The Southwest Oncology Group (SWOG) based at the University of Michigan has received $63 million in funding from the National Cancer Institute (NCI) to continue its clinical trials, personalized medicine, and comparative-effectiveness research programs.

SWOG said that over the course of the next six years its total funding package could surmount $120 million. The principal $63 million is the largest single research award to the University of Michigan Medical School, where SWOG is housed.

SWOG Executive Officer Carolyn Hoban said that the research funded through the grant will involve the collection and storing of biosamples and then the development of biomarkers for use in personalizing cancer treatments in clinical trials.

SWOG is a clinical research cooperative group that designs and conducts large-scale clinical trials of new cancer treatments and prevention regimens. Its network includes nearly 5,000 affiliated researchers spread across more than 500 institutions.

"We're proud to be first among the 10 NCI cooperative groups to embrace – and to be funded for – comparative-effectiveness research as part of our mission," SWOG Group Chair Laurence Baker said in a statement.

The grants will be dispersed by SWOG, which is involved with many commercial partners in its drug-trial programs, Hoban said.

The funding will support a cooperative bank biorepository that includes a range of specific tumor samples for multiple myeloma and other cancers.

The samples also will be analyzed and studied using proteomic and other technologies as part of a biomarker development strategy. Hoban said that this aspect of SWOG's research aims to discover and validate biomarkers related to cancer, including those that can be used to predict chemotherapy response and disease progression, and which can be used to stratify patients.

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, Purdue said.

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."

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.

NuSil Completes Work on Silicone Facility

U.S. firm NuSil Technology says new cleanroom manufacturing plant will help meet growing demand for silicone compounds for delivery systems.

Silicones, not to be confused with the element silicone, are polymer excipients with which active pharmaceutical ingredients (API) are combined, or compounded, enabling improved drug delivery.

Nusil’s new 2,400 sq.ft. facility, which is near the firm’s headquarters in California, will provide contract manufacturing and silicone compounding services for pharma and biotech industry clients.

Brian Reilly, NuSil’s product director for health care materials, explained that: “We’ve seen an increase in demand from manufacturers of controlled release and combination products to compound and deliver silicones that contain APIs.

“As a direct result of that spike in interest, we felt it was time to make a capital investment in multiple facility expansions that would ensure all future compounding was done in a safe and controlled environment.”

The completion of the new facility follows just days after NuSil expanded its range of drug delivery silicones (DDS) with two new transdermal adhesives.

The first new silicone, DDR-1370, is a pressure sensitive adhesive (PSA) designed to provide both “high cohesive strength and high release force,” which NuSil claim gives the material “favorable temporary adhesive properties.”

DDR-4355, in contrast, is a transparent, soft silicone gel that has a high-surface-tack, temporary silicone adhesive.

Speaking when the products launched on April 8, Reilly said that: “With a PSA and a tacky gel available to the transdermal drug delivery market, we are striving to offer two great options for temporary adhesives.

Clinilabs Adds ECG to Offering with NewCardio Addition

U.S. CRO Clinilabs has licensed NewCardio’s QTinno cardiac safety analysis software, adding ECG services to it drug industry offering.

The technology, which enables fully-automated cardiac safety analyses in cardiac intensive and QT studies, will be used at the contract research organizations (CRO) dedicated clinical research unit in Manhattan, New York.

The deal, financial terms of which were not disclosed, also includes a services agreement that will see NewCardio participate in the development of a new on-site electrocardiogram (ECG) analysis laboratory.

Clinilabs’ CEO, Gary Zammit, said: “We can now provide a differentiated and low cost solution for ECG data analysis to an industry that has been seeking a meaningful alternative to existing methods for some time.”

Vincent Renz, NewCardio’s COO was also upbeat about the partnership, explaining that it “is further evidence of the growing adoption of QTinno by innovative clinical trial service providers.”

“Our target customers are clinical trial service providers looking to deploy our proven technology to expand services and grow market opportunities. For Clinilabs, adding to its available scope of services by utilizing QTinno accomplished these two important goals.”

California-headquartered NewCardio, which has previously said its QTinno software is being used by a “Top 5 CRO,” expects growing regulatory pressure for early safety analysis will drive further demand for its technologies.

The firm explained that: “Screening for the risk of drug-induced adverse, often lethal, cardiovascular events – such as those identified with Vioxx, Seldane, and Avandia is of utmost importance for drug developers, and the public health in general.”

This, NewCardio went on to explain, can pose a problem for traditional ECG analysis during development which, for some studies, can involve the analysis of multiple ECG time points from one thousand or more patients.

“Using NewCardio’s 3-D approach, drug sponsors and CROs can automate this process, significantly reducing the cost and variability compared with non-automated methods, and reducing the time required to test new drugs in development.”

AstraZeneca Donates to Nemours Hospital

Surrounded by over 100 Nemours Associates, Rich Fante, President, AstraZeneca, U.S., presented Nemours President David J. Bailey, MD, MBA with a ceremonial check for $1 million, announcing AstraZeneca's contribution to the expansion of Nemours/Alfred I. duPont Hospital for Children in Wilmington, Delaware.

AstraZeneca U.S. President Rich Fante said, "AstraZeneca works with partners who share our commitment to improving the health of patients. Our support for Nemours/Alfred I. duPont Hospital for Children will enable the hospital to expand and build on their outstanding care of children in our community."

The project, which will be initiated later this year, marks the third time the Nemours duPont Hospital has expanded to meet the needs of its pediatric patients. Founded as a children's orthopedic hospital in 1940, the existing facility was built adjacent to the smaller original structure in the late 1970s, with a full array of pediatric specialties and services added during the next decade. Now, at the 70-year mark in its history, the 200-bed Hospital, has been named by Parents magazine as one of the Top 25 Children's Hospitals in the U.S.

DPT Expands Capabilities at NJ Center of Excellence

DPT Laboratories, Ltd. has expanded its aseptic manufacturing and development capabilities at its Center of Excellence for Sterile & Specialty Products in Lakewood, N.J.

The company’s sterile center will focus on aseptic production of sterile dosage forms, including small-volume parenterals, ophthalmic preparations, preservative-free nasal sprays and sterile ointments. DPT has invested more than $30 million in infrastructure to enhance the 175,000-sq.-ft. center, adding new water for injection, clean steam and HVAC systems, as well as a microbiology lab. The center is also equipped with pharmaceutical cleanroom Class A filling suites, Class B & C support suites and Class D component preparation areas.

“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.”

MicroConstants Begins Offering Nanosizing Services

MicroConstants of Salt Lake City, Utah, a GLP-compliant contract research organization (CRO) specializing in bioanalytical and pharmacokinetic analysis, has acquired access to a new nanosizing technology that transforms water insoluble compounds into nanoparticles, making formulation preparation and dosing for toxicology studies easier. The method has been proven to increase the gastro-intestinal absorption of highly insoluble compounds ensuring maximal oral exposure for toxicology studies.

Many commercially available medications and a large majority of New Chemical Entities (NCEs) produced are poorly soluble. For existing medications, this leads to costly and poorly absorbed medications that are minimally effective. For poorly soluble NCEs, higher doses, poor efficacy results, and increased production costs often make them non-commercializable. Nanotechnologies have been proven as a valuable adjunct to the development of new therapeutics. Nanoparticles provide a much larger surface area thereby increasing the dissolution rate resulting in enhanced absorption. Nanosizing a compound elicits improved drug loading, exposure, and bioavailability, and faster onset (earlier Tmax).

The patented, proprietary nanosizing process used at MicroConstants does not involve water or mechanical shear, so it is faster and more efficient than aqueous-based technologies. Furthermore, the process typically does not require the addition of excipients, leaving the pure active pharmaceutical ingredient (API) ready for easy dispersion as a convenient suspension formulation. The technique provides higher dose loading (50-60%), and is amendable to all routes of extravascular administration. The particle size is reproducible and the process is completely scalable.

NC State University Launches CESTAB

Textile companies looking to become more sustainable now have a place to turn. North Carolina State University’s College of Textiles and The Institute of Textile Technology recently launched the creation of the Council for Economically Sustainable Textile and Apparel Businesses (CESTAB). CESTAB is a joint undertaking of the college and the institute to address sustainability issues facing the textile and apparel supply chain industry.

“Sustainability has become one of the most pressing issues facing the textile industry,” says Allen Gant, president and CEO of Glen Raven, Inc. and chairman of the Board of Trustees of the Institute of Textile Technology. “The institute, in collaboration with the College of Textiles, is endeavoring to provide much needed leadership for the textile industry in addressing sustainability issues in a scientific and consistent manner.”

CESTAB was created in an effort to provide validated information, analyses and resources to promote sustainable social, economic and environment practices within the global textile supply chain. The goal of the council is to: provide resources to textile supply chain participants in hopes of providing a more uniform approach for addressing sustainability issues; generate objective and verifiable scientific research addressing gaps in the textile sustainability knowledge base; and provide and promote education at the undergraduate, graduate and continuing education levels for textile supply chain participants as well as the public.

“CESTAB will provide a well-needed focus in the textile industry bringing together leading companies, latest research findings and best practices,” says Blanton Godfrey, dean of the College of Textiles. “The institute’s leadership in creating this focus for the college and for industry is an important first step in helping us all focus on priorities and building programs for sustainability that will provide a solid foundation for important business decisions as well as research programs.”

Patheon Set for Softgel Capsule Production at Cincinnati

Contract manufacturing organization (CMO) Patheon has installed new soft gel manufacturing capacity at its facility in Cincinnati in response to “an unmet customer need.”

Spokesperson Wendy Wilson said that: “Customers have been looking for a top-tier supplier for softgel capsules that has Patheon's performance levels for some time.”

Wilson went on to say that the new manufacturing capacity suits development and small scale commercial projects and “should be operational within the next 30 to 60 days.”

In a press statement, CEO Wes Wheeler said the expansion compliments the existing liquid filled, hard gelatin capsule lines at the facility and “creates a more comprehensive service offering.”

The CMO also appointed Edgar Jaynes as its new associate director of pharmaceutical development services at the site, explaining that his “broad industry experience” includes expertise in soft gel technology.

Expansion in the softgel capsules sector will increase the competition between Patheon and rival CMOs such as New Jersey, US-based Catalent and Pfizer’s Capsugel unit, which both have existing manufacturing capacity.

In other news, Patheon recently announced that it will raise around $280m through a private placement of secured notes, equivalent to 8.6 per cent of the company.

The firm said that the move will allow it to repay “outstanding indebtedness under the company’s existing senior secured term loan and asset based revolving credit facility, to repay certain other indebtedness and to pay related fees and expenses.”

Jackson Lab Looks Out of State

Maine's largest biomedical research institution is planning to open its first out-of-state research branch if it wins enough public funding in Florida.

The Jackson Laboratory, which is based in Bar Harbor, ME and specializes in mouse genetics, has been in talks about building a 145,000-square-foot research center in southwest Florida where scientists would apply genetic research toward human health problems.

Jackson Lab trustees could decide by the end of summer whether to proceed if the Florida Legislature and the county government agree to spend more than $200 million.

Tentatively called The Jackson Genomics Institute, the center would be located in Collier County, Fla., outside of Naples, said Mike Hyde, Jackson's vice president for advancement. The goal of the institute is to apply scientists' extensive research directly to the treatment of human diseases.

"It is very futuristic and we're not certain today where it will go," he said. "But we know the implications are enormous and it's a part of the scientific world we want to understand."

If plans fall into place, the institute would employ about 200 people over first five years and grow to up to 300 employees over 10 years. In time, it could act as a magnet and draw a medical school, a teaching hospital and biotechnology and pharmaceutical companies with a total of 7,000 to 8,000 employees.

Some people are asking why the facility can't be located in Maine.

Florida was chosen because of the availability of public funding, the state's commitment to growing its biomedical community and the proximity of other nonprofit research institutes, Hyde said.

Florida lawmakers are now considering three budget scenarios that call for $100 million to $130 million going toward the development over three years. If that funding is approved, Collier County officials would have to approve matching funds for the project, he said. The Jackson Laboratory would also have to embark on a private fundraising campaign to raise another $120 million over 10 years.

The governor's office said Maine can't match the financial incentives being offered by Florida. Jackson Lab has received more than $42 million in voter-approved bond funding in Maine since 2001.

Maine would have liked to have the jobs that would be created in Florida, said David Farmer, spokesman for Gov. John Baldacci. But Florida's budget and population dwarf those of Maine — meaning Maine simply can't offer the same incentives, he said.

"We just don't have the scale to do the same types of things Florida does," Farmer said. "They're a much bigger state and it's a much different circumstance there than it is here."

The Jackson Laboratory still has plans to grow in Maine, Hyde said. It now has about 1,200 employees in Maine and another 94 employees at its mouse distribution and services facility in Sacramento, Calif.

The Jackson Laboratory said it will not waver from earlier plans to expand its workforce and research at its headquarters in Bar Harbor, Me., over the next five to 10 years, even as it pursues plans to develop a third campus near Naples, Fla.

"Far from leaving the state, Maine will be the headquarters for a thriving, multi-state research enterprise that promises so much in our efforts to relieve human suffering," Richard Woychik, Jackson Lab's president and CEO, said in a letter published in the April 7 edition of the Bar Harbor Times weekly newspaper.

Woychik said in the letter that Jackson Lab still plans to add 200 jobs to its Bar Harbor workforce of more than 1,300 people over the next five to 10 years. The distribution of the new jobs will be roughly the same as the headquarters campus' current mix of staffers, Joyce Peterson, said a spokeswoman for Jackson Lab.

At present, Peterson said, about 600 of Jackson Lab's Bar Harbor employees help the laboratory provide scientific services ranging from microscopy to bottle washing and other infrastructure maintenance; some 550 headquarters staffers hold positions in the lab's research branch; while the rest hold administrative jobs.

"The same ratio would pretty much continue," Peterson said.

As for research at Bar Harbor, Peterson said, Jackson Lab still plans to expand from its current 38 research groups to 45 over the next five years. Each group will consist of a principal investigator and support staffers.

"The mother ship will stay in Maine," Hyde said. "We believe this infusion of capital in Florida will make it possible for us to hit our growth targets in Maine."

Florida Bill Proposes Jackson Lab Contribute More Funds to New Site

The Jackson Laboratory is balking at a Florida lawmaker's proposal that it spend $330 million of its own money, in addition to the $120 million private fundraising campaign it envisions, toward its planned development of a third campus near Naples — in return for receiving hundreds of millions in incentive dollars from the State of Florida and the county where the facility would be built.

State Sen. Garrett Richter, R-Naples, has introduced an incentive measure for Jackson Lab as an earmark amendment to the state Senate's draft of Florida's budget bill for the fiscal year starting July 1. The amendment by Richter would have Florida spend $50 million for the laboratory in the coming fiscal year, the first of a three-year, $130 million state piece of the funding package he envisions for the project.

Collier County would match Florida's $130 million in incentive spending, according to the budget amendment — which is similar to an amendment expected to be offered in the state House of Representatives by Rep. Tom Grady, R-Naples. The House is set to vote on its version of the state budget on Thursday.

But Richter's proposal also envisions Jackson Lab shelling out $330 million in grants and revenues, in addition to what the laboratory expects to raise privately through supporters in the Naples region.

However, Jackson Lab envisioned receiving slightly more from the state and county than proposed by Richter — namely "something in the neighborhood of" $150 million from each level of government, in addition to the $120 million in private fundraising, said Michael Hyde, Jackson Lab's vice president for advancement and external relations.

"This is a project that's going to require $300 [million] to $400 million in investment during the first 10 years of its operation. It's not feasible for the Jackson Laboratory to consider funding anything of that magnitude, any more than it would have been feasible for Scripps [Research Institute] to come up with $500 million for their project," Hyde said. "This is a project that would be financed by a combination of state allocation, local match, and private philanthropy."

At deadline, neither Richter nor an aide had returned messages from GWDN. Under Richter's proposal, Florida would fund its share of the package by allocating money to its Innovation Incentive Fund for the first time since 2008.

How the county would raise its share of funds has yet to be determined.

"While we do know that the local match will come from a number of sources, including land donation, no firm plans for the match will be created until after the Legislature has made its decision," Dolly Roberts, a spokeswoman for the Economic Development Council of Collier County, told GWDN. "This effort is a long way from completion."

Roberts and Hyde spoke four days after Richter disclosed his incentive package proposal, as well as details of where the Jackson Lab's proposed Naples-area facility would be located, to members of the state Senate Policy and Steering Committee on Ways and Means.

In an interview, Hyde said the facility would be built within part of a 700-acre section of the 4,000-acre Ave Maria, Fla., mixed-use, master-planned community. The land is now owned by Barron Collier Cos., which has co-developed Ave Maria with Domino's Pizza founder Tom Monaghan.

"As contrasted with almost any other site that we know of, this would be a site where construction could start very soon" — a key factor in why the site is attractive to the laboratory, Hyde said. He noted that the site has already undergone zoning approvals following federal and state permitting reviews, and is near infrastructure.

Jackson Lab envisions opening in Florida a new institute specializing in personalized medicine. Details of the research program are under discussion by the laboratory's scientific staff. "I think that discussion is likely to continue for a while," Hyde said.

Back in January, Jackson Lab's President and CEO, Richard Woychick, told GWDN, "It's important as part of our growth strategy to make sure that we position ourselves to get closer to the bedside and do more translational and clinical work. We've done this through collaborations in the past, but the Florida opportunity could be the chance for us to become more directly translational in the nature of the work we do."

According to Hyde, the new personalized medicine institute would employ about 200 people, an employment level not expected to be reached until three to four years after the facility opened. Jackson Lab accounts for about half of the 400 jobs expected to be created during the laboratory's first year of operation — a figure that includes construction jobs and indirect jobs generated by the project.

"There will be very tight linkages between the activity in Florida and the research activities of our staff here in Bar Harbor. You'd see a lot of collaboration, and travel back and forth, but relatively few transfers," Hyde told GWDN. "My guess is it would be a relative handful of people from Maine. We see it as an opportunity to expand into some areas of genomics and computational biology that we'd like to expand into."

Researchers from Jackson Lab specializing in eye disease have a multi-institution collaboration in place that includes a Florida partner, the University of Florida College of Medicine in Gainesville, Fla. Jackson Lab also has held talks with several potential Florida collaboration partners, including universities and research institutes, Hyde said, though he declined to name them.

"We've had very, very positive receptions from all of them. I think that we would bring a new set of skills and a new scientific slant to the mix of research that's going on in Florida," Hyde added. "We don't have any contractual agreements, but we have had some very interesting discussions, and I'm quite confident that those collaborations will emerge as the project goes forward."

Indirect jobs — such as workers at institutions, spinout companies, and stores and restaurants — account for most of roughly 7,500 total jobs, and total $835 million annually in direct and indirect economic impact, anticipated over a decade as a result of the Jackson Lab project and a nearby research park expected to be filled in part by spinout companies, according to an economic study carried out for the project by Washington Economic Group of Coral Gables, Fla.

The laboratory disclosed its search for a Florida site last October. Hyde said Jackson Lab is attracted to Florida because of its availability of multi-million-dollar government incentives to research institutions, the presence of other potential collaboration partners, the ongoing effort by Naples and Collier County officials to build a life sciences cluster, and the attractiveness of the region to researchers and other potential hires.

"There's an enormously great quality of life available in Florida that we think will be a great boost to recruiting, and a complement to what we have in Bar Harbor," Hyde said.

But Hyde also noted that Jackson Lab remains committed to maintaining and growing its headquarters campus in Bar Harbor, Maine, while also growing in Florida. In addition, the laboratory also operates a facility in Sacramento, Calif., where a $40 million expansion was completed last year.

Jackson Lab hopes to join the parade of out-of-state research institutes that have won more than $1 billion in subsidies toward infrastructure and other economic incentives for the development of campuses in Florida. Those research centers include Scripps Research Institute, Sanford-Burnham Medical Research Institute, Max Planck Florida Institute, Torrey Pines Institute for Molecular Studies, and Oregon Health & Science University's Vaccine and Gene Therapy Institute.

Hyde noted that these institutes were not required to offer any money of their own, while Jackson Lab plans to chip in $120 million through its fundraising campaign, the feasibility of which is being studied by a consulting firm recently hired by the lab.

IntegenX Opens HQ in California

IntegenX (formerly Microchip Biotechnologies) has opened its new corporate headquarters and manufacturing facility in the Hacienda Business Park in Pleasanton, Calif.

The company was previously located in Dublin, Calif.

The new facility includes a microfabrication facility, custom-designed laboratories, and manufacturing space for commercial operations.

IntegenX manufactures automated DNA and RNA-based sample-preparation systems for life sciences, applied sciences, and diagnostics markets.

Vanderbilt U Med Center Wins $8.6 Million Stimulus Grant for Genomics Resource

Vanderbilt University Medical Center will create a new collaborative shared resource intended to accelerate discoveries in genome science and personalized medicine, using an $8.6 million, two-year federal stimulus grant.

The new Vanderbilt Technologies for Advanced Genomics, or VANTAGE, will co-locate and expand four existing core facilities as well as BioVU, the medical center's DNA databank, VUMC said.

The DNA Resources Core and the DNA Sequencing Facility will relocate from Light Hall, while the Functional Genomics Shared Resource Core, formerly the Microarray Shared Resource, will move from Medical Research Building II, the medical center said.

The three core facilities, according to VUMC, will be grouped in the basement of Medical Center North with the Flow Cytometry Core, as well as two facilities to be housed in their first physical home, the Genome Technology Core, and a soon-to-be-installed robotic store for BioVU, which is funded by a separate federal grant.

VANTAGE will operate in 12,500 square feet of laboratory space that will be renovated by early summer 2012, the medical center said.

The grant is the largest awarded to Vanderbilt University by the NIH under the $862 billion American Recovery and Reinvestment Act. According to the university, the NIH has provided $81.6 million in 179 stimulus grants led by more than 160 Vanderbilt scientists.

University of CT Lab Opens Doors to Stem Cell Research

The Univ. of Connecticut is just months away from opening a new research building in Farmington to enhance Connecticut’s role as a leader in innovative high tech research and technology transfer in the areas of stem cell biology, advanced microscopy and imaging, computational biology and genetics.

Especially designed with open labs that flow into each other and office areas located on hallways running between labs, the new Cell and Genomic Sciences Building intends to promote interdisciplinary research among the academic and industry chemists, geneticists, physicists, mathematicians, cell biologists, and computer scientists housed there. This collaborative effort aims to capitalize on the power of different areas of scientific expertise to revolutionize the practice of medicine.

“Our goal is to maximize the state’s investment in stem cell research by establishing an infrastructure to support scientists in their quest of turning discoveries at the bench into therapies for diseases such as autism and cancer and to advance the field of regenerative medicine,” says Marc Lalande, Director of UConn’s Stem Cell Institute, as well as professor and chairman of the medical school’s genetics and developmental biology department. “This is an unprecedented opportunity for us.”

Purchased by UConn with Board of Trustees’ approval in 2007, a former research and testing facility at 400 Farmington Avenue-–across the street from UConn’s Health Center campus-–has been undergoing a $52 million transformation and is to be equipped with the latest technologies for studying cells and their genomes. The new 117,000 square foot building is expected to open in July 2010.

The renovated building will house research laboratories, offices, a 100-seat auditorium, cafeteria, and incubator space for businesses eager to commercialize stem cell science. Designed by the Boston laboratory architecture firm Goody Clancy, the renovations will meet the requirements of a LEED Silver rating, according to project manager Kevin Norton.

The LEED (Leadership in Energy and Environmental Design) green building rating system-–developed and administered by the U.S. Green Building Council-–is the industry standard for measuring building sustainability.

Currently more than 100 construction workers are busy completing the mechanical and electrical systems, installing finishes, laboratory casework, interior window assemblies, and skylights over the corridors of the one-story structure.

“The overriding intent is to provide sufficient internal transparency to allow the entire research community in the building to interact, while providing natural light to internal spaces,” says Norton.

Scientists in the building will be involved in a wide spectrum of research projects, including the design and construction of new laser-based microscopes, computer simulation of living processes inside cells, and sequencing of human and animal genomes, says Lalande. Being located close to UConn’s Health Center will support the goal of translating basic research findings to clinical trials, he adds.

Two corridors lead off the entrance lobby of the building to private areas dispersed around the facility for focused research.

Three major research programs will be re-located from the Health Center to the new facility: the UConn Stem Cell Institute (UCSCI), the R.D. Berlin Center for Cell Analysis and Modeling (CCAM), and the Dept. of Genetics and Developmental Biology. Together these three programs include about 180 scientists and their staff.

The UCSCI was established after the state, in 2005, enacted legislation to fund stem cell research through the Connecticut State Stem Cell Advisory Committee. Over the first three rounds of competition for the state funds, UConn researchers won $20.8 million-–the majority of awards granted. The funding supports more than 32 laboratories at both the Farmington and Storrs campuses. UConn scientists have submitted 44 applications for the state’s fourth grant competition round, which begins next month.

UConn has spent more than $1 million to equip the human embryonic stem cell core facility that trains researchers and lab workers from around the state on lab techniques for stem cell research; 114 have been trained to date.

Recently, staff of the core facility developed induced pluripotent human stem cells, or iPS cells, which behave like embryonic stem cells and increasingly are being used by researchers to generate in vitro models of human disease.

The on-site presence of the UCSCI and the stem cell core facility will provide both hands-on expertise and resources to the wide range of investigators in the new building.

CCAM’s multidisciplinary team uses cutting-edge imaging, microscopy, and computational modeling to more accurately analyze living cells. CCAM has also developed a computer software and database system-–the Virtual Cell-–that allows researchers to construct computational models of cells, perform simulations, and analyze the results of those simulations to better understand cell physiology. More than 2,000 scientists from around the world have used the Virtual Cell to carry out simulations.

To handle these simulations (some are quite large), the new Center will house CCAM’s High Performance Computing Facility, which also provides computer support to the CCAM microscopy facility and other research projects of individual UConn faculty members.

Equipped with $1.1 million of state-of-the-art technology to read entire genomes, the translational genomics core facility will have all the equipment necessary for DNA analysis and sequencing, gene expression analysis, genotyping, and the associated bioinformatics infrastructure to facilitate data analysis.

The new building will afford the 17 scientists from the Department of Genetics and Developmental Biology moving there the opportunity to work with their colleagues in ways that haven’t been possible before, and to use these new tools to isolate and study rare cells.

Having these programs in the same building along with researchers applying a broad range of cutting-edge approaches will significantly speed up cell research at UConn, says Lalande.

The potential of the new facility and continued stem cell funding by the state has already helped recruit two new faculty with expertise in stem cell biology and nanomedicine who are expected to join the new building’s research community later this summer, he adds.

“We’re thinking about the intersection of cell biology, genetics, and computer science, and other disciplines that inform those areas,” he says.

Researchers will also find it easier to communicate with each other about their work, Lalande says, fostering collaborations that could lead to new insights into cell biology: “This building is designed to drive cross-pollination of scientific ideas to a new level.”

The new building will also expand the work of UConn’s Office of Technology Commercialization, including the Technology Incubation Program-–UConn’s business incubator-–by providing offices, conference rooms, and laboratories for six start-up biotechnology companies.

“While our scientists may generate the next stem cell breakthrough, to bring them to market there must be a group of people with the skills not only to start a company, but to help it grow,” says Rita Zangari, interim director of the Office of Technology Commercialization and executive director of the Technology Incubation Program.

The new building has already helped to attract two bioscience companies, Zangari says. One company seeks to use stem cells in bone cement products, while the other-–relocating to Connecticut from Massachusetts-–is conducting research using stem cells extracted from tooth pulp for therapeutic use in combating degenerative diseases.

“Having the resources in place for our researchers and their industry partners to move discoveries from the lab to the marketplace fosters a climate in which ideas are easily exchanged and partnerships are developed,” Zangari says. “Collaboration is the essence of UConn’s power to generate new discoveries and then build companies and jobs around them.”

Source: Univ. of Connecticut

UNC-Chapel Hill Eyes More Genomic Research in $14.5 Million Facility Expansion

The University of North Carolina at Chapel Hill says the planned expansion of its Bingham Facility — for which UNC was awarded $14.5 million in stimulus funding, will allow the school to expand ongoing genomic and proteomic research as well as consolidate several older facilities into a single site.

UNC-Chapel Hill won $14.5 million from the $862 billion American Recovery and Reinvestment Act toward construction of 30,000 square feet of new space in two buildings for Bingham. The facility carries out research on pigs and dogs in order to study bleeding disorders, such as hemophilia and von Willebrand disease, as well as thrombotic disorders related to atherosclerosis, heart attacks and strokes.

Timothy Nichols, director of the Francis Owen Blood Research Laboratory at UNC-Chapel Hill's School of Medicine, said that the expanded facility will help the lab build on existing collaborations that use genomics and proteomics technologies.

The blood lab will vacate its current building in Carrboro, NC, and move to part of the expansion space at Bingham, which dates back to the 1970s. “They’ve been in a facility that’s 50 years old and frankly, at the end of its useful life,” Robert Lowman, UNC’s associate vice chancellor for research, told GWDN.

Said Nichols: "We will be both expanding existing areas and accommodating research we're not getting to because we needed more room.”

In addition to the blood lab, the Bingham facility will also incorporate animal research facilities now leased by the university in a Hillsborough, NC, building once used by what is now GlaxoSmithKline. “It’s far away from campus, and [the three-site arrangement] means that we have our dogs and swine at three different places instead of one. And that’s a logistical difficulty, particularly for the veterinary staff, because they’re back and forth all the time.”

As for the post-expansion future of the blood lab and Hillsborough facilities, “I think we’re going to shut them down,” he added.

The expanded Bingham will house about 100 dogs, compared with the approximately 85 dogs now there; as well as 125 pigs, more than double the current swine population. The facility was originally built to quarantine animals before their transfer to vivaria on campus, not to house them permanently.

Lowman said the two buildings to be funded through the stimulus program are in design stages, with schematic drawings due to NIH on July 31.

As a result, Lowman said, construction of the buildings isn't expected to begin until “early 2012, and we would anticipate completion about mid-2013,” two years ahead of the deadline year set by the grant.

The expansion is not intended to specifically allow hiring of additional staff since it is a construction grant and has no funding for personnel.

The two planned buildings to be funded by ARRA are among four new facilities taking shape there.

Construction is in progress on a separate building for golden retrievers and other dogs whose muscular dystrophy is similar to Duchenne MD in humans. That facility will be designed to accommodate about 125 dogs, and be ready for occupancy this summer, Lowman said.

UNC-Chapel Hill also plans to construct an additional laboratory operations center building at about the same time as the two stimulus-funded structures. The university plans to spend between $5 million and $8 million to build the operations center, which will include suites for the division of lab animal medicine’s veterinary, necropsy and pathology suites, plus surgical suites and procedure rooms for investigators.

That building must be constructed at the same time as the two stimulus-funded buildings in order for the blood lab to relocate, Lowman added.

Two-thirds of the cost of the operations center is expected to come from the school of medicine, the remaining third from the Provost’s office. A more precise cost estimate will be possible once the school decides on the building's size, Lowman said.

Vetter’s Chicago Cleanrooms on Track

Germany drug delivery systems supplier Vetter highlighted the development of its sterile manufacturing offering, announcing that expansion of cleanroom infrastructure at its Chicago , US facility is on track to complete next month.

The new unit, which is intended to increase Vetter’s development services capacity when it becomes fully operational in Q4, will support pre-clinical through to phase II development projects.

Vetter is installing some 24,000 sq.ft. of microbiology and chemistry laboratories, including several cleanrooms one of which, featuring a Bosch MHI 2020 automated vial filler that will focus on high-value biopharmaceuticals.

The other cleanroom will operate as a semi-automated filling unit for liquid products and, according to Vetter, will be compatible with a range of packaging formats, including vials, syringes and cartridges.

Vetter also said that it is building a cleanroom that will be used for the filling of pre-sterilized syringes.

DPT’s $30 Million Sterile Unit Investment

DPT explained that it has invested over $30m (€25m) in the facility which, it added, will focus on the aseptic production small-volume parenterals, ophthalmics, preservative-free nasal sprays and ointments.

The CDMO highlighted the Lakewood unit’s new microbiology laboratory, sterility and endotoxin testing capacity and environmental monitoring capabilities.

The centre, which is also equipped with class A filling suites, class B & C support suites and Class D component preparation areas, is part of a restructuring project that has seen DPT establish centers for R&D, analytical development and technology transfer.

Amcor Adds Blown-Film Capacity at US 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 peel able 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 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.

For example, in the statement accompanying today’s 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.”

Klockner Expanding PVC and Shrink-Label Capacity

The Klockner Pentaplast Group has invested $37m (€27m) to expand PVC production capacity and add shrink-label film capabilities at its facilities in Thailand and the US.

Investing in shrink-labels and PVC production capabilities will boost Klöckner’s ability to provide pharma clients with a range of products, including tamper evident closures and barrier-enhanced films.

“These expansions will enable us to continue to support our customers’ growing global demand for high-quality packaging films”, added Tom Goeke, CEO of the Klöckner Pentaplast Group.

PVC film production machinery is being installed at Klöckner’s manufacturing facility in Rayong, Thailand. Klöckner expects the new production line to be operational by early 2011 and to add 12,500 tons of capacity.

The production line is designed to meet the requirements and regulatory standards of the pharma industry. Klöckner claims it is the only local producer in Asia to meet these manufacturing standards.

Products in Klöckner’s range of pharmaceutical packaging films range from mono films to high-performance barrier-enhanced films and have applications in clinical, ethical, compliance and blister display.

Klöckner is also adding shrink-label film capacity at its manufacturing facilities in Rayong and Rural Retreat, Virginia, US. A tentering line will be added at both sites to increase capacity for high-performance PETG and PVC shrink films.

The company is aiming to start production in early 2011 and expects that when operational the new lines will add 15,000 tons of shrink-film capacity.

Klöckner’s product range includes transverse-direction orientated (TDO) and machine-direction orientated (MDO) shrink films that have a variety of applications, including tamper evident closures.

The expansions are expected to add 64 employees worldwide.

Genentech Nears Completion of Hillsboro Plant; No Plans for R&D

US biotechnology company Genentech presents new $400m pharmaceutical manufacturing and distribution facility in Hillsboro, Oregon and says construction is nearly complete.

The firm, which is owned by Swiss drug giant Roche, first announced plans to expand its US manufacturing operations in 2006, buying the 75-acre Hillsboro site later that year.

By 2008 Genentech had used 25-acres of the plot to build a fill and finish, distribution and labeling centre that has employed a staff of 250 people.

Genentech plans to package key products at the plant and hopes to win first manufacturing approval by 2011.

The PBJ goes on to suggest that Rituxan, Avastin and Herceptin, three of Genentech’s best selling products, will be made at the facility, although the firm has not yet outlined its manufacturing plans.

What is clear is that Genentech has no immediate intention to turn the Hillsboro into a drug development base, despite considerable encouragement from attendees at yesterday’s opening ceremony.

Speaking at the event, Governor Ted Kulongoski said the proximity Oregon’s bioresearch infrastructure, notably the Oregon Health & Science University (OHSU), would encourage Genentech to add R&D capacity at the plant in due course.

Gerresheimer Invests in Plastics with Two New Plants

Gerresheimer is increasing its presence in the pharmaceutical plastics business, which it believes is increasingly important, by opening an R&D centre in the US and a production facility in Spain.

The pharmaceutical plastics sector has become Gerresheimer’s fastest growing business sector and the company has made strategic investments to ensure it has the capacity to meet rising demand.

Gerresheimer has achieved this by opening a production facility in Masalaves, Spain that it believes is the largest of its kind in Southern Europe. The plant will serve the Southern and Central European markets and is regarded by Gerresheimer as “a significant strategic base”.

From the facility Gerresheimer will produce pharmaceutical bottles and multifunctional dosage and closure systems, for delivery forms such as eye drops, nose sprays and tablets.

Gerresheimer has also invested to bolster its R&D capabilities, opening a technological centre in Peachtree City, Georgia, US. The site previously only housed a manufacturing facility but has now been upgraded with the addition of R&D capabilities.

Prior to the expansion Gerresheimer lacked a US site that could handle customized serial production of entire product and process development, with only its European sites having this capability.

Following the expansion the US site will work on highly developed inhalation systems for respiratory diseases, as well as insulin pens, skin-prick aids and lancets for the diabetes sector.

Gerresheimer has experienced steady growth in these sectors and the expansion gives it the capacity to continue strengthening its market position. Following completion of the recent expansions Gerresheimer has 15 sites operating in the plastics sector.

This capacity has been created through acquisitions and targeting investments, which, coupled to organic growth, have helped accelerate the division’s growth over the past five years. The division now accounts for a third of group sales.

Unilife Starts Production after FDA Clearance

Unilife has initiated a 24/7 manufacturing cycle at its facility at Lewisberry, Pennsylvania, US after it received marketing clearance for its Unitract 1ml insulin syringes from the US FDA.

The move to a four shift, 24 hour, seven day per week manufacturing cycle is intended to maximize annual production capacity, which is approximately 40m units, and improve cost efficiencies.

Unilife initiated the change in manufacturing cycle immediately after the US Food and Drug Administration (FDA) gave marketing clearance to the company’s Unitract 1ml insulin syringes.

In August 2008 the FDA gave marketing clearance for Unitract 1ml insulin syringes assembled by Unilife’s manufacturing partner at its facility in Shanghai, China but use of the Lewisberry site required submission of an additional 510(k).

Alan Shortall, CEO of Unilife, explained that the majority of its US-based customers want Unitract syringes manufactured in the US. Having gained market clearance Unilife will “accelerate the rollout” of its Unitract 1ml insulin syringes in the US.

The Lewisberry facility is also being used to meet the demands of Unilife’s Asian distribution partner, Stason Pharmaceuticals. Stason is coordinating local regulatory submissions, establishing relationships with local pharmas and has placed an initial order of 1m units.

Unilife added that it is currently negotiating with a number of interested healthcare and pharma companies in the US, Europe and Asia. Furthermore, it is continuing to send shipments to Haiti to support humanitarian efforts.

The company is also filing a 510(k) with the FDA to gain market clearance for its Unitract 1ml tuberculin (TB) syringes. This is a variant of the insulin syringe.

SAFC Opens $30 Million Expansion of HPAPI Production Site

SAFC has opened the $30m (€22m) expansion of a US production facility, adding HPAPI capacity to meet rising demand for Phase III and commercial manufacturing services.

High potency active pharmaceutical ingredients (HPAPI) are increasingly prevalent in pharmaceutical pipelines and this is driving demand for large-scale manufacturing services.

To meet this demand SAFC has expanded its facility in Madison, Wisconsin, US. The 51,000 sq. ft. expansion houses commercial scale reactors capable of producing batch sizes up to 4,000 litres, 10 times greater than was previously possible, for large-scale manufacture.

"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", added Gilles Cottier, SAFC President

SAFC’s expansion also includes development laboratories, a 150L mini-processing plant, quality control suites and a potent compound packaging area. These operations are supported by warehouse and office space.

The expansion complements the existing 63,000 sq. ft. HPAPI facility at the Madison site. Housed at the original facility are eight process development laboratories, eight kilo labs and two pilot plants with capacities of 200L and 800L.

Design and containment engineering used in the original facility, which is certified by Safebridge, has been applied to the expansion on a larger scale. Measures have been taken to maximize efficiencies, ensure safe handling in HPAPI development and adhere to category IV standards.

Expansion of the site will ultimately create 45 to 50 jobs, said Jim Doyle, Wisconsin State Governor. SAFC added that there is room for further expansion at the new facility in Madison.

SAFC^® Officially Opens New $30 Million High Potency API Facility in Madison

SAFC^®, a member of the Sigma-Aldrich® Group, announced the opening of a $30 million expansion to its Madison Manufacturing facility in Verona, Wisconsin. Designed to significantly increase the capacity to produce commercial scale High Potency Active Pharmaceutical Ingredients (HPAPIs), the 51,000 sq. ft. expansion was unveiled at an official ceremony attended by Wisconsin State Governor Jim Doyle, Mayor Jon Hochkammer from the City of Verona and Secretary Dick Leinenkugel from the Wisconsin Department of Commerce.

The new facility complements SAFC's existing 63,000 sq. ft. HPAPI site in Madison and houses commercial scale reactors capable of producing HPAPI batch sizes up to 4,000 liters, which is up to 10 times greater than the capacity of the Madison site. Constructed specifically to support pharmaceutical manufacturers with their Phase III and commercial HPAPI needs, the Verona plant features the same state-of-the-art facility design and containment engineering as the Safebridge® certified Madison Facility on a larger scale.

The site 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. The facility includes state-of-the-art development laboratories, a 150-liter mini-processing plant and two large-scale cGMP manufacturing suites. Specially designed quality control laboratories, a potent compound packaging area and warehouse and office space, plus expansion space, are also featured in the building.

"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," said 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."

At the opening ceremony Governor Doyle stated, "Sigma-Aldrich continues to invest significantly in the State of Wisconsin and we are delighted that they have chosen this location for what is a truly world class facility. I am also pleased that 45 to 50 jobs will ultimately be created as a result of its construction."

Life Technologies to Expand in Maryland

Life Technologies plans to expand its operations in Frederick, Md., potentially adding 100 jobs to its site there, a company official confirmed.

The Frederick County Board of County Commissioners supported a state grant of $500,000 for Life Technologies to help in its expansion efforts. The grant is conditional on the firm adding 100 jobs by the end of 2011.

The company official could not provide details on the types of jobs that are likely to be added to its operations there. The site was part of Invitrogen's operations before its nearly $7 billion merger with Applied Biosystems in late 2008, forming Life Technologies.

Life Technologies currently has nearly 400 employees at the Frederick site, and approximately 9,000 employees worldwide.

ACG Worldwide Launches U.S. Subsidiary

The capsule manufacturer ACG Worldwide launches its North American subsidiary ACG North America L.L.C. (South Plainfield, NJ) to accommodate the company's growing business in North America and its intention to introduce a broader range of products. The new subsidiary positions ACG to better serve the company's U.S., Canadian, and Mexican customers by offering locally based sales and technical support.

"ACG is not new to the North American market," says S. Brad Larson, Vice President, ACG North America. "For the past decade, ACG has marketed its capsules under the Universal Capsules brand and its capsule filling, packaging and cartoning machines under the PAM USA brand. We are planning to introduce a broader range of products for pharmaceutical, OTC, and dietary supplement companies. Marketing them all under the ACG brand emphasizes the synergy in our product offerings."

The company sells to hundreds of North American customers and has built a reputation for quality at cost-effective pricing. All products will now be sold under the banner of the ACG North America brand. In addition to capsules and capsule fillers, the ACG group of companies manufactures tablet presses, tablet tooling, blister packing and cartoning machines, and barrier films.

"ACG Worldwide had a strong international presence with the full range of its products," Larson says. "We believe that our North American customers will appreciate the convenience of purchasing from a company that supports every stage of the value chain."

ACG North America is headquartered in South Plainfield, NJ with offices in Indiana, South Carolina, and Utah in the United States; Montreal and Vancouver in Canada; and Mexico City and Guadalajara, in Mexico. The company also maintains climate-controlled warehouses to store capsules and machine parts in Florida, New Jersey, New York, Utah, California, Montreal, Vancouver, and Mexico City.

First U-M Employees Move to New North Campus Research Complex

The first group of University of Michigan employees moved into new permanent workspaces today at the North Campus Research Complex (NCRC), the former Pfizer property purchased by the University in June 2009.

This "pioneer" group moved into the office buildings near the southeast corner of Huron Parkway and Plymouth Road. They are all existing University of Michigan staff in the U-M's Institutional Review Boards office, known as IRBMED.

IRBMED oversees any research involving human participants that is conducted at the Medical School and some other areas of U-M and is responsible for protecting the rights and welfare of research volunteers.

They are among the 300 employees expected to move into NCRC during the month of April, all from units that support the University's research community in multiple functions.

Moving in during April will be employees from the Michigan Institute for Clinical & Health Research (MICHR), the development and clinical trials offices for the U-M Comprehensive Cancer Center, the Cancer Center's SPORE (Specialized Program of Research Excellence) group and the Medical School Office of Research's CRAO (Calendar Review and Analysis Office).

All of these units are moving from off-campus buildings leased by the University. U-M has kept some of those leases, as other U-M units move into the vacated space..

These office-based functions were easily moved into the former Pfizer buildings. The U-M Board of Regents approved on Dec. 17 an $1.8 million project for improvements including painting and new carpet in these structures. Other buildings in the NCRC, especially laboratories, will require more preparation and planning before they can be used.

As the first move-in occurs, researchers at U-M currently are submitting proposals to create grassroots faculty teams that will form interdisciplinary research clusters at NCRC.

The University also has identified the first two technology anchors to develop at NCRC. The first is a world-class program in biointerfaces, which includes an interdisciplinary mix of nanotechnology, microfluidics and sensors, cell and tissue engineering, and biomaterials and drug delivery. The second is a cutting-edge collaboration in molecular, functional, and structural imaging.

Biocius Plans Move to New HQ and Business Expansion

US drug discovery technologies and services firm Biocius says its new HQ in Wakefield, Massachusetts doubles candidate testing capacity.

The firm, which expects to complete the move by June, said the new base will help meet growing drug industry demand for high-throughput analysis solutions like its RapidFire compound screening technology.

Biocius, which spun out from genome analysis group BioTrove following its acquisition by Life Technologies last year , also believes the new office and laboratory facility will improve how it works with customers.

CEO Jeffrey Leathe explained that new site “was designed with our clients in mind, our increased capacity includes state-of-the-art facilities for demonstration and training.”

The firm also said that the new space will “facilitate employee collaboration and represents the ideal environment for the team to address new technologies in the company’s development pipeline.”

Biocius growth has been rapid since it joined the discovery services market last year. The firm claims its technologies are used 13 of the top 15 pharma companies in Europe, the US and Canada.

And, more recently, Biocius entered the Asian pharmaceutical sector by partnering with Japanese distributor Wako Pure Chemical Industrie. Under that deal, signed earlier this month, Osaka-headquartered Wako will exclusively supply Biocius’ RapidFire system to the country’s pharmaceutical and biotechnology industry.

Wako will also supply other Biocius drug discovery and absorption, distribution, metabolism, and excretion (ADME) technologies, including the recently launched RF 300 system.

Speaking when the deal was announced Leathe said that: “Japan is an important market for pharmaceutical discovery and …we strongly believe that Wako is the right partner to provide our portfolio to this dynamic sector.”

Haruki Oishi, general manager of Wako’s biomedical systems department, was also positive about demand for Biocius’ technology in the country, particularly for challenging drug development projects.

"At Wako, we see a tremendous opportunity for RapidFire in Japan; we feel Biocius' technologies will enable us to provide our customers with drug discovery solutions through the synergy with Wako's product line and a means to investigate therapeutic targets that have been difficult to analyze by

The move from the company's current home in Woburn, Mass., will result in a doubling of its capacity, which the company said is necessary due to increased demand for its RapidFire mass spectrometry product and service offerings.

The new facility, which is located around five miles from the firm's current one and will include an enhanced laboratory and a seminar and training room, will increase the company's contract research screening capabilities by around 50 percent, it said.

NanoGuardian and Capsugel to Help Protect Medications from Counterfeit

NanoGuardian™, a division of NanoInk^® that delivers brand protection solutions to defend against illegal diversion and counterfeiting, announced that it entered into a license agreement with Capsugel, a division of Pfizer and the global leader in providing capsule-based drug delivery systems, that gives Capsugel global access to NanoGuardian's NanoEncryption^™ technology for the protection of capsule-based medications against counterfeiting and illegal diversion.

NanoGuardian's NanoEncryption technology works directly on capsules, tablets, vial caps, and single-use syringes to provide a layered security strategy consisting of overt, covert and forensic security features. NanoGuardian's multi-layered security provides a dual-protective benefit to manufacturers by fighting both counterfeiting and illegal diversion with a single technology. The overt and covert security features allow dose-level authentication at any point in a manufacturer's supply chain, while forensic NanoCodes^™ provide comprehensive tracing information on each and every dose. NanoGuardian's technology provides a strong benefit over other on-dose technologies given that NanoGuardian's security features are implemented with no additional chemicals being added to the medication.

"Capsugel is committed to providing cutting-edge advancements in capsule dosage delivery technology. Given the concerning rise in counterfeit and illegally diverted medications throughout the world, we wanted to bring value to our customers by helping to protect their brands, companies, and the patients they serve. After evaluating available security technologies, we chose NanoGuardian as a technology partner because of the sophistication, sustainability and benefits of their NanoEncryption technology. This will allow our pharmaceutical customers to authenticate and trace every single dose, from plant-to-patient," said Guido Driesen, President and General Manager of Capsugel.

In addition to the traditional NanoGuardian model of using a proprietary machine to implement the NanoEncryption technology, Capsugel will offer pre-NanoEncrypted capsule shells to pharmaceutical companies, eliminating any significant additions to their current manufacturing process. Capsugel will market this new technology to current and future Capsugel customers and expects it to be able to supply NanoEncrypted capsules by mid-2010.

"NanoGuardian is a leader in the on-dose brand protection marketplace so it makes perfect sense for us to partner with the global leader in capsule-delivery systems. Together, NanoGuardian and Capsugel can extend product security and integrity to the dose level for capsule-based medications and help provide confidence to the millions of patients who rely on these medications for their health and well being," said James Hussey, chief executive officer of NanoGuardian.

Thermo Takes Over Trial Supply Production at Lilly

Thermo Fisher Scientific will take charge of clinical trial material production at Eli Lilly’s research technology facility in Indianapolis as the pharmaceutical firm further reduces in-house capacity to cut costs.

Under the new deal, Thermo’s clinical services unit will buy Lilly’s in-house manufacturing, packaging and labeling technology, taking charge of both production and, by the end of the year, distribution of trial materials at the facility.

In a press statement, Lilly said that the agreement helps “reduce some of its fixed costs,” although it did not specify how much it will save.

Also, according to the drugmaker, employees affected by the transition “will have the opportunity to apply for roles at Fisher Clinical Services.” A report suggests that the facility has a staff of 115.

The five-year agreement fits with efforts to reduce spending by $1bn (€741m) through workforce and capacity cuts and greater use of third-party contracts which, earlier this month for example, saw Lilly expand its R&D partnership with Covance.

Prent Poised for Growth on Two Continents

Prent Corp. (Janesville, WI) is opening two new facilities to enhance its presence in the global packaging marketplace. The company provides thermoformed custom packaging for the medical device industry.

In Shanghai, Prent China moved into a modern facility that specializes in thermoforming operations. Its capabilities include product design, thermoforming, production control, secondary operations, and just-in-time delivery. The facility meets Class 8 cleanroom standards and is compliant with medical requirements, including ISO 9001.

Prent’s Asia president, BJ Nielsen, says he expects the China market to continue to grow. “In the next 10 years, we believe China will experience a significantly higher growth rate than North America or Europe.” He also says that Prent China expects sales in the next five years to double at minimum, as more device OEMs move into China.

In January, Prent Denmark (Holbaek) opened, which is Prent’s first facility in Europe. It is designed to be a full-service thermoforming center. The building houses the firm’s newest thermoformers with robotics and also features Class 8 cleanrooms.

“As demand grows, we will add tool engineering, tool building, and secondary operations,” says Peter Bay, Prent Denmark’s managing director. The facility will employ 20–25 people, but Bay says that that total could reach 100 or more within five years.

CCS Opens Lab in Princeton

CCS Cell Culture Service, an international supplier of custom generated recombinant cell lines, and custom frozen cells and membranes is very pleased to announce the opening of its Princeton, New Jersey laboratory and office space.

This new CCS laboratory, customized for advanced frozen cell and membrane production and processing, has been established to service the growing needs of CCS’s expanding US client base. CCS will use these exceptional facilities for the advanced proprietary cell culture protocols and preparations for which CCS has become known. Conveniently located in Princeton NJ, a

center for scientific and academic excellence, the region offers exceptional resources for the company’s growth, and facilitates close communications with many of CCS’s pharmaceutical and biotechnology clients.

CCS Cell Culture Service provides the custom generation of recombinant cell lines, custom production of frozen Instant Cells, and production of cell membranes and recombinant proteins for cell based drug screening.

Vetter Launches Parenteral Fill-Finish Facility in Skokie, IL

Vetter (Ravensburg, Germany) is developing fill-finish capacity at a new facility in Skokie, IL that will include three manufacturing cleanrooms and state-of-the-art microbiological and chemical laboratories. An expansion of Vetter Development Service, the 24,000 sq. ft. facility will be operational by the beginning of the fourth quarter 2010, says Vetter managing director Thomas Otto.

“We will initially focus on early-stage products from preclinical through phase IIb, after which we will scale up and transfer products to our facilities for phase III filling and market production, Otto says.

“To help ensure a seamless transition to commercial manufacture, we’re replicating commercial processes at our early-stage (Skokie) site,” he adds.

One cleanroom will include a filling line for semi-automated, small-scale filling of vials, syringes, and cartridges. Filling operations in a second cleanroom are planned for pre-sterilized syringes. A third cleanroom will feature the MHI 2020 automated vial filler from Bosch Packaging Technology (New Richmond, WI). The unit can be used for filling liquid vials from 10 to 10,000 pieces per batch and for lyophilized vials from 500 to 5,000 pieces per batch, Otto says. “Vetter is the first company to use the new Bosch system, designed specifically for clinical-stage, high-value pharmaceuticals. The Bosch filler uses all disposable drug-contact components (which) eliminates the need for cleaning validation and thus supports time-to-market.

“It’s a compact machine with minimum tubing lengths, which increases API yield,” Otto says. “And it includes a 100% check-weight system. That’s important, because if the amount of drug in a vial is inaccurate, that may affect the outcome of a clinical study, especially in small, early-stage trials,” Otto adds.

For final assembly and packaging of prefilled injection systems, Vetter rounded out a complete service offering in parenteral packaging with last year’s launch of a Vetter Secondary Packaging facility in Ravensburg. The facility features a fully automated production line that automates processes including labeling, plunger rod insertion, packing in boxes, and the transport between stations. The line allows packaging twice the number of injection systems in half the time required before, Vetter says.

MGS Adding Cleanroom Medical Molding in Germantown, WI

MGS Manufacturing Group Inc. is investing more than $2.7 million to construct and equip a Class 100,000 cleanroom in an existing Germantown facility.

“With continual growth at our medical molding facility in Antioch, Ill., and steady growth within the medical industry as a whole, we determined that now is the right time to expand our clean- room molding capabilities,” Jeff Kolbow, chief operating officer of Germantown-based MGS, said in a release.

“The addition will allow us to enhance our manufacturing and value-added services for existing and prospective customers in the healthcare market.”

MGS anticipates completing construction by June and simultaneously obtaining Class 100,000 certification. MGS is working towards obtaining ISO 13485 certification during mid-2010.

“The 6,250-square-foot cleanroom is being constructed within the south bay of an 186,000-square-foot facility” currently used for molding operations, said John Berg, director of marketing. “It is the first clean room for MGS in Wisconsin. We have an existing [Class 100,000] cleanroom for molding and assembly in our Antioch facility.”

The cleanroom will be scalable to approximately twice the square footage as demand dictates.

Maintaining the original ceiling height will allow use of an existing 10-ton overhead crane system. “This will facilitate our ability to run tooling systems with higher cavitations,” Berg said via email. “The greater overhead space also allows MGS to easily retrofit injection molding machines with our vertically mounted (proprietary) Universal Multishot Systems portable injection units.”

Each press in the new cleanroom will be multishot capable. Existing and future customer requirements will dictate the number of machines and the tonnage requirements. “We are anticipating approximately eight to 14 presses in the 50-to-500-ton range” including some existing machines, Berg said. “We are currently evaluating the potential of new press purchases.”

Automation equipment will facilitate post-mold value-added operations.

“The budget for the construction of the facility-within-a-facility clean room is in the $1.2 million to $1.4 million range,” Berg said. “While all the manufacturing equipment decisions have not been made, we estimate an additional $1.5 to $2 million investment.”

MGS manufacturing experience for the medical and healthcare industry includes products for diagnostic, transfusion therapy and drug delivery applications and diabetic care. Products include luer fittings and other connectors, disposable plastic cannula and piercing devices, components for disposable transfusion therapy sets, single use liquid injectable delivery devices, housings, glucose metering devices and lancet devices.

MGS employs about 800 at four facilities in Germantown and one facility each in Antioch; Menomonee Falls, Wis.; Libertyville, Ill.; and Chihuahua, Mexico.

For the fiscal year ended Sept. 30, MGS had sales of about $110 million with about 65 percent from molding operations, 30 percent from tooling and 0.5 percent from equipment.

Consumer items accounted for about 25 percent of revenue, medical and healthcare 20 percent and electronics 15 percent. Other end markets include automotive, packaging and industrial/construction.

Berkeley Lab Fights Breast Cancer

The Dept. of Energy’s Lawrence Berkeley National Laboratory (Berkeley Lab) has been selected by the National Cancer Institute to host one of 11 new Centers for Cancer Systems Biology (CCSB). Under this grant, the Berkeley Lab expects to receive about $13.5 million over the next five years to develop computational models that predict breast cancer responses to therapeutic agents.

“We’re proud to have been selected by NCI to be a part of its effort to study cancer as a systemic disease, an effort we feel is critical to the future of cancer research,” says Joe Gray, director of Berkeley Lab’s Life Sciences Division and co-director of the new CCSB at Berkeley. “Our work will help advance the development of breast cancer diagnostic and therapeutic strategies that are effective and durable.”

Gray, a renowned cancer researcher, holds a joint appointment with the Univ. of California, San Francisco, where he is an adjunct professor of laboratory medicine and co-leader of the breast cancer oncology program. He will co-direct the new NCI CCSB with Claire Tomlin of UC Berkeley, where she is a professor of electrical engineering and computer sciences. Tomlin is a leading authority on the theory and design of models that predict the behavior of complex systems.

Traditional cancer research has concentrated on the identification and functional characterization of molecular defects. However, modern genomic analysis technologies show that individual cancers may involve the deregulation of hundreds to thousands of interacting genes. Consequently, within the cancer research community there is a move to treat cancer as a “systems biology” or network disease, in which breakdowns in regulatory molecular networks disrupt the normal restraints on a cell’s growth and behavior. That the exact details of these networks often vary between clinically similar cancers helps explain why some patients will respond favorably to a specific cancer drug while others won’t. In addition, the nature of these regulatory networks is such that they tend to resist therapeutic interventions.

“Research at our CCSB will focus on development of experimentally validated computational models that predict the responses of ductal breast cancers to the growing number of therapeutic agents that target aberrant receptor tyrosine kinase signaling,” Gray says.

Receptor tyrosine kinases (RTKs) are enzymes that form central components of cell signaling networks. They’ve been shown not only to be key regulators of normal cellular processes but to also have a critical role in the development and progression of many forms of cancer, including breast cancer.

Says Gray, “Despite the growing availability of a broad range of RTK network-targeted drugs responses vary substantially between patients and are often not durable. Our premise is that development of optimal RTK network-targeted drug combinations will require experimentally validated, computational models of the diverse resistance and response mechanisms that are specific to cancer subtypes and allow drug combinations to be tested in silico so that the most promising can be prioritized for clinical evaluation.”

In addition to researchers from Berkeley Lab and the UC campuses of Berkeley and San Francisco, the new CCBS at Berkeley will also involve participants from the MD Anderson Cancer Center at the Univ. of Texas, and the Univ. of Warwick in the UK. Experimental aspects of the research will be carried out at Berkeley Lab and UC San Francisco, while computational work will be conducted at all the participating institutions. Principal investigators will include Berkeley Lab’s Paul Spellman, Michael Korn of UCSF, Gordon Mills at MD Anderson, and Sach Mukherjee in England.

The CCBS hosted at Berkeley Lab and those at the other ten nationwide host sites are part of the Integrative Cancer Biology Program (ICBP), the primary sponsor of NCI’s cancer systems biology research.

Says ICBP director Dan Gallahan, “These centers represent a unique multidisciplinary union of outstanding scientists and clinicians; who will work to unravel the complexities of cancer through the novel application of technology and mathematical modeling. Their discoveries and models will be critical to our continued success in understanding and treating cancer disease.”

Added NCI director John Niederhuber, “This program is part of the next generation of cancer research, in that it will approach the disease from a holistic or comprehensive viewpoint in order to understand how all of the components of the disease fit together.”

DPT Establishes Centers of Excellence

DPT Laboratories has announced plans to restructure its facilities, creating three new Centers of Excellence, each focusing on a different area of expertise: Sterile & Specialty Products, Semi-solids & Liquids, and R&D.

“We feel each of these Centers of Excellence will provide our clients with access to experienced personnel who are experts in their field and who will provide comprehensive development and manufacturing services,” said Paul Johnson, president and chief operating officer of DPT.

DPT Laboratories in Lakewood, NJ is home to The Center for Sterile & Specialty Products. This center specializes in development and aseptic manufacturing of clinical trial material and commercial scale products to meet sterile requirements. The 175,000-sq.-ft. site recently underwent a multimillion-dollar transformation to provide state-of-the-art aseptic processing suites and filling equipment.

The Center for Semi-solids & Liquids in San Antonio, TX will provide cGMP pilot, clinical and commercial scale manufacturing for prescription and OTC products. The center also includes a dedicated cGMP aerosol and pMDI manufacturing facility. A multi-million-dollar investment was also made to this center to improve efficiency and increase capacity.

DPT’s Center for R&D in San Antonio provides pharmaceutical development services to include pre-formulation and formulation development as well as analytical development services. This center will perform R&D activities and support technical transfers to the applicable manufacturing center of excellence.

“We are committed to excellence and investing in our future. Our goal is to provide our clients the most efficient and the best development and manufacturing services,” said Mr. Johnson. “These strategic changes reflect our mission of providing enhancements to service, innovation, and technology for our customers as we move into our next strategic plan.”

HollisterStier Contract Manufacturing and Draxis Pharma Complete Audits

Jubilant Organosys, a leading integrated pharma and life sciences company headquartered in India, announced that two of its contract manufacturing facilities in North America successfully completed regulatory authority cGMP audits, recently. HollisterStier Contract Manufacturing, based in Spokane Washington, U.S.A, completed a successful audit by the Japanese Pharmaceutical and Medical Device Agency (PMDA) for the review of a sterile injectable client product. Draxis Pharma, based in Montreal, Quebec, Canada, also completed a successful audit by the US Food and Drug Administration (FDA) and Health Canada.

The audit by the Japanese Pharmaceutical and Medical Device Agency (PMDA) revealed no significant observations, which has resulted in a recommendation to the MHLW that Hollister-Stier be listed as an approved manufacturing site for the client's product. Independent of the PMDA audit, the HollisterStier facility was also recently approved by the European Medicines Agency (EMA) as a manufacturing site for this same product.

The audit of Draxis Pharma by the US Food and Drug Administration (FDA) included a comprehensive cGMP review of both sterile parenteral and non-sterile semi-solid manufacturing capabilities and a Pre-Approval Inspection for three client products. No observations were received from this audit. Recommendations for site approvals for the three new client products are expected. The audit of Draxis Pharma by Health Canada focused on a cGMP review of a dedicated packaging capability and revealed no significant audit observations. Marcelo Morales, CEO of HollisterStier Contract Manufacturing and Draxis Pharma, said "We are extremely pleased with the audit findings at both our HollisterStier and Draxis Pharma facilities. Maintaining a rigorous quality culture and robust quality systems, combined with effectively managing our clients' projects, assures the success of these projects in the global market place."

CEDRA First North American CRO to Offer Gyrolab Instrumentation

CEDRA Corporation is First North American Clinical Research Organization to Offer Gyrolab Instrumentation.

CEDRA Corporation, a division of Worldwide Clinical Trials, announced that it has purchased the Gyrolab™ xP workstation for use in its bioanalytical research, specifically for ligand binding analysis. CEDRA is employing the new Gyrolab in its Ligand Binding Assay (LBA) laboratory in Austin, Texas, and is the only CRO in North America to offer this technology to the pharmaceutical industry.

The Gyrolab represents significant innovation in the automation and advancement of

bioanalytical research. The patented technology transforms the numerous steps involved in

conventional LBA applications and streamlines them into single, nanoliter-scale procedures.

Efficiency and productivity are significantly boosted with the Gyrolab's ability to miniaturize and integrate assay steps for protein quantification immunoassays.

"We believe the addition of the Gyrolab to our LBA laboratories is significant and represents

our dedication to enhancing the capabilities offered to the biopharmaceutical research industry," said William Nowatzke, Ph.D., Director, Ligand Binding Assay Group, CEDRA Corporation. "A key driver to our business is the dedication to staying on the forefront of technology. The addition of the Gyrolab complements our other four LBA platforms, permitting CEDRA to transfer or develop practically any LBA method. One of the key strengths of the Gyrolab is its miniaturized assay format requiring extremely small sample volumes -- nanoliters -- ultimately minimizing the consumption of precious sample volume," continued Dr. Nowatzke. "It eliminates cumbersome multiplexing practices."

Ricerca Biosciences Finalizes Acquisition of MDS Pharma Services

Ricerca Biosciences, LLC, announced the finalization of the acquisition of the Discovery and Preclinical business of MDS Pharma Services with facilities and almost 600 associates in Bothell, Washington; Lyon, France; and Taipei, Taiwan.

The expanded organization provides the biopharmaceutical industry with access to a global contract research organization (CRO) focused on the developmental phase between intellectual property (IP) and submission of the investigational new drug (IND) application. The increased capacity and capabilities deliver numerous benefits, including:

Global toxicology allowing coordination of projects between North America, Europe and Asia.
Access to cGMP and non-GMP API synthesis and process development for IND-enabling toxicology performed in North America and Europe.
Expanded and enhanced DMPK services and efficacy models.
Streamlined lead optimization service combining efficacy and biomarker assays with medicinal chemistry.
Complete pharmacological profiling services including molecular, cellular, tissue and in vivo assays of development candidates.
Radio labeled compound synthesis available for all locations worldwide.

Ricerca Chairman and CEO Ian Lennox stated, "With facilities worldwide combining local experience, immense scientific expertise and a strong commitment to excellent client service, we provide unique discovery and development services. Our expanded organization is a research partner clients can rely on to think strategically about projects, anticipate needs and rapidly deliver study results."

Grace Receives 1st Ever IPEA Excipient GMP "Certification"

The IPEA's issuance of good manufacturing practice (GMP) “certification” is mark of manufacturing quality, says US specialty chemicals supplier W R Grace & Co.

The award, which is based on the results of a two-day inspection of Grace’s manufacturing facility in Baltimore, Maryland by the International Pharmaceutical Excipients Auditing (IPEA) group, covers the production of pharmaceutical grade silica for excipient applications.

IPEA, an independent subsidiary of IPEC-Americas, deemed that quality management systems, production, management and warehousing procedures at the plant met with current IPEC-PQG GMP guidelines which, although not a legal requirement, indicate Grace's commitment to quality according to company president Grace Davison.

Davison said: “Our customers can be assured that we maintain the highest levels of quality,” adding that “we continuously test ourselves and our business process with this audit being an example of that dedication.”

Such efforts to ensure product quality are likely to be welcomed by a pharmaceutical industry that is under pressure to ensure the safety of its products, particularly in the US where groups have issued concerns about excipients sourced overseas.

The IPEA's first ever certification is timely given that it follows just a few weeks after EU reignited the debate on the need, or otherwise, for such rules.

A plan to set up GMP rules for certain excipients was dropped by the European Commission (EC) last year on concerns that the requirements were inflexible and likely to damage the industry.

Early last month however, the EC committee on the Environment, Public Health and Food Safety (ENVI), resurrected the debate, suggesting in a draft document that some form of excipient GMP would help in the fight against counterfeit drugs.

The document also called for routine and unannounced inspects of excipient makers, importers and distributors both inside and outside the European Union by third party organizations.

Abbott Completes Acquisition of Solvay Pharmaceuticals

Abbott has completed its €4.5 billion acquisition of Belgium-based Solvay Pharmaceuticals. Solvay Pharmaceuticals is now part of Abbott’s global Pharmaceutical Products Group. Werner Cautreels, chief executive officer of Solvay Pharmaceuticals, will serve in a transitional role and

will then leave the company. The transaction also includes payments of up to €300 million if certain sales milestones are met between 2011 and 2013.

The National Cancer Institute's Facility Taking Shape in Frederick

The National Cancer Institute's 330,000-square-foot Advanced Technology Research Facility is taking shape in Frederick, MA.

The project, scheduled to be completed in 2012, celebrated a milestone, as the final concrete panels for the first phase were tilted into place by a 630,000-pound crane. Business people, scientists and political officials attended the concrete tilt-up party.

The research center, located in the177-acre Riverside Research Park, will be the only federally funded center in the country dedicated solely to biomedical research and development. It will consolidate and expand work that is currently spread among 33 buildings at Fort Detrick

The initial phase of the project is costing $250 million. There is already talk of a 100,000-square-foot expansion.

HistoRx Expands

HistoRx has received a loan of $1.5 million from Connecticut Innovations, which the Rocky Hill, CT.-based firm will use to build out its lab space and purchase equipment. HistoRx's Aqua technology quantifies specific protein expression within different parts of the cell within cancerous tissue samples. The firm is providing the technology to biotech and pharmaceutical firms as an aid in determining which drugs may be best suited to a particular patient's cancer. Connecticut Innovations is the state's quasi-public authority for technology investing and innovation development.

Med fusion Opens Clinical Facilities

Med fusion, a new clinical lab and clinical trials services firm, will begin operations this spring, the firm announced. Med fusion is a collaboration between the Baylor Health Care System, Texas Oncology, Pathologists Biomedical Laboratories, and US Oncology. Among its services will be pathology testing and molecular diagnostics, the Dallas-based firm said. Med fusion intends to hire 320 employees next year and have more than 900 employees by 2014.

Berkeley Lab to Build DOE Advanced Biofuels User Facility

The Lawrence Berkeley National Laboratory (Berkeley Lab) has been awarded nearly $18 million from the Recovery Act to build an advanced biofuels process development facility.

Funded by the U.S. Department of Energy (DOE) through its Office of Energy Efficiency and Renewable Energy (EERE), this new facility will help expedite the commercialization of next generation biofuels by providing industry-scale test beds for innovative technologies.

Called the Advanced Biofuels Process Development Unit (PDU), it will be the only facility of its kind available for public use.

"The Advanced Biofuels Process Development Unit will serve the efforts of major biofuels research across the nation, including the Bioenergy Research Centers in the DOE Office of Science," says Berkeley Lab director Paul Alivisatos.

"The establishment by EERE of this facility at Berkeley Lab, a DOE Office of Science national laboratory, reflects a renewed spirit of cooperation between the DOE technology and science programs. Berkeley Lab is proud to play its part."

The announcement of this grant was made by DOE Assistant Secretary for EERE Cathy Zoi, speaking at the Biomass 2010 conference on March 31, 2010, in Arlington, Virginia. Her agency oversees DOE's Biomass Program, which has been awarded about $718 million in Recovery Act funds to accelerate the commercialization of advanced biofuels and foster the growth of a sustainable U.S. bioindustry.

"The Department of Energy is committed to developing cost-effective and sustainable advanced biofuels," Assistant Secretary Zoi says. "With this investment in the Advanced Biofuels PDU, we will vastly increase the capacity to test new innovative approaches on a larger, integrated scale. Scaling up these clean energy technologies is crucial to addressing climate change and building a strong, domestic clean energy economy."

The Advanced Biofuels PDU is scheduled to be fully operational by early 2011, and multiple possible locations for the facility are now being considered in the San Francisco East Bay region.

Advanced biofuels, as defined by the Energy Independence and Security Act, are renewable fuels - other than ethanol derived from corn starch - with at least 50 percent less lifecycle greenhouse gas emissions than the fossil fuels they replace.

Berkeley Lab's Advanced Biofuels PDU will feature pre-treatment of biomass capabilities and bioreactors for the production of microbial or fungal enzymes that can break down biomass into fermentable sugars. The facility will also have substantial capabilities for fermentation or further conversion of sugars into advanced biofuels, along with the capacity to purify these fuels in sufficient quantities for engine testing.

Jay Keasling, the CEO of the Joint BioEnergy Institute (JBEI), one of three DOE Office of Science Bioenergy Research Centers, says researchers at his institute are looking forward to using the new facility's resources.

"One of JBEI's missions is to see that its scientific advances are translated into commercially viable technologies, as the rapid transfer of laboratory discoveries to the marketplace is crucial to solving the nation's most pressing challenges in energy and the environment," Keasling says. "The Advanced Biofuels PDU will be an important contributor to this national effort."

The new facility will be operated through Berkeley Lab's Physical Biosciences Division, which oversees $34 million in research programs, including Berkeley Lab's participation in JBEI as well as major efforts in bioenergy and environmental studies.

The Advanced Biofuels PDU will "add a powerful new capability to the division's portfolio," according to the division's acting director Paul Adams.

"Advanced biofuels have the potential to be used as direct replacements for several or all petroleum-derived components in gasoline, diesel and jet fuels," Adams says. "In order for these advanced biofuels to be widely adopted it is essential that they be available in quantities of tens of liters for laboratory and road engine testing. It will be the mission of the Advanced Biofuels PDU to produce such volumes of fuel."

Berkeley Lab is a U.S. Department of Energy national laboratory located in Berkeley, California. It conducts unclassified scientific research for DOE's Office of Science and is managed by the University of California. For more information visit www.lbl.gov/

University of Virginia Uses Modular LEED Buildings

The University of Virginia (UVA), known for its extraordinary Thomas Jefferson-inspired architecture, is choosing to use modular. The University recently installed a multi-story, modular, LEED-certified building constructed as an addition to its Medical Center.

The addition is 11,500 square feet, two stories and serves as office space for employees at the Medical Center. It was completed in four months. Comark Building Systems of North Carolina was the manufacturing company, Train & Partners served as the architects and Mobilease Modular Space, Inc. was the dealer for the project.

The Modular Building Institute interviewed Mobilease Modular Space about the project.

MBI: Why was modular chosen for the project?

Mobilease Modular: UVA needed a building that would be available for occupancy by the end of the year. The university planned a modular solution for a temporary structure that would be in place for 10-15 years, but the final design and specification are of such high quality that it we think it will likely remain as a permanent structure.

MBI: Describe some of the unique features of the project?

Mobilease Modular: UVA went first class in every regard on this building. They chose an architectural curtain wall window system, including fritted glass and sun shades on the west elevation of the building. The building exterior includes Reynobond® panels, each of which consists of two sheets of corrosion resistant aluminum permanently bonded to an extruded thermoplastic core material. The panels match the exterior of a nearby, multi-story addition to the Medical Center.

The panel installers are craftsmen in every regard. Each panel section has been field measured and custom fabricated to assure a perfect fit.

Another thing that makes this building unique is that it is LEED-certified. It includes a white, TPO roof, poured floors and fire-rated, steel construction. High efficiency heat pumps include R410A refrigerant, MERV 13 filters and carbon dioxide sensing to assure air quality. Interior finishes include floor coverings and suspended ceiling materials made with a high percentage of recycled material content.

MBI: Describe some of the other advantages to using modular on the project?

Mobilease Modular: The Medical Center did not have to close down any part of its facility in order for this addition to be constructed. The second floor of the Medical Center addition includes a pedestrian walking bridge which connects to adjoining Jordan Hall so employees don’t have to walk through the main Medical Center building to access the new structure.

MBI: Describe the process of putting the modules into place?

Mobilease Modular: The installation of the modular units took three days using a crane. Access to the site was very limited as the new building was installed very close to Jordan Hall and we had to locate the crane in between the two structures. It had to be removed from the fire lane at the end of each work day.

When the crane was set up, the building installation crew prepped the units and backed each into the very narrow space with a truck. They then removed the axles, tires and hitches before the units were lifted by the crane. As one modular unit was being put in place, another truck with a new module was ready to be brought in.

MBI: What is the significance of this project?

Mobilease Modular: The UVA campus is admired around the world. They’ve set the bar for architectural excellence and its School of Architecture is a national leader in architectural education. Walking around campus and seeing all of the buildings myself, it is easy to understand how they’ve earned the reputation they have. I’m also amazed by the beauty of this new modular building and how it fits in with the rest of the campus.

The project makes a statement about the future of modular construction. Architects across the country are aware of the significance of UVA. If UVA is considering modular construction, it probably makes it something that will be considered by other colleges and universities. In addition, we hope that architectural students in training at UVA will observe that modular construction can be a valuable tool to them to use during their professional careers.

REST OF WORLD

Baxter Expands Cytotoxic Contract Manufacturing in Germany

Baxter’s BioPharma Solutions is expanding its cytotoxic contract manufacturing facility in Halle (Westfalen), Germany, to meet client needs. Such efforts mark its third capacity expansion, further enhancing Halle’s complete range of resources to support early-phase drug formulation through commercial scale-up, introduction, and lifecycle management. Baxter reports in a press release that the expansion, which will be completed by next month, "has been designed to meet international manufacturing and regulatory requirements and will be followed by an additional phase of expansion to be completed by 2012."

The expansion includes upgrades across multiple specialized capabilities offered at the Halle facility. A large-scale lyophilization unit was added to increase freeze-drying capacity, which supports a large majority of the Halle manufacturing business.

To support large-scale production service needs for commercially marketed oncology drugs, part of the expansion project included replacing existing filling technology with a newer system, which will allow for a more than 50% increase in capacity for commercial cytotoxic manufacturing. The filling process uses advanced cRABS (closed Restricted Access Barrier System) technology for enhanced product sterility and operator safety. Baxter recently received the prestigious “Most Effective Scale-Up/Technical Transfer Award” at the 2009 European Outsourcing Awards for this project. The project was recognized for avoiding installation delays and maintaining manufacturing timelines to meet all client obligations during the expansion.

Baxter also supports small-scale production, which is primarily used in clinical production, when clients are studying and seeking regulatory approval for new drugs. The facility now features a hand-fill suite, which is able to manufacture these small-scale clinical cytotoxic batches.

Another new Halle capability is commercial-scale production of cytotoxic emulsions, liposomes and suspensions, with the addition of a nanoparticle suite equipped with a high pressure homogenizer. These technologies allow Baxter to stay at the forefront of parenteral cytotoxic manufacturing.

“By offering a full complement of services in one location to support oncology drug production needs, we are able to meet clients’ growing needs for cytotoxic manufacturing in a single location, including early-to-late stage support to fully engage and service our clients throughout the lifecycle of their products,” said Dr. Burkhard Wichert, vice president of manufacturing for Baxter’s Halle facility, in the press release.

With more than 50 years of experience, the facility offers capabilities including lyophilization; process development; aseptic filling of cytotoxic, non-cytotoxic, and highly potent liquid and sterile powder vials in clinical and commercial batch sizes; and sterile crystallization of cytotoxic active pharmaceutical ingredients.

DKSH Opens Food Application Lab in Lyon

Market expansion specialist DKSH is opening a new food application lab in Lyon, France, focusing on beverage and bakery products.

To be opened at the beginning of May 2010, the new lab has been built to support customers and suppliers looking to develop new products and formulations for the beverage and bakery industries.

DKSH already has three such labs in Asia where it works with food and drink suppliers including Wild in the development of new products.

By setting up a new application lab in Lyon, John Roemling, who heads up the DKSH food business in Europe, said the company is now looking to expand its Asian model westwards.

In Lyon, DKSH plans to focus on beverage and bakery applications, and the potential of barley beta-glucan in these products.

DKSH will work on extending the use of beta-glucan in beverages and overcoming formulation issues such as excess viscosity. The firm sees potential for beta-glucan in the bakery category and will be looking to develop new applications for the sector.

Roemling said the long-term goal of the Lyon site will be to extend the work of DKSH into more quality, value-added applications.

The food business at DKSH is worth about €50m in annual turnover and is orientated around three pillars; non-GMO soy ingredients, nutritional fibers, and frozen seafood.

DKSH does not itself manufacture these products but partners with companies to provide marketing and distribution services for them. It focuses on applications in four sectors; food service, beverage and dairy, nutritional supplement, and bakery and confectionery.

Overall the food business is a small part of the DKSH group, which employs 21,000 people and has an annual turnover of about CHF 8bn (€5.57bn).

The Swiss-based company offers market expansion services to companies in a variety of sectors including consumer goods, healthcare, performance materials, and technology.

BD to Make Syringes in Hungary

Becton Dickinson (BD) says its new Hungarian plant will be operational this year and producing more than 500m 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.”

In other news, 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 this month.

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."

Penn Updates on Cold Chain Facility

CDMO Penn Pharma says construction its new cold storage facility on the Tafarnaubach Industrial Estate in Tredegar, Wales will be completed by June.

The unit comprises 15,000 sq.ft. of temperature-controlled storage capacity and, according to Penn, has enough space to house secondary packaging and labeling processes.

The expansion is part of a $19m (€14m) program the contract development and manufacturing organization (CDMO) that has already seen Penn significantly expand transport infrastructure at the site according to CSO Paul Thomas.

"We have heavily invested in the expansion of our Tredegar site making it a portal into the EU,” explained Thomas, adding that “we look forward to our continued growth and expansion into the US."

Avon Actions and Plans

Beauty products seller Avon Products Inc. said it put four executives on administrative leave, as part of an investigation of bribery allegations that started in China.

Shares fell $2.23, or 6.4 percent, to $32.53 in midday trading. The stock has traded between $20.63 and $36.39 during the past 52 weeks.

The suspensions were first reported by the Wall Street Journal.

Avon confirmed the executives put on leave include: S.K. Kao, general manager of Avon China; Jimmy Beh, former finance head for Avon in China and most recently an executive in Malaysia; C.Q. Sun, head of corporate affairs for Avon China; and Ian Rossetter, most recently vice president of finance and tax.

Avon began investigating its China operations in 2008 after it received an allegation that some travel, entertainment and other expenses may have been improper, according to filings with the Securities and Exchange Commission.

Since then, the investigation has spread to other, undisclosed countries, Avon has said.

Avon spokeswoman Jennifer Vargas said in an e-mail to The Associated Press that the investigation is ongoing and the company hasn't reached any conclusions.

Avon's overseas sales account for about 80 percent of its revenue, mostly from emerging markets such as Latin America.

In 2009, revenue from China rose less than 1 percent to $353.4 million, while total Avon revenue fell 3 percent to $10.38 billion.

But Avon sees growth in Asia as important for its long-term expansion plans.

"We feel the revenue and profit opportunities in this market are immense, and we are committed to develop and grow our business there," CFO Charles Cramb said during its most recent quarterly earnings conference call in February.

Last month the company said it plans to open its largest research and development center outside the U.S. in Shanghai in an effort expand Avon's scientific capabilities in Asia.

Tetra Pak Unveils China Technology Center

Tetra Pak inaugurated its newest technology center in China today as part of its on-going strategy to consolidate its position in the domestic processing and packaging sectors.

The processing and packaging giant officially opened the 37,000 sq meter site in Pudong, near Shanghai.

“The centre, which brings together resources from product development and engineering, technical service, training, sourcing and distribution, provides Chinese customers with a one-stop service in food processing and packaging solutions,” said Tetra Pak spokeswoman Linda Bernier.

While the Shanghai Centre will not customize processing and packaging systems, a special feature of the facility will be to gear engineering solutions specifically to the China market. As part of this, the center will include the first Chinese road condition analysis lab. Equipped with state-of-the-art equipment that accurately records road conditions across the country, it will provide simulation data that customers can use to reduce potential transportation problems.

The center has 450 employees and began operations in December 2009.

“The Technology Centre in Pudong creates a world-class resource for customers, ideally placed to address the unique challenges of food and beverage packaging, processing and distribution in China,” said Dennis Jönsson, company president and CEO.

“This facility will make us more responsive to local needs, ensuring that our activities, our innovation pipeline and our service offerings are sharply focused on helping local customers better deliver their products to the people of China,” he said.

AB Sciex Opens China Center

Life sciences tools and services provider AB Sciex said that it has opened a new proteomics-focused support center in Shanghai.

The Asia Pacific Application Support Center will provide mass spectrometry, biomarker, food safety, environmental testing, and other services and support for life sciences researchers in China and in the broader region.

The center will offer sample analysis, instrument and workflow demonstrations, training programs, customer support, and it will host scientific collaborations in a range of disciplines. The facility contains seven demonstration labs, a wet chemical lab, three lab stock rooms, training facilities, and a service area, AB Sciex said

Sanofi’s China R&D Centre Up and Running

Sanofi Aventis’ expanded R&D centre in China opened for business, further building the French drugmakers presence in the country.

The unit was set up in 2005 and has already been involved in several global registration studies for a range of Sanofi products including Lantus, Plavix, rimonabant, dronedarone and idrabiotaparinux.

However in 2008, as part of an effort to expand in emerging markets, Sanofi announced plans to significantly expand capacity at the facility which, according to a report in the Shanghai Daily newspaper, has now been completed.

Thomas Kelly VP of Sanofi’s operations in China told the paper that: "We hope to become the first multinational drug company that completes truly home-grown research activities and will cooperate with local partners."

Company VP of R&D Marc Cluzel was equally upbeat about the R&D unit’s potential explaining that: “[It] is expected to accelerate the development of therapies and health solutions for the mass population in the region.”

Like the majority of its Big Pharma peers Sanofi has been actively targeting growth in emerging pharmaceutical markets, particularly in China.

In April 2009, for example, Sanofi invested $90m to boost capacity at its manufacturing facility in Beijing which, CEO Chris Viehbacher said, was evidence of Sanofi’s belief in “the strategic importance of the Chinese market”.

And, earlier this year, Sanofi further underlined its commitment to building in China by forming a consumer healthcare focused JV with Minsheng Pharmaceutical which is focused on the production of vitamins and supplements.

Clinical Trials in the UK and in Ireland

The UK has become a leading country in clinical research, thanks to its very good infrastructure and numerous initiatives implemented by the authorities over the past years.

“We, at Pharmalys, have extensive expertise in conducting clinical trials across a wide range of therapeutic areas in the UK and in Ireland and cover all clinical trial phases in a proactive and cost-conscious way. Through a network of strong partners, we have also the possibility to provide innovative solutions throughout Europe.”

“We can manage your local and international projects from the trial feasibility assessment right through to study reporting. Alternatively, we can offer stand-alone services, giving you just the level of assistance you require to complement your in-house competencies.”

“Our professionals have previously worked in small, medium and large pharmaceutical companies, in full service CROs and at investigational sites. This gives us a very good understanding of the industry and allows us to listen closely to our clients in order to develop a unique approach, tailored to their specific needs.”

NextPharma’s Belgian Steriles Facility Opens for Business

Sterile product development was also a focus for NextPharma Technologies with the official opening, on April 1, of a new dedicate centre in Braine-l'Alleud, Belgium.

The unit is, according to NextPharma, “specifically designed to meet the growing demand for formulation development and production of sterile investigational medicinal products.”

NextPharma explained that services offered cover pre-formulation through to lyophilisation capacity for Phase I and II trial supplies, and added that it has the capability to scale up for Phase III and commercial manufacture.

Sean Marett, MD of product development services, said: “We have already successfully undertaken ten development projects in the SPDC, and we have a strongly growing order book which reflects our ability to provide a more efficient and faster option [for sterile pharmaceutical manufacturing].”

Winsunny Licenses HGCP to Produce Generic API

Winsunny Pharma has exclusively licensed NMT’s HGCP technology, which produces APIs in low micron and nano-sized range, to manufacture a hyperlipidemia-controlling drug in China.

NanoMaterials Technology’s (NMT) proprietary high gravity controlled precipitation (HGCP) technology consolidates crystallization, micronization and conditioning processes into a single step. This saves time and money, according to Singapore-based NMT.

Beijing Winsunny Pharmaceutical has entered into an exclusive licensing agreement to use the technology to produce a generic version of “a worldwide blockbuster hyperlipidemia-controlling drug in China”.

“We believe that this is the beginning of a series of drugs using our technology to be made available in the market”, said Jimmy Yun, CEO of NMT. Yun added that NMT in talks with pharma companies “in the US, Europe and China to commercialize several compounds using HGCP”.

Using HGCP NMT will provide a new formulation of the hyperlipidemia treatment which will increase efficacy, lower drug dosage and improve patient compliance. NMT has applied HGCP to small and macro molecules for formulation into solid oral dosage and inhalation forms.

HGCP can also be used to design drug particles with suitable aerodynamic properties and specific particle size distribution for pulmonary inhalation. The technology allows for cost-effective scale up to large scale production, according to NMT.

NMT will receive an undisclosed upfront fee as well as milestone and royalty payments based on future sales. The potential market for the treatment is more than $900m (€677m), according to NMT, and there are 90m patients in China undergoing long-term treatment for hyperlipidemia.

Winsunny Pharma will cover development, regulatory and commercialization costs of the solid oral dosage form drug.

Graham Packaging Poised to Break into China

Graham Packaging Company Inc said it is poised to break into the China after signing an agreement to acquire a Chinese firm.

The US outfit said it expects to buy China Roots Packaging PTE Ltd., a plastic container manufacturing company located in the Chinese city of Guangzhou, from PCCS Group Berhad of Malaysia.

The plant makes plastic containers and closures for food, health care, and petrochemical products. Its customers include several global consumer product marketers, said Graham Packaging.

"The purchase will open a new door for our company," said company CEO Mark Burgess. "China is undeniably a major market and the opportunity to participate in its growth is very exciting for us."

Marchesini Opening New Ecofriendly Facility

Marchesini Group is counting down toward the opening ceremony of its new logistics building, which will be held during a five-day open house October 18-22, 2010. The new structure, which will house the group’s logistic activities, is the result of a project focusing on eco-compatibility and environmental sustainability. The new building will be located in Pianoro, Bologna, next to the Marchesini Group Headquarters.

The building, designed by Architect Stefano Visinelli, was been built to reduce environmental impact and maximize energy efficiency. The building, which develops over three thousand five hundred square meters (37,660 sq. ft.) and involves an investment of approximately € 6,500.000, will have an Airklima geothermal plant that will be able to guarantee a comfortable work environment (warm in winter and cool in summer), exploiting an environment friendly technology.

After cutting the tape, the new building will welcome customers from all over the world. The five-day open house will offer guests the opportunity to take a look at Marchesini’s new complete lines and stand-alone machines at work, all of which involve cutting edge solutions for packaging pharmaceuticals and cosmetics.

Air Products to Build New Hydrogen Plant in Malaysia for Oleochemical Industry

According to PRNewswire, Air Products is building a new hydrogen production facility in West Port, Selangor, Malaysia to support increasing product demand in the region. The steam methane reformer (SMR) will have a hydrogen production capacity of more than 1.5 million standard cubic feet per day and is projected to be completed in the first quarter of 2011. It will supply high purity hydrogen and steam to its on-site customer and also supply the fast growing merchant hydrogen market in central Malaysia. The new facility will be Air Products' second hydrogen plant in West Port. The hydrogen produced by the SMR is used by a variety of industries including oleochemical manufacturers who produce fatty alcohols, fatty acid and methyl esters. Ultimately these products are used to manufacture surfactants and derivatives for a variety of end use markets including cosmetics, toiletries, detergents, plasticizers, lubricants and disinfectants. An hour's drive from Kuala Lumpur and located along the Straits of Malacca, West Port is well connected to the rest of Malaysia and has positioned itself as the destination for container vessels plying the world's busiest shipping lanes. It is not only a leading port in Southeast Asia, but also one of the top five ports in the world in terms of productivity.

Gerresheimer Opening Two New Plants

Gerresheimer is increasing its presence in the pharmaceutical plastics business, which it believes is increasingly important, by opening an R&D centre in the US and a production facility in Spain.

The pharmaceutical plastics sector has become Gerresheimer’s fastest growing business sector and the company has made strategic investments to ensure it has the capacity to meet rising demand.

From the facility Gerresheimer will produce pharmaceutical bottles and multifunctional dosage and closure systems, for delivery forms such as eye drops, nose sprays and tablets.

Prior to the expansion Gerresheimer lacked a US site that could handle customized serial production of entire product and process development, with only its European sites having this capability.

Following the expansion the US site will work on highly developed inhalation systems for respiratory diseases, as well as insulin pens, skin-prick aids and lancets for the diabetes sector.

Gerresheimer Opens New Insulin Pen Plant in Brazil

German healthcare packaging group Gerresheimer says operations at its new Brazilian plant will begin in the near future.

The facility, in Indaiatuba, Sao Paulo, will produce insulin pen systems and ship them to Novo Nordisk’s manufacturing facility in Montes Claros, in neighboring Minas Gerais state.

CEO Axel Herberg said: "Cooperation with Novo Nordisk in Brazil is of substantial strategic importance for us. We support the customer in developing new markets and at the same time expand our technological base in South America."

The firm already owns two other pharmaceutical packaging plants in Brazil and one in Argentina.

Clearstone Expands Toronto Site but is Closing NJ Lab

Clearstone is expanding safety and esoteric capacity at its laboratory in Toronto, Canada, allowing it to close its facility in New Jersey, US and consolidate North American operations.

The New Jersey site mainly performs esoteric testing and by expanding the Toronto laboratory Clearstone will be able to consolidate without losing capacity or capabilities, said Lammert Albers, vice president, global business development at Clearstone.

Clearstone will wind down operations at the New Jersey site over the next six months. Closure of the site will result in “a few job losses” but Clearstone is aiming to retain and relocate some employees, added Albers.

Following closure of the New Jersey laboratory Clearstone will transfer remaining studies to its site in Toronto. Adding safety, esoteric and enzyme-linked immunosorbent assay (ELISA) testing, as well as flow cytometry, will allow Clearstone to cope with the transfer and meet client needs.

Albers added that there are more changes and developments in the pipeline at Clearstone.

Clearstone went through a lull between MDS announcing the sale and completion of the transaction, said Albers, adding that “it was a tough time”.

Customers remained positive and supportive though and Clearstone is now seeing a resumption of relationships and the creation of new business, according to Albers.

Activity includes a deal with Eli Lilly. Clearstone is providing Lilly with services from its site in Beijing, China which has been expanded by adding the Affymetrix DMET system to support the deal

The Beijing site was occupied just prior to the Olympics in 2008 and has five times more capacity than the previous site.

Ricerca Partners with LSP to Target Asian Market

Contract research organization (CRO) Ricerca Biosciences has entered into a business development deal with Japan-based Life Science Partner (LSP) to help penetrate the Asian market.

Ricerca has always had a strong presence in Japan, Phillip Cassidy, director, metabolism at the preclinical CRO, told Outsourcing-Pharma. Partnering with LSP will help boost Ricerca’s presence in Japan, as well as increasing penetration in Korea and other Asian markets.

Business generated by Ricerca in the region varies, according to Cassidy. Ricerca recently acquired assets from MDS, including a facility in Taipei, Taiwan, and is now making a concerted effort to increase business in Asia.

Cassidy said that LSP’s strong scientific knowledge and understanding of the local market were factors in Ricerca’s decision to partner with the Japan-based company.

“Their business model is unique and is embraced by the Japanese industry with a cost-effective and rapid turnaround time for laboratory studies”, explained Mark Crane, vice president of business development and marketing at Ricerca.

Crane added that the partnership will give LSP “a significant advantage” by granting it access to Ricerca’s radiolabelled synthesis, animal and plant metabolism, environmental fate, mammalian toxicology and microbiology.

Hiroko Suzuki, executive director at LSP, stated that he believes the “collaboration will largely help our customers develop new compounds and products for tomorrow and will provide higher value to meet customer needs”.

Ricerca finalized the acquisition of units from MDS last month, enhancing the CRO’s discovery and preclinical services portfolio by adding capabilities including molecular profiling, pharmacology and drug safety assessment.

Ian Lennox, chairman and CEO of Ricerca, said: “Our expanded organization is a research partner clients can rely on to think strategically about projects, anticipate needs and rapidly deliver study results.”

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 m2, with more than one thousand people (Scientists, Professors, technicians, students) working there. 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.

In summary, Cellvax is able to provide to its customers the services not only in small animals, but also in large animals in a more efficient way.

Celerion Acquires Operations from MDS Pharma Services

Celerion, a privately owned contract research organization (CRO), has completed the acquisition of the development and regulatory services consultancy and early stage development operations of MDS Pharma Services. The acquired assets include five clinical research facilities and two bioanalytical laboratories located in Lincoln, Nebraska; Neptune, New Jersey; Phoenix, Arizona; Zurich, Switzerland; and Belfast, Northern Ireland, as well as operations in Richmond, Virginia and Quebec, Canada. With over 700 beds worldwide, Celerion is an industry leader in the conduct of early clinical research, including first-in-man to proof-of-concept clinical studies, clinical pharmacology, bioequivalence trials, bioanalysis, and cardiac safety services.

Celerion is derived from the Latin celeritas meaning swiftness and speed. This word reflects one of Celerion's founding principles: to deliver services that enable clients to get their products to market faster. It also underlies another key goal of the business: to assist clients in reaching informed go/no-go decisions on compounds in development as early as possible.

Life sciences and CRO industry veteran Susan Thornton, Ph.D., is Chief Executive Officer of Celerion. "I'm energized by the prospect of taking this great business to the next level of market leadership," she said. "Its combination of experienced people, scientific excellence, and state-of-the-art facilities constitutes a strong foundation for future growth. We look forward to continuing to provide our pharmaceutical, biotechnology and generic clients with leading early stage clinical research services. Like the company I am leading, my roots are in MDS Pharma Services."

Pfizer’s Dublin Facility Upgrades in Neighborhood

Based on a 17 acre site, the Pfizer Dublin Manufacturing facility has been in operation since 1970. In 2004, an overview of the freeze drying network within Pfizer concluded that there was a need for additional freeze drying capacity within PGM (Pfizer Global Manufacturing). A significant expansion of the Pfizer Dublin site was approved to provide this additional capacity. The project involved the construction of one new production module (PM2) containing four freeze dryers and support facilities including labs, warehousing, central utilities building, dispensary and personnel and administrative support areas.

The design, construction and integration of the facility into the existing site while adhering to strict "good neighbor" policies has earned the company a coveted category award for Integration in the annual Facility of the Year Award (FOYA) program and has put it in the running to win the overall award.

The Pfizer Fill Finish Facility represented a unique proposition for modern pharmaceutical companies. That is - how to act sustainably to support new products on a long standing established site in a residential suburban area.

Pfizer site management was determined to stay loyal to its suburban site, supporting staff and their family commitments, the local economic community and the inherent sustainability of remaining linked to public and transport infrastructure, laid down up to a hundred years ago.

However, this much-considered decision carried many risks. How would the new facility relate to its residential neighbors? Did the aging infrastructure have the carrying capacity? Could Pfizer operate the plant within tough environmental constraints? Would Pfizer disrupt existing production on such a very tight site? How best to optimize facility integration and leverage the embedded value of all the facilities and services on site? These kinds of issues demanded a rigorous and inclusive design process.

Pfizer approached each decision for this facility using a structured and rigorous assessment process.

Thus site selection, site due diligence and site master planning tackled the macro issues and likewise the internal facility scoping and planning tested the optimization of the operations and logistics.

The project team went through several design phases until they arrived at an acceptable site plan. Mairead Kennedy, Engineering Team Lead for the project, explains this process; how long it took, and how this process was factored into the overall construction schedule, "We went through a conceptual/preliminary design phase at which point the cost, schedule and business case was fully understood. This was the formal kick off point for the project where the company approved funding and the project team committed to delivery on cost and schedule, and kicked off detailed design. Generally the conceptual/preliminary phase involves a very small team of 3 or 4 people and takes anywhere from 3 months to even a year. The longer timeframe would generally relate to time for the business case to become certain, rather than technical design issues."

The chosen option was selected to maximize the advantages of site integration. Having selected this arrangement, the design was developed to minimize its impact on its neighbors with the following characteristics:

1. The overall manufacturing program is divided in 5 distinct buildings, each with smaller massing and impacts but each linked to a coherent site manufacturing pattern.

2. Each building was given a distinct shape to further break down the visual scale and optimize its function.

3. The buildings and structures are consistently colored gray to prevent them forming a monolithic mass with the existing brown structures and to neutralize its color in the landscape.

4. The buildings have large glazed areas and attractive design features. Curved roof and plan elements add variety and liveliness, enhancing the visual impact.

5. The main buildings are cut into the existing site to lower visual impact.

6. The earth released by the deep basement was used to generate a large-scale attractive bermed structure to fully enclose the site and, in particular, to build a local attractive planted hillock beside the nearest residences so that their views are predominantly of landscape structures rather than buildings.

7. The bermed and landscaped enclosure of the site also significantly reduced and removed any residual noise or night lights from the site.

8. A new safer car and truck entrance was integrated into the site plan including improved fire truck access.

Kennedy described how important it was to Pfizer to work with the local residents. "This site is part of a residential community with many neighbors living in very close proximity to the site. It was essential that the design of the facility and its landscaping integrated well into the community. We had an extensive consultation process during the planning phase, and many enhancements were made to the landscaping design to accommodate the concerns of the local community. Obscuring the plant while maintaining views of the Dublin mountains became the key challenge."

During the design stage of the facility, PM2 was intended to be a high volume manufacturing facility with a low level of product changeovers.

However, during the commissioning stage of the project the Site Strategy changed and Dublin became the site of choice in the Pfizer Network for Biologics Drug Product clinical trials and New Product Introductions.

The project team combined with resources from the existing New Product Introduction team quickly adapted to the new requirements and added a Freeze Thaw unit (for cryo vessels), a disposable mixing system for making up small quantities of buffer, and adapted compounding and product transfer paths to minimize product losses. The Lev Mix disposable bag system in particular was a first of its kind qualification in Ireland.

This system consists of a single-use impeller inside sterile disposable fluid handling bags and a magnetic drive unit. When aligned with the specially designed impeller, the drive unit causes the impeller to levitate and lock in position. A variable speed controller allows the impeller to be run at the desired speed.

The IMA Edwards equipment consists of freeze dryers with automated, flexible loading and unloading systems

Asked specifically about the freeze dryer installation Kennedy adds, "We are particularly proud of our freeze drying technology. We have four pass-through freeze dryers each with a 42 square meter shelf area with fully automated loading and unloading system. They are arranged so that while loading is taking place on one side, another freeze dryer can be unloaded from the opposite side giving maximum flexibility for optimum plant throughput."

In compliance with Annex 1 the open product containers are handled under a grade A environment with grade B background. This means that the areas close to the freeze dryer slot-doors have received special attention having controlled airflow. Laminar air flow units were placed over the freeze dryer loading slot doors due to the risk of particulate generation when the doors were being opened. Doors are closed between cart loading to minimize moisture build-up during cold shelf loading.

The performance of the stoppering part of the freeze drying cycle has also been optimized. Historically, within the industry sticking stoppers have resulted in many problems with fallen vials and disordered vial packs. It has been almost impossible to avoid operator interference during unloading of a freeze dryer.

Jointly IMA Edwards and Pfizer initiated a collaborative action to solve this problem. A thorough, fundamental analysis of the cause and effect led to the development of an ideal solution. This solution is a combination of a specific surface structure of the metal surface and covered with a Teflon containing layer. The low surface-energy of this layer prevents the sticking of any material and therefore after CIP there is no remaining material.

A Bosch FLM filling and stoppering machine was chosen as the best technology to employ for this facility. The narrow balcony design allowed the filler to be installed against one wall of the filling suite, with only single-sided access required for the operator in the sterile area. All maintenance can be carried out from the Grade C area at the back of the machine. This has the significant advantage of eliminating the requirement for maintenance technicians and their tools to enter the sterile area and reduces downtime for cleaning and sanitizing of the room.

Based on the advanced technology used in the facility the selection of equipment vendors was obviously a critical part of the plants overall success, as Kennedy explains,

"Selecting the right equipment vendors was key to the overall success of the project. This plant would be on the high end of the equipment complexity scale, and integration of different vendor’s equipment was particularly important. The user requirements were very rigorous and detailed. On vendor selection we prequalified vendors and then competitively bid the equipment. The prequalification was rigorous so that once a vendor was on the bid list commercial performance in bidding was the only decision criteria."

Squeezing such a high-tech installation into an existing framework of buildings, while pleasing the neighbors was certainly an enormous task – and one well-deserving of an award. When asked about the facility and what she is most proud of Kennedy offered these thoughts, "While the project came in under budget, and construction was achieved with Zero LWD accidents, it was the schedule achievement which the project team was most proud of. There were many complexities to the build, and many challenges overcome in construction which made this achievement special. For example, planning permission came in 5 months late, and the team made up for this delay and still delivered ahead of schedule."

In addition, the facility has been getting a lot of notice, in particular the advanced freeze drying technology, as Kennedy mentions, "Our facility has received a very positive reaction within the pharmaceutical community, particularly in Ireland. We hosted a tour of our new facility for the Irish chapter of the ISPE in 2009 and have shared a lot of information regarding our freeze drying technology, and in particularly our automated load/unload systems with Genzyme, Allergan, Amgen and Octapharma."

Finally, when asked why the facility was chosen to receive the award, Kennedy opined, "I think our superior conceptual planning won the Facility Integration award for us. To take a narrow, steeply sloping site in a residential area and build a new Production Module, Central Utilities Building (CUB), Personnel Support Facility (PSF) and Warehouse while maintaining output from the existing Production Module was a fantastic achievement."

Hospira Completes Acquisition of Orchid's Generic Injectable Unit

Hospira, Inc. has completed the acquisition of the generic injectable pharmaceuticals business of Orchid Chemicals & Pharmaceuticals Ltd., for approximately $400 million.

"We are excited to acquire new capabilities that will create opportunities for commercial growth, position us strongly in a key antibiotics product area, expand our global footprint and enhance our ability to provide lower-cost, high-quality products to patients," said Terry Kearney, chief operating officer, Hospira. "We're also excited to welcome a talented base of 450 employees, including newly appointed managing director, Hospira India, Dr. C.B. Rao, who joins us with a wealth of diversified industrial and management experience, and will provide continuity of leadership for the Orchid team joining Hospira."

"Integration of Orchid's injectables formulations business with Hospira, the global leader in generic injectables, represents a strong strategic fit. Our team is committed to leveraging our world-class infrastructure, high-technology product range and organizational competencies to drive even greater business growth and strengthen Hospira's leadership position," said Dr. Rao.

The acquisition includes Orchid's beta-lactam antibiotic formulations manufacturing complex and pharmaceutical R&D facility in Chennai, India, as well as its generic injectable dosage-form product portfolio and pipeline. In addition, the companies have signed a long-term agreement for Orchid to supply APIs for the acquired generic injectable pharmaceuticals business.

Bayer MaterialScience Plans New Chlorine Plant

Pharmaceutical manufacturers will have more choice for their chlorine supplies after Bayer MaterialScience unveiled plans to build a new facility in Germany.

The new plant, in Chempark Krefeld-Uerdingen, will use oxygen depolarized cathode technology which, the firm said, uses 30 per cent less electricity than traditional membrane process-based chlorine production methods.

Bayer MaterialScience board member Tony Van Osselaer said the technology is part of the firm’s focus on tackling climate change, adding that “The more CO2 emissions we can prevent across the globe, the better.”

The company, which is working on the construction project with electrolysis cell manufacturer Uhde, expects the plant to be operational early in 2011 and to have the capacity to produce 20,000 metric tons of chlorine a year.

Klockner Expanding PVC and Shrink-Label Capacity

The Klockner Pentaplast Group has invested $37m (€27m) to expand PVC production capacity and add shrink-label film capabilities at its facilities in Thailand and the US.

“These expansions will enable us to continue to support our customers’ growing global demand for high-quality packaging films”, added Tom Goeke, CEO of the Klöckner Pentaplast Group.

The production line is designed to meet the requirements and regulatory standards of the pharma industry. Klöckner claims it is the only local producer in Asia to meet these manufacturing standards.

The company is aiming to start production in early 2011 and expects that when operational the new lines will add 15,000 tons of shrink-film capacity.

Klöckner’s product range includes transverse-direction orientated (TDO) and machine-direction orientated (MDO) shrink films that have a variety of applications, including tamper evident closures.

The expansions are expected to add 64 employees worldwide.

Source BioScience Opens Ireland Lab

Source BioScience has opened a new DNA sequencing service laboratory in Dublin, Ireland. The lab is located on the campus of Trinity College. Source said that it will offer DNA sequencing services to customers within the university, including access to its next-generation sequencing and genotyping platforms at its central lab hub in Nottingham, UK.

London Genetics

London Genetics, a non-profit company established in 2007 to promote the use of pharmacogenetics in drug discovery and development, has made the first three awards from its proof-of-concept fund. Projects funded through the program are intended to illustrate the value of using genetic data and resources from London Genetics' seven academic founding members in drug discovery and development. The first three awards went to teams at imperial College London and University College London for projects focused on immunotherapy, schizophrenia, and heart disease.

Dr. Reddy’s Opens mPEG Alcohol Plant in Mexico

Dr Reddy’s has made a “significant investment” in an mPEG alcohol production facility in Mexico to strengthen its presence in a sector it believes is on the rise.

Pegylation of biologics, peptides and small molecules is increasingly common, according to Dr Reddy’s, as companies seek to improve pharmacokinetics of treatments by prolonging their half-lives. In turn, this is driving demand for the materials used in pegylation.

To ensure supply of mPEG alcohols, raw materials for activated mPEGs, Dr Reddy’s has commissioned a commercial scale production facility in Cuernavaca in central Mexico.

Nick Johnson, commercial director at Dr Reddy’s, and Mark Pearson, PEGtech product manager, explained that Mexico was chosen as the location because of the “technical synergies” and economic advantages it offers.

Dr Reddy’s has made the “significant investment”, more precise details of which Johnson and Person would not disclose, to bring mPEG alcohol production in-house, having previously sourced it from Dowpharma.

The current good manufacturing practice (cGMP) compliant plant has a multi ton annual capacity and the ability to produce a wide range of molecular weight mPEGs. Products from the Mexico facility will be transferred to Dr Reddy’s site in Midfield, UK for downstream processing.

Johnson and Pearson believe the safety and stability of mPEG alcohol, coupled to Dr Reddy’s experience of transferring materials between its global sites, will ensure the supply chain logistics are unproblematic.

Products manufactured using raw materials from the Mexico facility, which has completed test runs and is now operational, will form Dr Reddy’s PEGtech brand of activated mPEGs. Salish Reddy, managing director of Dr Reddy’s, believes this will be an attractive product portfolio.

“By introducing the PEGtech brand, our customers can be assured of the same high quality standards and customer service as they develop their Paginated biologic drugs or small molecules from the laboratory right through to commercial applications”, explained Reddy.

Cargill Opens New Flavor Facility in China

Cargill has opened a new flavor facility in China, which is expected to enable it to better address regional demand and taste in Asia in a timely fashion.

The global agri-food firm has been honing its Chinese flavor focus in recent years. In 2007 it opened a new flavor application laboratory in Shanghai. It also has a flavor facility and application centre in Bangalore, India, and an application centre in Kuala Lumpur, Malaysia.

The new facility, in Pinghu, is billed as another leg on which Cargill’s Asian presence is based, and brings the company closer to the market.

“This latest venture demonstrates our commitment to being a worldwide partner for our flavors customers as we now have one or more manufacturing sites in each regional market,” said Peter Michielsen, head of Cargill Flavor Systems.

“Crucially, the plant will enable us to react even faster to the needs of our customers, whether local Chinese manufacturers, or global customers with sites in China. It also strengthens our worldwide flavor network where local knowledge becomes global knowledge, especially in terms of sharing expertise or spotting the rise and fall of consumer trends.

At Pinghu, in particular, we will apply our knowledge in connecting raw materials with specialty ingredients such as flavors.”

The new site has been built on the same site as Cargill’s starches and sweeteners plant, which will make it easier for customers to source and develop products using multiple Cargill offerings at the same time.

In addition, the company says that the enormous scope of its ingredients activities – including cocoa, juices, sweeteners, starches, and malt, slots into its flavor development. Michielsen said this allows it to offer “original and often unique taste solutions to… customers”.

Customers are expected to hail from both within China and outside, and to be driven by the quality assurances that a multinational player can provide.

NexMed Builds in Japan with Cosmo Bio Deal

U.S. CRO NexMed has increased its access to the Japanese R&D market through a new distribution deal with Tokyo-based Cosmo Bio.

Under the deal Cosmo will market the discovery and preclinical development services of NexMed’s BioQuant subsidiary to innovative pharmaceutical firms in the country.

NexMed CEO Bassam Damaj said that: “With the third largest concentration of biotechnology and pharmaceutical companies in the world behind the US and Europe, Japan represents a key growth opportunity.”

He explained that the agreement gives the contract research organization (CRO) a solid presence in Japan, building on the links the firm has already established with drugmakers that operate in the country.

Costa Rica Site Boosts Global Growth

The MedTech Group Inc. (South Plainfield, NJ) is increasing its global reach by adding an injection molding facility to its location in Heredia, Costa Rica. The company began operations in the country in 2004. Last year, it established a second site to provide injection molding for medical devices. The facility, which will also offer tool building, is adjacent to the company’s original site in Costa Rica and is expected to be fully operational in July.

“We have had a very positive experience thus far in Costa Rica and have found the skill level, dedication, and craftsmanship of our employees to be exceptional,” says George Blank, president and CEO of the MedTech Group.

The company’s two sites in Costa Rica total 60,000 sq ft, and offer cleanroom injection molding, product assembly, and packaging services. According to Gwen Gaal, director of administration at the MedTech Group, the company initially decided to establish locations in Costa Rica due the high quality of the workforce and relatively low cost of manufacturing in the country.

This new site will provide a local source for injection mold tooling. In addition to the new site in Costa Rica, The MedTech Group is also expanding its cleanroom in Puerto Rico, a project that is expected to be completed in March. The company also nearly doubled the size of its cleanroom space in its facilities Massachusetts and California last year.

Valeant Acquires Brazilian Company, New Facility

Valeant Pharmaceuticals International has signed a binding agreement to acquire a private branded generics and OTC company located in Brazil for approximately $28 million. Much of the unnamed company's product portfolio is in dermatology; it had annual sales of approximately $19 million in 2009.

Also, Valeant will acquire a new 165,000-sq.-ft. manufacturing plant in Sao Paolo, approved to produce solids, semi-solids and liquids for approximately $28 million. Both transactions, which are subject to customary closing conditions, are expected to close in the second quarter of 2010 and will be collectively accretive to Valeant in 2010.

"We are excited to advance our dermatology presence in the Brazilian market, which is one of the leading dermatology markets worldwide," stated J. Michael Pearson, chairman and chief executive officer. "This acquisition gets us closer to building the critical mass we need in the Brazilian pharmaceutical market. The new state of the art manufacturing plant will allow us to close our current subscale manufacturing facility and eliminates the need for any third party manufacturers — the combination of which should allow us to significantly improve margins."

GEA Opens Plant in India

GEA Pharma Systems opens new equipment facility in Gujarat, India and stresses price advantages of "low-cost manufacturing base."

The plant, in Gujarat's third biggest city Vadodara, will provide solid dose and liquid pharmaceutical processing equipment to local and global pharmaceutical companies, initially focusing on GEA's range of fluid bed and granulation technology.

GEA, which has previously manufactured equipment outside India, believes the new facility will offer cost advantages for customers.

“In most projects, around 70% of the project value is in peripheral equipment. It’s also essential for us to keep the technical know-how close at hand to help us maintain the efficient after-sales service our customers expect.”

"The effects of low-cost manufacturing, locally-sourced peripheral equipment and reduced transportation costs can often reduce the equipment price by around 40% or more when compared with equipment bought from Europe."

Furthermore, using nearby suppliers will benefit companies in the region and help GEA establish strong links to the local pharma industry. The Vadodara plant has been built adjacent to GEA’s existing office building which opened in 2007.

Opening the facility in Vadodara is part of GEA’s long-term strategy to ensure sustainable global supply. India will play an increasingly important role in these plans and this is highlighted by GEA’s recent deals with Mumbai-based ACE Technologies.

Under the terms of the agreements ACE will distribute GEA Courtoy’s Modul tablet presses and GEA Lyophil’s pharmaceutical freeze drying technology throughout India.

GEA believes that India-based pharma manufacturers are increasingly demanding equipment which complies with international quality standards. Using this equipment can improve the quality of products destined for the local market and help companies break into Europe.

IRL and Epichem Partner to Serve Australia

IRL and Epichem have entered into a strategic alliance to provide the Australasian pharma market with services from drug discovery through to cGMP production.

Partnering will “make the best use of capabilities in [the] region”, according to Richard Furneaux, general manager of Industrial Research Limited (IRL) industrial biotechnologies, and help drive biotech development.

Furneaux added that the companies “have complementary expertise that is valuable for biotechnology companies in taking their products forward for commercialization”.

Clients outsourcing to the partnership will have access to the carbohydrate chemistry and GlycoSyn teams at New Zealand-based IRL and Epichem’s synthetic and medicinal chemistry expertise.

These capabilities are being used in the alliance’s first collaborative project, which is co-funded by New Zealand Pharmaceuticals. Using this funding the research team has developed a range of chiral scaffolds for use in creating drug discovery libraries.

Future projects could be focused on a number of areas, with the respective strengths of IRL and Epichem potentially allowing a client to use the alliance from discovery through to current good manufacturing practice (cGMP) compliant production.

Epichem can synthesize known and novel compounds at scales ranging from milligrams to 1kg. Furthermore, the Australia-based company can quickly produce analogue libraries using its parallel synthesis and purification equipment.

These capabilities are supplemented by expertise in drug design. Using its drug discovery and medicinal chemistry capabilities Epichem claims it can improve the biological activity of lead compounds.

Companies approaching the alliance will also have access to IRL’s capabilities. The New Zealand-based business offers services covering chemical synthesis of active pharmaceutical ingredients (API), specialist fine chemicals and multi-step small molecule chemistry.

EWP West African Firm Operational Soon

A Ghanian drugmaker will soon start producing generic pharmaceuticals for the West African market, according to investment group Emerging World Pharma.

EWP, which targets non- branded drugmakers in developing countries, said that installation of the first production line at the, as yet unnamed, firm's production facility in Sunyani is due to be fully operational sometime next month.

EWP president Brandon Keks said: “We expect to have the initial revenues from the first line of production within the second quarter of 2010,” adding that his group may invest further in due course.

The group expects that, when the second production line is installed, operations will generate revenue of more than $20m (€14.7m) a year.

Teva to Buy Ratiopharm for Nearly $5 Billion

Israel's Teva has won the battle for German generic drugmaker Ratiopharm, paying an enterprise value of 3.625 billion euros to fix the industry leader's weakness in the world's second-largest generics market. Teva, which beat U.S. drugs powerhouse Pfizer and Iceland's Actavis in the race for Ratiopharm, said the combined company would have had 2009 revenues of $16.2 billion, up from Teva's own sales of $13.9 billion. Put on the auction block by Germany's Merckle family as its business empire crumbled, Ratiopharm vies with Stada for second place among Germany's generics makers, trailing Swiss drug major Novartis's Hexal business.

Avon Products to Open New Facility in Shanghai

Beauty company, Avon Products Inc., plans to open its largest research and development center outside the U.S. in Shanghai. The 40,000 square-foot building will contain six floors and have extra capacity to expand Avon's overall scientific capabilities in China and Asia. It will mostly serve China, but also serve other markets in the Asian Pacific region. An existing research and development center in Guangzhou focuses on cosmetics and nutritional supplements. Cosmetic research will move to the Shanghai building when it opens, with Guangzhou continuing to look at nutritional supplements. Individuals that will work at the new facility include those in the areas of product development, safety and quality testing, microbiology, chemical engineering and consumer research. The building is expected to open later this year. Avon, whose brands included Skin-So-Soft and Mark along with its namesake cosmetics, also has research and development centers in Argentina, Brazil, China, Japan, Mexico, Poland and South Africa.

Brain and Bayer Schering Pharma Cooperation

Brain AG and Bayer Schering Pharma AG are cooperating in the field of production process optimization of steroid compounds. The goal of the collaboration is the energy-efficient and thus sustainable fermentative production of steroid compounds using optimized microbial production strains, taking plant-derived raw materials as the starting material. With so-called “designer bugs” it is the goal, to achieve a higher yield by a reduced energy input. This will lead to an increase of efficiency in the production process, coupled with a reduction of the output of greenhouse gases.

McIlvaine Company,

Northfield, IL 60093-2743

Tel: 847-784-0012; Fax: 847-784-0061;

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