PHARMACEUTICAL / BIOTECHNOLOGY

UPDATE

 

May 2010

 

McIlvaine Company

www.mcilvainecompany.com

 

TABLE OF CONTENTS

 

UNITED STATES

New Plant Science Center Planned for Missouri

Eisai Opens Manufacturing & Development Site at RTP

NIH Spends $1 billion on Research Construction Projects

Jackson Lab Matches $1 Million Gift

Luminex, HTG Partner on Gene Expression Assay

Grace Earns Medical Device Certification

CareFusion Buys Medegen

Amcor Combines US and Australasian Operations

IU Grant Allows Renovation of Research Facility

Ground Broken on Phoenix Health Sciences Education Building

STERIS Announces Expansion

Construction of Cancer Research Center in Frederick

Purdue Wins $14.9 Million Stimulus Grant

Tufts Wins Grant for Cluster in Medford, MA

SHL Expands U.S. Operations

Chromatin Expands at University of Illinois

CGC Genetics Opens HQ in New Jersey

SAFC Opens Second High-Potency API Facility in Madison

SAFC to Invest $6.25 Million to Fortify Kansas Facility

UNC Awarded Stimulus Funding for Genetic Research

PerkinElmer to Take Over Signature Genomic Laboratories

IntegenX, Inc. Opens New Facilities

U Washington Medicine’s South Lake Union Campus to Expand

QB3 Opens New Incubator at UC Berkeley

Sigma-Aldrich's SAFC Unit to Expand in Kansas

Innovation Place Opens Doors in Melrose

Vision for New Providence, RI

First Phase of Abraxis Project Completed

Florida Sets Aside $130 Million for New Jackson Lab Campus

SCHOTT Begins Mass Production InJentle Syringe

Comar Builds Capacity with Unicon Addition

AIT Receives Updated ISO 9001:2008 Certification

Bristol-Myers Squibb Receives LEED® Silver Certification

Partnership for New Drugs

Pall Expands Manufacturing and R&D in Florida

UGA Opens Nano-bio Cleanroom

New High-Tech Cleanroom at Notre Dame

Cleanroom Completion at Vetter’s New Chicago Facility

DPT Laboratories to Expand Aseptic Manufacturing in Lakewood, NJ

Amcor Adds Blown-Film Capacity at U.S. Plant

Qiagen to Expand in Maryland

AMPAC Opens New Texas API Plant

Eastman Chemical Opens New Tritan Plant

REST OF WORLD

Kemwell Boosts Capacity with Sweden Plant

Parexel Adds Offices in China

BGI Expands Into Denmark

Japan's Astellas to Buy US OSI for $4 Billion

Charles River Shanghai Receives OECD Certification

Tetra Pak Begins Carton Output with China Launch

SIG Sells Cartons in China

Lonza to Boost Chinese Vitamin B Production

Eisai Expands into Canada

Beike Opens China Stem Cell Storage and Processing Site

China Biologic Products to Build Two New Plasma Stations

Yongye Begins Construction of Production Facility in China

Nestle Expands Production in Brazil

TCGLS Teams with Mantrax for Australian CRO Market

Jungbunzlauer Excipient Site Passes FDA cGMP Inspection

FDA Clears Eye-Drop Factory for Production

PPD Opens New Bulgarian Unit

Beard Construction Builds Hospital Cleanroom

Evonik's China API Plant Operational

PPD has Plans for New Facilities in Philippines and India

Glycos Biotechnologies to Build Biochemical Plant and R&D Facility in Malaysia

DSM Joins with Australian Government for Biologics Plant

PPD Opens Vaccine Clinical Research Center in Taizhou, China

Corealis Expands Ops in Quebec with New Facility

Comar Builds Capacity with Unicon Buy

Charles River to Acquire WuXi PharmaTech

Baxter Expands for Large-Scale Cytotoxic Capacity

Valeant Will Buy Brazilian Pharmaceutical for $56 Million

Blu Pharma Plans Expansion at New Puerto Rico Plant

Cellvax Moves to New Laboratory

Almac Completes Pharma Services Expansion

PRA Sets Up in New Zealand

Thermo Fisher Launches Global Food Safety Response Lab

BD to Make Syringes in Hungary

BD Innova Uses Dynacon/Lab Systems Technology

 

 

 

 

UNITED STATES

 

New Plant Science Center Planned for Missouri

A new biotechnology hub dedicated to researching and developing new functional foods, nutraceuticals and plant biotechnology products is planned to open in Mexico, Missouri within the next three to four years.

 

The Missouri Plant Science Center (MPSC) will encompass research and manufacturing development for a range of nutraceuticals and functional foods ingredients and finished products.

 

The project is the result of a partnership between leading soy-based ingredient supplier to the nutrition industry, Soy Labs, University of Missouri and Missouri state and federal government agencies.

 

Soy Labs president, Ryan Schmidt said: “The goal of this project is to combine cutting-edge, plant-science research with pilot-scale manufacturing capabilities. A rich campus of innovators and companies, like Soy Labs, that want to bring cutting-edge products to market, it will help better the lives of Americans through healthy, value-added (functional food and nutraceutical) products.”

 

The center will allow companies with commercially-viable, plant-sourced products to prove their concepts and develop novel manufacturing methods to bring the products to market, he added.

 

Soy Labs will be the managing tenant of the 25,000 square-foot facility and will introduce other companies to the biotechnology science centre. Companies will share facilities including office space, wet and dry research laboratories, and manufacturing equipment to process soybeans and other plant-based material.

 

A statement from the soy ingredient supplier said that the company intended to “…focus future research and product development efforts on the combinatorial and formulaic compounds which include Lunasin and other phytonutrients that will play a role in the prevention of chronic disease.”

 

Its strategy involved collaborating with other companies in the nutrition, functional-food, nutraceutical, medical-food, and cosmeceutical industries to create new intellectual property and uniquely positioned products, it added.

 

The collaborations are expected to include many more supplements, cosmeceuticals, soy foods, functional foods and beverages.

 

The company spearheads research and develops proprietary, soy peptides, ingredients, and formulaic compounds for inclusion in nutritional products.

 

Funding for the center was supplied by several government entities. Investors include: The Missouri Department of Economic Development which contributed $5m in Community Development Block Grant and the Missouri Technology Corporation and the University of Missouri which each dedicated $2.5m.

 

The city of Mexico also contributed $950,000 in federal funds.

 

Representatives from Soy Labs joined officials from Missouri state and federal agencies to break ground joined forces at the new plant centre which is sited within an 80-acre Business Innovation Park.

 

Eisai Opens Manufacturing & Development Site at RTP

Eisai has opened a $100m (€81m), 65,000 sq. ft. commercial manufacturing and drug development site for intravenous treatments in Research Triangle Park (RTP), North Carolina, US.

 

The new site expands the breadth of Eisai’s manufacturing operations, complementing its existing 190,000 sq. ft. oral solid-dose facility, to reflect the composition of its drug development pipeline.

 

Isolator containment technology has been installed, giving Eisai the capacity to process the highly potent compounds used in its pipeline of oncology treatments. Aseptic processing suites, laboratories and other support functions are also housed at the site.

 

Opening the facility will give Eisai the capacity to support the commercialization and development of its oncology pipeline, including breast cancer therapy eribulin mesylate.

 

Following completion of Phase III trials this treatment has been submitted for regulatory approval in Japan, the US and the European Union. If successful, the product may become the first treatment to be manufactured at the new site.

 

Eisai has a longstanding interest in oncology and has increased its presence in the field through the acquisition of Morphotek and expansion of its infrastructure and North American sales and marketing efforts.

 

Eisai first established a presence in RTP in 1997 when it finished construction of an 85,000 sq ft oral solid-dose production and development facility. This was expanded in 2001 and again in 2003 to create a 190,000 sq ft operation.

 

The new facility complements the existing operation by expanding the capabilities Eisai has at RTP. To support these operations, and future expansion, Eisai opened a $22m central utilities building in 2008. This supplies power, steam, chilled water and compressed air to the facilities.

 

"Constructing this new facility at our current location has allowed for the seamless integration of our production and research and development operations", added Hajime Shimizu, Chairman and CEO of Eisai Inc.

 

NIH Spends $1 Billion on Research Construction Projects

The US National Institutes of Health (NIH) has awarded $1 billion (£700 million) to universities and medical centers across the country for the construction or upgrading of scientific research laboratories.

 

The 146 grants, announced on 14 May, were funded through the US economic stimulus package enacted in early 2009. The money, doled out between last summer and the end of April, is being spent on actions ranging from constructing whole new sites for cutting-edge research to updating the sanitation and working space within a facility.

 

These building projects are particularly attractive to the federal government because they spur the economy, an NIH official tells Chemistry World. Not only will the initiatives provide a better environment for research while simultaneously creating more space and employment opportunities for researchers and their support staff, they will also create jobs for engineers, architects, plumbers, carpenters, and those who provide building materials.

 

Among the recipients of these construction grants is the University of Utah, which has received $8 million to expand and update its chemistry building, which is over 30 years old. The goal is to provide a cutting-edge interdisciplinary environment for biomedical and biologically related research. The investment from NIH has also triggered additional contributions from other donors, including the local chemical industry.

 

The expanded building will feature greatly enhanced biological chemistry and instrumentation capabilities. The university is recruiting new faculty to occupy the additional space, which is expected to house as many as six major research groups.

 

The University of Mississippi also benefitted, awarded just shy of $14 million to build a new facility to help commercialize natural product discoveries for applications within agrochemicals, pharmaceuticals and biotechnology. Alice Clark, the university's vice chancellor for research and sponsored programs, says the new funding will help the university and its researchers by providing much needed facilities, like laboratories for scale-up production and development of lead compounds.

 

'As with all research activities, there will ultimately be significant direct and indirect impacts on the local economy, by creating high-tech jobs, drawing visitors to our local community, attracting research-related businesses to our area, and creating spin-off businesses based on research discoveries,' Clark adds. She expects that 70 new jobs will be created for scientists who will work in the facility, and over 200 jobs will be created in constructing the facilities.

 

Jackson Lab Matches $1 Million Gift

The Jackson Laboratory announced it has matched with $1 million in donations a $1 million "challenge" gift given by a trustee last year.

 

Weslie Janeway, a geneticist and author from Cambridge, UK, and New York, gave $1 million to Jackson Lab in March 2009, subject to the institution raising at least an equivalent amount in gifts. The combined funding is intended to help the laboratory recruit and support new scientists.

 

"I had expected this campaign to take two years," Janeway said in a statement.

 

According to the laboratory, 20 percent of the 414 matching gifts it received were from first-time donors.

 

Jackson Lab said that funds from the challenge gift and matching gifts will pay for faculty starting salaries, lab equipment, and experiments. Under its five-year strategic plan, the Bar Harbor, Maine, research institute has committed itself to adding seven new principal investigators, each of whom will lead a team of research assistants and other support staffers. Jackson Lab has said it expects to add about 200 new jobs.

 

The seven PIs do not include two specialists in the genetics of neurological development and diseases, Elissa Chesler and Da-Ting Lin, who were recently hired by the Jackson Lab

 

"The Laboratory is currently recruiting researchers in cancer, neurobiology, bioinformatics, immunology, aging, and other areas," Jackson Lab said in the statement.

 

Luminex, HTG Partner on Gene Expression Assay

Luminex and High Throughput Genomics have partnered to develop an integrated assay that Luminex will sell to the gene expression research market.

 

Luminex said that the new qBead Gene Expression Assay puts HTG's qNPA chemistry technology on the Luminex xMAP multiplexing platform to create a high-throughput assay with a simplified workflow that requires no extractions, cDNA synthesis, or amplifications, Luminex said.

 

The qBead assay is used to acquire gene expression data from degraded samples or difficult samples, such as formalin-fixed paraffin-embedded and other fixed tissues.

 

"The combination of xMAP Technology from Luminex and the qBead Assay represents an advance for many scientists, including cancer researchers who perform retrospective studies on large numbers of archived samples," Luminex CEO and President Patrick Balthrop said in a statement.

 

Balthrop also said that the partnership will use the two firms' technologies "to create high-throughput, custom assays that will advance the work of researchers in the critical, growing mid-plex custom gene expression research arena."

 

Grace Earns Medical Device Certification

W. R. Grace & Co. has earned an additional certification for the Quality Management System at its facility in Hesperia, California. This ISO 13485:2003 certification was issued by SGS Inc., a global provider of certification and testing services, for Class I medical devices manufactured at this location.

 

Grace markets to customers in the life science, pharmaceutical, anesthesiology, forensic and biotechnology industries through Grace Davison Discovery Sciences. Products include flash chromatography cartridges and systems, liquid chromatography columns, solid phase extraction devices, detectors, instruments, accessories, bulk media and preparative purification columns and systems.

 

Hesperia joins four other Grace facilities that were previously certified to the ISO 13485:2003 standard for medical devices: Epernon, France (certified in 1997); Chicago, Illinois (certified in 2004); Surat, India (certified in January 2009) and Deerfield, Illinois (certified in March 2009). Pursuing each certification was a proactive and voluntary decision by Grace in an effort to test the company's quality management systems.

 

"We are very proud that all our facilities manufacturing medical devices around the world have achieved this certification," says Greg Poling, Vice President, W. R. Grace & Co. and President, Grace Davison. "Our customers can be confident that, with Grace Davison, they are receiving premiere quality products which help pharmaceutical and biotechnology companies develop drugs more rapidly and efficiently."

 

As one of several chromatography media manufacturing sites within the Grace Davison Discovery Sciences product line, Hesperia manufactures and modifies silica for use in some of the world's leading biotechnology drugs as well as analytical, preparative and process applications.

 

This is the second certification focused on the pharmaceutical industry that Grace has earned in 2010. In March, Grace successfully garnered an Excipient Good Manufacturing Practices (GMP) certification of its quality management system in Baltimore, Maryland. That particular certification verified that Grace's Quality Management System met the requirements of the Joint International Pharmaceutical Excipients Council--Pharmaceutical Quality Group GMP Guide for Pharmaceutical Excipients. Pharmaceutical excipients are inactive ingredients (additives) used in drug formulations.

 

CareFusion Buys Medegen

Nautic Partners LLC completed the sale of medical device company Medegen LLC, the private equity firm said.  CareFusion Corp. acquired the company for $225 million in cash.

 

Medegen, based in Ontario, CA, manufactures and markets disposable intravenous therapy products under the Maximus and KippMed brands.

 

The company also provides contract manufacturing to other medical device manufacturers and pharmaceutical companies.

 

San Diego-based CareFusion, also a medical device company, was spun off from Cardinal Health in August. The purchase of Medegen was its first acquisition since the spinoff.

 

In midday trading, CareFusion shares added 31 cents to $25.86.

 

Amcor Combines US and Australasian Operations

Amcor is to merge its Australasian operations and North American packaging distribution division as it seeks to send a “strong signal to the market” over costs and service standards.

 

The packing giant announced the move at it confirmed the US Amcor Packaging Distribution chief Eric Bloom would be moving from Los Angeles to Melbourne to take up a new role under Australasia president Nigel Garrard.

 

The common ground occupied by the US and Australian corrugated businesses and the chance to “leverage the skills of the Packaging Distribution business into the Australian market” had been the main divers behind the move, said the company.

 

“This new structure is a strong signal to the market that there is an important role for distribution and manufacturing to work together worldwide to provide a unique value proposition,” added Amcor.

 

Nigel Garrard said: “This is an opportunity for the business in Australasia to bring the sales and marketing expertise of the Packaging Distribution business to this market.”

The move comes in the wake of a series of announcements by the firm to invest over A$700 million to major capital investments in Australasia. These include a new paper mill in Sydney, major expansion of its glass business and a new beverage can line in New Zealand.

 

Eric Bloom said the consolidation was an opportunity to enhance the firm’s corrugated, specialty box and distribution operations.

 

“With the new paper mill being commissioned in calendar year 2011, the business will be the low cost manufacturer and have a superior product offering,” he added. “This means we will have a truly differentiated product in terms of value and performance and it will be my task to create a service culture that when combined with superior product performance, sets us apart from our competitors.”

 

The merging of the North American operations – formerly known as Amcor Sunclipse – would be effective immediately and the two companies would be financially combined in the 2010/11 accounts.

 

Peter Brues, president at Amcor Flexibles Europe & Americas, said the company’s prime focus in the wake of the takeover of Alcan would be on optimizing it supply scales and cutting cost bases to leverage profits both for the company and its customers. He did not rule out some rationalization but stressed the firm would target putting an administrative structure in place to “maximize cross fertilization and avoid duplication.”

 

IU Grant Allows Renovation of Research Facility

A new research facility at Riley Hospital for Children will dramatically improve the process of turning the results of laboratory research into new treatments for sick children, federal and local officials said.

 

A grant of nearly $8.5 million to the Indiana University School of Medicine will enable the renovation of a former research floor of the Clarian Health hospital into a state-of-the-art facility for conducting clinical research trials that are designed for children.

 

The IU grant is one of 146 American Recovery and Reinvestment Act construction awards, totaling $1 billion, to construct, repair and renovate scientific research laboratories and related facilities across the country. The grants were announced here by U.S. Secretary of Health and Human Services Kathleen Sebelius and National Institutes of Health Director Francis Collins, along with IU President Michael A. McRobbie and IU School of Medicine Dean D. Craig Brater.

 

The grant from the National Center for Research Resources of the NIH, for $8,386,919, will enable the IU School of Medicine to transform a former research floor of Riley Hospital into the pediatric clinical research center. The project comes as the NIH and the Food and Drug Administration, recognizing that children are underrepresented in clinical research, are encouraging investigators to include more children in clinical trials.

 

“Indiana University is deeply grateful to the National Institutes of Health for this Recovery Act award to the IU School of Medicine,” said President McRobbie. “This award will greatly impact the future of pediatric research conducted at Riley Hospital for Children. It will provide IU School of Medicine researchers with the facilities and resources they need to conduct path-breaking research into disorders that affect the health and lives of so many of our nation’s children.”

 

“The Children’s Health and Evaluation Facility will enable us to conduct studies that will improve health care for countless children in the future,” said Dr. Brater. “For example, most drugs and diagnostics are tested in adults – but children aren’t just little adults. They respond to therapeutics differently than their older counterparts, and this facility will give us the ability to understand those differences.”

 

After renovations are completed in late 2012, the 18,500-square-foot center will house laboratory, bio-storage, office and other research-related space specifically designed to be flexible and accommodate the growing emphasis on collaborations between basic and clinical researchers and among researchers at different institutions. The facility will enable researchers to conduct comprehensive phenotyping, which is the use of many state-of-the-art research techniques to identify more clearly how genetic versus environmental factors contribute to the appearance and ongoing manifestations of a disease.

 

“This new facility will significantly enhance our ability to conduct the clinical research trials that test the safety and effectiveness of potential new treatments that emerge from our scientific discoveries,” said Mervin Yoder, M.D., Richard and Pauline Klingler Professor of Pediatrics and director of the Herman B Wells Center for Pediatric Research.

 

Some Wells Center researchers had been housed in the area to be renovated in Riley, but nearly all Wells Center researchers now occupy labs in a research building across the street from Riley Hospital.

 

"As Indiana's most comprehensive academic health center, research and clinical trials are essential to offering our patients access to leading edge therapies and treatment options," said Daniel Evans, president and CEO, Clarian Health. "This new research facility will benefit patients for years to come by developing new approaches to the prevention, diagnosis and treatments of childhood diseases."

 

The new clinical research facility will bridge the gap between the laboratory research facilities and the hospital, neither of which was set up to meet the unique demands of human clinical trials in children, said Dr. Yoder.

 

“The lack of dedicated space to see children and their families to discuss enrollment into clinical trials and to obtain the necessary patient samples for those trials has been a major barrier to conducting research at Riley Hospital,” said Scott Denne, M.D., associate chair for clinical research in the Department of Pediatrics.

 

The Riley facility will include both state-of-the-art video conferencing facilities and laboratories that visiting scientists can use on a short-term basis. Such resources, Dr. Denne noted, will further the goals of the Indiana Clinical and Translational Sciences Institute (CTSI), a statewide enterprise involving IU, Purdue and Notre Dame that was created to help speed the movement of scientific discoveries into new therapies and diagnostic products.

 

“One of our CTSI colleagues from Purdue or Notre Dame could come to this new facility to work with researchers at the medical center, performing tests on patient samples from a clinical trial here instead of shipping them back and forth between institutions,” said Dr. Denne.

 

In conclusion, President McRobbie said, “This major investment in scientific research and innovation at IU will help to further strengthen our health and life sciences economy, which is so vital to our state’s prosperity.”

 

Ground Broken on Phoenix Health Sciences Education Building

The shovels were in the dirt on Wednesday for the construction of the new Health Sciences Education Building on the downtown Phoenix Biomedical Campus.

 

“Today, we have moved one step closer to fulfilling the urgent need for health care professionals in our state,” said Arizona Board of Regents President Ernest Calderón. “This one-of-a-kind interdisciplinary facility will provide greater access to medical education in Arizona and will have a tremendous economic impact on the state by creating new jobs and pumping revenue into the economy.”

 

A ceremonial groundbreaking was held for the building, part of the expansion of the University of Arizona College of Medicine – Phoenix. Gov. Jan Brewer, Arizona House Speaker Kirk Adams, R-Mesa, Arizona Senate Minority Leader Jorge Luis Garcia, D-Tucson, Arizona Board of Regents President Ernest Calderón, Phoenix Mayor Phil Gordon, University of Arizona President Robert Shelton and Northern Arizona University President John Haeger all took part in the ceremony at the campus, near Seventh Street and Van Buren.

 

“The Health Sciences Education Building will have a profound impact on the University of Arizona’s ability to educate doctors and relieve our state’s critical shortage of physicians and health care professionals,” Shelton said. “These students — future physicians, pharmacists, nurses, public health and allied health professionals — will serve Maricopa County, Arizona and our nation.”

 

After approval from the Arizona Board of Regents, the state Legislature and Gov. Brewer, plans were developed for the $187 million, 268,000-square-foot education building that will house the expansion of the medical school, as well as programs from the UA College of Pharmacy, the UA Mel and Enid Zuckerman College of Public Health and Northern Arizona University College of Health and Human Services programs.

 

The new building will allow the College of Medicine – Phoenix to expand its class size to 120 students per year (from 48 per year). It also creates space for training other health sciences students and for interdisciplinary education, with classrooms, labs, pre-clinical training suites, a learning resource center, study areas and faculty offices.

 

The UA College of Pharmacy also will have programs in the new building, with plans to build a program around the emerging understanding of the genetic basis for diagnosis and treatment of disease. The College of Pharmacy will continue to have fourth-year students in the Phoenix area.

 

Northern Arizona University will begin its critical need physician assistant and occupational therapy programs and expand its doctor of physical therapy program in the new building with plans to graduate 150 new primary care health professionals each year.

 

“Northern Arizona University will continue to develop programs that provide solutions to Arizona’s most pressing primary care and therapy needs,” Haeger said. “The biomedical campus allows us to continue our innovative interdisciplinary teaching and research in partnership with UA. All Arizona will benefit for many years to come.”

 

Shelton added, “From an economic standpoint, the building will help transform Arizona’s economy. It solidifies the Phoenix Biomedical Campus as the center of biomedical innovation, research and engineering. The Health Sciences Education Building will help the UA increase our research portfolio and enhance and establish important biotechnology partnerships in greater Phoenix.”

 

The new building is part of the overall plan to create a major academic health center in downtown Phoenix that will include health education facilities, research and clinical programs. In addition to the medical school, the Phoenix Biomedical Campus is home to Translational Genomics Research Institute (TGen) and has been developed over the last five years by the Arizona Board of Regents, the state universities and the City of Phoenix.

 

DPR Construction and Sundt Construction, Inc., in a joint venture, are the builders with architects Ayres/Saint/Gross and CO Architects.

 

The DPR Construction • Sundt Construction, Inc., Joint Venture (DPR • Sundt) is a seasoned, award-winning Life Science Building Team. The DPR • Sundt team has a proven track record for uniting each company’s individual ideas and experiences to create streamlined processes, and develop new methods of constructing state-of-the art, LEED® certified life science, laboratory, healthcare and educational projects. With over 127 LEED® Accredited Professionals on staff in the Southwest alone, the joint venture is committed to sustainability. Together DPR/Sundt built The Biodesign Institute at Arizona State University, Buildings A and B, each achieving LEED®-NC New Construction Certification. Building A achieved Gold, while Building B became the first Platinum-certified building in the state of Arizona.

 

The University of Arizona, Arizona State University and the Arizona Board of Regents agreed to expand the Phoenix campus of the UA College of Medicine to a full, four‐year program in 2004. The College of Medicine – Phoenix admitted its first class of first‐year medical students in August 2007 and currently has 120 students training to be physicians. The college seeks to promote health and improve the prevention, diagnosis and treatment of disease for the people of Arizona and beyond through education, research and patient care.

 

STERIS Announces Expansion

Officials joined STERIS President and Chief Executive Officer Walt Rosebrough to announce an $11 million investment in a Customer Solutions Center and other renovations at the STERIS Mentor Campus, creating 300 jobs and retaining 800 jobs.

 

"I believe in Ohio because of home-grown companies like STERIS that are committed to innovation through life-changing technology," Strickland said. "We are working everyday to lay a foundation for Ohio's growth, and a cornerstone of our plan is to make strategic investments in high-growth industries such as bioscience. Our partnership with STERIS is creating good Ohio jobs that are hard to outsource and strengthening Northeast Ohio's leadership position in the bioscience industry."

 

The new 55,000 square-foot center is an expansion of the company's national headquarters, set to open February 2011. The project was a result of collaboration between the Ohio Department of Development and the City of Mentor, and the State of Ohio provided an incentives package for the expansion.

 

"Governor Strickland is committed to making Ohio an even more attractive place to locate and grow a business," Rosebrough said. "We appreciate the strong support we've received from the Ohio Department of Development, as well as the City of Mentor. This project will bring jobs to Ohio and will create a first class opportunity for our Customers from around the world to work with STERIS to create solutions for their specific needs."

 

STERIS Corp. will also renovate existing buildings on the Mentor Campus. The company currently employs approximately 5,000 employees across the globe.

 

"This STERIS project represents an important progression of the company's long history in Ohio," Ohio Department of Development Director Lisa Patt-McDaniel said. "Few people may realize that in 1986 STERIS technology was initially sported by a grant from the Thomas Edison program, a precursor of the Ohio Third Frontier. It helped STERIS launch its first product and since then, the company has grown significantly, showcasing the success of public-private partnerships."

 

STERIS Corp. is a biotech company dealing with infections prevention, decontamination and health science technologies, products and services. This investment provides the company with the most advanced resources needed, allowing STERIS to showcase its strengths and compete on a level playing field in the biotech industry.

 

Construction of Cancer Research Center in Frederick

Construction work continues on the advanced technical research facility for the National Cancer Institute being built at Riverside Research Park off Monocacy Boulevard in Frederick.

 

The National Cancer Institute's Advanced Technology Research Facility being built at Riverside Research Park may look like a typical office building, but hardly anything about the structure is typical. From ground to roof, the center will be crowded with innovation. Even its pursuit of science will be original.

 

"The way it's being designed is probably like no other place in the country," said Frank Blanchard, public affairs officer for SAIC-Frederick, regarding the planned research campus, which has the Advanced Technology Research Facility as its nucleus. "This place is focused on one thing, and that's cancer. And because of this intense focus and because of the way the park is being built out, we're hoping that it really will be kind of an intellectual think tank around this problem of translational research."

 

The facility is largely designed from the inside out with most construction decisions guided by the type and size of equipment to be installed.

 

"Typically with an office building you can build, truly, just a shell and any office user can come in and do their fit out," said Pete Ireland, construction manager for Matan Cos. For example, here the spacing between floors is higher. Certain floor areas are reinforced to carry heavier loads, depending on where equipment will be placed. Other areas are recessed to accommodate subzero freezers or autoclaves. And throughout the buildings, custom-designed openings are built into the floors to allow pipes and ventilation ducts to pass through.

 

Matan Cos. is the overall developer for Riverside Research Park and owns the research building. Matan is also responsible for delivering the first phase of construction -- what is called the "cold, dark shell." Transforming the hollow structure into a flagship cancer research center is the work of SAIC-Frederick, NCI's prime contractor.

 

"The complexity of each wing is very specific, depending on the science being done there," said Hoyt Matthai, SAIC-Frederick's operations manager for the research facility. "The electron microscope requires vibration isolation, the nuclear magnetic resonance spectrometer needs liquid nitrogen for cooling the magnet. Mass spectrometers require nitrogen gas, incubators for various cell cultures require carbon dioxide, and then all the environmental factors like cooling to offset the heat generated by most of this equipment. And then there are all the various pumps and utilities to make the units work properly."

 

Inventiveness starts at ground level. Instead of resting on traditional concrete footers anchored on bedrock, the four research wings will be supported by an array of geopiers, stiff columns of crushed rock that help distribute the building's weight out to the sides rather than just straight down, which helps isolate the structure from ground vibrations.

 

"We took vibration readings to get some assurance very early on that the site was a good site for our equipment," Matthai said. "If there's a minor tremor we don't want to be having foundations or a supporting pillar on bedrock that would clearly transmit that vibration into the buildings."

 

Some highly sensitive instruments, such as the electron microscope, will rest on pads of concrete cut free from the rest of the floor. "So when someone is rolling a cart down the hallway, or people walking or whatever, we don't have that vibration," Matthai said.

 

Managing the heat generated by all this equipment while maintaining a safe operating environment is another challenge. The air conditioning system for most of the lab spaces is "single pass air," meaning that room air is not recirculated as in standard systems, but rather goes through the building only once. Some parts of the building will have high-efficiency particulate air filters to ensure aseptic conditions.

 

"A lot of the scientific equipment has a very limited functional temperature range," Matthai said. "We have heat specifications from the manufacturer for each piece of equipment; we know how many BTUs it gives off, and have the calculations for the needs of heating, ventilation and air conditioning. Every room has been mapped with the equipment, what the heat load is, so that when we start up, it's going to be as prepared as it can be."

 

To boost efficiency, cooled or heated water will circulate through specially designed radiators incorporated into the ventilation system, a technology known as chilled beams.

 

To further increase energy efficiency, the lab wings are oriented on a east-west axis to maximize the amount of light coming in through the windows while minimizing the heat energy that comes with it, Matthai said.

 

At the other end of the temperature scale are the stores of liquid nitrogen that are essential for the cryopreservation of cells and biologically active compounds. With a boiling point of minus-321 degrees Fahrenheit, liquid nitrogen is useful as an open-cycle refrigerant, but requires special vacuum-jacketed pipe that costs $300 a foot, so all the work areas requiring liquid nitrogen are grouped together close to the storage tanks.

 

The most complex part of the new building is also the largest, the current good manufacturing practices developmental and manufacturing labs for the production of pharmaceutical and biologically active materials. Once up and running, the facility will be able to turn out new products that meet specific government requirements for identity, strength, quality, and purity.

 

A distinctive feature of the cGMP production area is a "walkable ceiling," that is, a network of elevated catwalks outside and above the environmentally controlled cleanrooms. Technicians can reach lighting fixtures, environmental equipment and related utilities without entering the controlled, aseptic environments of these labs.

 

"They can certify HEPA filters, adjust airflow, can address items without going into the clean- room," Matthai said. "Because you have to be certified in gowning to go in."

 

Workers have to be trained and certified in the proper use of protective clothing before they can enter a clean room, both for their own safety and the safety of others. Not only could this lead to delays, but would add another layer of complexity to an already complicated arrangement. Time and time again people who have built (buildings like this) say the easiest way is to give it a walkable ceiling so you don't have to certify maintenance technicians that need to work on equipment."

 

When a promising new pharmaceutical or biological agent is isolated, the cGMP will help put it on the fast-track to potentially life-saving clinical trials.

 

"Say I can make a liter of it, (equivalent to) a thousand doses," Matthai said. "But I want to make 500 liters of it. So how do I scale up from one-liter production to 500 liters, and then dispense it? This type of cGMP development work will also be performed at the facility."

 

Special requirements for water purification, air filtration, and fire suppression also have to be met. Just tracking all the specifications is a major job in itself.

 

"It's enough to lose some hair over," Matthai said.

 

"Things change on a daily basis," Ireland said. "And as the things change, we're going back and redesigning and implementing changes in the field. We could have waited (until the plans were all complete) and just let them build a building at the end of the day but that would have taken about a year longer."

 

This rapid pace of development is already being felt in the surrounding area. Best estimates by planners at Matan Cos. and SAIC-Frederick project 300 construction jobs will be needed to complete the facility by 2012. When up and running, the complex is expected to employ 575 people, of which 200 will be new hires. To help pave the way for the housing, restaurants, shopping centers, and other services that will be needed to support all this activity, nearly 1,400 acres east of the town center have been designated a BRAC Revitalization and Incentive Zone, offering tax credits and other inducements to stimulate growth.

 

"You want businesses and work to stay within the Frederick limits," said Pam Reppert, a Frederick city planner. "You want your people to be able to work where they live."

 

"We looked at a number of different possible locations and this one really presented the best of the best," Blanchard said. "Because of where it sits, because of the opportunity to build out, because it's a brand new place, it gives the opportunity to plan out a campus environment."

 

Purdue Wins $14.9 Million Stimulus Grant

Purdue University has landed a $14.9 million grant from the National Institutes of Health to expand the Bindley Bioscience Center and its cancer and life sciences research programs.

 

The American Recovery and Reinvestment Act funding from the National Center for Research Resources will be used for a 29,000 square-foot expansion to establish the Multidisciplinary Cancer Research Facility, which will create 30 to 40 new staff jobs.

 

"The expansion will complement the capabilities of Bindley and the Purdue University Center for Cancer Research in biophysical and biomolecular analyses, conventional cell imaging and separation, and high-throughput screening technologies," Timothy Ratliff, director of Purdue's Center for Cancer Research, said in a statement. "Laboratories are planned for cancer cell biology, therapeutic and medical device development, cell-based screening, medicinal chemistry, and next-generation imaging."

 

"This major Bindley Bioscience Center expansion addresses a critical need for disease researchers from across multiple disciplines at Purdue," Richard Kuhn, director of the Bindley Bioscience Center, said. "This also builds on the university's strengths in cancer research, drug discovery and development, engineering, chemistry and instrumentation, and veterinary medicine with a disease research-focused, multidisciplinary facility for biomedical research."

 

Tufts Wins Grant for Cluster in Medford, MA

Tufts University's School of Arts and Sciences has won an approximately $9.5 million federal stimulus grant toward design and construction of its planned Collaborative Cluster in Genome Structure and Developmental Patterning in Health and Disease.

 

The facility is designed to focus on "genome to organism" research, with the goals of advancing treatment of hereditary diseases, preventing birth defects, and facilitating tissue regeneration, Tufts said in a statement.

 

The collaborative cluster will house some 70 researchers from Tufts' biology department and be located at an existing building in Medford, Mass. The cluster is designed to foster cross-disciplinary research between engineers and biologists specializing in genome structure and stability, developmental and regenerative biology, and tissue engineering, according to Tufts.

 

Over the next two years, Tufts said, it will redesign office and laboratory space at 200 Boston Ave. into 16,527 square feet of wet laboratories and support facilities. The new space will be built to the "gold" standard of the Leadership in Energy and Environmental Design energy efficiency standard developed by the US Green Building Council.

 

The building, owned by Cummings Foundation Inc. of Woburn, Mass., is already home to biomedical researchers from the university's biology department and School of Engineering. They collaborate on research in regenerative medicine, nanobiological structures, neural processes, and biomimetic devices.

 

Tufts said its current collaborations include studies in model systems of diseases, such as fragile X mental retardation, Huntington's disease, and Friedreich's ataxia.

 

"We also expect the cluster to intensify collaboration with math and computer science faculty, and with researchers from such external organizations as Harvard Medical School, and the National Institutes of Health," Juliet Fuhrman, chair of Tufts' biology department, said in the statement.

NIH's National Center for Research Resources has awarded the funding to the university as part of the $862 billion American Recovery and Reinvestment Act.

 

SHL Expands U.S. Operations

SHL is continuing to expand operations in the United States with the establishment of SHL Pharma Systems, a state-of-the-art final assembly and packaging operation. Located in South Florida, this new facility will offer final assembly, labeling, and packaging services to SHL's pharmaceutical and biotechnology customers.

 

 “We are excited about this latest expansion project as it is very customer driven,” says Lucio Giambattista, executive VP, SHL Group, and managing director, SHL Medical USA. “We have built up close relationships with some of the world's largest pharma and biotech companies over the years and this facility will allow us to offer even more services to these partners. Now, with packaging, labeling and distribution services available in-house, SHL will truly be a one-stop-shop for drug delivery devices, from product design to delivery.

 

 SHL (shl-group.com) has been significantly expanding facilities and recruiting new employees as the result of several recently signed long-term supply agreements. SHL has publicly announced capital expenditures of more than $100 million. The company is forecasting to hire an additional 1,000 new employees during the next few years in addition to the 1,500 members of existing staff. The new Florida facility is scheduled to be operational in the first quarter of 2011.

 

SHL is a privately owned designer, developer, and manufacturer of advanced drug-delivery devices. The company employs more than 1,500 staff globally with about 1,000 employees in Taiwan. Primary design centers are located in the United States and Sweden and manufacturing centers located in Asia. SHL supplies auto injectors, pen injectors, and inhaler systems to global pharmaceutical and biotechnology companies.

 

Significant investment in R&D has enhanced the company’s broad pipeline of next-generation, drug-delivery systems. These devices include a range of disposable and reusable injectors with fixed or variable dosing, enhanced precision, and the ability to accommodate high viscosities.

 

The organization comprises three distinct group companies. SHL Medical Designs develops and manufactures advanced drug-delivery devices for pharmaceutical and biotechnology companies. SHL Healthcare develops and manufactures equipment solutions for home, hospital and long term care use. SHL Technologies provides contract manufacturing and engineering services for the production of complex medical technology and industrial products.

 

Scandinavian Health (SHL) says new US drug delivery tech and packaging facility in will create 1,000 jobs.

 

The $100m (€79m) facility, in South Florida, will act as a hub for assembly and distribution of SHL’s range of auto-injector delivery devices for pharmaceutical and biotechnology industry customers when operational early next year.

 

Lucio Giambattista managing director of SHL Medical USA explained that development of the plant had been driven by several new contract wins and increasing customer demand.

 

“We have built up close relationships with some of the world's largest pharma and biotech companies over the years and this facility will allow us to offer even more services to these partners.”

 

Giambattista added that: “Now, with packaging, labeling and distribution services available in-house, SHL will truly be a one-stop-shop for drug delivery devices, from product design to delivery."

 

Chromatin Expands at University of Illinois

The University of Illinois announces that Chromatin, Inc., a biotechnology company that has occupied space in the University’s Research Park since 2005 as part of the EnterpriseWorks incubator, is expanding operations and graduating to a 5,000 square foot facility in the Research Park. The expansion marks the company’s continued significant progress in commercializing its proprietary technology, including mini-chromosomes which were originally developed at the University of Chicago by company co-founder and CEO Daphne Preuss.

 

“Central Illinois and the Midwest are a natural fit to grow the burgeoning 21st century bioenergy sector given the strength of agricultural research and industry.”

 

Chromatin will transition to the newly constructed facility, which is located in the “Graduation Building” of the Research Park, in April of 2010. With the larger laboratory and office space, the company will continue to expand its R&D activities which enable the development of new seed products and the delivery of multiple genetic traits in plants through gene-stacking, while widening their focus to pursue new applications, such as improved feedstocks targeting the bioenergy sector.

 

Avijit Ghosh, U of I VP of Technology and Business Development, said Chromatin’s commercialization success is a model for biotechnology startups in Illinois. “Chromatin is graduating from our EnterpriseWorks incubator where the Research Park provided laboratories, equipment and greenhouse space,” Ghosh said. “IllinoisVentures, the university-affiliated venture capital firm, was an early Chromatin investor. Also, The University of Illinois provided early support to fund student employees to work as researchers for Chromatin, MBA students to provide commercialization consulting, and entrepreneurship support services with regular events and training.”

 

Otto Folkerts, Director of Transgenic Programs and manager of Chromatin’s Champaign operation, said the University and Research Park support enabled the company to focus on advancing its technology and its business. “The EnterpriseWorks incubator has been the ideal place to launch our R&D programs in crops such as corn, cotton and sugarcane,” Folkerts said. “With the support of EnterpriseWorks, we’ve been efficient with our resources and better able to focus our efforts on innovation while developing our technology. By expanding the scale of our operations within the Research Park, we can further develop our existing programs and broaden our focus into new areas such as bioenergy feedstocks.”

 

Daphne Preuss, Chromatin’s CEO, said “We are very pleased to be growing our presence in the Champaign area and at the University’s Research Park location in particular. Our current expansion is a direct result of our success in commercializing Chromatin’s technology and successfully attracting financing, both of which were greatly facilitated by the University’s resources, facilities and significant talent pool.”

 

Chromatin was founded in 2000, is headquartered in Chicago and initially opened an office/lab in the University of Illinois’ EnterpriseWorks incubator in 2005. Chromatin has successfully licensed its technology through commercial agreements with leading agbiotech companies including Syngenta, Monsanto, Dow AgroSciences, and Bayer CropScience, for applications including corn, soybeans, cotton, sugarcane, and canola. The company is now leveraging that success and its core technology base by pursuing new value-added opportunities in the bioenergy feedstocks market. Chromatin now employs over 30 people, including 11 in Champaign, with plans for further increases in 2010.

 

Ghosh said he hopes other companies follow Chromatin’s success model and decide to remain in the park as their businesses grow. “We share in the pride of Chromatin’s success,” Ghosh said. “Central Illinois and the Midwest are a natural fit to grow the burgeoning 21st century bioenergy sector given the strength of agricultural research and industry.”

 

About Chromatin: Chromatin, Inc. is developing and marketing innovative technology and products that can benefit the agricultural, energy, chemical, nutritional, and pharmaceutical sectors. Its proprietary gene stacking technology can be used in any plant to simultaneously and precisely introduce multiple genes, and this technology has been licensed to leading agbiotech companies for use in corn, soy, cotton, canola and sugarcane. Chromatin is building on this platform to create next generation crop products that are better designed to meet yield and performance requirements, including products targeted to the renewable energy industry.

 

About the University of Illinois Research Park: The Research Park at the University of Illinois at Urbana-Champaign provides an environment where technology-based businesses can work with faculty and students on collaborative research on campus and also access University labs, equipment, and services. The Research Park is now home to 80 companies and growing, employing over 1,400 people in high-technology careers. At any given time over 400 UIUC student interns with leading-edge technical skills are working in these companies gaining valuable work experience while making real contributions to internal corporate R&D and product development programs. Publicly traded firms in the Research Park include: ADM, Abbott Laboratories, Caterpillar, Deere & Company, Littelfuse, QUALCOMM, Riverbed, SAIC, Sony, State Farm, and Yahoo. The Research Park is home to 35 startup companies that are commercializing technology in the EnterpriseWorks incubator.

 

About the University of Illinois: The University of Illinois is a world leader in research and discovery, the largest educational institution in the state with more than 71,000 students, 24,000 faculty and staff, and campuses in Urbana-Champaign, Chicago and Springfield. The U of I awards more than 18,500 undergraduate, graduate and professional degrees annually.

 

CGC Genetics Opens HQ in New Jersey

Portuguese genetic testing company CGC Genetics has opened its US headquarters in Newark, NJ, and has established an affiliation agreement with the Institute of Genomic Medicine (IGM) at Newark's New Jersey Medical School.

 

The company held a ribbon-cutting for the facility with Newark Mayor Corey Booker and other representatives from city government.

 

CGC Genetics offers more than 1,500 genetic tests for prenatal screening, diagnostics, and pharmacogenetics in a range of areas including oncology and other common and rare diseases.

 

CGC and IGM share complementary genetic diagnostics technologies, the company said, including "a broad menu of clinical tests that cover almost every genetic test available and a significant R&D infrastructure ensuring the rapid development and availability of new tests to CGC clients and partners."

 

CGC was wooed to New Jersey in part by efforts from the City of Newark and by Brick City Development Corporation, both of which traveled to Portugal three times in recent years and hosted Portuguese companies through a business attraction campaign.

"Our medical genetic business will benefit from Newark's convenient location, extensive infrastructure, and prestigious medical schools," CGC Genetics' CEO Purificação Tavares said in a statement.

 

CGC Genetics has facilities and offices in Oporto and Lisbon in Portugal, in Madrid, and in New York City.

 

SAFC Opens Second High-Potency API Facility in Madison

SAFC has opened a $30 million, 51,000 sq. ft. facility in Verona, Wisconsin that increases its capacity to produce commercial-scale high-potency active pharmaceutical ingredients (HPAPIs). The new plant complements SAFC's existing 63,000 sq. ft. HPAPI site in Madison, WI.

 

The Verona facility was built specifically to support pharmaceutical manufacturers with their Phase III and commercial HPAPI needs. It houses commercial-scale reactors capable of producing HPAPI batch sizes up to 4,000 liters, 10 times greater than the capacity at the smaller Madison site. The facility includes quality-control development laboratories, a 150-liter mini-processing plant, two large-scale cGMP manufacturing suites, a potent compound-packaging area, as well as a warehouse and office space with the ability to further expand.

 

“With the high-potency market continuing to experience double-digit growth and ongoing significant advances in clinical pharmacology and oncology, there is a significant need for the large-scale production of HPAPIs,” points out Gilles Cottier, SAFC president. “This new facility represents a significant step toward addressing that market demand and supports SAFC's desire to maintain a leadership position in commercial-scale high-potency manufacture.”

 

The Verona plant also features the same design and containment engineering as the Safebridge®-certified Madison facility but on a larger scale, according to SAFC. It is designed to maximize efficiencies and safe handling in high-potency development and to adhere to Category IV standards, the highest guideline for HPAPI handling and containment.

 

SAFC is the custom manufacturing and services business unit within Sigma-Aldrich that focuses on high-purity inorganics for high-technology applications, cell culture products and services for biopharmaceutical manufacturing, biochemical production, and the manufacturing of complex, multistep organic synthesis of APIs and key intermediates.

 

SAFC to Invest $6.25 Million to Fortify Kansas Facility

SAFC® has decided to expand its Lenexa, KS, facility with a $6.25 million investment. It will create a global Center of Excellence for upstream and downstream production of dry powder media and reagents.

 

The project will include expanded pin milling and blending capabilities, enabling an increase of approximately 30% in batch production capacity. The expansion is expected to be completed by the end of this year.

 

SAFC previously performed milling operations at three sites using differing milling techniques. Through its Center of Excellence program, the company plans on consolidating all milling activity at Lenexa, KS, using proprietary pin-milling technology. In comparison with other milling platforms such as ball milling, pin milling allows greater process control including temperature, feed rates, and milling speed to provide powder media with increased consistency and performance, SAFC asserts.

 

The expansion will feature completely separate areas for animal component free (ACF) and animal component containing (ACC) manufacture, both featuring pin-milling technology. Upon completion, two dedicated manufacturing suites will have the capacity to produce ACF dry powder media in batch sizes ranging from 25 to 4,000 kg, with customized packaging available for all quantities. A separate dedicated manufacturing suite for ACC dry powder media products will also come on line as part of the expansion.

 

The project is supported by a $250,000 economic development grant from the Kansas Bioscience Authority. “This grant will see the Lenexa, KS, site become SAFC's first global Center of Excellence for dry powder media manufacturing and is a clear demonstration of our commitment to our biopharmaceutical partners, as we look to reduce their manufacturing costs by minimizing cell culture powder variability while enhancing their supply chain integrity,” says Bruce Lehr, SAFC's director of development.

 

UNC Awarded Stimulus Funding for Genetic Research

The University of North Carolina at Chapel Hill has been awarded about $14.5 million in American Recovery and Reinvestment Act (ARRA) funding from the National Institutes of Health to build 30,000 square feet of new buildings at its Bingham Facility.

 

The Bingham Facility is an animal research facility in Orange County. UNC is a leading center for research in hemophilia and muscular dystrophy, and research supported by the Bingham Facility focuses on these genetic diseases. The grant provides funding to build two buildings, to be completed by 2013, to house animals and support the infrastructure of the facility.

 

Because the funding is an economic stimulus grant, the project will create jobs and encourage the purchase of materials made in America. Since March 2009, not including this award, UNC researchers have received nearly $110 million in ARRA grants or awards. About $129 million in total ARRA funding is expected.

 

 “To receive a construction award in such an extremely competitive grant program is an achievement that reflects the extraordinary quality of work by our faculty researchers,” said Tony Waldrop, vice chancellor for research and economic development at UNC-Chapel Hill. “The researchers whose work will be supported by the Bingham Facility are national leaders in discovering new gene therapy for hemophilia, muscular dystrophy and cardiovascular disease. They give new hope daily to patients with these diseases.”

 

In addition, the University will fund and construct a building to house veterinary services, laboratories and offices. This work will take place alongside the construction sponsored by the federal government.

 

The Bingham Facility has been in operation since the 1970s. This funding ensures that the facility can continue to grow to meet research needs now and in the future, University officials said. The additional construction is consistent with a master plan prepared in 2004. At full build-out, the plan calls for the facility to span 103,000 square feet in several buildings clustered together on the 57-acre site.

 

Planning for the new construction will be completed in the summer or fall of 2011 and construction will be completed in mid-2013.

 

PerkinElmer to Take Over Signature Genomic Laboratories

PerkinElmer is acquiring Signature Genomic Laboratories, a genetic testing company based in Spokane, WA. The company expects the deal to strengthen its existing genetic testing service business, expand its position in early detection of disease, specifically in the molecular diagnostics market, and provide additional strengths in cancer diagnostics.

 

“Signature brings very strong complementary assets for diagnosing disorders that are often undetected by traditional genetic tests,” notes Robert Friel, chairman and CEO of PerkinElmer.

 

Founded in 2003 by Lisa G. Shaffer, Ph.D., and Bassem A. Bejjani, M.D., Signature performs diagnostic cytogenetic testing of chromosome abnormalities in individuals with unexplained physical and developmental disabilities. Additionally, Signature’s microarray diagnostic technology is available for both prenatal and postnatal identification of DNA alterations associated with genetic diseases. More recently, the firm launched a suite of services for the diagnosis of patients with leukemia.

 

“As a global leader in genetic screening technologies and services, PerkinElmer clearly has the resources and worldwide presence to enable our combined testing services to reach more patients and families,” says Dr. Shaffer, president and CEO, Signature. “We believe that this move will not only benefit patient populations around the world but help us continue our success in genetic diagnostic innovation.”

 

Signature has approximately 120 employees and was reportedly the first laboratory to provide microarray-based diagnostic testing of individuals with developmental disabilities with its SignatureChip® microarray.

 

IntegenX, Inc. Opens New Facilities

Microchip Biotechnologies, a maker of automated microscale biotech laboratory systems, announced that it has changed its business name to IntegenX. The new name acknowledges the company’s focus on integrating sample preparation and analysis technologies into complete products that address generic problems shared by life science and biotechnology research laboratories worldwide.

 

Also, IntegenX, Inc. (formerly Microchip Biotechnologies, Inc.), announced the grand opening of its new corporate headquarters and high-tech manufacturing facility at 5720 Stoneridge Drive, Pleasanton, California, in the Hacienda Business Park. In attendance at the event’s ribbon-cutting ceremony and open-house celebration were the company’s executive staff, employees and their family members, investors, board members, representatives of the Pleasanton Chamber of Commerce, Pleasanton City Mayor Jennifer Hosterman, and Congressman Jerry McNerney, serving California’s 11th district.

 

Having out-grown their previous location in nearby Dublin, California, IntegenX again selected the Tri-Valley area as their headquarters. The new location features a microfabrication facility, custom-designed laboratories for the company’s research and development, and manufacturing space for commercial operations. IntegenX will use the in-house microfabrication facility to rapidly prototype microdevices for use in its fully integrated systems supplied to life science research laboratories worldwide.

 

”As we grew out of the old space, we were determined to preserve the advantages of keeping everyone together in one building and in the Tri-Valley where we can attract skilled biologists and engineers to invent and develop the next generation of life science tools,” said Stevan Jovanovich, PhD, President and Chief Executive Officer at IntegenX. “This new location provides a more collaborative environment where we can discuss ideas easily and solve problems quickly, and the space and facilities we need to ramp up operations.”

 

U Washington Medicine’s South Lake Union Campus to Expand

UW Medicine’s four-building site on South Lake Union is preparing to nearly double in size. The campus was authorized to follow through with plans to construct three additional buildings.

 

 “The growth on the site is actually very important in terms of achieving the intellectual mass — the critical mass — that you have to have in order to have a thriving site,” said John Slattery, vice dean of research and graduate education at the School of Medicine.

 

The construction of the three buildings is the third phase of the growth plans for the South Lake Union campus and has been a possible option since the site’s inception in 2003. In a special meeting, the Board of Regents approved the move ahead to the Phase-III option and the construction of the first of the three buildings.

 

Opened in 2004, the South Lake Union campus hosts biotechnology and medical research, including cancer and stem-cell research. A few ongoing projects include studies for a vaccine to prevent breast cancer, using stem cells to replace damaged heart muscle and the hormonal control of appetite for research on obesity and diabetes.

 

With the expansion, some new research groups may be brought on to the site, including those that specialize in allergies and infectious diseases, vision sciences or neuroscience, and others.

 

Some faculty members at the South Lake Union campus look forward to the chance to collaborate with new research groups upon the site’s expansion.

 

“We’ve just really dramatically expanded our collaborations [in the South Lake Union campus],” said Anthony Blau, professor of hematology in the School of Medicine. “And so we collaborated with many people on this campus that we didn’t collaborate with before when we were at the main campus. … And I very much look forward to having a lot more excellent researchers here.”

 

Two of the new facilities will have seven floors, and the third will have eight, surpassing the existing five-floor buildings in the South Lake Union campus. The projected total cost for all three buildings is $516.3 million. The first building, to be completed in 2013, costs $165.6 million.

 

“No state funds are budgeted for the project,” said Ruth Mahan, vice dean for administration and finance in the School of Medicine, in an e-mail. The project will be supported primarily by funding from federal granting agencies like the National Institute of Health.

 

Slattery attributed the growth of the South Lake Union campus to the overall growth of the field of biomedical research.

 

“The real motivation is what’s going on in terms of biomedical sciences and what you can deliver to health care,” Slattery said. “It’s just an extremely exciting period that people that are undergoing training right now just have a really great ride ahead of them. … This simply responds to that opportunity.”

 

All three buildings will be constructed over the next 10 to 12 years.

 

QB3 Opens New Incubator at UC Berkeley

The California Institute for Quantitative Biosciences, or QB3, later will open a new incubator space at the University of California Berkeley — the institute's first incubator in the East Bay, and second in the broader San Francisco Bay Area for housing startup companies.

 

UC Berkeley is one of three UC institutions that comprise QB3; the others are UC San Francisco and UC Santa Cruz. "We hope that this business incubator will jumpstart new companies with origins in UC research labs," Susan Marqusee, director of QB3's UC Berkeley branch and a professor of molecular and cell biology, said in a statement.

 

The new incubator's first tenant — set to occupy a 100-square-foot space at Stanley Hall — is Aperys LLC, launched by a recent PhD graduate of UC Berkeley, Wesley Chang. Aperys sells specialized cell culture platforms allowing researchers to grow nerve cells in precise patterns, with the goal of simplifying their experiments.

 

Chang and a part-time employee will work within Aperys' space, part of an 800-square-foot windowless room. QB3's statement said Chang will have access to the Biomolecular Nanotechnology Center at Stanley Hall, as well as the campus' microfabrication and cell culture labs.

 

"Within two years, it's expected that Aperys will be out the door to make room for other nascent companies," QB3 said.

 

QB3 also said it hopes the Berkeley facility will enjoy the success of its QB3 Garage@UCSF incubator. Opened in 2006, that incubator has nurtured some 28 biotech startups — both within its 2,500-square-foot original space within UCSF's Mission Bay campus, and one block east within a 10,000-square-foot section of FibroGen's headquarters at 409 Illinois St.

 

The UC Berkeley and Garage incubator are two of several that QB3 hopes to operate across the Bay Area through the QB3 Mission Bay Incubator Network, which uses public and private funding to assist startups. Network partners include QB3; the city of San Francisco; the San Francisco Center for Economic Development/Chamber of Commerce; FibroGen; and Alexandria Real Estate.

 

Sigma-Aldrich's SAFC Unit to Expand in Kansas

Sigma-Aldrich's SAFC unit will spend $6.25 million to expand its Lenexa, Kan., facilities, the firm said. The expansion will create a global "center of excellence," which will produce dry powder media and reagents. The expansion also is supported by a $250,000 economic development grant from the Kansas Bioscience Authority.

 

Innovation Place Opens Doors in Melrose

The Innovation Place, a 25,000 sq. ft. flex building located in downtown Melrose, has opened its doors to local high tech companies, targeting specifically those requiring access to flexible offices and lab space without affording the capital investment. As the economy recovers, innovation is a key driver for job recovery and the development of new technologies, and Innovation Places hopes to foster such opportunities.

 

Located at 10 Corey Street in Melrose, the building has a top secret history as well as one of landmark innovation. The property was used as a US top secret facility in WWII for the construction of dummy equipment in preparation for D-Day, manned by an armed 24/7 detail. Innovation Place is also the home to Boston's renowned Boston Baked Beans.

 

A former factory, the building has been redesigned to meet the needs of the firms in Massachusetts' rapidly expanding life sciences sector, many of whom are small and don't have adequate access to wet/chem labs and cannot afford to build ones on their own.

 

The Innovation Place has retained Jeremy Cyrier, CCIM and Paul Lam of MANSARD Commercial Properties to handle leasing and marketing for the property.

 

The building offers maple hardwood floors, glass pained doors, exposed fir beam ceilings and an on-site gym. Current tenants include Q Developments, Diagnostyx and ASC-LxCAM.

 

Vision for New Providence, RI

For the past month, construction workers have been gutting the 1920s-era building at 222 Richmond St. Walls have been demolished; floors and ceilings stripped bare.

 

The former home of the Brier Manufacturing Co. — makers of a line of jewelry called Little Nemo — it will become the first permanent home of the Warren Alpert Medical School at Brown University.

 

Governor Carcieri, Mayor David N. Cicilline and Brown University President Ruth Simmons on Monday spoke at a formal groundbreaking for the $45-million project. About 300 other officials, labor leaders and major university financial supporters were also in attendance.

 

State and city leaders hope the medical school will be an anchor for the state’s research-based economy and spur the second wave of the Providence Renaissance.

 

“Twenty years from now, we’ll look back on this as one of the moves that made an enormous contribution to the Capital City and this state,” Carcieri said at the groundbreaking.

 

“It’s the most important decision in decades to growing this Knowledge Economy,” said Cicilline.

 

The governor and the mayor say the project, which will be completed in August, is already producing positive results.

 

Isis Biopolymer, a three-year-old medical-device company that is rolling out an anti-aging patch next year, recently relocated from Warwick to a building across the street to be a part of the district’s buzz.

 

The state’s congressional delegation is shepherding a $460-million request for federal funding for infrastructure upgrades in the Jewelry District. That proposal, which calls for a new clinical-trials lab, a streetcar system, a supercomputing system, utilities upgrades and more, was developed earlier this year by Cicilline’s administration and the city universities and hospitals.

 

And a proposed voter referendum to build a $60-million nursing school for the University of Rhode Island and Rhode Island College downtown is currently before the General Assembly.

 

The fact that the medical school project is moving forward now, as the state struggles to crawl out of a national recession, is not lost on Simmons, the Brown president. “We’re proud to be providing jobs in this economy,” she said. “We recognize that we have a responsibility to this community and to this state.”

 

From now until August, nearly 500 construction workers will be employed. About 15 percent of the man hours on the job will go to low-income, minority city residents as part of the Building Futures program.

 

When it opens, the medical school will bring nearly 500 students, faculty and administrative staff to the downtown, injecting life into an underutilized section of the city.

 

It will overlook a four-acre city park on Eddy Street that will replace the former sections of Route 195 cutting through the downtown (those sections may come down as soon as December). A bridge using the highway’s footings will take pedestrians over the Providence River from the East Side to the Jewelry District.

 

Brown sees the new medical school among the key capital projects to solidify its reputation as a world-class research center. The project is part of almost $260 million in capital investments over the next few years to the university’s historic College Hill campus and the planned downtown campus.

 

The new medical school, with its state-of-the-art classrooms and labs and close proximity to the state’s major hospitals, will raise its national profile and allow the school to increase enrollment over time, says Dr. Edward J. Wing, the medical school dean.

 

The medical school has about 414 students and is currently ranked 34th in the nation, according to the U. S. News and World Report.

 

The university owns six other buildings along Richmond Street, some of which are already being used for life-sciences research. Other buildings may soon be converted to research or education uses.

 

“It’s a major symbolic move,” Wing said. “It shows that Brown is committed to this neighborhood, this city and this state.”

 

At the same time it opens the medical school, Brown will also open a new, $40-million creative-arts center on Angell Street designed by the architects that produced the Institute for Contemporary Art in Boston.

 

Elsewhere, it is investing $20 million to renovate the university student center, Faunce Hall; building a $40-million fitness and aquatics center on Hope Street; and spending $42 million to renovate space for its cognitive-sciences and linguistics departments.

 

While these projects all represent scaled-back versions of projects proposed during more economically flush times, they are no less significant for the local construction industry, which has seen unemployment rates of more than 50 percent since the economic downtown, according to Michael F. Sabitoni, president of the state Building and Construction Trades Council.

 

“For the local building trades, Brown has been second to none,” he said.

 

The Alpert Foundation is a private philanthropy with primary interests in health care. Its gift to Brown University is the largest in its history. Alpert died in March 2007 at the age of 86.Brown University Medical School

 

The university is renovating an office building for its new medical school.

About the building: built in 1928 and on National Register of Historic Places; three stories (with a partial fourth floor); 135,000 square feet.

Projected cost: $45 million

Jobs: 500 construction jobs; 57 jobs post-construction

Expected completion: August 2010

 

First Phase of Abraxis Project Completed

Irvine-based LCS Constructors has put the finishing touches on the first major phase of a renovation project for Abraxis BioScience's facility in Costa Mesa.

 

The 165,000-square-foot property was formerly occupied by ICN/Valient Pharmaceuticals and will serve as the site for Abraxis' research and development operations once the entire revamp is completed.

 

The biotechnology firm, which is relocating its research and development business from Marina del Rey, first hired LCS Constructors to evaluate the property, then signed the company on as the project's design-builder, after the study revealed a number of issues that need repair or retro-fitting. 

 

The first phase included significant seismic upgrades and renovating existing lab space, creating a new “state-of-the-art” laboratory for chemistry, biology, formulation and a biological safety lab.

 

“Although the team faced several unique challenges that accompanied these seismic upgrades, the team’s resourcefulness, combined with careful and deliberate planning, led to the successful completion of the first major phase of this project,” says Jim Koons, who is coordinating daily production of the renovation.

 

LCS Constructors was founded in 1980 and opened its first corporate office in 1991 in San Juan Capistrano. Management and field craftsmen at LCS Constructors have completed more than 3,000 lab projects.

 

Currently, the construction group is involved in projects for Cal Tech in Pasadena, ExxonMobil in Torrance and Plus Diagnostics in Irvine.

 

Abraxis, a biotechnology company based in Los Angeles, works to find new treatments for cancer and other pathological disorders.

 

The Abraxis portfolio includes the first and only protein-based nanoparticle chemotherapeutic compound. 

 

The next phase of the Abraxis project is pending. 

 

Florida Sets Aside $130 Million for New Jackson Lab Campus

Florida's House of Representatives and Senate have agreed to commit $130 million over three years — $50 million of that during the fiscal year that starts July 1 — to The Jackson Laboratory toward its development of a third campus near Naples, Fla., that would specialize in personalized medicine.

 

That commitment has been written into the compromise $69 billion budget that the state House and Senate are expected to approve. The measure will require the signature of Gov. Charlie Crist, who is now running for US Senate.

 

Leaders of the chambers' appropriations committees added the $130 million to the state's Innovation Incentive Fund. The $130 million is part of a $380 million economic incentive package for Jackson Lab, technically an amendment by state Sen. Garrett Richter (R-Naples) to the state Senate's version of the budget.

 

The package requires an equal $130 million from Collier County, where officials have verbally committed to assisting the lab, as well as another $120 million from Jackson Lab, which has said it will raise that money from supporters in and outside the community through a philanthropic campaign.

 

While Jackson Lab is not mentioned by name, it is understood to be the beneficiary of the economic incentive package, which says the money will be used "to fund the development of a research institute focused on genetics and personalized medicine."

 

The earmark contrasts with the House's original plan to set aside for Jackson Lab $50 million of a total $119 million that the chamber originally approved for economic development projects statewide.

 

The laboratory has identified a potential site for the campus, namely 50 acres owned by developer Barron Collier Cos., co-developer of the nearby Ave Maria mixed-use master planned community. Jackson Lab has projected its Florida campus will employ about 200 people, a workforce size expected to be reached three to four years after the facility opened.

 

Richard Woychik, president and CEO of the Jackson Lab, said in a statement the promise of state funding was "an important first step" in advancing the Florida campus, and that the budget, if signed by Crist, "will be an essential vote of confidence that will help us attract the institutional partnerships and the matching funds we would need for the project to proceed."

 

SCHOTT Begins Mass Production InJentle Syringe

SCHOTT Pharmaceutical Systems will begin mass production of the staked syringe system InJentle at its Lebanon, PA facility at the end of this year. The SCHOTT InJentle syringe was developed for the special requirements of highly sensitive drugs. According to the company, its unique design offers improved drug stability and a gentle application.

 

“The drug is not in contact with the needle or the adhesive during storage,” says Carmen Heiter, product manager of syringes at Schott. “This prevents sensitive drugs from interacting with the adhesive or the metal of the needle.” The seal design allows the drug to flow into the needle only at the moment when the syringe is opened and the tamper-evident closure enables physicians or patients to determine if the syringe is still unused.

 

Additional advantages, according to the company, are that the InJentle syringe is completely tungsten-free due to the special geometry of the glass barrel, and the needle point is fully protected and does not touch the needle shield or any other material.

 

Comar Builds Capacity with Unicon Addition

U.S. drug packaging firm Comar says acquisition of Universal Container Corp (Unicon) provides capacity for growth, particularly in key liquid medication delivery device market.

 

Cavey, Puerto Rico-based Unicon produces injection, blow and extrusion molded high-grade plastic packaging and container parts for the pharmaceutical manufacturing industry

 

Financial terms of the transaction, which completed on April 16, were not disclosed, neither were details of the likely impact on Unicon’s existing manufacturing workforce.

 

Comar president Mike Ruggieri suggested that: “Unicon’s products, production capabilities, and facility will complement and enhance Comar’s existing product lines and position the combined entity for future growth.

 

He highlighted manufacturing space as a key motivation for the deal, explaining that it “gives our business a high quality, redundant facility for production while also expanding our capacity to keep up with our rapid organic growth.”

 

The acquisition is the latest step in Comar’s strategic refocusing on building in plastic pharmaceutical and medical packaging, which began in 2007 with the sale of its glass vial unit to Germany’s Gerresheimer.

 

The addition of Unicon’s various plastics molding and production capabilities also fits with Comar's recent efforts to expand its range of oral, liquid medication dispensing technologies.

 

Earlier this month the Buena New Jersey-headquartered firm announced the launch of enhancements to its tow-piece oral dispenser line, specifically changes to barrel and plunger design.

 

Comar also began using new standard colorants that contain no fillers and all use the same carrier resin which, it claimed, will provide greater performance consistency across the product range.

 

AIT Receives Updated ISO 9001:2008 Certification

AIT Laboratories received the updated ISO 9001:2008 Quality Management Standard certification. The International Organization for Standardization (ISO) is a global system for developing a quality management system and measuring customer satisfaction. AIT has held this honor since 2001 and was the first toxicology lab in North America to be certified to these standards.

 

“AIT achieved this updated certification due to our continued commitment to following the strictest quality assurance procedures and industry guidelines,” said Michael Evans, Ph.D., founder, president, and CEO. “Holding this honor sets us apart in our industry and reinforces our pledge to provide clients with ‘A Higher Standard of Service.’”

 

The certification is active until January 2011, and AIT will be eligible for recertification in November 2010. To qualify, AIT had to undertake a rigorous audit last November in which NSF International Strategic Registration, the registrar certified to accredit these standards, evaluated the company’s documentation, process of corrective action, quality objectives, client satisfaction, and validation and control points.

 

“It is not required for us to hold this accreditation, but AIT recognizes the value it brings to the science and services we provide,” said Justin Taylor, director of quality assurance. “ISO goes above and beyond to ensure the needs of our clients are met.”

 

ISO-certified companies are responsible for adhering to the following guidelines:

 

o   Lab processes

o   Work flow

o   Doing something the same time every time to ensure quality testing of every sample

o   Product verification

o   Confirming that testing processes and reporting outcomes meet company and industry standards

o   Verify that companies are fulfilling their customers’ expectations

 

o   Targeted client surveys

 

Bristol-Myers Squibb Receives LEED® Silver Certification

Bristol-Myers Squibb Company announced that it has received Leadership in Energy and Environmental Design (LEED) Silver certification for its biologics manufacturing facility in Devens, Massachusetts. The laboratory and office building at the same facility received LEED Gold certification in December 2009.

 

LEED certification, established by U.S. Green Building Council and verified by the Green Building Certification Institute, is the nation's preeminent program for the design, construction and operation of high performance green buildings.

 

"We are especially pleased to have received this recognition," said Chris Perley, vice president and general manager of Bristol-Myers Squibb Devens operations.

 

"Our new facility, one of the largest of its kind in the world, demonstrates how Bristol-Myers Squibb is incorporating sustainability into its facilities and operations," said Perley. "The company chose a former military base and consciously designed and constructed the facility in such a way to earn this distinction."

 

To gain certification, the project used advanced energy modeling during the design. "Through the selection of high efficiency windows, insulation, and high efficiency motors, the manufacturing building is expected to consume 11 percent less energy compared to a building of similar size and use," said Daniel Noberini, associate director of Environment, Health and Safety for the Devens operations.

 

If approved by the U.S. Food and Drug Administration (FDA) for commercial production in 2011, the Devens facility is expected to manufacture Orencia (abatacept), the company's first internally discovered biologic therapy for rheumatoid arthritis.

 

"For us, being green goes beyond meeting environmental mandates. Bristol-Myers Squibb is committed to reducing the impact of its operations on the environment," said Susan Voigt, vice president for Environment, Health, Safety and Sustainability.

 

Some of the environmental highlights of the Devens facility include:

 

 

The building has been designed to reduce water consumption by 46 percent compared to a building of similar size and use through the use of ultra-low flow lavatories, low-flow showers and janitor sinks.

 

 

The laboratory and office building, awarded LEED Gold certification late last year, features no enclosed office spaces. As a result, 92 percent of all the work spaces receive natural light from the building's large glass windows — an exemplary achievement which creates a pleasant work environment for employees. The greenness factor at Devens has also gained the attention of prospective employees who favor companies with strong sustainability programs.

 

LEED certification is the latest in a drumbeat of recognition for the company's sustainability achievements and its commitment to the preservation of natural resources and efforts to minimize the environmental impact of its operations and products.

 

In September 2009, Newsweek named Bristol-Myers Squibb one of the greenest companies in America in the magazine's first ever Green Ranking of the nation's 500 largest companies, placing the company in eighth position.

 

Also in September, Dow Jones included Bristol-Myers Squibb in its annual Sustainability North America Index, a key reference for investors, while Corporate Responsibility Officers Magazine recognized the company as its Best Corporate Citizen for 2009 and ranked the company in seventh place for 2010.

 

Partnership for New Drugs

Alabama-based biotechnology firm DiscoveryBioMed (DBM) has partnered with Californian botanical specialist ChromaDex to tap into the group’s phytochemical expertise as it steps up work on the development of anti-inflammatory drugs.

 

As part of the partnership, ChromaDex, which specializes in botanical reference standards and analytical tools, will be providing a library of natural products to use as a reference in DBM’s human cell-based platforms.

 

According to DBM, the two firms “share the same core conviction that natural product-derived small molecules are of huge potential value to the pharma and biotech and OTC industry”.

 

"The integration between our human cell platforms for drug discovery that are of biological and disease relevance and ChromaDex's phytochemical small molecules and botanical extracts is a huge 'value add' for both companies," said DBM director, Dr Erik Schwiebert.

 

The move comes at the same time as a $200,000 grant awarded to DBM by the US National Institutes of Health (NIH) for the discovery of anti-inflammatory drugs. The Small Business Innovations Research Phase 1 grant will be used to continue research into the discovery and development of anti-inflammatory phytochemicals for nasal and pulmonary inflammation, dermatitis, and kidney disorders with an inflammatory component.

 

According to Dr Schwiebert, the new partnership with ChromaDex “empowers” its research program by providing access to botanically-derived small molecule phytochemicals and extracts.

 

DBM said it designs phenotypic high-throughput molecular screening programs where the human cell platform accelerates drug discovery. The firm’s program aims to discover broad spectrum anti-inflammatory phytochemicals.

Last year, NIH set up a separate agreement with ChromaDex designed to provide its various groups with easier access to the botanical firm’s products and services.

 

The Blanket Purchase Agreement (BPA), set up in June 2009, covered all areas of ChromaDex’s activities, including botanical reference materials, phytochemicals, bulk chemical production, analytical testing services, analytical method development, contract research, isolation of compounds, chemical synthesis and natural product libraries.

 

Just last month, the firm also won a five-year contract to supply federal agencies with scientific services.

 

The new contract with the General Services Administration (GSA), which took effect on March 1, covers all aspects of food and dietary supplement testing, analytical method development and validation, contract research services, report and manuscript preparation and laboratory technique training.

 

Pall Expands Manufacturing and R&D in Florida

According to a report in the Pensacola News Journal, Pall has added 40,000 sq.ft. of manufacturing space, bolstering the sites existing production space, laboratory units and analytical chemistry space.

 

The unit, on the Ellyson Industrial Park near Pensacola, produces filtration materials for the life science research and pharmaceutical manufacturing sector and currently employs a staff of 200 scientists, technicians and operators.

 

While Pall has not disclosed further information, the 2006/7 annual report of the Pensacola Bay chamber of commerce suggests the firm had earmarked investment of $25m for the project.

 

UGA Opens Nano-bio Cleanroom

The University of Georgia opened its new nano-bio cleanroom on March 12. The facility cost $2.3 million and was built to engineer devices at the atomic and molecular level interface with biology.

 

Drug discovery, disease diagnosis and therapeutics, food safety, and bioenergy projects are planned for the new facility. It is a co-located with the Georgia BioBusiness Center. Project partners include the Savannah River National Lab, Emory University, and Georgia Tech.

 

New High-Tech Cleanroom at Notre Dame

As reported by the South Bend Tribune, a new cleanroom at Notre Dame University will provide researchers with the opportunity to work on cutting edge projects that were previously inconceivable. The cleanroom will provide the controlled environment that is required for the construction of integrated circuits and nanotechnology devices.

 

Half of Notre Dame's cleanroom is Class 100. About 40 percent of the space is Class 1,000 — no more than 1,000 particles larger than 0.5 microns per cubic foot. The remaining 10 percent is Class 10,000. The cleanroom was designed to be reconfigured easily for the constantly changing needs of researchers.

 

Cleanroom Completion at Vetter’s New Chicago Facility

Vetter, a provider of aseptic pre-filled drug-delivery systems, announced that cleanroom infrastructure will be completed by early May at its new Chicago facility—an expansion of Vetter Development Service (VDS)—and the site remains on schedule for launch of operations at the beginning of the fourth quarter 2010.

 

VDS Chicago is located at the Illinois Science + Technology Park in suburban Chicago and will support pre-clinical through phase II development projects. The state-of-the-art facility includes 24,000 square feet of microbiology and chemical laboratories, and three cleanrooms, whose infrastructure will soon be finished, including the installation of monitoring and laminar airflow equipment. Vetter will be installing filling units over the coming months, and the site will be operational in beginning of the fourth quarter 2010.

 

One cleanroom will house Bosch’s new MHI 2020 automated vial filler. Vetter is the first company to use Bosch’s new system, which was designed specifically for clinical-stage, high-value biopharmaceuticals. The unit will fill up to 10,000 liquid or 5,000 lyophilized vials per day.

 

A second cleanroom offers semi-automated filling of up to 500 units per day. The system can fill a variety of packaging materials, including vials, syringes, and cartridges. This cleanroom is intended for liquid fills, although the unit may also perform fills for non-cGMP lyophilized units.

 

Filling operations in the third cleanroom are planned for pre-sterilized syringes.

 

DPT Laboratories to Expand Aseptic Manufacturing in Lakewood, NJ

DPT Laboratories, Ltd. announced additional details on the expansion of its aseptic manufacturing and development capabilities at its Center of Excellence for Sterile & Specialty Products in Lakewood, N.J. DPT’s sterile center will focus on aseptic production of sterile dosage forms to include small-volume parenterals, ophthalmic preparations, preservative-free nasal sprays, and sterile ointments.

 

“This is truly a state-of-the-art site with some of the best equipment and newest suites in the industry,” said Gene Ciolfi, DPT’s general manager for Sterile & Specialty Products.

 

DPT has invested more than $30 million in infrastructure to enhance the 175,000-sq.ft center. Some of the investments include new water for injection, clean steam, and HVAC systems, as well as a state-of-the-art microbiology laboratory. The new micro lab provides comprehensive in-house microbiology testing services such as environmental monitoring, sterility testing using isolation technology, and endotoxin testing. The center is also equipped with pharmaceutical clean room assets that include Class A filling suites, Class B & C support suites, and Class D component preparation areas.

 

“Not only did we invest in the facility, but we also hired the right individuals who are experts in this field,” Ciolfi added. “Our employees will leverage their expertise combined with the company’s 70-year history to provide our customers with quality services.”

 

In addition to the personnel onsite, this center will be supported by DPT’s Center of Excellence for Research & Development in San Antonio for pre-formulation and formulation development activities as well as analytical development services and technology transfers. DPT has more than 1,000 employees, including more than 100 scientists and engineers.

 

“The industry is ready for a service provider who is focused on providing solutions for clinical, small-lot, and large scale sterile manufacturing needs,” said JJ Feik, Director of Marketing and Corporate Development for DPT. “I believe with our combined reputation for expertise, quality, service, and regulatory compliance, we are a logical choice for contract sterile manufacturing and development services.”

 

Amcor Adds Blown-Film Capacity at U.S. Plant

Amcor Flexibles has expanded its drug packaging capacity with the installation of a new blown-film production line at its facility in Mundelein, Illinois, US.

 

The firm said the nine-layer line is “specifically tailored to the production of medical films” and equipped with “auto­-gauging, web cleaners, and vision systems to ensure the highest quality.”

 

Michael Barr, product manager of Amcor’s coextruded and converted units, said the line "enhances our capabilities to develop and manufacture next generation peelable films, oxygen and moisture barrier films, and high­ performance forming films."

 

Demand for more effective barrier films has grown markedly over the last few years as drug makers have sought ways to improve both the shelf and safety of increasing potent and costly pharmaceuticals.

 

However, while this is good news Amcor, and indeed specialist firm maker Klockner Pentaplast which recently boosted production capacity, in the longer term demand may shift towards nanotechnologies.

 

At least this is the contention of analysts at iRAP who recently suggested that: “demand for better barrier protection for new high-tech, high-value drugs is driving development of nanotechnology packaging technologies.

 

Since the acquisition fellow pharmaceutical packaging firm Alcan earlier this year Amcor has sought to reorganize its range of products and geographic coverage, with the announcement being just the latest move.

 

For example, in the statement accompanying the news, the Australian firm revealed it has already installed identical blown film capacity for pharmaceutical products at its manufacturing facility in Ghent, Belgium.

 

Prior to that, and as a condition of the Alcan takeover, Amcor agreed divest plants in Tobepal, Spain - which had combined sales of €110 million – after European regulators raised competition concerns about “flexible packaging used in the pharmaceutical sector.”

 

Qiagen to Expand in Maryland

Qiagen has plans to invest around $52 million in expanding its operations at its North American headquarters in Germantown, Md., according to a statement released by Maryland Governor Martin O'Malley.

 

The firm intends to add 90 full-time positions in connection with the expansion by 2015, as well as 117,000 square feet of new manufacturing and office space.

The State of Maryland will aid the expansion with a $700,000 loan provided by the Maryland Economic Development Assistance Authority and Fund. In addition, Montgomery County, in which Qiagen is located, will provide a $300,000 grant through its Montgomery County Economic Development Fund.

Qiagen also is eligible for Maryland's job creation tax credit, as well as local property tax credits and workforce and training programs.

 

"We are experiencing rapid growth of our global business, and are pleased to expand our operations and employee base here in Maryland, a region that is an epicenter of bioscience and genomics research, discovery, manufacturing and commercialization," Sean Augerson, senior director of Qiagen's North American Operations, said in a statement.

 

Qiagen currently employs around 3,500 people worldwide, with 1,150 of those positions in the US. It employs 580 individuals in Montgomery County and nearly 700 employees state-wide, according to the statement.

 

Qiagen established its US headquarters in Germantown 10 years ago. It expanded its operations in the State of Maryland through its 2007 acquisition of Digene and 2009 acquisition of SABiosciences.

 

AMPAC Opens New Texas API Plant

AMPAC Fine Chemicals boosts reactor capacity 30 per cent with new manufacturing plant and says North America is attractive for API production.

 

The new facility in LaPorte, Texas, houses 23 gallons of reactor capacity and is capable of a range of energetic chemistry processes, including azide, cyanide and phosgene production and commercial-scale hydrogenation.  Spokesman Scott Watson told in-Pharmatechnologist that AMPAC bought the plant from the ZaCh System unit of Italian chemicals maker Zambon as part of a strategy to grow capacity and take advantage of opportunities provided by the economic downturn.

 

Watson said that, unlike rival manufacturers that have exited North America in the face of competition from countries where production is cheaper, AMPAC sees attractive growth potential for fine chemicals.

 

He added that the AMPAC unit “differentiates its offering through technology” citing continuous processing and high potency active pharmaceutical ingredient (API) capacity as particular examples.

 

The LaPorte facility, Watson continued will support large-scale production of both development projects and existing commercial manufacturing carried out at AMPAC’s facility in Rancho Cordova, California.

 

He was not able to say which customers AMPAC will work with at the plant for reasons of confidentiality, but listed Gilead, Biogen Idec and Incyte as examples of industry clients.

 

In a statement company president Aslam Malik said: "With the addition of these facilities, we continue to move toward our vision of creating value-added growth in cGMP pharmaceutical chemical manufacturing."

 

Malik added that: “While it will take some time to fill this expanded capacity, our pipeline remains strong and we foresee the need for this capacity as our development products mature."

 

Joe Carleone, CEO of AMPAC Fine Chemical’s parent America Pacific, predicted that: "Pharmaceutical companies will continue to grow their outsourcing strategy for chemicals, especially when unique technologies are involved; as the industry rebounds, we will be there to serve our customers' increasing needs."

 

Eastman Chemical Opens New Tritan Plant

Eastman Chemical Co. celebrated the opening of a new plant exclusively dedicated to the production of Eastman Tritan copolyester at its headquarters in Kingsport, TN. The plant expands production capacity of Tritan in alignment with increasing market demand for the material. Tritan is a new-generation copolyester that balances the properties of clarity, toughness, and heat and chemical resistance, and is manufactured without bisphenol A (BPA).

 

“At Eastman, our philosophy is inspiring innovation to benefit our customers,” said Dante Rutstrom, vice president and general manager, specialty plastics business, Eastman, in a press release. “The opening of the new plant for Eastman Tritan™ copolyester is just another example of our long history of growth based on innovation. With this new facility, we can continue to expand and strengthen our offerings while demonstrating our commitment to making this material successful in the marketplace.”

 

Since the launch of Tritan in 2007, marketplace use of Tritan has increased from three initial industries—reusable sports water bottles, housewares, and small appliances—to seven target markets, including medical, infant care, bulk water, and signs. 

 

“The future outlook for Eastman Tritan copolyester is promising, especially considering numerous brands are commercializing innovative applications requiring sizable volumes of Tritan,” Rutstrom said. “By responding to our predicted annual global copolyester market growth of 6% to 8%, we are already exceeding expectations of marketplace success. We are now even more equipped to increase the opportunities available in the industry.”

 

The manufacturing facility utilizes operations designed to minimize the environmental impact of processes and products, showcasing Eastman‘s continued commitment to sustainable material solutions. 

 

The grand-opening celebration included tours of the new facility for local government officials, as well as select customers and employees, and presentations by Eastman executives, including Jim Rogers, president and CEO, Eastman, and Mark Costa, executive vice president, specialty polymers, coatings and adhesives, and chief marketing officer, Eastman.  

 

In addition to celebrating the plant opening, Eastman Chemical released test results that demonstrate that Eastman Tritan copolyester is free from bisphenol A (BPA) and estrogenic activity (EA). Tests were conducted by various third-party research laboratories using well-recognized methods.

 

“We understand that the marketplace is focused on issues such as endocrine disruption. Eastman and independent third-party laboratories have conducted rigorous tests to confirm Eastman Tritan copolyester is free of bisphenol A and estrogenic activity,” said Rutstrom in a press release. “These tests went beyond the requirements needed for regulatory clearance and are intended to provide our customers with even greater confidence in the safety of this product.”

 

REST OF WORLD

 

Kemwell Boosts Capacity with Sweden Plant

Indian CMO Kemwell says new manufacturing plant in Sweden will help meet customer demand for European production capacity.

 

The plant, on the Uppsala Business Park, is a 31,000 sq. meters (333,560 sq. ft.)  plant that will significantly increase tablet, capsule and suppository manufacturing capacity when fully operational later this year.

 

Kemwell AB CEO Agneta Bergvall said that: “Existing and potential new customers ask for production in Europe and we can also see other synergies in the company out of the existing production.”

 

She added that the type of “production [undertaken at the plant] will also depend on new business received,” going on to say that “at present we have discussions with several international and domestic pharmaceutical companies.”

 

Bergvall also stressed the ability to customize manufacturing operations at the plant as another of its key advantages, explaining that: “Flexibility in production is one of the topic demands of today from the market.”

 

Swedish real estate firm Klovern, which leased the facility to Kemwell for 16 years, said that the CMO “is already conducting laboratory operations” at the new plant and will also lease an adjacent office building.

 

Kemwell joined Sweden’s drug manufacturing sector with the acquisition of a facility formally owned by Pfizer in 2006 as part of an effort to develop a presence in Europe.

 

And, looking forward, Bergvall said that the CMO “is open to and pursuing more acquisitions in Europe and US” as part of wider plans to remain competitive in contract manufacturing the sector.

 

Parexel Adds Offices in China

Parexel has opened two offices in China, expanding its presence in Asia Pacific to 17 sites, as part of efforts to provide cheaper, faster drug development services.

 

Continuing its expansion in China, Parexel has added sites in Chengdu and Guangzhou, building its presence in the country. Parexel first established operations in China approximately 15 years ago and has added to this as pharma’s interest in outsourcing to the country has grown.

 

Primary drivers of this are the commonly cited benefits of a large patient population, cost effective environment and expanding medical infrastructure, according to Josef von Rickenbach, CEO of Parexel.

 

These characteristics can help clients lower development costs, accelerate patient recruitment and reach market sooner. Furthermore, Rickenbach explained that “a high prevalence of certain cancers, diabetes and other diseases in China can benefit from more extensive clinical research”.

 

In addition to the new sites, Parexel has offices on Beijing, Shanghai and Kowloon, Hong Kong. The contract research organization’s (CRO) presence in Asia Pacific extends into Australia, India, Indonesia, Japan, Malaysia, the Philippines, Singapore, South Korea, Taiwan and Thailand.

 

Parexel believes its experience of operating in Asia Pacific helps it assess diverse patient populations, navigate regulatory issues, identify investigators and ensure data quality.

 

The International Association of Outsourcing Professionals (IAOP) delivered its annual report, ranking Parexel as one of the top 10 outsourcing companies for the pharma.

 

The other companies in the pharma industry top 10 are Corbus, CPA Global, Intelligroup, Johnson Controls, Jones Lang LaSalle, Nair & Co, Synygy, TEKsystems Global Services and Wicresoft.

 

BGI Expands into Denmark

BGI will create a $10 million European headquarters in Copenhagen, where it plans to eventually hire up to 150 scientists and support employees.

 

BGI will recruit between 20 and 50 people during the first year of the Copenhagen HQ — to be called BGI Europe — then establish a sequencing platform allowing for the hiring of between 50 and 100 people. The project will be China's largest investment in Denmark.

 

The "strong and still growing research community within biotech in Denmark has attracted our attention," Songgang Li, associate director of BGI, said in a statement. "We see some interesting prospects for partnership, and I feel confident that we have acted wisely in selecting Denmark as our European base."

 

BGI expects to generate DKK 5 billion ($829 million) in first-year revenue from the Copenhagen HQ, according to a statement released by Denmark's Ministry of Foreign Affairs.

 

Chinese and Danish officials signed an agreement creating BGI's European HQ on May 17, during the Denmark-China Economic & Trade Cooperation Forum held in Copenhagen. The signing ceremony was attended by Denmark's Minister for Economic and Business Affairs Brian Mikkelsen and China's Commerce Minister Chen Deming.

 

According to the official Chinese government press agency Xinhua, Deming led the largest-ever Chinese trade delegation to visit Denmark, which is China's second largest source of foreign investment. The delegation consisted of more than 100 Chinese entrepreneurs focused on promoting trade and investment with China.

 

The trade forum was timed to coincide with the 60th anniversary of the establishment of diplomatic relations between China and Denmark, one of the first Western countries to recognize the People's Republic government.

 

BGI actually announced the creation of BGI Europe six days before the trade forum on May 11, through a pair of one-sentence statements on its website. One statement said the Copenhagen HQ "will offer scientific and technological collaboration and services to the whole European countries, providing R&D in technology and products, [and] seeking out opportunities of cooperative projects in the fields of sequencing and bioinformatics."

 

The other statement said BGI Europe's priorities include "jointly establishing key laboratories with universities and other research institutes" on the continent.

 

Founded in 1999 as the Beijing Genomics Institute, BGI is based in Shenzhen. Facilities at BGI Shenzhen include the Sino-Danish Cancer Research Center, opened last year by the institute in cooperation with University of Copenhagen Denmark, Aarhus University, Southern Denmark University and other research institutions. According to BGI, the center uses next-generation sequencing technology for the identification, development, and clinical validation of new biomarkers for early diagnosis of breast cancer.

 

Denmark is home to more than 130 biotech companies and more than 270 providers of services for the biotech industry, with some 25,000 people employed in the life sciences, Ole Frijs-Madsen, the director of the Danish trade promotion agency Invest in Denmark, said in a statement released by the Danish law firm MAQS, which facilitated the BGI-Danish agreement.

 

Japan's Astellas to Buy U.S. OSI for $4 Billion

Japanese drug maker, Astellas Pharma Inc., said it will buy U.S. cancer drug company OSI Pharmaceuticals Inc. for $4 billion in cash in a bid to expand its cancer drug business worldwide. Astellas said it will pay $57.50 per OSI share, up from $52 the Japanese company had offered earlier. The transaction will be completed within a month. The deal ends a contentious 14-month courtship that began in January 2009. The acquisition is part of Astellas' drive to expand its cancer drug business worldwide. OSI's drugs include Tarceva, for lung cancer, which generated $1.2 billion in global sales last year. Tarceva is marketed through a partnership with Roche's Genentech unit. OSI reported about $428 million in revenue in 2009, and more than 80 percent of that total -- about $359 million -- came from the Tarceva partnership. The Japanese maker said it hopes to jointly develop cancer drugs with OSI. Astellas is developing treatments for cancer of the prostate, breast, skin, pancreas, and ovaries. Its main areas include urology and transplant drugs, and it's trying to expand its capabilities in immune and infectious diseases, metabolic diseases, and neuroscience. Astellas made a written offer of $52 per share for OSI in February 2009, but OSI said that price was too low. After several refusals, Astellas took its offer directly to shareholders in a hostile bid. It also filed suit to prevent OSI's board from blocking the deal. Both boards have approved the transaction. 

 

Charles River Shanghai Receives OECD Certification

Charles River Laboratories, Wilmington, Mass. announced the company’s Shanghai facility became the first preclinical laboratory in China to receive a Certificate of Good Laboratory Practice (GLP) compliance from an Organization for Economic Cooperation and Development (OECD) member country. The certificate acknowledges the site is operating in compliance with OECD Principles of GLP for both toxicology and laboratory services.

 

The one-week inspection was conducted by the Belgian national GLP compliance monitoring authority. In addition to an extensive facility assessment, the inspection included an audit of three completed and two on-going studies. The facility inspection evaluated key operations areas including: vivarium rooms, pharmacy, analytical chemistry, bioanalytical chemistry, clinical pathology, and histopathology.

 

The Belgian national GLP compliance monitoring authority certified that Charles River’s Shanghai facility is operating in compliance with OECD Principles of Good Laboratory Practice. “The facility has best practices in place for conducting GLP studies, which are supported by sophisticated systems and a well organized site,” said Guido Jacobs, GLP inspector, Belgium Government Scientific Institute of Public Health, Bureau of Quality Assurance.

 

“Our China facility was established on the premise that we would provide our clients with the same high standards of research, safety, animal welfare, and good laboratory practices that distinguish Charles River,” said James C. Foster, chairman, president, and chief executive officer of Charles River. “As the first preclinical CRO to receive a Certificate of Compliance from an OECD member country, Charles River is distinctively positioned to help our clients develop IND-enabling programs at our Shanghai facility. This certification marks a significant milestone in our commitment to strategically partner with our clients globally to accelerate their drug development programs.”

 

Charles River’s Shanghai facility has also received accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), the Canadian Council on Animal Care (CCAC), and the Shanghai Laboratory Animal Commission (SLAC).

 

Tetra Pak Begins Carton Output with China Launch

Tetra Pak has unveiled plans to produce billions of eco-friendly aseptic cartons for the Chinese market over the next two years.

 

The company said the cartons bearing the Forest Stewardship Council (FSC) label will be available in July. The announcement comes just months after rival SIG Combibloc said it would begin selling FSC-labeled cartons in China.

 

Tetra Pak said its cartons would be available in three formats - Tetra Fino Aseptic, Tetra Prisma Aseptic and Tetra Brik Aseptic. The packaging giant forecast that the number of its FSC carton sold in China would reach two billion by the end of this year and a staggering 14 billion by the end of 2011.

 

The Sweden-based company said it had sold a total of 2.3 billion FSC cartons across the globe in 2009 – after pioneering the concept with the introduction of the world’s first FSC-labeled liquid food cartons in the UK two years previously.

 

Tetra Pak spokeswoman Linda Bernier said the move in China represented a further step in its commitment to support responsible forest management and drive environmental performance. She added that while none of its paperboard for Chinese cartons was currently sourced domestically, the company was working to change that by supporting sustainable forestry management in the country. In the meantime, the company said it worked closely with its paperboard suppliers to ensure “all supply comes from known and acceptable sources”. Its eventual goal is to have all supply certified to the standard currently set by FSC, added the firm.

 

SIG Sells Cartons in China

In March, SIG Combibloc, another major producer of aseptic cartons, announced it would be the first to sell a range of FSC-cartons in China after securing a deal with Inner Mongolia Yili Group to sell three of its premium yoghurt drinks in the containers. The company said the products would be launched at the World Expo in Shanghai. SIG said the burgeoning significance of China’s economic influence meant the promotion of green issues was of paramount importance.

 

“With China’s fast-growing economy, its importance in respect to global environmental and climate protection also rises,” said Karl Eagle, CEO of SIG Combibloc Asia-Pacific. “The launch of beverage cartons carrying the FSC label will make consumers and other companies and industries more aware of where the packaging comes from. Responsible forest management has an important role to play here."

 

Tetra Pak said it welcomed the move by its rival and that it had launched its own FSC-label carton in the country as part of a “global deployment plan” for the materials.

 

“As part of the Alliance for Beverage Cartons and the Environment (ACE) Tetra Pak, SIG Combibloc and Elopak committed to achieving verified traceability through a 100 per cent chain-of-custody certification of all wood fiber used in beverage carton manufacture by 2015, thus helping to prevent the use of wood from unacceptable sources and to reach 100% traceability certification of their packaging material plants by 2018,” said Bernier.

 

Lonza to Boost Chinese Vitamin B Production

Lonza has confirmed that its planned vitamin B3 production expansion will occur in China, where the firm expects a double digit surge in demand for the ingredient in coming years.

 

The Swiss company is due to construct a new nicotinate plant in Nansha, adjacent to its existing site in the region. This is expected to add an additional 15,000 metric tons to its manufacturing capacity.

 

Nicotinates, which include both nicotinic acid and nicotinamide, are vitamin B3 supplements used in the food, animal feed, cosmetics and pharmaceutical industries.

 

Lonza, which first announced its intention to expand vitamin B3 production in 2008, said China was the location of choice due to growing demand in the country. “We expect to see at least double digit growth in the Chinese market, compared to only 2-3 per cent growth in Europe and the United States,” said Michael Frizberg, head of corporate communications at Lonza. “It’s a natural market development that is occurring with the growth of the Chinese economy.”

 

The decision to build a new plant was prompted by the imminent closure of Lonza’s existing vitamin B3 site in Guangzhou, China, which currently runs around the clock and produces 5,000 metric tons of ingredient per year. However, the Chinese government has requested that the plant be closed down by 2014 as the city has expanded around the site, which is now located in a residential area.

 

The new manufacturing site is expected to be up and running by 2012, in time to make up the shortfall in production and meet the increased market demand.

 

Together with production from Lonza’s Vitamin B3 plant in Visp, Switzerland, the firm’s total capacity for the ingredient is expected to be 48,000 metric tons by the time the new Nansha site is running and the Guangzhou site has been closed. This represents an increase of over 40 per cent on its current capacity.

 

Lonza will be investing a total of CHF 50m (€35m) in the construction of the new plant, which will supply vitamin B3 to the food, feed and cosmetics industries.

The key focus for the firm, explained Frizberg, is to be able to increase capacity to meet demand while at the same time “being right next door” to the customer in order to save on logistical costs.

 

Another major consideration is the need to remain competitive in both the Chinese and global markets, which mean the firm must be prepared to lower prices if it is squeezed by competition – a move likely to occur several years down the line once competitor Jubilant completes its new plant in India.

 

“There is a need for better prices, and we need to be ready for that,” said Frizberg.

 

The firm hopes to cut production costs by using innovations in technology and process development in its new site.

 

“These innovations will provide cost and efficiency advantages to all the company’s nicotinate facilities,” said Roman Quinter, senior vice president and Head of Lonza’s Nutrition Ingredients business.

 

Eisai Expands into Canada

Eisai Inc., a U.S. subsidiary of Eisai Co., Ltd., headquartered in Tokyo, has established a wholly-owned subsidiary Eisai Ltd. in Mississauga, Ontario.

 

“Eisai’s entrance into Canada supports our strategy to strengthen our business operations and presence in North America as we prepare for future expansion in this region,” said Hajime Shimizu, chairman and chief executive officer, Eisai, Inc. “Most importantly, this new subsidiary will enable Eisai to introduce many of its first-in-class products to people living in Canada who currently do not have access to these treatments, further supporting Eisai’s human health care (hhc) mission to satisfy unmet medical needs and contribute to the health and well-being of people worldwide.”

Eisai Ltd. is working with Health Canada on the approval of select products from Eisai Inc.’s portfolio for the Canadian market with plans for additional currently marketed products to be introduced to the Canadian market as well. The company’s areas of focus will include neurology, gastrointestinal disorders and oncology/critical care.

 

Beike Opens China Stem Cell Storage and Processing Site

Beike Biotechnology has opened a stem cell storage and processing facility at the 20,000 sq. meter (215,200 sq. ft.) regenerative medicine base in China, furthering the nation’s development in the field.

 

China has identified stem cell research as an area that it can become a global leader in and is willing to invest to make this happen. Beike is a beneficiary of this policy, receiving support from Jiangsu government-backed China Medical City (CMC) to establish the stem cell site.

 

The 20,000 sq. meter (215,200 sq. ft.) site, called the Stem Cell Regenerative Medicine Industrial Facility of National Bio-Industry Base (NBPD), forms part of a multi-stage project to give China a central research zone.

 

Industry partnerships form part of this strategy. The NBPD gives Beike the capacity to process and store 1 million stem cell samples, making it the largest facility of its type according to the company. This represents a significant expansion on Beike’s earlier 1,800 sq m, 100,000 sample site.

 

Beike broke ground on the new site in April 2009 and now it is operational, ahead of schedule, researchers will begin work. Using the processing, storage and clinical application development capabilities Beike intends to “produce the highest quality stem cell therapies” in the world.

 

"Stem cells are the crown jewel of medical research", explained Ying Song, the site’s vice president for medical, scientific and regulatory affairs. Song added research at the site will serve as a model for scientists around the world.

To advance stem cell research three main goals have been established for the site. Firstly, the facility will be involved in adult stem cell collection and storage. This will be supported by the establishment of international standards, such as ISO9001 certification.

 

By forming these working processes and infrastructure Song believes the site can work towards its third main goal – to patent and develop stem cell therapies into clinical practice.

 

China Biologic Products to Build Two New Plasma Stations

China Biologic Products, Inc., a leading plasma-based biopharmaceutical company in China, announced that its majority-owned subsidiary, Shandong Taibang Biological Products Co. Ltd. ("Shandong Taibang"), has been approved by the Shandong Province Health Department to build two new plasma stations.

 

"This approval is a major milestone for the company, providing a unique opportunity to expand our plasma collection capacity to meet the significant market demand in China," said Mr. Chao Ming Zhao, China Biologic's Chief Executive Officer. "We are proud to receive the first Shandong provincial government approval for new plasma station construction since privatization of the industry in 2006. We hope to complete the two new stations by the end of this year."

 

The Company estimates capital expenditure during 2010 for the two sites will be between RMB 16 - 20 million (approximately, $2.4 - 2.8 million). Once the new stations are operational, China Biologic will own seven of the eight plasma collection stations in Shandong province, and 18 total plasma collection stations nationwide, with up to 660 metric tons of plasma collection capacity.

 

China Biologic will build its two new plasma collection stations in Yishui and Ningyang counties, which have a combined population of nearly two million. Both counties are economically underdeveloped regions that with the appropriate promotional programs, marketing efforts and nutritional supplement fees, may offer reliable sources of plasma donors over time. The construction of the new stations will also provide the company with the opportunity to invest in the commercial vitality of these counties through job creation in the construction and healthcare sectors. Construction of the new stations will commence once final site selection is completed. Management hopes to receive approval to begin commercial plasma collection by the end of 2010.

 

"We expect the two new plasma stations to expand our overall collection capacity by up to 80 metric tons, or 14%, over the next few years," added Mr. Zhao. "With the additional plasma supply and the advancement of our product pipeline, we believe that we are well positioned to increase our market share in China."

 

Yongye Begins Construction of Production Facility in China

Yongye International, Inc. a leading manufacturer, developer and distributor of Shengmingsu brand plant and animal nutrient products in the People's Republic of China, announced that the company has started the construction of a new production facility in Wuchuan County, Hohhot Municipal City, Inner Mongolia Autonomous Region. The company's current production facility is operating at near full capacity in order to meet market demand. The new production facility will be capable of producing 20,000 tons per annum of the company's Shengmingsu liquid plant nutrient product and 10,000 tons per annum of the company's Shengmingsu powder animal nutrient product. The new facility is expected to be operational by the end of the third quarter of 2010. Capital expenditures for the new production facility are expected to be between $15 million to $20 million. The company plans to use proceeds from its December 2009 financing towards the construction.

 

Nestle Expands Production in Brazil

Nestlé’s aseptic milk brands Ninho and Molico will benefit from its new production plant in Brazil that can produce 100 million liters of drinking milk every year.

The plant in Araraquara, which produces Nestle Moca, a condensed milk, is expected to provide around 1,600 jobs in the region, with an investment of $ 65 million, BRL120m.

 

Ivan Zurita, chairman of Nestle Brazil, said: "Since April this year, when we entered the premium milk market, Nestle has been providing the consumer with extremely high-quality milk. This new plant reinforces Nestlé’s image as a nutrition, health and wellness oriented company.”

 

According to him, the growth prospects from the production site and the collection of raw materials from south of Minas and Ribeirao Preto, will create a positive impact on the dairy industry in these regions.

 

Nestle and its DPA subsidiary constitutes the main milk buyers in Brazil in 2008, with 1.9 billion liters of milk, according to the Brazil Milk Association.

 

Nestles also opened a global R&D center for biscuits and cereal-based snacks in Santiago, Chile.  The new facility will benefit from synergies between R&D and biscuit manufacturing by being based at Nestles industrial site in Maipu, which employs more than 1,200 people. 

 

TCGLS Teams with Mantrax for Australian CRO Market

Discovery services firm TCG Lifesciences (TCGLS) says its partnership with Mantrax Ventures “opens door” to Australian contract research sector.

 

Under the new collaboration, Mantrax will market the Indian contract research organization (CRO) to Australia’s bioscience and pharmaceutical industries from its base in Melbourne, Victoria.

These marketing efforts will focus on the promotion of TCGLS’ Chembiotek, discovery, Clininvent, research solutions, and Lab Vantage, enterprise informatics, divisions to groups seeking to further the development of biotech intellectual property.

 

A TCGLS spokesperson said that Mantrax is a “strong player” with a proven track record of facilitating alliances between India, Australia and Japan.

 

She went on to explain that the high level of competition from Indian and Chinese CROs targeting the region’s drug research sector was a key motivation for the collaboration.

 

“TCGLS stands a much better chance of gaining some traction by partnering with people who are already known and trusted and have extensive networks within the Australian and New Zealand biotechnology industries.”

 

And, despite the competitive nature of the market, TCGLS believes that it still represents a significant business opportunities, particularly for early-stage development projects.

 

“It is well known that many Australian companies have more IP than they have the resources to exploit and many Australian companies are struggling for funding.

 

“By outsourcing research work to TCGLS they will be able to exploit this IP for a lot less money than it would cost in Australia without compromising quality and without giving away any ownership of the IP.”

 

The choice of Melbourne as a base of operations for the new partnership is also likely to benefit according to Victoria State innovation minister Gavin Jennings.

 

He said that: “Companies like TGCS Lifesciences are choosing Victoria as an entry into Asia Pacific because of our high quality infrastructure, support for the biotechnology sector and our strength in research and development.”

 

Jungbunzlauer Excipient Site Passes FDA cGMP Inspection

The FDA has found Jungbunzlauer Ladenburg to be in compliance with cGMP, furthering the company’s strategy to strengthen its presence in the pharma excipient market.

 

An inspection of the firm’s Ladenburg, Germany site by the US Food and Drug Administration (FDA) found it to be in compliance with current good manufacturing practices (cGMP).

 

The successful inspection forms part of the company’s PharmaChoices@Jungbunzlauer strategy, which aims to strengthen its presence in the pharma sector, in the US and other markets.

 

Jungbunzlauer produces a range of pharma excipients at the site, including citric acid, tripotassium citrate, trimagnesium citrate, tricalcium citrate and calcium lactate gluconate.

 

FDA Clears Eye-Drop Factory for Production

The Sanda factory of R-Tech Ueno, Ltd. has received notice from the FDA that its facility has been classified as acceptable for the production of pharmaceuticals by meeting compliance with U.S. cGMP regulations. The FDA inspected the Sanda factory in December 2009. By passing this inspection, Rescula Eye Drops (unoprostone isopropyl eye drops) manufactured at this factory may be exported for sale in the United States.

 

R-Tech Ueno announced the signing of a contract with Sucampo Pharmaceuticals, Inc. for the sale of Rescula Eye Drops in the United States and Canada in a press release dated April 24, 2009. Under this agreement, Sucampo Pharma Americas, Inc., a wholly owned subsidiary of Sucampo Pharmaceuticals, is granted the right to sell Rescula Eye Drops in the United States and Canada for the treatment of glaucoma and ocular hypertension and is licensed to use Rescula's patent protection to develop new uses. R-Tech Ueno has the exclusive right to supply the eye drops to Sucampo Pharma Americas.

 

Passing this inspection will not affect the performance of R-Tech Ueno at this time. However, it allows the company to manufacture and export this pharmaceutical to the United States, which is one of the world's largest markets for pharmaceuticals. R-Tech Ueno believes that successfully passing this inspection will lead directly to future growth in R-Tech Ueno's contract manufacturing services.

 

"We will aggressively pursue opportunities to manufacture pharmaceuticals and investigational drugs for customers in the United States. We also plan to offer R&D support services for U.S. pharmaceutical companies," stated R-Tech Ueno President Yukihiko Mashima. "In addition, we can provide customers in Japan with high-quality services such as OEM production and technical assistance for their research programs. I believe these capabilities will allow us to capture more outsourcing contracts and broaden the scope of our business operations." 

 

PPD Opens New Bulgarian Unit

PPD has continued its global expansion with the opening of a new pharmacovigilance services and medical communications center in Sophia, Bulgaria

 

The unit, PPD’s third largest European facility, will provide the contract research organization’s (CRO) drug safety testing and medical writing services to the increasing number of pharmaceutical firms conducting clinical trials in the region.

 

The firm said it had been attracted by the large pool of highly trained health care professionals provided by Sophia’s medical and pharmacy schools and add that it plans to hire around 200 people over the next 12 months.

 

PPD CMO Christine Dingivan explained that: “There is strong demand for both pre- and post-approval safety services, and we have an experienced management team on the ground in Bulgaria to oversee our operations and to create customized programs that meet client needs."

 

Beard Construction Builds Hospital Cleanroom

Despite the predicted slow return to growth in construction, the Swindon-based arm of Beard, is cautiously optimistic.

 

With a current order book of over £6.5m and a positive trend in the number of new enquiries, construction director, Marc Bayley sees encouraging signs for the rest of the year.

 

The company has secured a range of new contracts across the region including initial contracts under a new multi-year framework agreement with Aspire Defence Services, where Beard is a preferred supplier – one to refurbish and remodel the Officer’s Mess at the Tidworth Garrison in Wiltshire and a second involving the construction of new offices for the MOD in Aldershot.

 

Other new contracts for the Swindon-based team include refurbishment projects at the Royal United Hospital in Bath to form a cleanroom for the Urology Department, a new internal secure area for Stanley Security Solutions in Swindon, and a new £1.3m Salt Depot for Wiltshire Council in Marlborough. The Education sector also remains strong with contracts for a new seven classroom school building at Lydiard Millicent School, a new two storey administration block at Downe House School in Thatcham as well as school contracts in Bath and at Eton College.

 

Evonik's China API Plant Operational

Evonik says new active pharmaceutical ingredient (API) plant in China is part of horizontal integration strategy.

 

The current good manufacturing practice (cGMP) compliant facility, in Nanning in Guanxi province, will supply an unnamed European company that collaborated on development of the site.

 

Evonik Rexim, the subsidiary that will run day-to-day operations at the facility, will also produce API for China’s rapidly expanding drug manufacturing sector.

 

Hans-Josef Ritzert, who head up Evonik's $1b exclusive synthesis business said: "The new plant is an expression of our horizontal integration strategy," explaining that "horizontal integration" stands for a network of western and Asian production sites.

 

"With this plant we will further consolidate our position as a high performing partner for exclusive synthesis," added Ritzert.

 

PPD has Plans for New Facilities in Philippines and India

PPD is opening offices in Manila, Philippines, and Bangalore, India, to expand its Phase II–IV development services in response to growing client demand in Asia Pacific. The offices position the company to capitalize on the growth of the outsourcing market in Asia Pacific.

 

“With 90 million people living in the Philippines and more than 20 million in Manila, there is enthusiasm for local expansion and involvement in clinical trials,” says Lesley Gerrard, director of clinical management in PPD’s Melbourne office. “The recent opening of the Manila office demonstrates PPD’s commitment to the growth and development of emerging markets in Southeast Asia and to further exploration of the opportunities that exist within this region.”

 

Denzel Benjamin, director of clinical management in PPD’s Bangalore office, adds, “India is expected to conduct nearly five percent of global trials by 2010, and the opening of our Bangalore office advances our plans for expansion in India. This office provides us easy access to all of our sites across south India, which means cost savings for our clients and greater efficiencies for PPD.”

 

PPD services range from discovery and development to post-approval as well as compound partnering programs. It reportedly has offices in 40 countries and more than 10,500 professionals worldwide.

 

The company has been aggressively expanding in Asia since the end of 2008 but has had an office in Beijing since 2003. In 2008, the company signed an exclusive agreement with Peking Union Lawke Biomedical Development. In September 2009, it opened a new facility in Singapore to enhance already established services in that country and allow cross-validation of offerings with its other labs. In October 2009, it picked up Excel, a contract research organizations in China. A month later it acquired BioDuro, a drug discovery outsourcing company based in China.

 

Glycos Biotechnologies to Build Biochemical Plant and R&D Facility in Malaysia

 Glycos Biotechnologies (GlycosBio), a biochemical company focused on metabolic engineering and microbiology innovations for the production of sustainable biochemicals, inked an agreement with Bio-XCell for assistance with construction of its biochemical plant and biotechnology R&D facility within Bio-XCell’s industrial park in Malaysia.

 

Construction of the plant will begin in Q3 2010 with an expected completion date in early 2012. In addition to the partnership with Bio-XCell, GlycosBio will also work closely with the Malaysian Biotechnology Corporation, the national agency set up by the Malaysian government for the development of biotechnology in Malaysia.

 

“We see the palm-oil industry as being a long-term source of renewable feedstocks, which directly align with our technology,” says Walt Burnap, president of Glycos Biotechnologies. “Using GlycosBio’s microbial strains and related downstream engineering processes will allow the Malaysian palm-oil industry to meet the market demands of the 21st century.”

 

“As the biggest producer and exporter of palm oil and having one of the largest oleochemical industries in the world, Malaysia is aggressively seeking alternative approaches to ensuring more sustainable production methods,” explains Dato’ Iskandar Mizal Mahmood, CEO of BiotechCorp and chairman of Bio-XCell. “Our partnership with GlycosBio supports Malaysia’s interest in developing and creating new business opportunities for international companies focused on advanced biotechnology. By implementing technology from biochemical and biotechnology companies like GlycosBio, palm-oil and oleochemical producers will be able to convert lower-value product streams into renewable feedstocks that can then be used to produce greener, more valuable biochemicals.”

 

GlycosBio’s technology facilitates the metabolic engineering of microbial strains to consume multiple nonsugar-based, low-value feedstocks for the production of sustainable chemicals and advanced ethanol. By designing differentiated microorganisms, GlycosBio’s bioconversion technology reportedly lowers production cost and provides a nonfood energy balance savings to the chemical and biofuel industries.

 

DSM Joins with Australian Government for Biologics Plant

DSM Biologics has entered into a partnership with the Australian government to build a 70,000 sq. ft. biopharmaceutical contract manufacturing facility.

 

Australia has a growing biotech sector but lacks a local contract manufacturing organization (CMO), leading to A$60m ($56m) of business being outsourced overseas each year. To remedy this Queensland State Government and Commonwealth of Australia are funding the facility.

 

DSM will provide no capital for the project but will offer the technological expertise needed to design and set up the facility. Combining this expertise with state funding will create a 70,000 sq. ft. facility offering mammalian process development and clinical and commercial scale production.

 

Companies outsourcing to the current good manufacturing practice (cGMP) compliant facility will be able to choose between standard technology processes and DSM’s proprietary XD and DSP optimization methods.

 

DSM’s involvement also means the site will support the PER.C6 cell line, which it has co-exclusive licensing rights for proteins and monoclonal antibodies (mAbs), as well as standard Chinese hamster ovary (CHO)-based systems.

 

The cGMP manufacturing facility is expected to be operational in 2013 and is located within the Queensland Translational Research Institute (TRI) in Brisbane, Australia. TRI is expected to open in 2012 and will be a one-stop-shop for discovery, production and clinical testing of biologics.

 

Federal and Queensland governments have invested more than A$100m in the TRI, which is intended to provide economies of scale and improved efficiency in research through greater collaboration.

 

For DSM the facility forms an “important element” of its CMO strategy, improving its ability to serve clients at all phases of development and commercialization.

 

PPD Opens Vaccine Clinical Research Center in Taizhou, China

Company believes that it is well positioned to tackle the unique requirements of developing vaccines in China.

 

PPD has opened a vaccine clinical research center in Taizhou, China. Through the center, PPD will provide clinical-monitoring services to global and local biopharmaceutical companies seeking to develop vaccines in China.

 

Located at the Taizhou China Medical City, the center will help biopharmaceutical companies address unique requirements for conducting vaccine clinical trials in the country. Vaccine studies in China are conducted by the Chinese Center for Disease Control and Prevention instead of at Phase I clinics or by investigators at hospitals. Additionally, these trials require thousands of patients for enrollment, compared to hundreds for studies conducted in other countries. Yet, China has a short recruitment period for vaccine trials, PPD points out.

 

“The vaccines market is one of the fastest growing segments in the industry, and in China the clinical trial market is growing at about 20 percent each year,” according to Simon Britton, PPD’s VP of clinical development for Asia Pacific. “Our strong expertise in vaccine clinical research and large presence in China make us well positioned to help our clients ensure adherence to global standards while addressing unique requirements for monitoring vaccine studies.”

 

PPD opened its first office in China in 2003 and says that it is now the largest contract research organization in the country with nearly 1,100 employees. Its acquisitions of Excel PharmaStudies and BioDuro last year strengthened the company’s drug discovery and development services in the country.

 

Corealis Expands Ops in Quebec with New Facility

Corealis Pharma has acquired a new 33,000-sq.-ft. pharmaceutical research facility in the Cité de la Biotech in Laval, Quebec, Canada. The company is hiring highly skilled scientists and purchasing complementary analytical and manufacturing equipments. These investments are part of Corealis' ongoing strategic development plan to be recognized as "the reference in oral solid dosage formulation development," according to a company statement.

 

Dr. Yves Roy, president of Corealis Pharma, remarked, "In the last few years, we have had to decline projects on a regular basis. With these investments, we will now be able to consolidate all of our services under one roof, tighten our project timelines, increase our capacity, reduce our operating costs and triple our yearly capacity. To our customers, this means shorter development time for their drug products. As a result, they will get noticed faster by large pharma for potential acquisition or partnership. We strive to make our clients succeed and I believe that we have now taken actions that will further help them achieve their goals!"

 

Corealis is maintaining all the existing quality systems active in the facility to offer services that comply with the Health Canada, FDA and EMEA Pharmaceutical GMP requirements.

 

Comar Builds Capacity with Unicon Buy

US drug packaging firm Comar says acquisition of Universal Container Corp (Unicon) provides capacity for growth, particularly in key liquid medication delivery device market.

 

Puerto Rico-based Unicon produces injection, blow and extrusion molded high-grade plastic packaging and container parts for the pharmaceutical manufacturing industry.

 

Financial terms of the transaction, which completed on April 16, were not disclosed, neither were details of the likely impact on Unicon’s existing manufacturing workforce.

 

Comar president Mike Ruggieri suggested that: “Unicon’s products, production capabilities, and facility will complement and enhance Comar’s existing product lines and position the combined entity for future growth.

 

He highlighted manufacturing space as a key motivation for the deal, explaining that it “gives our business a high quality, redundant facility for production while also expanding our capacity to keep up with our rapid organic growth.”

 

The acquisition is the latest step in Comar’s strategic refocusing on building in plastic pharmaceutical and medical packaging, which began in 2007 with the sale of its glass vial unit to Germany’s Gerresheimer.

 

The addition of Unicon’s various plastics molding and production capabilities also fits with Comar's recent efforts to expand its range of oral, liquid medication dispensing technologies.

 

Earlier the Buena New Jersey-headquartered firm announced the launch of enhancements to its two-piece oral dispenser line, specifically changes to barrel and plunger design.

 

Comar also began using new standard colorants that contain no fillers and all use the same carrier resin which, it claimed, will provide greater performance consistency across the product range.

 

Charles River to Acquire WuXi PharmaTech

Charles River Laboratories will acquire WuXi PharmaTech for approximately $1.6 billion. WuXi is a drug R&D outsourcing company with expertise in discovery chemistry, operating in China and the U.S. The combined company, to be called Charles River, will offer an expanded portfolio of products and services for early-stage drug development from chemistry to first in man, and is expected to close by the end of 2010.

 

“This transaction revolutionizes the contract research landscape by creating the only global contract research organization, or CRO, to offer fully integrated research and drug development services from molecule creation to first-in-human testing,” said James C. Foster, chairman, president and chief executive officer of Charles River.

 

Dr. Ge Li, chairman and chief executive officer of WuXi, said, “This combination represents a true win-win scenario that significantly expands the global reach and growth opportunities for both companies. As a result of this transaction, Charles River will be able to immediately expand its presence in China and avail itself of WuXi’s expertise in chemistry services, while WuXi will be in a position to accelerate its good laboratory practice (GLP) toxicology capabilities. Together, we will offer our clients unparalleled support to meet their early-stage drug development needs.”

 

Mr. Foster will continue to lead the combined company and Dr. Li will serve as corporate executive vice president and president of Global Discovery and China Services, a new reporting segment for the company. In addition, Dr. Li and two other WuXi directors will join the board of Charles River.

 

Foreign drug companies have been rushing to expand research and development operations in fast-growing China, with much of the activity concentrated in the Shanghai region, where WuXi PharmaTech is located.

 

WuXi expanded its own international reach by acquiring AppTec Laboratory Services, a supplier of medical tests in St. Paul, Minnesota, for $163 million in 2008.

 

The combined company will be called Charles River Laboratories and will include a widened variety of products and services for drug research companies and institutions, the statement said.

 

The deal calls for Charles River, which is based in Wilmington, Massachusetts, to pay $21.25 for each WuXi American Depository Share, which is a 28 percent premium over WuXi's closing price Friday of $16.57. Of the $21.25, about $10 will be in Charles River stock and the rest in cash, the two companies said in a statement.

 

The deal will be financed through a combination of cash and debt financing, Charles River said. It is subject to shareholder and regulatory approvals.

 

Baxter Expands for Large-Scale Cytotoxic Capacity

Baxter’s BioPharma Solutions unit has expanded its manufacturing facility in Halle, Germany, adding capacity to meet clients’ demand for large-scale production of cytotoxics.

 

Efforts to develop cancer treatments have increased interest in cytotoxic compounds, creating demand for contract manufacturing organizations (CMO) with specialized capabilities. Baxter has expanded its plant in Halle three times to keep pace with demand and changing requirements.

 

The most recent expansion, which is due to be completed next month, includes the addition of a large-scale lyophilisation unit to boost freeze-drying capacity. Lyophilisation supports the majority of the plant’s manufacturing and consequently is a fundamental process at the site.

 

Baxter has also upgraded the filling technology it uses in large-scale production. Installation of the new system, which uses advanced cRABS (closed Restricted Access Barrier System), will allow for a more than 50 per cent increase in capacity for commercial cytotoxic production.

  

Valeant Will Buy Brazilian Pharmaceutical for $56 Million

According to Reuters, Valeant Pharmaceuticals International has agreed to buy a privately held Brazilian pharmaceutical company for about $56 million. The private company focuses on branded generics and over-the-counter (OTC) products and had annual sales of about 49 million Brazilian reals in 2009, Valeant said. The deal is expected to close in the second quarter and will add to Valeant's results in 2010, it said.

 

Blu Pharma Plans Expansion at New Puerto Rico Plant

Capacity at Blu Pharmaceutical’s recently acquired solid dosage production plant in Puerto Rico is set to expand considerable over the next three years according to company president Bill Luster.

 

Manufacturing operations at the facility, in Dorado on the island’s northern coast, began with the production of the first batches of the generic antibiotic ciprofloxacin for the US market.

 

The drug is commonly used to treat anthrax, by preventing replication of the causative bacteria Bacillus anthracis, and is one of a number of products Blu supplies to government agencies in the US.

 

In time, Blu will make other generics at the 145,000 sq. ft., US Food and Drug Administration (FDA) approved facility but declined to name any specific products.

Luster  did explain that: “By the end of next year we will be producing 2bn tablets [a year] in Puerto Rico,” adding that the firm is “in the process of adding equipment for the increase in capacity.

He went on to say that Blu, which is expected to invest some $60m in the facility, plans to further increase annual production capacity to around 4bn tablets by 2013.

 

Blu’s sister company, Blu Caribe, bought the facility from fellow generics firm Biovail, which decided to transfer manufacturing operations from Puerto Rico to its production plant in Steinbach, Canada in 2008 .

 

Blu has hired 170 former Biovail employees and plans to increase its workforce at the facility to around the 250 mark to coincide with the capacity expansion.

 

And, although further financial terms of the acquisition were not disclosed, media reports suggest that the Economic Development Bank for Puerto Rico and Small Business Administration provided in funding for the deal $10m

 

Cellvax Moves to New Laboratory

Cellvax has recently moved to a new laboratory facility, just on the border of Paris, inside the Ecole Nationale Vétérinaire Alfort (ENVA). The ENVA is one of the oldest and largest veterinary universities in Europe, created in 1766, with an easy access by subway. The ENVA is located on a large surface of 110,000 sq. meters (1,183,600 sq. ft.), with more than one thousand people (Scientists, Professors, technicians, students) working here. In this new facility, Cellvax is able to provide to its customers a number of new services especially with different species of animals (mice, rats, rabbits, dogs, minipigs, etc.), spontaneous naturally developed tumors, in vivo imaging plat-forms, MRI, Scanner, Scintigraphy, histological analysis, biomarkers.

 

Cellvax is a French service company which provides complete in vitro and in vivo preclinical innovating services allowing to accelerate the drug development process for unmet needs related with severe human diseases, mainly in oncology field.

 

Cellvax was created in 2001 as a French SME by a motivated and complementary team consisting of scientists and experts in these fields. By offering its know-how and its capacity of innovation, Cellvax has successfully accomplished numerous in vitro and in vivo studies for different companies in Europe, Israel and in the world.

 

Cellvax’s expertise is based on its know-how in vitro models, especially original in vivo models. These services can be offered to all laboratories involving in anti-cancer drug development process. These proposed services adapt to the validation and development of anti-cancer drug candidates and are fully validated such as sub-cutaneous and orthotopic tumors models in animals; in vitro and in vivo angiogenesis models; an original “Nodule” system, tumor invasion tests, in vivo imaging, bio-distribution, pharmacokinetics, toxicity, histological analysis, biomarker studies.

 

Almac Completes Pharma Services Expansion

Almac’s Pharma Services has completed a $13.8 million facility expansion at its headquarters in Craigavon, Northern Ireland. Remodeling of the now 120,000-sq.-ft. commercial manufacture facility was completed in March 2010.

 

The company has significantly expanded its microbiological and sterility test areas, and doubled the analytical chemist headcount to 80 staff, with capabilities and space available for recruiting further personnel. Also, the expanded facility offers a range of technologies for method development, validation and transfer support for multiple client projects.

 

Graeme McBurney, president and managing director of Almac Pharma Services, commented: “Increased client demand for our integrated services, from Product Development to Commercial Supply, has resulted in the strategic decision to make this investment and expansion, both in terms of space and the additional team members we are recruiting. I look forward to working with the current and new members of our team and to the continued success of Almac Pharma Services.”

 

PRA Sets Up in New Zealand

PRA has expanded into New Zealand, complementing its Asia-Pacific network and establishing a point of contact for pharmas interested in benefiting from the county’s high recruitment rates.

New Zealand offers high recruitment rates, an efficient regulatory environment and a skilled workforce, according to PRA, and these traits are attracting pharmas looking to conduct clinical trials.

 

Edward Ian, senior director of clinical operations at PRA Asia-Pacific, said that clients are “highly interested in conducting trials in New Zealand”. Ian added that there has been an increase in requests for proposals and information about the country in recent years.

 

Major reasons for interest in New Zealand include “reputable, experienced and skilled investigators”, an efficient regulatory environment, high study subject compliance and cost-effectiveness, according to Ian.

 

New Zealand also offers counter seasonality. This allows companies to perform studies normally restricted to certain times of year, for instance an influenza trial, during other months because when it is winter in New Zealand it is summer in the northern hemisphere.

 

Ian believes the other major factor attracting pharma companies to New Zealand is high recruitment rates. These are underpinned by the availability of study subjects, especially in indications such as neurology, immunology and oncology, and a willingness to take part in trials.

 

Other factors boosting recruitment rates include a research friendly regulatory process and institutional review board requirements and clinical investigators with an interest in trials and high enrolling capabilities.

 

To better serve clients interested in utilizing these strengths PRA has established a legal entity and hired staff in New Zealand. PRA has worked with investigators and study institutions in New Zealand since 2001 but believes there are benefits to formalizing its presence.

 

Ian explained that PRA will now have tightened partnerships with the local clinical research community, increased opportunities to represent sponsors seeking to include New Zealand in trial programs and an expanded medical knowledge repository.

Furthermore, staff in New Zealand will work closely with the PRA office on Sydney, Australia. Both countries have similar healthcare and clinical research environments, creating “an ideal situation for collaboration”, and companies frequently conduct trials in both countries.

 

Thermo Fisher Launches Global Food Safety Response Lab

Thermo Fisher Scientific opened a dedicated food safety testing laboratory in a bid to help contain costly and life-threatening chemical contamination crises.

 

The company’s Food Safety Response Center (FSRC) in Dreieich, Germany, is equipped with state-of-the-art equipment and staffed by a team of five chemists who will mobilize to aid governments and businesses facing an unknown food safety threat involving chemical contaminants.

 

“This facility is unique in that it is designed to respond rapidly to chemical contaminations”, Thermo Fisher marketing director for food safety Gerry Broski said. “It will do no processing of samples, nor routine or contract testing - and will therefore be in a unique position to respond quickly to food contamination emergencies.”

 

The 55 square-meter (592 sq. ft.) lab will be able to develop testing methods for any chemical contamination crisis in food – including toxic elements such as arsenic, mercury and lead, organic pollutants like dioxins, marine biotoxins, pesticides, banned food dyes as well as industrial chemicals such as acrylamide and benzene.

 

The facility’s speed of response and development of analytical method are exceptional, said the company. The lab’s ability to rally into action in an emergency is unmatched and it can cut the delivery time of analytical methods and instrument standard operation procedures from the current norm of 6-8 weeks to around three.

 

The site does not address bacterial contamination such as Campylobacter, Salmonella, L.monocytogenes or E.coli O157:H7.

 

“We will be constantly monitoring for contamination crises around the globe through all our sources,” said Broski. “In the event of an emergency, we will develop a testing method, and provide protocols, training programs and instrumentation lists.”

 

Regulators, contract testing labs and end users will be able to take the method developed by the FSRC and analyze the food matrix for the specific chemical contaminant, said Thermo Fisher.

 

“This is a service that we see as helping government regulatory bodies, research institutes, independent test labs and companies in a crisis,” added Broski. “We see it as supporting global food safety and as an investment in developing our business.”

 

When the lab is not dealing with a contamination issue, staff will be constantly reviewing and improving its methods and expanding its food safety expertise.

 

"Identification and containment of food toxicity require a rapid response, otherwise the threat to human health and global commerce is magnified with each passing day," said Marc N. Casper, president and chief executive officer of Thermo Fisher Scientific. "Chemical contamination in food is a growing and costly threat. Our Food Safety Response Center will be a valuable resource whenever food companies, governments and the people they serve are at risk.”

 

BD to Make Syringes in Hungary

Becton Dickinson (BD) says its new Hungarian plant will be operational this year and producing more than 500 million pre-fillable glass syringes by 2015.

 

The €100m ($136m) plant, in the North-Western city Tatabanya, is BD’s first in Central Europe and is similar to existing manufacturing units the New Jersey, US medical technologies firm has in France and Spain.

 

Csaba Vecsernyes MD of the new facility said  it was built to increase capacity in line with demand, adding that “Hungary is ideal because of its proximity to the European markets these products will serve.”

Vecsernyes went on to explain that, in terms of potential customers, the firm “will target all pharmaceutical and biopharmaceutical companies with European filling locations.

 

“The Tatabanya Industrial Park is the first and largest industrial park in Hungary, and has attracted many large investors. It offers a well-developed industrial environment.”

 

He also highlighted the available workforce and “an enlightened body of public officials who understand how to set standards for manufacturing operations and regulate them” as drivers for the decision to set up in Hungary.

 

Vecsernyes added that the facility will create around 500 new jobs when fully operational, many requiring “high-level” capabilities in “production monitoring, trouble-shooting, and supporting computer-driven equipment.”

 

BD Innova Uses Dynacon/Lab Systems Technology

BD Innova, the US firm’s system division recently launched a new pre-analytical automated microbiology specimen processor designed to help increase efficiency in the microbiology laboratory.

 

The technology is one of several platforms BD gained through acquisition of Canadian group Dynacon earlier.

 

By acquiring the Lab Systems division of Dynacon, a privately held corporation based in Ontario, Canada, BD adds innovative product platforms from a leader in preanalytical microbiology automation. These product platforms include the innovative InocuLAB and Innova platforms.

 

Philippe Jacon, president of diagnostic systems, said: "[BD is committed] to providing labs with the tools and products they need to enhance the quality of their tests results, improve turnaround times and make the most cost-effective use of their resources."

 

 

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