vaccine unit, imaging, immune monitoring, and –omics technologies furnished by the Duke Institute for Genome Sciences & Policy, which is part of the university's Translational Medicine Institute.

 

The unit also includes a sample processing laboratory, and access to Duke core labs at the medical center and in Kannapolis, NC, at the North Carolina Research Campus. Near the campus, the DCRU plans eventually to store most of its samples at a 10-million-sample capacity, 40,000-square-foot biorepository recently developed by Laboratory Corporation of America, and operated by LabCorp in partnership with Duke's TMI.

 

Other DCRU resources will include an Echo magnetic resonance imaging system, informatics professionals, nurses trained in clinical research as well as patient care, a bionutrition division with metabolic kitchen and clinical nutrition services, a biostatistician, and a research subject advocate.

 

"If you know there's somewhere you can go where you will get something done, and it will be done efficiently and it will be cost-effective, and it won't take too long and you've got access to modern technologies or –omics or whatever it might be, you're much more likely to work with it and to be successful," McHutchison said in an interview. "What we've tried to do with the DCRU is create a local infrastructure where investigators can explore a novel drug or a novel intervention or some biology in a very safe, user-friendly environment."

 

Catherine Lavin, the unit's director of operations, told GWDN that the DCRU will be staffed by 30 to 40 full-time equivalent employees, which will include a mix of core staff and other staff on an as-needed basis.

 

Duke funded the cost of building the DCRU facility and launching the unit — an expanded replacement for the General Clinical Research Center — as one of several expenses it agreed to shoulder in return for being designated one of 46 institutions within a national consortium to receive Clinical and Translational Science Awards from NIH. Duke's CSTA award, announced in 2006, called for the university to receive nearly $51 million over five years — a funding program for which Duke is expected to seek renewal in the 2011 federal fiscal year, which starts Oct. 1.

 

The CSTA consortium is designed to ultimately grow to 60 institutions, a goal NIH first said would take place in 2011, then 2012. Last July, in a Q&A on its web site, the NIH's National Center for Research Resources insisted the agency remains committed to the 60-institute goal, but did not tie that goal to a specific year.

 

Among the first studies under way at the DRCU is one designed to personalize aspirin therapies, ultimately enhancing its ability to prevent heart disease and stroke. The project is being funded through a two-year, roughly $1 million grant secured from the National Institute of General Medical Sciences through the $862 billion American Recovery and Reinvestment Act, according to the study's Principal Investigator, Geoff Ginsburg, founding director of the Institute for Genome Sciences & Policy's Center for Genomic Medicine.

 

"We've been using aspirin for, what, 100 years? Preliminary evidence and data suggest that there are certain people who are super-sensitive to it and certain people who are insensitive to it. Surely working that out is pretty important," McHutchison said.

 

The DCRU's 30,000 square feet includes a 17,000-square-foot, 30-bed unit for adults, as well as a 13,000-square-foot pediatric unit with six confinement beds and two infant family rooms.

 

Duke also hopes that the DCRU will be a resource that will help build relationships with industry partners. "We have examples that I'm not at liberty to talk to you about because of confidentiality [requirements]. We're exploring early treatment, early toxicity, trying to biologically understand what's going on," McHutchison said.

 

McHutchison said DCRU is one of only a few research centers nationally to enjoy easier access to disease-specific patient populations of children, adults, and senior citizens due to its location within DUMC, where he is a professor of medicine. The medical-center location also offers the clinical research unit immediate, round-the-clock access to an on-site, full-scale emergency response team.

 

"It's always safety-first when you're giving things to people in the stage of humans, in the stage of proof of concept early on. So you need to be doing that in a safe environment. The safest environment is a hospital," McHutchison said. "Would you rather receive a new drug in a hotel setting where you had to call 911 and the ambulance was five minutes away? Or would you rather do it in a hospital?"

 

Life Technologies to Close Camarillo Facility

Life Technologies confirmed that it is closing its Camarillo, CA, facility and will lay off an undetermined number of employees.

 

The firm said that the operations supports its Cell Systems Division and will be consolidated at the company's site in Frederick, Md. Life Technologies said that the consolidation "will allow for scalability of those activities by relocating them to a site that offers room for long-term expansion."

 

It added that the closure of the Camarillo site, which will wind down through 2011, will result in some job cuts. However, the firm said that it "cannot confirm the number or timing of these reductions."

 

Life Technologies is planning to provide a "significant number of employees" with an opportunity to apply for new positions elsewhere in the company.

 

Life Technologies gained the Camarillo facilities through the 2005 acquisition of BioSource by Life Technologies' predecessor company Invitrogen.

 

Avrio Manufacturing Plant Cleared for Biologics

U.S. CDMO Avrio Biopharmaceuticals’ new aseptic fill-and-finish facility in Irvine, California has been approved for the manufacture of biologics by state drug regulators.

 

The firm, founded by contracting group Irvine Pharmaceutical Services in 2008, said that California Department of Public Health, Food and Drug Branch (Cal FDB) clearance for the 20,000 sq. ft. facility completes its portfolio of services.

 

Initially, Avrio will try and capture a share of the rapidly expanding contract fill-and-finish market for biopharmaceuticals, which most observers predict will continue to grow rapidly as drug makers move away from traditional small molecule production.

 

The contract development and manufacturing organization (CDMO) went on to say that, in addition to aseptic fill-and-finish services for biopharmaceuticals, the new plant houses laboratory space, a formulation unit and a pilot plant.

 

Irvine Pharmaceutical Services’ CEO, Assad Kazeminy was pleased that the new business and facility are operational, explaining that: "The addition of Avrio, we can now support our clients from start to finish via a seamless partnership."

 

Irvine has been operating since 1988, initially serving as an independent contract testing and chemistry support laboratory for the pharmaceutical and biopharmaceutical sectors

Since then it has gradually extended its portfolio to include a broad range of services including method development and validation, analytical chemistry, stability storage and testing, microbiological support, preformulation and formulation, drug delivery testing, as well as inhalation and nasal testing.

 

More recently, Irvine began offering biopharmaceutical development services, such as API manufacturing, cell line development, peptides and proteins production as well as the development of dosage forms.

 

Berlin Packaging Acquires All-Pak

Berlin Packaging (Chicago) has entered into a definitive agreement to buy All-Pak, Inc. (Pittsburgh), combining two ISO-certified suppliers of rigid packaging products and services.

 

The combined company with annual revenues approaching $500 million will provide customers with wider geographic coverage operating in over 40 sales offices and warehouse locations in the US and Puerto Rico.

 

The transaction “unites two highly complementary businesses and will enable us to continue to unlock value for our customers, suppliers and employees,” said Andrew Berlin, Berlin Packaging chairman and CEO.

 

Berlin said the transaction will enhance the company’s ability to realize faster growth, lower system costs, and improve productivity. As the company provides a broader network of expertise, customers will be offered an expanded array of services including custom package design, international sourcing, capital lending, supply chain optimization, inventory management, and assembly.

 

The combined firm will be headquartered in Chicago, with All-Pak maintaining significant operational presence at all of its geographic locations, the company said.

 

Colorado University Applies for Federal Grants to Help Finish Biotechnology

The University of Colorado has applied for multi-million dollar federal grants to help finish the construction of its biotechnology building since the cash-strapped state is rejecting the school's funding requests.

 

CU's Boulder campus split the building's construction into two projects so that it could move forward on construction, without depending on state funding. The first phase of the building will be 257,000 square feet, and CU expects it to be finished in fall 2011. The school has plans for a 54,000-square-foot addition, which hinges on funding.

 

Instead of waiting for an economic turn-around at the state level -- which could leave construction on the final wing of the building stalled for an indefinite period of time -- CU is looking for money elsewhere.

 

Russ Moore, interim vice chancellor for research, said CU has applied for two federal stimulus grants from the National Institutes of Health that each amounts to about $15 million. University officials are waiting to hear back from the agency.

University officials estimate that donations, federal dollars and the Boulder campus will cover the $148 million for the initial building, located on CU's east campus northwest of Colorado Avenue and the Foothills Parkway, and hope that $31.8 million will eventually come through from the state to finish the biotechnology hub.

 

CU is requesting $26.95 million this year, but state officials have told school leaders to not expect the money because of the tight budget. The university was also hoping to secure $4.82 million for the building from the state next year. University officials are hopeful for both federal and state money.

 

Regardless, the university has listed the biotechnology building No. 1 on its capital construction wish list to demonstrate its importance, said Steve McNally, associate vice chancellor for budget and finance.

 

State leaders have celebrated the project and expect the biotechnology center will help create jobs in Colorado.

 

Gov. Bill Ritter, who attended the ground breaking of the building in September, said the research of complex biomedical problems that will happen in the building will give the state a competitive edge in the global market and stimulate the state's business environment.

 

Colorado boasts particular potential in the biosciences, with existing businesses generating more than $400 million in state taxes and supporting 36,000 workers. At CU, biotechnology research has led to more than a dozen startup companies and attracts tens of millions of dollars annually in sponsored research grants.

 

The university has 57 doctorate biochemistry students -- more than double what CU officials predicted back in 2007 when the degree was approved.

 

So far, the state has only pledged $5 million toward the building. That money is coming from state "economic development funds" generated from gaming proceeds, which is a separate pot of money than the capital construction budget. The money will help CU's biomedical team partner with the private industry and expand lab space.

 

School officials say they appreciate the state's support, even though the construction funding requests are going unmet for a project that is lauded by state leaders.

 

The new biotechnology hub will bring together leading scientists, including 60 senior faculty members and more than 500 research and support staff members.

 

Together, they will collaborate and explore medical problems, looking to develop new therapies for cancer, infectious diseases and cardiovascular disease.

 

The scientists and engineers who make up the Colorado Initiative in Molecular Biotechnology will be housed in the building. Nobel laureate Tom Cech rejoined CU's faculty last spring to head up the initiative, and he is also teaching undergraduate chemistry.

 

Watson Buys Eden Biodesign

US generics group Watson Pharmaceuticals has bought UK contract biomanufacturing specialist Eden Biodesign.

 

The deal, worth some $15m (€10.7m), sees New Jersey- headquartered Watson take control of Eden’s dedicated biologics production plant in Liverpool as well as its contract development and manufacturing business.

 

Watson first gained a 36 per cent share of Eden in December when it took over fellow generics firm Arrow Group. At the time Watson said that the Liverpool manufacturer provided a “long-term foundation for biosimilars.”

 

This point was reiterated by Watson CEO Paul Bisaro who said that: "Completing the acquisition of Eden is the next strategic step in our commitment to establishing a major position in biologic products on a global basis."

 

"In addition to development and manufacturing facilities, the Eden acquisition adds substantial intellectual capital to Watson's biologics activities, as Dr. Crawford Brown and the Eden management team will remain with Watson.”

 

The acquisition clearly indicates that Watson thinks biosimilars will be an important sector for it going forward, which is an idea that fits with a recent study which predicted that such drugs would generate $19.4bn a year by 2014.

 

The manufacturing capacity and expertise that Eden brings with it removes one of the key barriers to entry in the biogenerics sector, namely that the production of biologics is more complicated than traditional small-molecule therapies.

 

This point was stressed by Crawford Brown, Eden Biodesign CEO, who said his firm is “delighted to become part of Watson Pharmaceuticals and excited by the prospect of accelerating their biologic development strategies.”

 

“Our passion and commitment to serving our customers remains undiminished and I firmly believe that the resources and market expertise now available to us will prove to be of tremendous benefit to Eden Biodesign’s current and future client base.”

 

Nelson Labs Adding As Many as 300 New Utah Jobs

Significantly contributing to job recovery after defying a difficult economic downturn, Nelson Laboratories estimates it will hire as many as 300 people during the next ten years with as many as 75-100 of those jobs coming in 2010. Nelson Labs made the announcement from its just completed nearly 50,000 square foot building—the latest in its expanding campus of medical device testing laboratories, clean rooms, and support and operations offices.

“This is really good news for Utah,” said Jeffery R. Nelson, president and CEO of Nelson Laboratories. “During a time when a lot of companies were cutting back and laying people off, we were able to keep our employees and build this progressive new building to house our expansion. We’ve committed to our customers, our employees, and to the State of Utah our plans for on-going growth.”

 

Nelson Labs is one of the top providers of full, life-cycle microbiology testing services for medical devices, pharmaceuticals, and natural products. It has a national reputation for quality and rigorous testing standards. Its philosophy, The Science of Success™, looks beyond test results for its customers by helping them reach goals, be first to market, mitigate risk, and find success with their customers.

 

Nelson Labs has a strong history of growth in Utah. During its 25-year history, the company has roughly doubled in size every five years and anticipates the growth trend to continue. Its original facility was 24,000 sq. ft. and was expanded to 62,000 sq. ft. in 2001. Including the new building, Nelson Labs now has over 110,000 square feet of office space.

Of the expected new jobs in 2010, hiring has already started with several current positions available.

“We’ve experienced thoughtful and progressive growth,” said Nelson. “This has resulted in a very loyal customer base who appreciates the integrity of our services and the professionalism of our entire staff.”

 

The first and third floors of the new building will house support offices. The second floor is dedicated to new laboratories for the biocompatibility, microbiology and pharmaceutical departments. The floor will connect via a bridge to the original building, which is now expansion room for the company’s 12 laboratory departments.

 

Laboratories will include the latest technology and lab equipment in order to continue providing the highest level of service to its customers. The expansion will make Nelson Labs one of the largest laboratory facilities in the country.

 

With an emphasis and commitment to its employees, the building also includes a gym, a full size cafeteria with company subsidized hot lunches, and a child care and mothering room with work facilities so staff members can continue working while caring for their children.

Big D Construction built the approximately $14 million building. Architect and design firms included Joseph Linton Architect and Babcock Design.

 

Mocon Unveils 'One Stop' Food and Packaging Testing System

A new one-stop testing service will speed up trial times of the analysis of food and beverages along with their related packaging - from raw material to transport to shelf life, said Mocon.

 

The US-based company said its Advance Packaging Solutions model provides a “single point of entry for virtually any type of testing which can impact shelf life”, and goes beyond its usual existing services that include barrier analysis, headspace, water vapor and vacuum decay.

 

Alan Shema, company product manager for consulting/testing services, said: “Historically, brand owners who needed different types of testing services would have to engage more than one company. For example, if you wanted to study food deterioration and shelf life, you would typically go to two places. For transportation concerns you would need a third service. This resulted in a longer testing timeline and much less coordination/ integration between testing phases and partners.”

 

The new program will consist of tests for determining factors that accelerate food deterioration, as well as modeling studies on shelf life. Microbial and accelerated aging studies, gas mix optimization, MAP system audits, and shelf life optimization are also part of the initiative.

 

It will also include sensory panels consisting of trained human testers to evaluate food taste, color etc, along with transportation testing to simulate shipping conditions.

 

Mocon marketing manager Guy Wray said that while none of the services were new, the company had spotted what it believed was a gap in the market in that they had not all be gathered in one place before. He said it was the first one stop program to tackle the entire food and packaging life cycle.

 

“We discovered there is no single ‘go to’ place that is a complete service,” he added. “We can advise processors on how to achieve the shelf-life they want and what this means in terms of cutting waste and implications for how far they can ship their product. It can address existing issues and also anticipate and solve other issues before they arise.”

 

Mocon Buys into Irish Bioscience Firm

Mocon Inc has prioritized the development of a pathogen screening process for a range of foods after announcing it has acquired a 16.9 per cent stake in Irish company Luxcel Biosciences Ltd.

 

The US-based company, a leading global supplier packaging test equipment, said it had completed the deal to invest €2.5m (US$3.6m) in Luxcel on 15 January.

 

The Irish firm was founded in 2002 as a spin-off from University College Cork to create commercialized research and technology in phosphorescence-based sensor development and the applications of these sensors for biological testing. Their products enable rapid, high throughput screening and detection of bacterial contamination of food samples, non-invasive analysis of gas in food, beverage and pharmaceutical packaging.

 

Mocon confirmed that as part of the initial post-investment activity it would be dedicating some of its research and development resources to a project to help bring a lower-cost screening process for high-throughput pathogens such as Listeria, E.coli and salmonella for a range of food processing industries. The application will be suitable for the meat, poultry, seafood, produce and dairy sectors, it said.

 

“Luxcel’s technology, products and services represent a strong strategic addition to Mocon’s core instrumentation business,” said Mocon CEO and president Robert Demorest.

 

He added that the move would help provide a new generation of products and services “including faster, less expensive testing for pathogens”.

 

Luxcel CEO Richard Fernandes described the partnership with Mocon as a "perfect fit". He confirmed the U.S. company planned to design and manufacture dedicated instrumentation to measure Luxcel’s sensor and launch the new systems in the US and other markets.

 

Deputy Prime Minister of Ireland and Minister for Enterprise Trade and Employment Mary Coughlan said the deal was a “major opportunity” for both companies. Enterprise Ireland, the governmental agency responsible for the development of that country’s business sector, also announced that it was increasing its equity position in Luxcel.

 

Mackenzie Medical Plaza and New Surgery Center

 Congero Development, LLC, hosted a groundbreaking ceremony for the Iain Mackenzie Medical Plaza, a new destination health care campus in York, Penn. The 7.3 acre project will include Brookeside Surgical Arts at York, a Medicare certified and Joint Commission accredited Ambulatory Surgery Facility (ASF).

The namesake of the project, Dr. Iain Mackenzie, was in attendance along with members of the state Legislature, and local government officials.

"This project is resulting from the vision of our amazing physician partners, the cooperation of local government, and the support of Susquehanna Bancshares," said Bruce Wallace, CEO of Congero Development. "Together with our partners, we are committed to realizing your vision and bringing a new standard of surgical care to the York community."

The Iain Mackenzie Medical Plaza is intended to bring together existing and needed services in one convenient location for residents, and is expected to create approximately 150 new, highly compensated jobs with benefits. Located at 2050 South Queen Street at the former Blazenet site, the plaza will include three medical buildings, the first of which houses 8,100 square feet of medical office space plus an additional 16,500 square feet for the ASF. Dr. Mackenzie founded Digestive Disease Center, which is among the first committed tenants of the new medical plaza.

Brookeside Surgical Arts at York is being developed in partnership with local surgeons as an innovative, multi-specialty surgical facility. Brookeside will be housed in the first medical building on the property and includes six operating rooms with private recovery and step down areas. Designed by award winning medical architecture firm Anthony C. Pings and Associates, Brookeside will bring together functional aesthetics with the most sophisticated surgical and infection control technologies available.

 

The medical offices at Iain Mackenzie Medical Plaza are anticipated to be complete this winter, with the surgery center tracking toward a Spring 2010 opening.

The general contractor is Benchmark Construction Company, an award-winning, full service construction manager and general contractor servicing the central and southeastern Pennsylvania region. Benchmark specializes in commercial and institutional construction with an emphasis in healthcare and senior living.

CS Davidson, Inc. is handling structural engineering for the project. C.S. Davidson, Inc. is a leading engineering firm serving south central Pennsylvania. They offer a broad array of services ranging from municipal engineering to construction inspection and material testing. With a tradition of service since 1923, C.S Davidson has built a reputation for quality design and one-on-one service to clients and is widely regarded for its integrity and community involvement.

Mechanical plumbing and electrical services are being provided by Barton Healthcare-a division of Barton Associates, Inc. Incorporated in 1968, Barton Associates, Inc. is a nationally recognized consulting engineering firm providing mechanical, electrical, plumbing, fire protection, control systems design and commissioning services. Barton has nearly 60 employees and provides engineering consulting services for a variety of education and healthcare facilities throughout the Mid-Atlantic Region.

Construction financing is being funded through Susquehanna Bancshares, Inc., a financial services holding company with assets of approximately $14 billion. Headquartered in Lititz, Penn., the company provides banking and financial services at more than 230 branch locations in the Mid-Atlantic region.


Congero Development, LLC, is a full service, health-care specific developer, providing full service turn-key development services including business development, licensing and accreditation, equipment planning and procurement, supply side purchasing, vender and insurer contracting for healthcare facilities throughout the United States. Congero prides itself on partnering with its physicians to create a scalable, efficient long-term investment that will enhance the delivery of healthcare to the communities in which they are located.

 

NIGMS Awards Contract to Coriell Institute for Medical Research

The National Institute of General Medical Sciences (NIGMS) has awarded a $27 million, five-year contract to the Coriell Institute for Medical Research in Camden, N.J., to continue and expand operation of the NIGMS Human Genetic Cell Repository (HGCR).

 

Under the new contract, the HGCR plans to enhance its collection of carefully maintained human cell lines by adding induced pluripotent stem (iPS) cells that carry disease gene mutations.

 

"The addition of iPS cells will make the repository an even more valuable resource," said Jeremy M. Berg, Ph.D., director of NIGMS. "In addition to teaching important lessons about biology, these cells hold great promise for studying -- and maybe one day treating -- a wide range of diseases."

 

While not derived from embryos, iPS cells offer the same scientifically desirable properties as embryonic stem cells. They reproduce indefinitely and have a similar potential to become any of the more than 200 cell types in the body. The iPS cells will enable scientists to more readily examine normal cell development and study the effect of one or more disease genes in many different cell types. The iPS cells will be available to researchers in about six months.

 

Established by NIGMS in 1972, the HGCR provides human cell lines and DNA for use in genetic and genomic research. Scientists use the cells and DNA to identify genes and biochemical changes associated with a wide range of conditions and to study rare genetic diseases. The repository's materials have helped scientists gain important insights into a number of disorders, including Huntington's disease, cystic fibrosis and Fragile X syndrome.

 

The HGCR collection currently contains over 10,000 cell lines, each of which has been comprehensively characterized, tested to ensure genetic integrity and maintained free of contaminants. The largest part of the repository is the inherited disease collection, which represents more than 1,000 disorders.

 

To aid understanding of human genetic variation, the HGCR collection also includes cell lines and DNA samples from populations around the world and from several ethnic groups within the United States.

 

Under the new contract, the HGCR will also begin meeting custom orders, such as for panels of RNA samples or cells grown under specific conditions.

 

The HGCR distributes samples for a nominal fee through a Web-based catalog. Each entry includes detailed information about the clinical characteristics of the donor as well as the genetic and biochemical features of the cell line.

 

Samples in the repository come with informed consent from people with inherited diseases and from healthy donors. The repository protects the privacy of donors by stripping its records of personally identifying information.

 

US Oncology, Baylor, Starting PGx-Focused Lab

The Houston-based cancer care and research company US Oncology is working with Baylor Health Care to start a joint venture in metropolitan Dallas that will provide a range of lab testing, molecular diagnostic, and pharmacogenomic services.

 

The joint venture will use the talent, patient pools, and resources from Baylor Health Care Systems and Baylor College of Medicine, as well as individuals, assets, and technologies from US Oncology, in the venture, which for the moment is going by the temporary name NewCo, said the venture's CEO, Keith Laughman.

 

The four strategic investors in the venture include US Oncology and Baylor HC, as well as Texas Oncology, and Pathologists Biomedical Laboratories, according to Laughman, who formerly was president of esoteric services at pathology services provider AmeriPath and president of Mayo Medical Laboratories.

 

NewCo has leased a 172,000-square-foot space in Lewisville, Texas, where it aims to employ more than 200 people by the end of this year, and perhaps more than 900 in five years.

 

The company will be a full-service clinical lab focused on molecular diagnostics, and will emphasize its focus on pharmacogenomics efforts. The effort will particularly focus on validating the clinical utility of certain pharmacogenomic and companion diagnostic tests, Laughman said.

The NewCo labs initially will use both the US Oncology network and Baylor's resources to provide testing services and clinical trials support services, and it will eventually expand to become a full contract research organization focused on oncology services, Laughman said.

 

He said that "a lot of what we will do, will be to create a distribution channel… for new and novel technologies" that need to be used and tested in medical contexts before they may be useful for wider use.

 

"A lot of these diagnostics invite more questions at first than they provide answers," when they are being tested because there are "diagnostic gaps" the need to be filled, and because "as you get more information, it triggers other clinical questions."

 

Dell Children's Medical Center First Healthcare Facility to Achieve LEED Platinum Certification

Located in Austin, the Dell Children's Medical Center of Central Texas is the first healthcare facility in the world to achieve a LEED Platinum certification by the U.S. Green Building Council (USGBC). The 503,000 sq-ft medical center, set on a 32-acre campus, opened in July 2007 and is part of the Seton Family of Hospitals.

 

In 2005, Seton's team of MEP engineers and general contractors set out to achieve USGBC's LEED Platinum certification for the healthcare facility. Alan Bell, AIA, Seton's LEED AP director of Design & Construction, said, “Though we began to open portions of this 169-bed facility in mid-2007, we received the official LEED Platinum certification in early 2009. To achieve this goal, we were rated in the six key LEED categories: Sustainable Site development, Water Efficiency, Energy & Atmosphere (EA), Materials and Resources, Indoor Air Quality, and Innovation & Design.” Of the 69 total possible points, Seton and Siemens Building Technologies collaborated to earn a total of 54 points.

 

A key component to the Dell Children's Medical Center achieving the LEED designation was attaining the points associated with Energy & Atmosphere and IAQ. Central to this aspect of the project was the implementation of the BAS. BAS implementation helped achieve two of three LEED prerequisites in the EA category (Fundamental Building Systems Commissioning and Minimum Energy Performance). The control technology and its proper integration were also an essential part of achieving five other EA points. Of the 17 total points in this category, the hospital received 14 points.

 

BAS and control are essential contributors to another key LEED category, IAQ. For Dell Children's Hospital, the BAS helped achieve one of the two prerequisites—Minimum IAQ Performance, as well as the acquisition of 4 of 11 total points—enough points in this category to anchor this portion for Platinum certification.

 

IAQ is a critical aspect of the interior environment within a hospital. In the pursuit of LEED in the category, 15 points are available. The BAS was central to achieving one of the two prerequisites (Minimum IAQ Performance) and its associated control, monitoring, and reporting of the interior (and exterior) air. Seton achieved 11 of 15 total points, with CO2 monitoring, Controllability of Systems, Thermal Comfort as it applies to ASHRAE 55-1992, and Thermal Comfort, Permanent Monitoring System.

 

In conjunction with general contractor White Construction of Austin, Seton selected BAS supplier Siemens Building Technologies to install and integrate the solution across the new facility. On the technology side, Siemens delivered its APOGEE suite of building automation and controls as part of an overall building system and energy management solution that also included fire detection, alarm, and emergency air handling system control.

 

Siemens APOGEE BAS provides the data-handling capability necessary to properly monitor building systems and automate complex control functions. The BAS monitors the incumbent operating conditions of energy-intensive systems including the facility's underfloor air distribution, hot water generators, outside-air conditioning, data center cooling units, as well as myriad pumps, fans, and critical fire/life safety and smoke purge systems. The BAS also monitors the heating of the 15,000-gal therapy pool.

 

The APOGEE BAS is configured to alarm in the event that any equipment fails or ambient conditions stray from required setpoints, such as the operation of critical air handler unit fans, or operating/isolation room environmental conditions. The Siemens BAS closely monitors and controls the conditioning and use of outside air, as well as detecting and adjusting air-handling devices based on the predetermined night setback and other occupancy conditions. Because the hospital runs around the clock, the system's responsiveness is vital to overall performance and energy efficiency levels.

 

Each of the on-site facilities engineers at the hospital can be notified in real time if a problem occurs. Siemens' remote paging and notification software allows the operators to immediately receive alarms and monitoring points via cell phones or pagers. Access and control are further facilitated through virtual private network access via the Internet or through PDA-style devices.

 

Load management is critical at all healthcare facilities like Dell Children's Hospital. Unique for the site is a combined heating and power (CHP) plant that serves the electricity, chilled water, and steam needs of the entire campus. The 4.5-MW natural gas turbine-powered CHP supplies all the electricity, chilled water, and steam required by the facility, making it more than twice as efficient as an equivalent coal-fired plant. The BAS automatically trends utility data regularly. With this historical data, facility managers can track costs and troubleshoot equipment operating out of normal ranges, such as power spikes during a given period. The facility owner conducted extensive design versus actual load assessments on all energy consuming systems, from electric to chilled water and steam, using the Siemens BAS monitoring capability and historical database. A 32 percent drop in total energy use was recorded in the facility's first year of operation, despite higher than normal temperatures in Austin during the period.

 

The overall building rating went from 17.2% to 61% above the applicable ASHRAE 90.1 energy efficiency standard for facilities of this type based on the efficiency of the CHP. Lastly, the CHP provides 46% more primary energy use than the conventional grid-to-substation-to-hospital power service model. The two local substations provide backup power to the hospital while an on-site emergency generator provides a third backup for all life/safety systems at the hospital.

 

Yakult Honsha to Commence U.S. Production in 2012

Japanese probiotics pioneer, Yakult Honsha, will commence manufacturing its little probiotic dairy bottles in the U.S. for the first time in 2012, the company has announced, as it seeks to move into eastern seaboard U.S. states.

 

Reuters reported senior international operations managing director, Yoshihiro Kawabata, stating the company would build the facility in an as yet undesignated location to cater for forecast growth.

 

"We are planning to expand our business in the United States, starting sales of our products on the East Coast, in the north and in other areas in the near future," Kawabata told Reuters.

 

Yakult’s probiotic drinks run a distant second to Danone’s DanActive drinkable and Activia spoonable in the US but the company has been building a presence principally in west coast states of California, Hawaii and Arizona.

 

Its entire US product is currently imported from a production facility in Mexico which also happens to be one of the company’s strongest markets outside of its Japanese base.

 

About half of Yakult’s sales occur in Japan, where the product has been established for more than 50 years, with another quarter coming from the Asia/Oceania area and the rest in the Americas and Europe. Sales have hovered around the 25 million bottles consumed per day level since 2005, according to the company’s 2009 annual report.

 

Yakult sells products in 30 countries and has stated it wants to expand to 45 countries in the short to medium term.

 

The company is also expanding its operations in China where it already has two plants and plans to open a third and is set to post its first profit there, albeit modest.

 

While Yakult outsells Danone in Japan and some Asian markets, it has struggled in the U.S., as with Europe, against the might of Danone, which was the first to establish itself in both markets.

 

Danone’s probiotic brands helped drive a rapid expansion of the US and Canadian probiotic foods market that has seen it grow to be worth $1.77 billionn according to Euromonitor figures.

 

Euromonitor predicts the North American market for pro- and prebiotic spoonable and drinkable yogurts will grow to$2.78 billion by 2013, and it will overtake the Asian market in value in 2012.

 

SurModics Opens Facility in Alabama

SurModics has opened a 90,000 sq. ft. cGMP manufacturing and development facility in Birmingham, Alabama, US to support its partnerships and shorten time to market.

 

Roche and Genentech were among the companies to ink deals with SurModics last year. Boosted by these deals SurModics posted a 111 per cent increase in operating income in the 2009 financial year and the expansion is designed to support this growth.

 

Notably, the expansion gives SurModics commercial-scale manufacturing capacity. The company believes this will help clients shorten time to market. Also, it maximizes the opportunity for programs to reach the royalty-generating phase of SurModics’ business model.

 

Work began on the site when SurModics acquired a new building in April 2008. Since then the company has made a significant infrastructure investment to build a current good manufacturing practice (cGMP) compliant facility for parenteral and drug coated device products.

 

Housed at the site is 16,000 sq. ft. of cleanroom production space. This is split into four suites, each with independent air handling systems, to allow SurModics’ to work on multiple drug compounds simultaneously.

 

Half-suit isolators have been installed for aseptic manufacturing, typically of therapeutic proteins, as have a 6,000 gallon water-for-injection system, vial washer, autoclave and depyrogenation oven.

 

To support these operations SurModics has built a 5,300 sq. ft. quality control laboratory and a 2,400 sq. ft. microbiology testing room. These laboratories will monitor the facility and test and release products for clinical and commercial use.

 

Also housed at the site is a 4,600 sq. ft. engineering laboratory for scale up and development of additional processes. Housing all these functions at one location consolidates SurModics’ Birmingham operations.

 

Arthur Tipton, president of SurModics Pharmaceuticals, said that many current and prospective clients have expressed a strong interest in the facility and expanded suite of services now offered.

 

University Research and Funding Examples

It began in 1965 with a simple dilemma, posed by an assistant football coach to a university researcher.

 

Why, coach Dwayne Douglas wondered, were his University of Florida players losing so much weight during games? And could anything be done about it?

 

Researcher Robert Cade began to analyze the problem and soon discovered that fluid loss affected the players' performance, and sometimes their health. He and three colleagues began mixing water, sugar and salt with the idea that the concoction would replace carbohydrates and electrolytes the players lost when they sweat. After false starts because early versions were unpalatable, Cade followed his wife's suggestion to improve the taste by adding lemon juice.

 

The rest, in the annals of university research, was history.

 

Gatorade, as the drink was called, sustained Florida's players through 102-degree heat in a stunning fourth-quarter victory over powerhouse LSU. Soon, Stokely-Van Camp was selling hundreds of thousands of gallons of Gatorade annually. Before Gatorade's 40th birthday, beverage giant Pepsico had acquired the brand and was selling $2 billion worth each year, according to the Web site for Florida's research programs.

 

And money poured into the university -- the payback for developing a great answer to one basic question, and getting the idea to a place where it could generate revenue.

 

"When universities are able to bring products (developed with research funds) to market, the community wins," said Donna Lupardo, the assemblywoman whose district includes Binghamton University.

 

Doing more and better research — that which stimulates the local economy — is key for public universities across New York in general; and specifically for BU, as it begins its search for a new president.

 

Lois DeFleur, BU's president for the past 19 years, will retire July 30. That presents the opportunity for the university to hire a leader who can build on the $35.6 million in research grants the university received in 2008-09.

 

Why is research so crucial?

 

"For every $1 million in federally sponsored research ... it results in 29 jobs in your community," said John B. Simpson, president of the University at Buffalo, the largest of SUNY's four university centers. "Simply put, research is good business."

 

That said, there's no lone blueprint for success. And public colleges within New York are taking different approaches to using the research dollars they attract from funders. (The National Institutes of Health and National Science Foundation are the major players in sponsored academic research, though there are a number of other funding sources.)

 

On the University at Albany campus, millions of dollars of investment in programs at the School of Nanosciences and Nanoengineering have produced jobs for more than 2,500 people. A complex of buildings has sprouted as investment grew, spurring jobs for contractors and other non-university businesses.

 

In 2006 -- the last year for which information is available -- the school and its research and business partners were filing patent applications at the rate of one per business day.

 

Cornell's College of Agriculture and Life Sciences used research funds to develop strategies to help reconfigure school, corporate and home kitchens to promote healthier eating. Federal funding helped develop a winter wheat that yields 5 percent more grain than its predecessors, yet is disease resistant, which helps New York's farmers.

 

At Binghamton, the Center for Advanced Microelectronics Manufacturing opened in 2008 and quickly grew to include a 10,000-square-foot area and clean room for the creation of tiny electronic components for use in such things as household lighting and homeland security. The Innovative Technologies Complex provides office services and equipment to start-up companies that use technology developed at BU for work in the life sciences.

 

BU's 2008-09 figure for research grants is up 37 percent in five years, university spokeswoman Gail Glover said. Still, it trails the larger campuses in New York's state university system.

 

And the entire system needs to attract and do more with research dollars, according to the chairman of the state university system's board of directors.

 

"New York is only beginning to understand the link between the economy and healthy research institutions," said board chairman Carl Hayden, a huge proponent of increasing SUNY's investment in research. "The jobs of this century will be built on intellectual capital."

 

Simpson saw that link as a professor and administrator in Seattle at the University of Washington, where he spent most of his academic career.

 

Eventually, the region built a reputation for a good economy based on innovation and brainpower at Microsoft and other locally based "idea companies" -- many fueled by the research and talent at the university. But 30 years ago, when the manufacturing economy was struggling, jobs were vanishing and so were the people.

 

"I went to the city, and saw this billboard," Simpson said. "It said, 'Will the last person in Seattle please turn out the lights." Seattle eventually lost Boeing Inc. and its jobs to the greener pastures of Chicago.

 

The image of a darkened city is a scenario New York Gov. David Paterson may have had in mind when he announced this month that the state would invest $25 million in seed money designed to help colleges take ideas to market.

Eventually, Paterson said, the goal will be to create more than 9,000 faculty and staff jobs across SUNY, and provide construction employment for another 43,000 people as the university system expands its colleges and medical centers.

 

Meanwhile, back in Florida, the university reports that Gatorade has brought the university more than $80 million to create jobs, build buildings and develop other ideas -- a classic example of what faculty research is meant to do for universities and their host communities.

 

Progenitor Cell Therapy Expands Manufacturing Operations

Progenitor Cell Therapy LLC (PCT), a Hackensack, N.J.-based provider of manufacturing and consulting services supporting the development of cellular therapies, recently announced that the initial phase of construction of its new manufacturing facility in Allendale, N.J., has been completed.

 

The company’s new cell therapy development and manufacturing facility in Allendale is being built to accommodate increasing client demand for clean-room and support space, according to the company.

 

The company-owned 30,000-square-foot facility will provide clients with access to multiple clean-room manufacturing suites, each with independent air-handling and laboratory systems, to support PCT’s existing and future clients with projects ranging from process/product development to phase I-II-III clinical trial, fill/finish operations and commercial product manufacturing, according to PCT.

 

“Progenitor Cell Therapy is proud of the work we have performed for clients over the past 11 years in what was our very first manufacturing facility in Hackensack, N.J.,” said PCT President Robert Preti. “We are excited to now be moving operations into and serving our clients from our third location, a new state-of-art facility which will allow us to combine our multiple East Coast operations into one facility with increased capacity and significant room for continued expansion.”

 

The development of the new facility is a multi-phase project, according to the company.

 

The first phase, now completed, provides for new headquarters for the company’s operations and for the initial installation of the freezer farm.

 

The “freezer farm” unit at Allendale houses several liquid nitrogen (LN2) freezers, designed to provide PCT with storage capacity for customers’ developmental cell lines and candidate therapies.

 

PCT added that when fully operational later this year, after in-progress work is completed, the facility will support everything from the production of trial supplies to process development and commercial manufacturing.

 

The firm, which claims to be the only firm in the US to provide this type of specialist manufacturing capacity, already has one plant in New Jersey in Hackensack as well as one in Mountain View California which is currently being upgraded.

 

Subsequent phases, already underway, will bring the company’s processing, manufacturing and development capabilities online during the remainder of the year, according to the company.

 

$54 million Upgrade at Hudson Valley Community College

In a little more than half of a century, Hudson Valley Community College has transformed its campus from acres of unused land to a nationally-recognized institute that was recently visited by President Barack Obama and which will soon have a state-of-the-art science center.

The college said that it has secured all of the funding needed for its $54 million construction project which will include a new $35 million science center and building renovations.

Between 100 and 150 construction-related jobs are expected to be created, officials said.

Construction for the 100,000 square foot center will begin in the summer of 2011 and will conclude in the summer of 2013. Before construction starts on the four-story edifice, the head architect firm for the project, East Greenbush-based Mosaic Associates, will conduct research and interview faculty and staff about the needed aspects of the building’s design, said Drew Matonak, the college’s president.

“As the college continues to serve the Capital Region, we will continue to grow and expand and upgrade our facilities,” said Matonak. “Hudson Valley Community College must be poised to offer a 21st century education that meets the needs of the 21st century workforce. To do this, the college’s academic buildings must have the academic atmosphere and technology that empowers students to learn and to thrive in 21st century laboratory settings.”

The new science center, planned to be located west of Brahan Hall on the Route 4 side of campus, will include classes for biotechnology, biological sciences, chemical technicians, and environmental sciences. It will have 33 laboratories, 18 classrooms, a study area, storage areas, 60 faculty offices, and a science conference room.

“We are thrilled to bring a team of international experts to work with Hudson Valley Community College in bringing to life the vision of an advanced, modern facility that will inspire students and faculty alike,” said Hana Panek, a partner with Mosaic Associates. “Realizing the significant role community colleges will have on the future of teaching, research and workforce training, the new science center will evoke a vital presence on campus and serve as a vital resource in our community.”

About $19 million will be spent on renovating Amstuz Hall and Fitzgibbons Health Technologies Center, and other related projects. These renovations are set to start following the major construction in the spring of 2013 and end in the summer 2014, officials said.

The funding for the construction has come from a $27.2 million bond resolution passed in December by the Rensselaer County Legislature and another $27.2 million from the state’s Dormitory Authority.

“Hudson Valley Community College is one of the outstanding community colleges in the nation, and the county legislature is proud to continue our strong support for this great educational resource,” said Legislator Judith Breselor, R- District 4, chairwoman of the legislative body’s education committee.

There are 7,000 students, of the 13,500 enrolled at the school, taking science courses and the college officials expect this to annually increase 4 to 5 percent.
“It wouldn’t hurt to do these changes. It’s certainly good to do updates like this every now and then considering changes in technologies,” said Erik Benamati, a sophomore at Hudson Valley Community College.

The county approved Troy-based U.W. Marx Construction Company as the project manager.

Green building materials are expected to be used in the project.

“In bad times, we prepare for the good times. The college has provided, and I am certain will continue to provide the educational programs that students need and that will enable them to pursue careers not only in current fields, but in emerging industries as well,” said Rensselaer County Executive Kathy Jimino.

While developing a master plan for the college’s master plan in 2006, school officials determined such a science center was needed and included the construction in their final master plan in 2007, said Matonak.

Due to the increases in enrollment and in offered programs, parking has become a problem at the school. A parking garage project is underway at the school which will relieve this issue, said Matonak.

With many of the buildings dating back to the 1960s, Matonak hopes the new science center and renovations will better prepare students for careers in police forensic labs, hospitals, dentistry, zoology, botany, meteorology and veterinary sciences.

Pres. Obama, who has emphasized the important of community colleges, made a short visit to the school in September.

 

University of Florida Receives $15 Million, and Berkeley Lab Obtains $12.8 Million in ARRA Funding

The University of Florida's (UF) Institute on Aging has received close to $15 million from the NIH through the American Recovery and Reinvestment Act (ARRA) to construct an almost 40,000-square-foot complex for clinical and translational research. Separately, Lawrence Berkeley National Laboratory (LBNL) was awarded $12.8 million in ARRA funding by the NIH for research into cancer, neurodegenerative diseases, radioactive decontamination, and a variety of other health conditions.

 

The UF building is expected to bring together scientists from a range of disciplines to enhance aging research on the campus. “This is a unique opportunity to have basic science, clinical, epidemiology, and health services researchers working under the same roof on a common goal of improving the health and independence of older adults,” says Marco Pahor, M.D., principal investigator of the grant and director of the UF Institute on Aging.

 

The facility will reportedly make it easier for mobility-restricted older adults to take part in clinical trials. There will be facilities for clinical-research recruitment and assessment, laboratories, training, conferences, and lifestyle intervention including an indoor walking track, demonstration kitchen, and a behavioral counseling suite.

 

The project is estimated to create or retain about 376 jobs, three quarters of which will be construction-related. The remaining jobs include 30 faculty positions as well as graduate assistants and support and administrative staff.

 

The new grant comes on the heels of a recent $64 million NIH research award to the UF Institute on Aging to study whether physical activity can help prevent mobility disability and other morbidities in older adults. Together the institute's researchers have more than 90 active NIH and other grants in basic, clinical, and translational science totaling more than $200 million and almost 150 pending grant proposals that would garner close to $200 million more.

 

For Berkeley Lab, today’s NIH grants bring its total ARRA funding to more than $240 million in areas covering energy, computing, and general science, as well as infrastructure projects. “The Recovery Act grants from NIH have allowed us to create quite a few new positions for scientists, technicians, research associates, and postdoctoral fellows as well as retain some jobs,” comments Joe Gray, associate laboratory director for life sciences.

 

The $12.8 million will go to 14 individual research projects ranging from disease investigation to the development of tools for medical researchers. The largest single grant is $4.2 million for a two-year research project to develop treatments for contamination by radioactive actinide particles such as those from nuclear accident fallout or a dirty bomb.”

 

The only existing method of mitigating risks of actinide contamination is a treatment developed in the 1950s that must be given through an injection, which would not be viable in a situation where residents of an entire metropolitan area must be injected in a matter of hours. Further, this agent, known as DTPA, is effective only on a few actinides, Berkeley Lab points out.

 

Two molecules that have been developed at Berkeley Lab to sequester actinides can reportedly target a much wider range of actinides, the most well-known of which are uranium and plutonium. These compounds help excrete up to 90% of the radioactive particles within 24 hours. Additionally, given doses over subsequent days, nearly complete excretion is possible, the researchers say.

 

“The ARRA funding will enable us to proceed with preclinical development of two compounds that have been designed and tested,” says scientist Rebecca Abergel. “They are very promising. We have not observed major toxicity issues, and the efficacy is in the range we want it to be. What we want to accomplish in the next two years is to gather data to get approval from the Food and Drug Administration.”

 

The Berkeley Lab research group, led by GTSC director, Kenneth Raymond, will partner with SRI International and the Lovelace Respiratory Research Institute to conduct toxicology and pharmacology tests with the goal of filing an investigational new drug application with the FDA in two years.

 

Other Recovery Act awards to Berkeley Lab from NIH include:

 

 

 

 

 

 

 

 

 

 

Catalent and Compass Boost Blister Capacity

New Jersey, US-based contractors Catalent Pharma Solutions and Compass Pharma Services expanded their respective blister pack offerings, both citing growing drug industry demand.

 

Catalent said that the installation and validation of a Zed in-line blister card sealer at its facility in Philadelphia is “beneficial for both small and high-volume clinical trial packaging.”

 

The firm also highlighted the unit’s filling capacity that allows eight different blister strips to be processed simultaneously, which it said is ideal for the complex card designs that are increasingly being used in clinical trials.

 

Frank Lis, VP of the Catalent’s Clinical Supply Services Unit, said that that investment recognizes customer “needs for new strategies to streamline supply chain management.”

 

January has been a busy month for Catalent's trial packaging Operations with the latest expansion following hot on the heels of the addition of a Harro Hofiger Omindose filling unit at its facility in North Carolina.

 

In contrast, Compass’ expansion is more geared towards commercial scale production. The firm added an Uhlmann thermoformer UPS4 unit at its plant in Clifton.

 

COO Tony Fenno explained that demand for unit dose packaging continues to grow among Compass’ customers in both the pharmaceutical and nutritional supplements sectors and that the investment “was necessary to keep pace.”

 

Fenno added that the new machine “supports Compass’ business strategy of providing contract pharmaceutical packaging services with the same quality and consistency of in-house production.”

 

REST OF WORLD

 

WuXi PharmaTech Passes EMEA Inspection of Facilities in Shanghai

WuXi PharmaTech, a pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China and the United States, announced that it received the formal certificate of GMP compliance from the Medical Products Agency (MPA) of Sweden, acting on behalf of the European Medicines Agency (EMEA), for its c-GMP drug product manufacturing and analytical testing facilities located in Shanghai.

 

WuXi produces solid oral dosage forms-tablets and capsules-for use in clinical trials in its Shanghai c-GMP manufacturing facility. In its analytical testing facility, WuXi develops and validates methods of analyzing APIs and formulated drug products for properties such as potency, purity and solubility. The company also offers compound stability tests and tests necessary for the release of APIs and drug products for clinical trial use. WuXi also delivers services related to regulatory compliance with chemistry, manufacturing and controls, or CMC, requirements, including creation of a readiness testing package for an Investigational New Drug filing and development of a full CMC package.

 

"We are very pleased to have passed this EMEA audit," commented Dr. Ge Li, Chairman and Chief Executive Officer of WuXi PharmaTech. "The agency's inspection outcome confirms that these two facilities meet international GMP standards.

 

"We pride ourselves on the quality of our facilities, processes, and people," Dr. Li continued. "Research manufacturing and analytical testing are important functions in a continuum of integrated drug discovery and development services that WuXi provides to our global customers. Our mission is to help our global customers to improve the success of discovery and shorten the time of development of new medical products."

 

Parexel Opens another Early Phase Unit in South Africa

Parexel has opened a 40 bed early phase clinical trial unit in South Africa, increasing its Phase I capabilities in the country and adding to its patient recruitment focused SuperSites network. South Africa has a treatment naïve and generically diverse population which makes it easier for contract research organizations (CRO) to quickly recruit patients for clinical trials. Parexel has recognized and benefited from this, leading to it adding a third early phase unit in the country.

 

The new site in Port Elizabeth brings Parexel’s global early phase capacity, including the two other South African units in Bloemfontein and George, to 580 beds. Parexel believes this is among the largest early phase capacities in the world.

 

At the Port Elizabeth site Parexel will conduct early phase studies in patients, from first in man to proof of concept. This is the core focus of the unit but it will also conduct a variety of studies on healthy volunteers.

 

Patients and healthy volunteers will be recruited using the tools and techniques Parexel deploys at its SuperSites. These include using dedicated patient recruitment specialists, building relationships with local health care professionals and drawing on its database.

 

Fast recruitment is generally welcomed because of its positive impact on drug development timelines, an important issue for pharma and biotech, but Parexel believes there are additional benefits.

 

"Increasing the number of patients per site and reducing the overall number of sites in a study serves to decrease variability--improving study quality and reproducibility", explained Michelle Middle, corporate vice president and worldwide head of early phase at Parexel.

 

The Port Elizabeth unit will be integrated into Parexel’s early phase network, which spans three continents, by using harmonized systems that help handle complex global studies.

 

Helvoet to Build Parenteral Component Plant in India

Helvoet Pharma is to build a €14m ($10m) rubber parenteral packaging component facility in India to meet rising demand for products made to international quality standards.

 

The growth of the Indian generic market is driving demand for parenteral devices and this is now accompanied by rising quality standards. Helvoet Pharma believes this creates an opportunity for a company with an established reputation to set up a facility operating to international standards.

 

Currently there are two to three domestic companies producing components of a similar quality, said Jean-Paul Thans, vice president, sales and marketing at Helvoet Pharma.

 

Despite this competition Thans believes Helvoet will capture a share of the market. Thans stated that Helvoet’s reputation as a reliable, global supplier and use of the same standards and equipment in its Indian, U.S. and European plants will attract business.

 

When the site is operational in 2012 it will employ 30 to 50 people and manufacture a limited range of very standardized products for use by domestic companies. The site and product portfolio may be expanded in the future.

 

This expansion could add price sensitive components for exportation to the rest of the world, according to Thans. By adding this capacity Helvoet would be able to reduce the production costs of components used by companies in Europe, the US and Asia.

 

Construction work on the facility, which will be located near Pune in Maharashtra state in Western India, will start in the third quarter. The facility will be housed in a newly developed industrial zone with a secure energy supply, good transport links and access to trained personnel.

 

Helvoet currently does around €2m of business with companies operating in India but these products are mainly for re-exportation. The new facility will be its first in Asia.

 

PerkinElmer Opens New Lab in Chennai, India

PerkinElmer has opened a new lab in Chennai, India, focused on expanding its fetal, maternal, and neonatal health-screening capabilities in that country. The firm also said that it has launched a collaboration with MediScan Systems, a referral diagnostic ultrasound center in South India with a focus on fetal medicine.

 

Caleco Pharma Signs Lab Facilities and Service Agreement with Natac Research

Caleco Pharma Corp., a biopharmaceutical and consumer health products company focused on developing a broad pipeline of products derived from natural sources, has reported the signing of a Laboratory Facilities and Service Agreement with Natac Biotech S.L., a Spanish biotechnology corporation engaged in the research and development of health related products. Under the terms of the Agreement, Natac, through its subsidiary Natac Research, has agreed to provide Caleco with the services of senior research scientists and the associated laboratory facilities, which are located at the Universidad Autonoma de Madrid. The lab facilities are state-of-the-art facilities specifically oriented toward the identification, isolation, extraction and standardization of unique biologically active compounds from plants and oils. This coincides with Caleco's business plan to develop health and wellness products derived from plants and oils into over the counter supplements, dermatologic products and prescription drugs.

 

Singapore Biotech Sector Churns On

The country's biotechnology industry, which made progress in 2009 despite a recession-beset year, is expected to continue making strides in 2010, according to government officials.

 

Two months into the new decade, local industrial developer and landlord JTC announced it will spend up to S$100 million (US$70.8 million) to expand the Biopolis project by 40,000sqm (430,400 sq. ft.). The biomedical research and development (R&D) hub was opened in 2004.

 

The government entity also revealed plans to establish a new medical technology cluster in the western part of the island-state, which will encompass warehouses, laboratories, sterilization facilities, equipment manufacturers and other supporting industry players.

 

These expansion efforts will be rolled out in phases spanning three years until 2013.

 

Beh Kian-Teik, director of biomedical sciences at the Singapore Economic Development Board (EDB), said, "continued to draw a steady stream" of R&D announcements in 2009, in spite of the challenges that confronted the global pharmaceutical and biotech sector. Biotech, which is sometimes referred to as the life sciences industry, is one of the EDB's focus verticals.

 

Beh said one such R&D initiative is S*BIO, a local biotech company poised to receive over US$600 million through licensing agreements with Onyx Pharmaceuticals and Tragara Pharmaceuticals.

 

"Today, over 50 small and midsize global biotech and medical technology (medtech) companies carry out activities ranging from R&D to manufacturing, and even [locating their] headquarters in Singapore to fully leverage the city-state's strategic location to expand their outreach into Asia," he noted.

 

Biologics, in particular, has grown significantly, he said. The industry segment has attracted leading companies such as Baxter, GlaxoSmithKline and Lonza, which have collectively invested US$2 billion in six major projects.

 

"Within the past five years, Singapore has extended from its strong track record in chemical-based active pharmaceutical ingredient (API) manufacturing and made great strides in complex biologics manufacturing despite starting from scratch," Beh noted.

 

"Most recently in 2009, [Swiss company] Roche opened its first US$500 million biologics facilities in Asia, while Baxter commenced construction of its first biopharmaceutical plant in Asia that will manufacture Advate," he added. Advate is used on patients who have hemophilia, a blood disorder.

 

Beh highlighted that over the next few years, the biologics sector will employ more than 1,000 skilled employees trained in the companies' global and local facilities.

Lim Tit Meng, assistant professor at the National University of Singapore, noted that "commendable progress" has been made in the pharmaceutical domain. Drug development and production, along with aquaculture and agriculture, are the more advanced biotech areas, he added.

 

Emerging biotech fields, said Lim who is also chief executive of the Science Centre Singapore, lie in the areas of water treatment, waste processing, green energy and bioengineering innovation.

 

A spokesperson from A*Star (Agency for Science, Technology and Research) reported that between 2006 and 2008, scientists in its affiliated biomedical research institutes and units generated 1,927 papers in international peer-reviewed journals and 216 priority patent applications. In that same period, A*Star was engaged in 66 industry projects including research collaborations with France's Humalys and Switzerland's Cytos Biotechnology to develop human monoclonal antibodies against infectious diseases.

 

"Growth in the last three years has been significant compared with the earlier five-year period (from 2001 to 2005), during which only 1,010 papers were published, 154 patent applications filed and 32 projects carried out with the industry," she said, adding that A*Star currently employs close to 1,000 biomedical researchers from over 50 countries.

 

According to the spokesperson, Singapore's advancements in biotech are playing an increasingly important role in manufacturing. "The biomedical manufacturing industry was responsible for 7.6 percent of the country's total manufacturing output in 2008, almost double the 3.9 percent [recorded] in 2000--[representing] a compound annual growth rate of 10 percent."

She attributed these achievements to the country's focus on developing human capital, intellectual capital and industrial capital.

 

Going forward, the challenge remains for Singapore to "capitalize on the good start" it has made in research and clinical trials, and to sustain growth, the A*Star spokesperson noted. The country will also need to stay ahead of the competition, in particular, from China and India, she said.

 

Haupt Pharma Completes FDA Inspection

Haupt Pharma has completed a successful inspection by FDA at its site in Italy. The inspection covered all areas of the organization and systems involved in the production of sterile penicillin products. Following the seven-day audit, the site is now approved to produce two sterile penicillin antibiotics for the U.S. market.

 

“We have reached an important milestone by successfully passing the FDA inspection in Latina, which confirms the high standards of good manufacturing practice at our company," said Hans-Christian Semmler, chief executive officer.

 

This first pre-approval inspection at the Latina site was triggered by the submission of two pre-approval supplements for sterile penicillin products from one of Haupt’s customers.

 

The company is now able to deliver from five FDA-inspected sites in Italy and Germany for the U.S. market.

 

Quintiles Launches New Testing Services in China

Quintiles has expanded its capabilities to include anatomic pathology services through its central lab in Beijing, China, in an effort to help biopharmaceutical companies develop more effective cancer treatments. These services complement assay development, digital pathology and core lab offerings available through the facility to help customers comply with China’s restrictions on tissue import/export.

 

“Within China, we are providing the tools and infrastructure to investigate cancer and match patients with optimum treatments for their genetic makeup,” said Christopher Ung, vice president strategic business and operations, Oncology for Quintiles. “These capabilities enable personalized medicine and enhance oncology research to bring medicines to market faster.”

 

Additionally, the Beijing anatomic pathology lab was accredited by the College of American Pathologists (CAP). This accreditation is issued following an on-site evaluation by a team of practicing lab professionals who examine records, quality control, staff qualifications, equipment, safety, and overall site management.

 

Thermo’s New UK Facility to Manufacture Chrom Products

Thermo Fisher Scientific has announced the opening of a new research facility in Runcorn,Cheshire, for the study of anatomical pathology. The facility is the largest Thermo center in northern England and one of its biggest in the UK.

 

Thermo manufactures products used in hospitals and laboratories around the world, helping doctors treat patients and scientists to advance human knowledge. Thermo chose the Northwest of England as home for the new facility due to the strength of the region’s academic, hospital, pharmaceutical and biotechnology industry sectors. The new facility has created approximately 60 new jobs, and the total workforce onsite is now more than 200. UK Trade and Investment worked closely with the North West Regional Development Agency to ensure that Thermo’s requirements were met.

 

The facility houses Thermo’s Anatomical Pathology and Chromatography Consumables businesses. This includes products and services to improve the detection and diagnosis of cancer and advance research for drug development. In 2009, Thermo Fisher Scientific consolidated operations from locations in California and Eastbourne, UK to Runcorn. The facility’s R&D Director has relocated from the U.S. to oversee product development. The Anatomical Pathology business is uniquely positioned to serve the need for new and more effective diagnostic technologies and treatments as cancer rates increase around the world.

 

The new facility is also a manufacturing center for Thermo’s Chromatography Consumables business. These products are used in laboratories specializing in chromatography and mass spectrometry analysis. They enable detection, quantification and isolation of complex sample mixtures that are commonly encountered in pharmaceutical, environmental, biomedical, chemical, toxicology, forensics and food safety industries. The state-of-the-art technology developed in Runcorn enables the company to meet demands for more specific and sensitive yet robust testing to support its customers.

 

Giulio Cerroni, the company’s vice president of Anatomical Pathology commercial operations in Europe, the Middle East and Asia Pacific, says of the new facility: “We are delighted to announce the opening of the new Thermo Fisher Scientific facility in Runcorn, Cheshire. This is an important investment for the company, and we are already considering the next phase of development for the site. As the world leader in serving science, our customers and suppliers rightly expect that we set very high standards in our operations. The new facility in Runcorn demonstrates the company’s commitment to better serving our customers by investing in the future of the business.”

 

The facility was officially opened by Yuh-geng Tsay, president, Specialty Diagnostics and Roger Platt, chairman, Northwest Science Council. The ceremony also included presentations by Steven Broomhead, CEO, NWDA and Thermo Fisher Scientific customers.

 

PPD Singapore Lab Okayed by CAP

PPD’s recently opened laboratory in Singapore has been accredited by the U.S. College of American Pathologists (CAP).

 

The laboratory, which was set up in September last year to provide early-stage analysis services, was deemed to meet all of the CAP’s criteria for data that can accelerate drug development and improve patient safety.

 

The unit is the fourth facility owned by the US contract research organization (CRO) to have been approved by the CAP.

 

Steve Lobel, vice president of PPD's global central laboratory operations, said that: “Achieving CAP accreditation six weeks after opening our Singapore facility demonstrates the expertise of our scientists and our commitment to excellence."

 

Elder’s New Plant Will Boost Sales

Indian drugmaker Elder Pharmaceuticals says its new manufacturing plant in Dehradun, Uttarakhand State will boost sales 15 per cent and provide capacity for expansion in overseas market.

 

The INR1.5 billion (€23 million) facility, will make sterile injectables including antibiotics like cephalosporins which, according to company director Alok Saxena, “offer a good opportunity both for the domestic as well as export markets.”

 

The global market for injectables is growing at a rate of around 11 per cent a year and is predicted to reach a total value of $245bn with generics generating around $500m a year, according to figures quoted by the Economic Times.

 

These numbers clearly support Eldar's belief in the market's potential as does Pfizer deal with Strides last month in which the US major cited expansion into generic injectables as a key driver for the agreement.

 

Injectables aside, Elder's new facility will provide the firm with other benefits according to Saxena. He said the firm plans to centralize the production of syrup-based drugs in Dehradun in a move expected to provide significant cost advantages.

 

He added that: “We expect the new facility to add 15 per cent to our revenues,” which grew 28 per cent last year on significant gains made by key products like Shelcal, Chymoral Forte and Formic-O.

 

Elder also believes that new facility’s location in one of India’s “excise benefit zones” where taxes are not levied pharmaceuticals that are shipped overseas will help its efforts to grow outside India.

 

The firm is the second Indian drugmaker to have highlighted the benefits of these zones in as many weeks, following hot on the heels of Sohm India which formed a partnership with a manufacturer based in Himachal Pradesh .

 

In related news, operations at Elder’s subsidiary in Bulgaria began. The unit, which is one of three acquired in the country, will be responsible for the distribution of the firm’s drug products nationwide.

 

Symrise and International Flavors & Fragrances Invest in Russia and Singapore

Symrise is extending its reach in two high potential developing markets, with the acquisition of a new facility in Russia and the opening of a new plant in Singapore.

 

In the nine months of the current financial year reported to date, about 41 per cent of Symrise’s €352.4m sales came from regional and local customers in emerging markets. The German flavor and fragrance company has described emerging markets as its “growth drivers”.

 

It is now building on its long history in Russia with the acquisition of property and buildings from Aromaros-M Group. The main building has around 3500 square meters (37,660 sq. ft.), and will be the hub of new production facilities and laboratories that will focus initially on dry blends.

 

The value of the property acquisition has not been disclosed, but Symrise says it will help it increase its penetration in the local market, and prove helpful to global customers as it is closer to the target region. It will serve not only Russia, but the CIS states too.

 

Heinrich Schaper, president of flavor and nutrition for Symrise EMEA, said: “The establishment of a fully integrated facility in Russia enables us to service them faster and more directly, and it will provide an important advantage to our partners in our mutual drive for sustainable business growth”.

 

In 2008, Symrise set up new sensory testing labs for sweet, savory and testing labs.

 

But it is by no means the only flavor firm gaining a foothold in the country. In December International Flavors and Fragrances announced the opening of its new Moscow facility.

 

Symrise celebrated the opening of a new plant in another high potential market, Singapore. Billed as state-of-the-art, with energy- and waste-saving features built in, it dedicated to liquid flavors, for use in beverages, ice cream and dairy products.

 

DEO Dr Heinz-Juergen Bertram called Singapore “a highly innovative market and, therefore, an ideal location for trendsetting technology”. The plant was built with cooperation from the Singapore Economic Development Board, which promotes Singapore as a prime business location.

 

Such a local set up is said to help Symrise respond better, more quickly and more flexibly to the needs of its customers in Singapore and South Asia. Around 50 per cent of the flavors Symrise produces in Singapore for the South Asian market are for Asia Pacific.

 

In 2008 Symrise opened a new plant for flavor encapsulation in Singapore. Over the next three years it plans to invest some 40m Singapore dollars in the location.

 

SCM Gets Grant for Expansion Plans

UK CMO SCM Pharma says a grant from UKTI is a boost for expansion plans and efforts to win clients in key pharmaceutical industry R&D hubs.

 

The firm, a supplier of specialist contract fill and finish services, received £30,000 from the UK Trade and Investment (UKTI) which, according to SCM managing director Shirley Dann, will supplement global expansion plans.

 

Dann said that: “We will be using the grant to help us market to these new territories in terms of raising SCM Pharma’s profile, communicating our specialist services and generating enquiries.

 

“We will be looking to promote our services in the USA along with Northern and Western Europe. These territories have being identified as geographic markets with significant levels of R&D and include companies with needs that fit our offerings.”

 

Dann explained that the grant is a significant boost for the firm’s promotional efforts, adding that: “It will help us carry out activities that we might not have been able to do in order to help us raise awareness of SCM Pharma in new markets.”

 

She also said the award is recognition of SCM’s strength in “a niche area…in which we are offering specialist growing services such as the production of potent and radio-labeled products and products of biological origin we believe that these are in line with current market trends.”

 

UKTI international trade advisor Craig Daglish, who will work with SCM on a 10-month promotional campaign, predicted that the firm’s range of manufacturing services will be of significant interest to a number of pharma and biotech companies worldwide.

 

HST Global Identifies Global Partner for Panamanian Treatment Facility

HST Global, Inc. announced that it has identified a global partner for the possible development of a Clinical Treatment Facility in Panama. This information signifies HST Global’s commitment to develop Cancer Treatment Centers worldwide. HST Global is relying on international markets to reach a worldwide audience. The Company is continually being presented with opportunities to bring its integrative science-based cancer treatment protocols to a global population. Mr. Ron Howell, CEO and President of HST Global, Inc., stated, “At HST, we continue to take advantage of the relationships we have groomed over the past year. The fact we have partners that are familiar with the demographic idiosyncrasies, economic conditions and political climate of a particular region is invaluable during the initial stages of developing a facility. Through this partnership, we will be able to exploit this indigenous knowledge as well as leverage and align our resources in an effort to develop our Panamanian Treatment Facility.”

 

Perfecseal's Puerto Rico Facility Registered to ISO 13485

Perfecseal has announced registration to the ISO 13485:2003 Medical Device Quality Management System for its facility in Carolina, Puerto Rico. This completes the registration of all U.S.-based Perfecseal facilities to this Quality Management System and brings the total number of Perfecseal facilities registered to ISO 13485:2003 to six, including the Perfecseal facility in Derry, Northern Ireland. Perfecseal’s five U.S. locations include: Carolina, Puerto Rico; Philadelphia, PA; Mankato, MN; Oshkosh, WI; and New London, WI.

 

Perfecseal, a division of the Bemis Co., offers a range of medical device and pharmaceutical packaging solutions. The international company specializes in the manufacture of coextruded films, laminated films, flexible forming films, foil barrier films, pouches, bags, thermoformed trays, lids, labels, heat seal-coated DuPont Tyvek, and heat seal-coated medical-grade paper. Perfecseal has facilities located in Oshkosh and New London, WI; Mankato, MN; Philadelphia, PA; San Juan, PR; Londonderry, Northern Ireland; Selangor, Malaysia; and Suzhou, China. 

 

Watson Buys Eden Biodesign

US generics group Watson Pharmaceuticals has bought UK contract biomanufacturing specialist Eden Biodesign.

 

The deal, worth some $15m (€10.7m), sees New Jersey- headquartered Watson take control of Eden’s dedicated biologics production plant in Liverpool as well as its contract development and manufacturing business.

Watson first gained a 36 per cent share of Eden in December when it took over fellow generics firm Arrow Group. At the time Watson said that the Liverpool manufacturer provided a “long-term foundation for biosimilars.”

 

This point was reiterated by Watson CEO Paul Bisaro who said that: "Completing the acquisition of Eden is the next strategic step in our commitment to establishing a major position in biologic products on a global basis."

 

"In addition to development and manufacturing facilities, the Eden acquisition adds substantial intellectual capital to Watson's biologics activities, as Dr. Crawford Brown and the Eden management team will remain with Watson.”

 

The manufacturing capacity and expertise that Eden brings with it removes one of the key barriers to entry in the biogenerics sector, namely that the production of biologics is more complicated than traditional small-molecule therapies.

 

This point was stressed by Crawford Brown, Eden Biodesign CEO, who said his firm is “delighted to become part of Watson Pharmaceuticals and excited by the prospect of accelerating their biologic development strategies.”

 

“Our passion and commitment to serving our customers remains undiminished and I firmly believe that the resources and market expertise now available to us will prove to be of tremendous benefit to Eden Biodesign’s current and future client base.”

 

Canadian CMO Patheon Will Consolidate its Puerto Rican Facilities

Canadian CMO Patheon will consolidate its Puerto Rican activities at its facility in Manati and sell or close its plant in neighboring Caguas by 2011.

 

The two manufacturing operations in Puerto Rico have underperformed for Patheon since the firm acquired them from Mova Pharmaceutical in 2004.

 

In recent months these difficulties have continued, particularly in Q3 when process optimization problems that impacted on batch release were deemed to have played a large part in a 45 per cent drop in the firm’s EBITDA.

 

Nevertheless, prior to the latest announcement all the indications were that the Canadian contract manufacturing organization (CMO) had resolved the problems and that both plants were back on track under the leadership of new VP of operations, Francisco Negron.

 

Now however, the situation seems to have changed. CEO Wes Wheeler said that, despite continued demand for contract pharmaceutical manufacture in Puerto Rico, for Patheon it is no longer practical to operate two plants within close proximity of one another.

 

He added that, therefore, the firm “will consolidate our people, resources and investments at Manati and therefore concentrate on growing one 'flagship' site” and that available positions would be offered to staff at Caguas.

 

Luis Fortuno, Governor of Puerto Rico said: "We appreciate Patheon's contribution to the continued economic growth of the northern most region of the island, as well as its efforts to maintain its operations as the sole provider in Puerto Rico of contract development and manufacturing services to the global pharmaceutical industry."

 

The firm expects the consolidation process will cost $7m (€4.7m) on its completion at the end of 2011 and will result in the accelerated depreciation of Caguas assets of another $7.0 million during the 2010-2011 period.

 

Gorbec Pharmaceutical Announces GMP Laboratory in China

Gorbec Pharmaceutical Services, a rapidly expanding contract developer and manufacturer of prescription pharmaceutical products, is opening a GMP-compliant analytical laboratory in Yantai, China. This new facility will expand Gorbec's current services for analytical method development and testing. Gorbec is taking this action to better serve its U.S. customer base as well as develop a presence in the emerging Asian market.

 

Gorbec currently provides complete development, regulatory, analytical, and manufacturing services for U.S.-based customers. Gorbec's future plans call for an increased capacity to develop and submit New Drug Applications (NDA'S) and will require an expansion of analytical services. In an effort to improve efficiencies and reduce costs, the company has elected to locate the new analytical facility in China. The company's core business services, current 26,600 sq. ft. analytical laboratory, and commercial manufacturing will remain in the U.S. The China facility is expected to open May 1st, 2010 but Gorbec is already working with customers who have plans to use some of the new facility's capacity.

 

The Yanti facility will operate under the direction of Gorbec's Vice President of Analytical Chemistry, Dr. Jing Chen. Dr. Chen received her PhD from Stanford University and brings a wealth of pharmaceutical experience to the operation.

 

Gorbec's Founder and CEO, Mike Gorman added, "We are very excited about our future and our ability to offer a GMP laboratory in China. This new location will allow us to serve our own needs as well as the needs of companies looking to develop and distribute pharmaceutical products for the Asian Market."

 

Esco Adds Manufacturing Floor Space

Esco announces new Singapore manufacturing facility expansions which will add an incremental 100,000 sq. ft. manufacturing floor space to existing operations. This will enable Esco to eventually double manufacturing capacity for laboratory and controlled environment equipment products. Esco will commence outfitting the new facilities in Jan, 2010.

 

"The expanded, modern facility provides us with better manufacturing conditions that will enable Esco to drive quality, productivity, customer satisfaction and innovation to the next level," said XQ Lin, Esco Vice President. "Concurrent investments in state-of-the-art laser/sheet metal processing machinery/robotics have also been made, to enable Esco to design/build the best quality in our products."

 

Esco has been on a path of rapid growth, which is expected to accelerate, with the introduction of many new product lines in 2010.

 

About Esco

Since 1978, Esco has emerged as a leader in the development of controlled environment, laboratory and cleanroom equipment solutions. Products sold in more than 100 countries include air showers, biological safety cabinets, downflow booths, ductless fume hoods, fan filter units, hospital pharmacy isolators, IVF workstations, lab animal research products, laboratory fume hoods, laboratory incubators, laboratory ovens, laminar flow cabinets, microplate shaker/incubators, modular cleanrooms, PCR cabinets, thermal cyclers and instrumentation, and powder weighing balance enclosures.

 

Catalent Expands Capabilities at German Facility

Catalent Pharma Solutions (Somerset, NJ) expands capabilities in the company’s Schorndorf, Germany site, to include a new potent products area. This important new capability enables Catalent to provide customers with complex and innovative dose-form production, over-encapsulation, and packaging solutions for potent products at its Schorndorf site.

 

“We believe the addition of this new potent handling and over-encapsulation area will help to meet the needs of our customers, both global and local,” says Eric Schmidhaeuser, managing director of the Schorndorf operation, Catalent. “I am also pleased that this investment was made here in Schorndorf, as it builds upon our team’s commitment to operational excellence, our regulatory track record, and our consistent focus on meeting our customers’ needs.”

 

For about 50 years, Catalent’s Schorndorf operation has provided a broad range of services to global, regional, and local pharmaceutical customers. Catalent provides oral dose form development, manufacturing, and packaging services, as well as comprehensive supply chain solutions.

 

In the fall of 2009, Catalent’s Schorndorf facility successfully completed an FDA inspection adding to a long track record of regulatory compliance, including German and other European Union and international regulatory authorities.

 

Sanofi-Aventis Enters Joint Venture in China

French drugmaker Sanofi-Aventis said it has formed a joint venture with Chinese drugmaker Minsheng Pharmaceutical Co. Ltd. focusing mostly on vitamins and mineral supplements.

 

The joint venture focuses on the largest consumer healthcare segment in China, where Minsheng sells the 21 Super-Vita multivitamin brand.

 

Sanofi-Aventis will hold a majority equity stake, though terms of the deal were not disclosed.

 

Sanofi-Aventis and other U.S. and European drugmakers have expanded their research and manufacturing presence in Asia in recent years. Sanofi-Aventis operates three manufacturing sites in China and announced a research and development expansion there in 2008.

 

The Paris-based company is the world's top maker of vaccines and fifth-biggest prescription drugmaker by revenue, with blockbusters including blood thinners Plavix and Lovenox and Lantus insulin.

 

Also, Sanofi-Aventis said regulators cleared its $1.9 billion purchase of Gold Bond skin products maker Chattem Inc. The drugmaker had agreed to buy the Chattanooga, Tenn., company in December for $93.50 per share, gaining products like Icy Hot pain relief creams and Selsun Blue shampoo.

 

Roche Invests in Singapore-Based Center for Translational Medicine

Roche is ploughing CHF 100 million (roughly $94.94 million) into the establishment of a Hub for Translational Medicine in Singapore. The company’s vision is to set up a public-private partnership that combines its own expertise in translational medicine and clinical development with the complementary capabilities of Singapore’s network of research and medical institutions.

 

The Roche-Singapore Hub for Translational Medicine center will focus on expanding scientific knowledge of disease biology to accelerate the development of personalized treatment approaches. Employing about 30 scientists, the center will be led by a steering committee comprising members from Roche and participating Singapore institutes, which will define strategic directions and oversee research.

 

Roche claims Singapore’s research institutions offer outstanding scientific excellence combined with state-of-the-art translational medicine facilities. “The powerful combination of intellectual and technology capabilities together with outstanding government commitment at the heart of this collaboration will provide a unique opportunity to drive personalized healthcare,” claims Jean-Jacques Garaud, global head of Roche pharma research and early development.

 

“Leveraging Singapore’s close-knit research community and clinical research infrastructure, companies are well-positioned to develop cost-effective, efficacious therapies more quickly for Asia and global markets,” adds Professor Edward Holmes, M.D., chairman of Singapore’s National Medical Research Council. “Within just one decade, Singapore has emerged as a key partner for leading pharmaceutical and biotech companies that seek to accelerate drug discovery in Asia.”

 

Romaco and CRO Ankur Complete Upgrade

Indian CRO Ankur Drugs and Pharma is a step closer to starting production of Romaco’s Siebler StripTabs now that the German firm developed a fully integrated manufacturing line.

 

StripTabs are micrometer thick starch film “tablets” designed to carry up to 25mg of an active pharmaceutical ingredient (API) for delivery through the inner lining of the mouth.

 

Their thinness, which Romaco claims allows for absorption rates comparable to injection, was a significant factor in development of the manufacturing new line according to group marketing director, Egbert Heid.

 

Heid told Outsourcing-pharma that: “The product behaves like a wing of a butterfly and reacts with humidity, so handling must be carried out very smoothly. That was one of the biggest challenges.”

 

He added that, while the line was developed in collaboration with Ankur, the technology is owned by Romaco and will be available to other pharma firms and contract manufacturing organizations (CMO).

 

In terms of the collaboration with Ankur the next step in the project is to install the Siebler StripTabs line, which combines Romaco’s FrymaKoruma, Siebler and Promatic brands, at one of Indian firm’s manufacturing facilities.

 

Heid explained that: “The original plan was to install it at the Ankur’s facility in Baddi North East India; however, there is a chance that the line will be installed in another plant.”

 

In a press statement Ankur chairman Pumandu Jain, set out the reason for investing in the technology, explaining that: “Our customers are very interested in taking the user-friendly film tablets.”

 

Jain also stressed the benefits of film strip tablets for drug delivery, suggesting that: “This innovative pharmaceutical dosage form has the potential to dramatically change and expand the landscape of traditional dosage forms.”

 

This fits with Romaco’s hopes for the StripTab technology. According to Heid while at present there are no ethical drugs that use the technology for drug delivery, “we expect some pharmaceutical products to enter the market in the second half of this year.”

 

SPMC Seeks Loan to Meet Sri Lanka’s Medical Needs

The SPMC of Sri Lanka is seeking a $10m (€7.1m) loan to buy high-speed tablet and capsule filling machines and ensure it can meet the island’s demand for safe medicines.

 

Since its establishment in 1987 using grant aid from the Japanese government the State Pharmaceutical Manufacturing Corporation (SPMC) has produced essential medicines for Sri Lankans.

 

However, over the past 20 years demand has risen significantly. The facility was designed to produce 550m tablets and capsules a year. SPMC has increased this to 1035m a year by operating the site for 16 hours a day but this is still insufficient for current demand.

 

Furthermore, the Japanese and German equipment used at the site has been in use for 22 years. Old and obsolete, the equipment has become increasingly expensive to maintain, especially with it now being difficult and costly to source spare parts.

 

Consequently, SPMC is seeking to revamp its facility and is searching a financier or funding organization that can loan it $10m. SPMC would pay back the loan within 10 years.

 

Using this funding SPMC plans to install high capacity machines over the next two years. This is intended to minimize disruption to supply and help it meet the estimated demand of more than 4000m tablets and capsules a year.

 

Currently SPMC supplies 20 of its 59 products to the Medical Supplies Division (MSD) of the Sri Lankan Health Ministry. The annual requirement for the MSD alone is 1862m tablets and capsules, which is considerably more than SPMC’s current capacity.

Furthermore, SPMC has developed several other products for the MSD but is unable to begin manufacturing them because of capacity constraints, restricting the flow of essential medicines to Sri Lanka’s poor.

 

SPMC states it adheres to good manufacturing practices (GMP) established by the World Health Organization (WHO) and follows the standards of the US and British Pharmacopoeias (USP and BP).

 

Crospon Spins out Transdermal Patch

Crospon has spun out its transdermal controlled release patch into a distinct company, two years after it licensed the system from HP, using funding from a pharma firm to further its development.

 

Pharma has been investing in transdermal patches to develop a more convenient, less painful alternative to injections. The drive to develop alternatives has been intensified by the increased presence of biologics in pharma companies’ portfolios and pipelines.

 

Crospon has become the latest company to benefit from this trend. Supported by co-development funding “from a leading pharmaceutical company”, Crospon has spun out its drug delivery technology into a distinct company, Janisys.

 

Furthermore, the company is planning to engage in a round of fundraising during the first half of 2010. Using the capital from the pharma company and fundraising, Janisys will develop the initial prototype and complete the commercial version of the system.

 

This will be based on the technology Ireland-based Crospon licensed from Hewlett-Packard (HP) in September 2007. The system uses inkjet printing technology from HP to deliver drugs under the skin.

 

Using microneedles the technology can deliver drugs, either small molecules or biologics, intradermally. In addition a single patch can deliver multiple drugs.

 

The release of the therapeutics can be controlled wirelessly to ensure precisely timed administration. Patient activation mechanisms, inherent safety protocols for preventing adverse drug interactions and dosage history can also be incorporated into the system.

 

John O’Dea, CEO at Crospon, added: “Today’s announcement is an exciting step in the continued development of the Janisys drug delivery system. This industry-first skin patch will offer a superior drug delivery platform for doctors and patients.”

 

Janisys expects to begin preclinical trials of the system later this year.

 

BBSRC, UK Partners Launch Start-up

The UK government's bioscience funding arm and regional development agencies in Norwich are building a new £5 million ($8.1 million) facility at the Norwich Research Park (NRP) that will provide lab space that researchers can use to translate their discoveries into commercially viable technologies.

 

The Biotechnology and Biological Sciences Research Council (BBSRC) will contribute the land and buildings to host the new facilities, along with £500,000.

 

The East of England Development Agency will chip in £1.4 million, the Greater Norwich Development Partnership will add £1 million, and the University of East Anglia will chip in £500,000. The remainder of the funding will come from other NRP partners.

The NRP includes several partners, including the University of East Anglia (UAE), Norfolk and Norwich University Hospital, and four research centers, including The Genome Analysis Centre, the Institute of Food Research, the John Innes Centre, and the Institute of Food Research (IFR).

 

The facility will be managed by the BBSRC, the IFR, and the UAE, as well as a new joint venture company called Colney Innovations (CIL).

 

"This new facility will play a key role in helping our scientists, and others, to translate their excellent science into products, services, advice, and jobs to benefit the economy and people of the UK," BBSRC's Chief Executive, Douglas Kell, said in a statement.

 

"The office and laboratory suites will provide unrivalled facilities for new and expanding research businesses attracted to the cluster of science facilities at the Norwich Research Park," BBSRC's Director of Finance and CIL's Director David Parfrey added.

 

Gemabank Opens New Laboratory

In May 2008, stem cell bank "Gemabank" completed the construction of a new laboratory equipped with a reliable modern equipment. During construction works, procurement and installation, special attention was drawn to the world standards of safety and quality.

The new lab Gemabanka fully complies with sanitary and epidemiological requirements of the RF.

Laboratory Gemabanka "engineered to meet international standards GMP (good manufacture practice). This means that it has a special coating of walls, floors, ceilings, special metal furniture, which do not generate dust particles that are easily washed and treated with antiseptics.

 

In addition, a specially designed ventilation system through a special filter, H-14, pore size, which does not transmit germs to the laboratory receives sterile air at a certain overpressure. As a result, the laboratory is always clean, and the air from the outer space cannot get into the sterile zone.

 

Human Stem Cell Institute Expands

Human Stem Cell Institute” (HSCI) was founded in 2003 to advance projects in stem cell technology. HSCI is now an international biotechnology company with laboratories and offices in Moscow, St. Petersburg (Russia), Ukraine and Germany. HSCI has modern processing laboratories and storage facilities for cellular materials, as well as research laboratories such as the Laboratory of Stem Cell Technologies in Moscow and the SymbioTec Co. biotechnological laboratory in Saarbrücken, Germany. HSCI is also the main publisher of the scientific journal Cellular Transplantation and Tissue Engineering.

 

On September 23, 2009 HSCI won the ”Promising Business” award and was granted a Golden Certificate at the 10th Russian Venture Fair.

 

Schott Russian Plant Operational by Year End

Schott says its new Russian packaging plant will help meet demand of growing local pharmaceutical market.

 

The facility in Nizhny Novgorod, which was first announced in 2007 , is due to become operational by the end of the year as a production hub for the manufacture of pharmaceutical ampoules, vials and glass tubing.

 

Schott spokesperson Christa Fritschi said that: “The growing market in Russia with its increasing demand for high-quality packaging and growing GMP requirements were important factors [in deciding to build the new plant].”

 

Fritschi explained that although Schott has sold pharmaceutical glass packaging in Russia since the early 90s, the products were made at a facility in Hungary before being shipped to the country.

 

“With our local plant in Russia, we will be able to meet the specific local requirements even better than in the past,” continued Fritschi, adding that the plant will provide a more flexible and secure supply.

 

She added that the Nizhny Novgorod plant will supply primary packaging to customers throughout the Russian Federation and the CIS, while the Hungarian facility will act as a backup.

 

Fritschi stressed that: “The quality of the products from Russia and Hungary will be of the same high quality. Furthermore the Hungarian plant will strengthen its position in Europe by developing new customers and markets.

 

According the Schott the facility will have the capacity to produce hundreds of millions of ampoules and vials from its Fiolax glass tubing and will initially employ a staff of 60, which will expand to 200 by 2014.

 

Mocon Buys into Irish Luxcel Biosciences

Mocon Inc has prioritized the development of a pathogen screening process for a range of foods after announcing it has acquired a 16.9 per cent stake in Irish company Luxcel Biosciences Ltd.

 

The US-based company, a leading global supplier packaging test equipment, said it had completed the deal to invest €2.5m (US$3.6m) in Luxcel on January 15th.

 

The Irish firm was founded in 2002 as a spin-off from University College Cork to create commercialized research and technology in phosphorescence-based sensor development and the applications of these sensors for biological testing. Their products enable rapid, high throughput screening and detection of bacterial contamination of food samples, non-invasive analysis of gas in food, beverage and pharmaceutical packaging.

 

Mocon confirmed that as part of the initial post-investment activity it would be dedicating some of its research and development resources to a project to help bring a lower-cost screening process for high-throughput pathogens such as Listeria, E.coli and salmonella for a range of food processing industries. The application will be suitable for the meat, poultry, seafood, produce and dairy sectors, it said.

 

“Luxcel’s technology, products and services represent a strong strategic addition to Mocon’s core instrumentation business,” said Mocon CEO and President Robert Demorest.

He added that the move would help provide a new generation of products and services “including faster, less expensive testing for pathogens”.

 

Luxcel CEO Richard Fernandes described the partnership with Mocon as a "perfect fit". He confirmed the U.S. company planned to design and manufacture dedicated instrumentation to measure Luxcel’s sensor and launch the new systems in the US and other markets.

 

LANXESS Building Chemical Plant in Bitterfeld, Germany

LANXESS AG is building a new chemical plant at its site in Bitterfeld, Germany. This marks the specialty chemicals group's move into a new segment of the water treatment business. The company is investing a total of around EUR 30 million in this pioneering project. LANXESS plans to develop and produce membrane filtration technology in Bitterfeld. The State of Saxony-Anhalt is sponsoring this project by up to EUR 6 million. In the long term, this project will create 200 new jobs at the Bitterfeld site.

 

The new plant is scheduled to be taken into operation for a pilot and development phase towards the end of this year. The first products should be launched on the market in 2011. An area totaling some 4,000 square meters (43,040 sq. ft.) has been set aside for the creation of high-tech laboratories, logistics areas, offices and a new, state-of-the-art production facility.

 

Patheon Building State-of-the-Art Development Center in France

Contract drug maker Patheon Inc. has begun constructing a new pharmaceutical development centre at its existing manufacturing facility in Bourgoin-Jallieu, France.

 

Patheon said that the state-of-the-art facility has been designed for the supply of late-phase clinical trial tablets and capsules, and will be capable of handling batch sizes up to 120 kilograms.

 

It consists of a new pilot plant and equipment designed to contain high potency products. Process trains will be scalable to commercial lines, offering clients the ability to produce phase 3 and commercial product in the same location.

 

"We currently provide our customers with solid dose phase 3 and commercial supply from our facilities in North America," Patheon president and CEO Wes Wheeler said.

 

"With this expansion, we will offer the same services in Europe by the end of 2010," he said. "The investment reinforces our commitment to provide our customers with a full range of product development services, from pre-clinical through late phase stages, on to commercialization."

 

Mississaugua, Ont.,-headquartered Patheon provides contract development and manufacturing services to the global pharmaceutical industry, including hundreds of leading pharmaceutical and biotechnology companies.

 

Roche Expands Manufacturing Sites to Produce Self-Administration Device for Herceptin

Roche is making a CHF 190 million (about $181.83 million) investment into two European production facilities to allow the commercial-scale manufacture of a patient-friendly device that could allow the subcutaneous self-administration of biological anticancer drugs.

 

The company is developing a new infusion-free device for delivering a formulation of Herceptin based on Halozyme Therapeutics’ Enhanze technology (rHuPH20, recombinant human hyaluronidase). In October 2009, the two companies reported the start of a Phase III trial evaluating this formulation.

 

Roche claims subcutaneous Herceptin administration takes only about five minutes. The company also suggests that subcutaneous delivery could allow patients to receive Herceptin at their doctor’s clinic or even at home. In contrast, infusion of the drug, which is generally carried out at a hospital, takes about an hour.

“There is also hope that patients will experience fewer infusion reactions due to the slower absorption after subcutaneous administration,” according to Pat Yang, head of Roche Pharma Global Technical Operations.

 

Roche and Halozyme first signed an agreement to apply Halozyme's Enhanze technology to Roche's biological therapeutics in 2006. The deal has been expanded on a number of occasions to encompass multiple biological targets. Roche now has an exclusive, worldwide license to develop and commercialize product combinations of its compounds with rHuPH20.

 

Roche’s new investment in the manufacturing facilities will allow its production line in Kaiseraugst, Switzerland, to supply the device for clinical studies and market launch. Commercial-scale manufacture using a fully-automated process will be carried out at Roche’s facility in Mannheim, Germany.

 

Quotient and GE Deal Secures Supply Ahead of Move

Quotient Bioresearch has secured the supply of 14C labeled compounds for its customers ahead of its move to a new purpose built facility in Cardiff through an extension of its agreement with GE Healthcare (GEHC).

 

UK contract service group Quotient moved into the 14C market with the acquisition of Amersham Radiolabelleing Services in June, forming a chemistry and metabolism unit and investing £15m (€17m) to build a new facility in the Welsh capital, Cardiff.

 

Since the deal, former Amersham owner GEHC, has provided customers with labeled compounds and, under this agreement, will continue to do so until Quotient’s operations in Cardiff are up and running.

 

Quotient CEO Paul Cowan said that: "Work on the new facility is on schedule," adding that "we sought the extension so as to increase the overlap between when the new facility opens and when we have to vacate the old facility."

 

Cowan also said that the extension will allow Quotient to manage the logistical challenges of moving from the old facility more easily and added that regulatory approval for the Cardiff site is on track for operations to begin in March.

 

Stephen Lewinton, MD of Quotient’s chemistry and metabolism unit, said extension of the agreement with GEHC “allows client work to continue as normal at the existing labs until commissioning of the new facility is completed.

 

“The bottom line is that we can assure our clients that at no time will all of the labs be closed, and so service can effectively be maintained throughout the transition period.”

 

By moving into contract radiolabelling service Quotient, which claims that its facility "will house the largest and most experienced team of radiosynthesis chemists in the world," is entering a market that, although small at the moment, will expand considerably if Phase 0 microdosing studies become widely adopted in the pharmaceutical industry.

 

DSM to Close Intermediates Business

DSM Speciality Intermediates (DSI) is to close by the end of 2010, with activities at its production site ceasing in July, in response to pricing pressures caused by the rise of rivals in India and China.

 

The low production costs in emerging markets such as India and China have made it increasingly difficult for Europe-based facilities to compete. This has led some chemical companies, for example Lonza, Dow and DSM, to focus efforts on more complex products with higher margins.

 

In this environment businesses such as DSI, which produces intermediates for pharma, have suffered. DSI acknowledged the threat posed by competitors in emerging markets in 2007 when it closed a number of production plants and integrated the remaining facilities with other DSM sites.

This was intended to improve the fortunes of the company but it has found it to be “impossible to make DSI structurally profitable, even after these measures”. As a result, DSI will now close.

 

Production activities at the Chemelot industrial site in Sittard-Geleen, the Netherlands will stop on July 1 2010. DSI intends to discontinue all operational activities by December 31 2010, with product stocks being used to meet remaining supply obligations after the plant closes.

 

Closure of the Sittard-Geleen plant will affect 37 employees. DSI has stated it intends to find the affected employees alternative roles within DSM but if this proves impossible they will be declared redundant when their job ceases to exist.

 

To help ensure it avoids forced redundancies DSI has sought advice from the local works council. Staff made redundant as a result of the closure will be covered by the DSM LBV Supervision of Employment Plan as agreed with the trade unions at DSM Limburg BV.

 

 

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