U.S. biotech Emergent BioSolutions has bought a manufacturing facility from Maryland’s MdBio Foundation is a bid to expand its production infrastructure.

Emergent CEO Faud El-Hibri said that its new 55,000 sq.ft. Baltimore facility, which previously operated as a Food and Drug Administration (FDA) approved contract manufacturing plant, will provide a significant capacity expansion.

El-Hibri explained that: “[The plant] houses several suites capable of manufacturing multiple products at the same time,” adding that it also provides “the flexibility to conduct large-scale manufacturing of rPA while also producing other products in our pipeline.”

Emergent has also purchase land surrounding the facility, paying the city some $8.2m, suggesting that expansion is a possibility.

Vaccine producer Emergent plans to create up to 125 new development and manufacturing jobs at the site over the next three to five years.

In a press statement, Emergent COO Daniel Abdun-Nabi said: "The acquisition … reflects our commitment to both continually creating jobs and investing additional capital in the State of Maryland, where Emergent headquarters and one of its product development sites are located."

Emergent’s new plant, formerly known as the MdBio BioProcessing Center, has a significant history. Constructed in 1996, the facility was first occupied by New York headquartered contract manufacturing organization (CMO) Bio Science Contract Production (BSCP) corp.

In 2000, it was sold to New Jersey based generics manufacturer Cambrex, which operated the facility until the company’s acquisition by Swiss health care industry supplier Lonza in 2007.

The plant was taken over by the MdBio Foundation following Lonza’s decision to reduce capacity.

Genzyme Drug Faces Delay Over Facility Woes

Genzyme Corp. said the Food and Drug Administration will not approve the potential Pompe disease treatment Lumizyme until the company fixes manufacturing problems at the company's Boston-area facility.

Pompe disease is a genetic disorder that interferes with muscle development and can cause deadly respiratory problems.

In March, the FDA made a similar statement to the company, saying it wanted Genzyme to fix manufacturing problems at its Allston Landing plant before it would grant marketing approval along with arranging the design of a post-approval study. The key problem involved a virus in the bioreactors, which are used to create living cells, a key component in biotech-based drugs.

While not harmful to people, the virus slowed down the production process. In June, the company had to shut down the Allston facility to clean the viral contamination, impacting production of the enzyme disorder drugs Fabrazyme and Cerezyme.

Separately, the FDA said it found tiny particles of trash in drugs made by Genzyme. The particles included bits of steel, rubber and fiber found in vials of drugs. The agency recommended that doctors closely inspect vials for particles before injecting the drugs into patients. The drugs affected include Cerezyme, Fabrazyme, Myozyme, Aldurazyme and Thyrogen, all of which are made in the Allston facility.

The FDA has now completed a five-week inspection of the Allston facility, the company said. Genzyme is working with the FDA to fix any remaining problems at the facility.

"Genzyme believes the other elements of the Lumizyme review, such as the Risk Evaluation and Mitigation Strategy (REMS), the product label, and post-marketing requirements, have been satisfactorily addressed," the company said in a statement.

Lumizyme is now being produced at the company's larger-scale facility in Geel, Belgium, in order to meet global demand, the company said.

Shares of Genzyme rose 72 cents to $50 in morning trading.

Dow AgroSciences and Chromatin Reach Agreement

Dow AgroSciences and Chromatin announced that they have struck a pair of agreements. The first provides Dow AgroSciences, a subsidiary of Dow Chemical Company, the rights to Chromatin's "mini-chromosome" genetic elements for delivering specific traits into plant cells. The second establishes an exclusive research and license agreement to combine Dow's EXZACT Precision genome-modification technology with mini-chromosomes, creating a technology platform to develop next-generation traits in corn, soybeans, and canola.

Duke University and India's Jubilant Organosys form Partnership

Duke University and India's Jubilant Organosys inked a letter of intent to jointly expedite translation of discoveries by Duke scientists into clinical therapies. Under the partnership, Duke researchers will work with scientists from Jubilant Organosys' drug-discovery subsidiary, Jubilant Biosys, to select and manage a portfolio of translational research projects over a period of five years. In addition, Jubilant and Duke will collaborate on two biomarker studies to be conducted in Kolkata, India. One study aims to develop a cohort to gain insights into clinical and molecular characteristics of several chronic diseases that are highly prevalent in the Indian population. The second study will validate in an Indian population metabolomic biomarker signatures found to be associated with insulin resistance and cardiovascular disease in Caucasian populations.

Danisco’s Madison, Wisconsin Plant Expansion Underway

Danisco has started expansion of its cultures plant in Madison, Wisconsin, which it says responds to increased demand for direct vat inoculants (DVI) cultures in the US.

DVI cultures have become increasingly popular with cheese and yogurt manufacturers during the global recession, as they seek ways to raise productivity. The reason for this is that DVI cultures, although more expensive than traditional bulk starter cultures, reduce wastage and increase yield.

DVI systems are also designed to combat bacteriophage – an age-old problem in dairy production that kills bacteria, thereby slowing the production process – by enabling manufacturers to rotate cultures. Traditional bulk starters are less easy to rotate, so it is said that the risk is higher.

Danisco said that the expansion will increase the size of the Madison plant by about a third, adding new ultra-cold storage facilities, pelletizing production rooms, shipping area, offices and maintenance shop. Part of a $90m investment in cultures plants worldwide, the expanded facilities are expected to be in operation by August 2010.

Cultures division executive vice president Doug Willrett said in a statement: “This investment reflects the strong commitment that Danisco has always demonstrated to Madison since acquiring local operations in 2004.”

Indeed, the company has made considerable investment, not only at the Madison plant, but across its cultures business worldwide. The $90m expansion budget is equal to 23 percent of Danisco Cultures’ revenue for full year 2008/9. It has been earmarked to expand the Madison site as well as another existing site in Niebüll, Germany, and to convert a Genecor enzyme plant in Rochester, New York to cultures.

Danisco completed expansion of a probiotic facility in Madison back in 2007, as consumer interest in probiotic dairy skyrocketed.

No one from the company was available to provide further comment on the current expansion effort prior to publication.

Genmab Selling Plant and Turning to CMOs

Genmab has put its Brooklyn Park, Minnesota, US facility up for sale, which will reduce its headcount by 300, and plans to use CMOs to cover the loss of capacity.

The Denmark-based pharma has experienced a decline in workload as a consequence of partners taking on increasing responsibilities in upcoming studies, according to the company.

In response to this decrease in demand Genmab is selling its Brooklyn Park facility and will deal with the loss of capacity Genmab by working with contract manufacturing organizations (CMO).

By adopting this plan Genzyme believes it will create a more flexible model "to address varying demand for clinical development work going forward" and allow it to focus resources on developing new medicines.

"It is vital that we refocus our energies on what Genmab is best at and what the pharmaceutical industry needs most - innovation," explained Lisa Drakeman, CEO of Genmab. She added: "The challenging demands on our industry require Genmab to take a hard look at our organization and continue to prioritize spending."

To achieve these goals Genmab has put its facility in Brooklyn Park up for sale. Until a sale is agreed the facility will operate on a maintenance-only mode with a small staff.

By undertaking the restructuring Genmab anticipates achieving annual savings of DKK300m ($60m) but severance, retention payments and other charges will cost it DKK105m.

As a consequence of these charges Genmab has lowered its guidance for the year. Genmab acquired the facility from PDL BioPharma for $240m in 2008 but believes a fair value, minus the cost of selling the site, is $145 million.

Genmab’s announcement comes just a couple of weeks after the company and partner GlaxoSmithKline reported accelerated FDA approval of the fully human CD20 antibody, Arzerra™, as a treatment for patients with chronic lymphocytic leukemia (CLL) that is refractory to fludarabine and alemtuzumab. During August Genmab announced positive Phase II results of Arzerra as a front-line treatment in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with previously untreated follicular non-Hodgkin’s lymphoma (NHL).

Arzerra is being co-developed worldwide with GSK. The antibody is in various stages of clinical development for indications including CLL, NHL, rheumatoid arthritis, diffuse large B-cell lymphoma, relapsing remitting multiple sclerosis, and Waldenstrom’s macroglobulinaemia.

Genmab’s clinical pipeline also includes the EGF receptor antibody, Zalutumumab (HuMax-EGFr), which is being developed in house as a treatment for head and neck cancer either alone or in combination with radio/chemotherapy. RG1507 is a fully human antibody created by Genmab under a collaboration with Roche. The molecule targets the insulin-like growth factor-1 receptor and is in development as a treatment for sarcoma and a variety of solid tumors. Genmab’s earlier-stage clinical pipeline includes antibody products discovered and developed either in-house or through its collaboration with Roche.

Delivery Science Partners with Rhode Island’s College of Pharmacy

US contract polymer maker Delivery Science has ramped up its formulation and analytical testing offering in a partnership with the University of Rhode Island’s (URI) College of Pharmacy.

Under the accord, showcased at AAPS 2009 in Los Angeles, researchers develop polymer-drug formulations that can be produced using hot melt extrusion, with a particular focus on improving delivery characteristics.

In practice, Delivery Science determines the chemical properties, thermal characteristics and optimal delivery route of a particular polymer/ active pharmaceutical ingredient (API) combination, at which point URI conducts analytical testing.

Company managing director Tony Listro said that URI’s analyses, primarily dissolution and stability assessments, will focus on further optimising the drug formulation.

“The tests determine whether the active is present in and stable in formulation,” explained Listro, adding that: “they also determine the dissolution and release properties of the drug, whether or not any degradants are formed”.

Once all the relevant data has been gathered Delivery Science blends and extrudes the mixture in batches suitable for clinical assessment at its current good manufacturing practices (cGMP) facility in Putnam, Connecticut.

Listro said that the aim of the partnership is to industry clients a faster path through the drug development process and added that working with URI is a “natural extension of Delivery Science’s development capabilities and services.”

Dave Worthern, visiting assistant professor of biomedical and pharmaceutical services at URI, was also positive about the collaboration, explaining that it has already made considerable progress.

“[The partnership] has led to developments in basic and applied sciences, educational opportunities and student internships in a hands-on, real world setting [as well as] breakthroughs in product development and global health issues.”

SRI International Expands with Opening of Virginia Facility

SRI International has opened the $22 million Center for Advanced Drug Research, or CADRE, in Harrisonburg, Va., a facility that fulfills the nonprofit research and technology development institute's longtime plan to expand its biosciences division to the East Coast.

CADRE's main area of research will be applying proteomics-based technologies to understand host-vector pathogen interactions in infectious disease, "with an aim to prevent, detect, and treat some of these neglected infectious diseases," said Krishna Kodukula, executive director of CADRE.

"The center is focused on proteomics, and we apply all the other techniques that are associated with proteomics to drive any program," he added.

CADRE focuses on insect-borne viruses, respiratory and diarrheal pathogens, and diseases linked to parasitic protozoa, such as West Nile fever, dengue fever, tuberculosis, leishmaniasis, and malaria.

CADRE's recent projects include discovery of a new insecticide targeting mosquitoes, and research into antibiotic resistance in people with tuberculosis, the latter supported by a $100,000 Grand Challenges Explorations grant from the Bill & Melinda Gates Foundation announced in May.

The center also seeks to discover new markers, "well-characterized" targets, and therapies by identifying critical links underlying the mechanisms of antibiotic resistance, intracellular toxin transport, and vector competence. In addition, CADRE applies computational biology, mining the databases of SRI and other research partners for data on biological pathways that shape disease development.

Kodukula said CADRE's new facility will complement, and not change programs at SRI's two other facilities. SRI is headquartered in Menlo Park, Calif., where it carries out basic bioscience research and works to translate that into preclinical development of new molecules for investigational new drug applications. Also at Menlo Park, SRI focuses on oncology and neurobiology, in addition to infectious disease.

In Arlington, Va., SRI is focused on government business development and some policy research, with no labs based there.

SRI had decided on a second Virginia site when it began searching for a permanent home within the state for CADRE. That search ended in December 2006, when Gov. Tim Kaine announced the research institute had agreed to build the facility in Harrisonburg.

The new CADRE facility occupies a 40,000-square-foot first building to be completed within the Rockingham Center for Research and Technology.

CADRE has moved out of the leased space it occupied since it was launched in January 2007 in Harrisonburg, within the campus of James Madison University. But SRI will continue to collaborate with JMU, whose presence Kodukula said was "a very critical factor" that drew CADRE to Harrisonburg and Rockingham County.

Other factors were the Harrisonburg site's location within the Washington, DC, metro area, its suburban quality of life, its lower cost of living compared with much of the region, its proximity to the National Institutes of Health and other federal agencies, its educated workforce, and the presence within the county of Merck, which manufactures the cervical cancer vaccine Gardacil from a plant in Elkton, Va.

Also key, according to Kodukula: The availability for long-term lease of its 25-acre parcel within the 365-acre research park, which is owned and operated by Rockingham County. SRI has rights to expand its new facility to 100,000 square feet.

"They were willing to build the facility and lease it to us long-term, on an option to acquire basis," he said.

CADRE employs 18 people now — a figure Kodukula said will rise to 24 people by year's end and 100 people by the end of 2012. "Of this, I would say about 80 percent will be researchers, investigators at different levels," Kodukula said.

He said most of the staffers at Harrisonburg are expected to be new hires, though hiring is open. While employees from the other two SRI facilities could apply for the positions, Kodukula said, he was the only one who has shifted jobs from Menlo Park.

The job growth was among conditions set for SRI by Virginia in return for $22 million in state, county, and local incentives intended to cover the development of the facility, which was designed by the architectural firm HOK, and constructed by Nielsen Builders.

In addition to developing CADRE, SRI has sought to help grow Virginia's life sciences and other tech sectors. Last year it joined with Shenandoah Valley Partnership and local business leaders to complete the Shenandoah Valley 21st Century Workforce Transitions Project, designed to assess how well local schools and training programs were meeting long-time employer needs.

SRI conducts client-sponsored R&D for government agencies, commercial businesses, foundations, and other organizations. Including a for-profit subsidiary, SRI operations generated $490 million in consolidated revenues last year.

Pfizer to Close 6 Research Facilities

Less than a month after buying Wyeth, drug giant Pfizer Inc. has mapped out a new structure for its research and development operations.

The plan will bring the closure of six of their 20 research facilities, reorganize and consolidate others, and cut the jobs of up to 2,000 scientists and laboratory technicians.

New York-based Pfizer solidified its position as the world's biggest drugmaker with its $68 billion purchase of drug and vaccine maker Wyeth on Oct. 15, diversifying overnight by adding Wyeth's biotech drugs and consumer and animal health divisions.

In addition, Pfizer will eliminate about 35 percent of the 16 million square feet of research space it now has around the world.

It will now have five key research centers, each focused on specific disease areas, plus nine other laboratories with specialized research capabilities. Research operations in Princeton, N.J.; two sites each in New York and North Carolina, and one in the United Kingdom will be closed.

"We have really built the very best from the two companies," Martin Mackay, president of research and development for traditional medicines such as pills, said in an interview.

The five primary research centers include two Wyeth facilities: a large biotech lab in Cambridge, Mass., that will focus on inflammation disorders, and a plant in Pearl River, N.Y., that will handle vaccine research.

The others are Pfizer facilities. One in Sandwich, United Kingdom, will do pain research, and one in La Jolla, Calif., will do cancer research. The third, in Groton, Conn., will work on diseases including Alzheimer's and diabetes and will add 1,500 workers from a nearby New London facility being closed. Each site will have other operations as well.

"We have positioned them to tap into internal and external science (resources) on the West Coast, the East Coast, in Europe and at our Shanghai (China) research center," said Mikael Dolsten, president of research and development for vaccines and for biotech drugs, which are produced by living cells rather than by synthesizing chemicals.

Major sites being consolidated include a sprawling Wyeth facility in Collegeville, a suburb of Philadelphia, that will keep manufacturing but have most of its research division shifted elsewhere, and a large facility in the St. Louis suburb of Chesterfield, Mo. That site is being sold back to its original owner, Monsanto Co., for $435 million, and Pfizer will keep a small research group there under a lease agreement. About 600 of the 1,000 Chesterfield jobs will be cut, but some workers will get transfer offers.

Mackay would not specify the total number of people who would lose jobs, but said it would be in line with the 15 percent of total staff Pfizer plans to cut.

Before the companies combined, Pfizer had about 9,000 researchers and technicians, and Wyeth, which was based in Madison, N.J., had roughly 4,500. Besides those losing their jobs, some will be asked to move to other sites.

Savings from the job cuts and the plant closures will be poured into research on key diseases Pfizer is targeting, including Alzheimer's and other neurological diseases, cancer, pain and inflammation, diabetes and infectious diseases, plus new vaccines.

That's an unusually fast transition for an already-huge company that just completed one of the industry's biggest deals ever, giving it a combined work force of about 129,000 people.

By comparison, when Pfizer acquired Warner-Lambert Co. in 2001, it spent the next two years making a series of decisions about what to do with different parts of the research organization. It still hadn't finished the integration of the two companies when it bought another drugmaker, Pharmacia Corp., in 2003. That delay hurt research productivity.

In afternoon trading, Pfizer shares rose 43 cents, or 2.5 percent, to $17.39.

Pfizer Will Sell Missouri Research Center to Monsanto

Monsanto and Pfizer announced that they have entered into an agreement for Monsanto to acquire Pfizer's Chesterfield Village Research Center located in Chesterfield, Mo. Under the terms of the agreement, Monsanto will acquire the property from Pfizer for $435 million to be paid over time, and Pfizer will continue to have operations at Chesterfield Village through a lease agreement, primarily performing Biotherapeutic Pharmaceutical research. The research center comprises 1.3 million-square-feet and includes approximately 250 laboratories, 122 plant growth chambers and 2 acres of greenhouse. Monsanto has leased more than 400,000 square feet of the property from Pfizer, and more than 400 Monsanto employees and contractors work on site, most of whom are researchers. Monsanto expects the site to continue to support its pipeline, which is focused on increasing agricultural productivity such as drought-tolerant corn and higher-yielding soybeans, and will enable the company to reach its goal of doubling yields in its core crops by 2030. The companies expect to complete the transaction in the first half of 2010.

Norwich Expands Services with New Pilot Scale Facility in Norwich, New York

Norwich Pharmaceuticals has a newly built and commissioned pilot scale development facility. The new area's features state-of-the-art equipment, according to Norwich, and a company statement said the facility "offers greatly expanded contract outsourcing capabilities enabling them to work with customers earlier on in the development cycle, continuing right through scale up and commercial launch."

With the addition of compatible bench scale equipment, the facility has significantly increased its capabilities. The new equipment includes a four, eight, sixteen quart PK Blend Master with intensifier bar, an Aeromatic MP1 Fluid Bed Dryer, a Vector GMX-10 and GMX-25 Hi-Shear Mixer and a Vector FL-M-1 Flo-Coater. These new additions provide a working range of one to 25 Kgs.

Norwich also recently added new commercial large scale facility capabilities, including a Niro precision coater for the Niro MP5 commercial scale fluid bed to support customer product scale up from the development suite. This three-column coater has a volume range of 30 to 245 liters.

Vetter Adds U.S. Development Facility in Illinois

Vetter will open Vetter Development Service (VDS), a technologically advanced customer service facility located in Chicago, IL. The site will allow the company to provide greater commitment and support toward the product needs of its North American customers, according to a Vetter statement. Vetter will be capable of aseptically filling very small quantities of products in the new facility, providing faster and more streamlined product delivery and customer service. Headquartered in Ravensburg, Germany, Vetter sees the new facility as a significant investment in Vetter Pharma International GmbH. The 25,000-sq.-ft. facility will open end of 2009.

With its new location in the heart of the U.S., Vetter can now process and test small quantities of materials by bringing the development process closer to key customers, enabling greater cooperation at the earliest stages of development and minimizing the need to transport products, according to the company.

The site is intended to facilitate a shorter time to market for Vetter's North American customers. Peter Soelkner, managing director at Vetter, remarked, “The opening of this new cutting-edge VDS facility shows Vetter’s firm, strategic commitment to the North American market by bringing the state-of-the-art technology to the heart of the U.S..” “The support VDS delivers throughout the entire product development cycle can now start earlier, and the proximity to our customers will contribute to streamlining the process and delivering the final product faster.”

Althea Adds Formulation Development to Contract Services Slate in San Diego, CA

Althea Technologies has added customized formulation development services to its portfolio. The services will be overseen by newly appointed Dr. James Matsuura, who takes the title director of Formulation Development.

According to a company statement, "This investment in an experienced team of formulation and analytical scientists, along with new laboratory facilities and state-of-the-art equipment, enhances and complements Althea's existing expertise and capabilities in cGMP biologics manufacturing and aseptic filling of injectable products, and completes the full integration of development and manufacturing services available for clients from early-stage development through commercial supply."

The new formulation laboratories are an expansion to the clinical manufacturing facility located on the San Diego campus and are further supported by the analytical expertise of Windrose Analytica, which Althea acquired earlier this year. "The addition of our new formulation development laboratories is the perfect complement to our advanced protein and peptide analytical capabilities, and will allow us to bring our clients' products into the clinic with unmatched speed, efficiency and effectiveness," noted Dr. Alan Herman, vice president of Product Development & chief scientific officer.

The expanded facilities include a new development lyophilizer, which allows the group to optimize lyophilization cycles for products requiring enhanced stability. The new formulation laboratory and staff, operating closely with the analytical development group, complete Althea's product development group and enable Althea to support clients with critical development steps, as well as the manufacture of API and finished product.

ABC Laboratories Expands Biotech Development Services in Missouri

Analytical Bio-Chemistry Laboratories has expanded its offerings to include comprehensive support for large molecule development.

"This recent investment in biotech development services complements ABC's long history of ELISA, RIA and EIA experience and bioanalytical support. It also leverages ABC's extensive analytical capabilities to provide our clients with more comprehensive support for both large and small molecules," said John Bucksath, general manager and senior vice president of ABC's Pharmaceutical Services division.

To lead the development of a dedicated biotech team and laboratory, ABC recruited industry veteran, John C. Anders, Ph.D., who brings more than 24 years of experience in biopharmaceutical development from both the sponsor and CRO sides of the business.

Dr. Anders has assembled a team of biopharmaceutical experts, each with more than 18 years of experience in protein chemistry and chromatography. To ensure the team is well equipped to meet client demand, ABC has invested in a leading-edge biotech lab housed in ABC’s new, 90,000-sq.-ft. pharmaceutical development facility in Columbia, MO.

“Despite a challenging economic environment, 2009 was a positive year for ABC Laboratories,” said Mr. Bucksath. "Recent investments in people, processes and systems have resulted in 13% growth over 2008 and positioned us well to deliver on our customer’s needs in the years to come.”

NOAA Commissions New Research Ship and New Laboratory

Senior NOAA officials have commissioned NOAA Ship Pisces, the nation's most advanced fisheries research vessel, and dedicated a new fisheries laboratory in Pascagoula, Miss. The vessel and the NOAA laboratory will support fisheries research in the Gulf of Mexico, southeastern U.S. and the Caribbean.

"Our fisheries and the marine ecosystems that support them are vital to our nation's economy," says Jane Lubchenco, undersecretary of commerce for oceans and atmosphere and NOAA administrator, who attended the ceremonies. "The knowledge we'll gain from Pisces and the Pascagoula laboratory will greatly enhance our understanding and stewardship of these precious resources."

Pisces was built by Pascagoula-based VT Halter Marine and is equipped with high tech research equipment and quiet-hull technology. The vessel is so quiet and so advanced that scientists can study fish populations and collect oceanographic data with minimal impact on fish and marine mammal behavior.

The 208-ft ship is the third of four newly constructed NOAA fisheries survey vessels of the same class. Pisces is operated by the NOAA Office of Marine and Aviation Operations and is home-ported in Pascagoula.

The new Southeast Fisheries Science Center's Pascagoula laboratory replaces the laboratory that was destroyed by Hurricane Katrina in 2005. At approximately 55,000 ft2, the building contains office space for 104 scientists, a library, and meeting rooms. This enables NOAA to consolidate several previously dispersed programs in the Pascagoula area including the Pascagoula Laboratory; National Seafood Inspection Laboratory; and the Documentation, Approval and Supply Services office.

One new feature at the facility is an environmental laboratory that will allow scientists to analyze environmental data such as temperature/depth profiles, oxygen data, and other environmental data collected on all survey cruises. These data will be useful in monitoring environmental factors such as hypoxia, but also will be incorporated into ecosystem models.

The structure is also designed to be more hurricane resistant, with a first floor elevation of 17 ft and is capable of withstanding winds up to 150 mph.

Abraxis Dedicates Nanobiologics Site in AZ

Abraxis Health has dedicated its manufacturing facility in Phoenix, Arizona, US which is the result of a $70m (€47m) investment to give the company the nanotech and biologics capacity needed for Abraxane production.

From 2004 to 2007 Abraxis set about boosting its manufacturing capacity in anticipation of increased demand for cancer treatment Abraxane (paclitaxel protein-bound particles for injectable suspension) and its pipeline of pharmaceuticals.

One aspect of this was the purchase of the 200,000 sq.ft. sterile injectables Phoenix site, which also houses chemistry and microbiology laboratories, from Watson Pharmaceuticals in 2007.

Abraxis has revamped the site to make it “the world’s largest and most sophisticated protein nanobiologics manufacturing plant” and equip the company for growth.

Following the improvements the site will be capable of producing 10m units a year and this could be expanded to 20m in the future. There is also the possibility that Abraxis will invest in new technology and equipment in the future.

The facility needs to be checked by the US Food and Drug administration (FDA) and European regulators before commercial production can begin. This is due to happen in late 2010.

Improvements to the facility will create up to 200 high tech jobs. Abraxis has hired more than 100 former Watson employees and recruited additional staff since it bought the site in 2007. The company plans to further expand its workforce as production increases.

This could occur in response to increased demand for Abraxane but the technology at the Phoenix facility is also being used in multiple agreements for the development of novel, insoluble compounds.

CTI Buys German Research Staffing Firm CRS

Ohio, US-based CTI Clinical Trial and Consulting Services (CTI) has bought German trial staffing specialist CRS Clinical Research Services (CRS) to build its presence in Europe’s contract research sector.

The deal will combine Hamburg-based CRS’ late-stage trial offering with CTI’s existing range of contract research services that operate from its offices in Frankfurt.

Speaking shortly after the acquisition was announced CTI CEO Timothy Schroeder, explained that firms’ respective focuses are a good match and should create a firm European base for growth.

“The primary therapeutic focus of CRS has been immunology and oncology, which complements our critically ill population expertise well.

Schroeder also said: “CTI also looks forward to maintaining and developing the business relationships CRS has established and maintained for nearly a decade through its operations across Europe.”

CTI also plans to set up a new regional office in Southern Germany sometime over the next few months, but did not provide any further details.

Cincinnati-headquartered CTI is contract research organization (CRO) that is primarily focused on the early-phase development market, particularly in critically ill patients suffering from immunological disorders.

The firm also recently boosted its presence in the biostatistics and outcomes research field with the establishment of a new dedicated consulting office in Raleigh, North Carolina.

At the time CTI said that the move was designed to meet anticipated growth in demand for this type of service in the wake of the US Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Programs (REMS).

Company president Lynn Fallon explained that: “With CTI’s focus on the critically ill patient population we are seeing an increasing number of FDA mandated REMS programs from our sponsors.

USDA Bug Lab Moving to Kansas

Another federal research lab dedicated to animal diseases is headed for Manhattan, Kan. Congress earlier this fall approved $1.5 million to move the Arthropod-Borne Animal Disease Research Laboratory from Laramie, Wyo., to Kansas.

The lab works with livestock diseases spread by insects and arachnids, such as ticks, midges and mosquitoes.

The lab, which employs about 25 researchers and other staff, is expected to be operating in Manhattan by next summer, said Michael McGuire, associate area director for the USDA. The Laramie researchers will be offered positions in Manhattan, he said.

Tom Thornton, chief executive officer of the Kansas Bioscience Authority, said his agency is providing a matching $1.5 million to help with the move.

Thornton said the lab represents a major win for the region's growing reputation as a national center for animal health research. Manhattan already is home to the National Agricultural Biosecurity Center and has been chosen to eventually house the National Bio and Agro-Defense Facility, which will deal with highly contagious diseases, such as foot-and-mouth.

In addition, dozens of private companies working in animal health have set up shop in a corridor running from Manhattan to Columbia, Mo., taking advantage of proximity to area universities and many of the nation's livestock operations. "We as a region, as a state can certainly expect additional federal investment in the animal health realm because we've shown why this region can support and accelerate research in this area," Thornton said.

With increased concern about insect-borne diseases, such as West Nile Virus, making the jump from livestock to humans the lab's research won't be restricted to the farm, he said. "This research is vitally important.”

The USDA opened the arthropod lab at the Univ. of Wyoming in the mid-1980s. Agency officials began searching for a new home two years ago when the facility no longer met minimum requirements for containing some of the diseases researchers work with, including Rift Valley fever and bluetongue virus.

In some cases, researchers have had to travel more than 70 miles to more secure facilities in Fort Collins, Colo., and Canada to do their work, McGuire said. USDA officials originally recommended moving the lab to the newly renovated and expanded National Centers for Animal Health in Ames, Iowa. But during the congressional appropriations process this year, the direction was changed to Manhattan, despite a USDA review that determined moving there would cost more than Ames and not meet all the agency's requirements.

With the decision made, however, McGuire said the USDA had no worries it could operate the lab in Manhattan. While some of the buildings in Manhattan are double the age of the Laramie facility "it's not a concern because we just went through a modernization," he said.

Eli Lilly Opens New Campus Point Biotechnology Center in San Diego, CA

Eli Lilly (Indianapolis, IN) opened a new biotechnology center on the West Coast known as the Lilly Biotechnology Center—San Diego. The facility opened three months after Lilly announced it would move its ImClone (New York) research headquarters, which specializes in developing cancer biologics, into a new biopharmaceutical research cluster in New York. One year ago, Lilly completed construction of its biotechnology research and development complex at the company headquarters in Indianapolis, Indiana.

The San Diego biotech center is located within an extensive hub of life science activity near the Univ. of California, San Diego and other prominent biomedical research institutes, which is consistent with Lilly's FIPNet strategy to leverage external resources and knowledge to advance its pipeline.

Of the nearly 200 scientists based at the center, more than half are from Applied Molecular Evolution (AME), a wholly-owned Lilly subsidiary that discovers, engineers and develops biotechnology-based therapies built specifically from human proteins.

Additionally, the center is the work base for scientists from discovery chemistry research and technology (DCRT), a division within Lilly that includes scientists from what was previously known as SGX Pharmaceuticals. (Lilly acquired SGX in 2008 and incorporated it into DCRT.)

"The results of Lilly's transformation into a biopharmaceutical powerhouse are quite evident and very exciting, with over 50% of our mid to late-stage pipeline now consisting of biologics-potential medicines for a range of diseases, including diabetes, cancer, autoimmune diseases, musculoskeletal disorders and Alzheimer's disease," says Steve Paul, executive vice president, science and technology, and president, Lilly Research Laboratories.

AME, in collaboration with Indianapolis-based biotechnology research efforts, has made important contributions to building Lilly's biotechnology portfolio. Specifically, AME has helped develop eight of the approximately 60 molecules in Lilly's current clinical pipeline. Additionally, it has helped design and engineer four molecules that are currently in pre-clinical development.

At the new San Diego biotechnology facility, the scientists from AME and DCRT-San Diego are drawing on each other's expertise to further speed and enhance innovation. For example, DCRT-San Diego group is a world leader in pioneering strategies that use protein-crystal structures to aid in the design of new molecular entities. This technically complex effort requires expertise in small molecules and structural biology, which is being applied, through collaboration with AME, to the discovery and development of innovative biologic therapies (large molecules).

"We're optimizing the synergies between AME and DCRT-San Diego by co-locating them," says Tom Bumol, VP of biotechnology discovery research at Lilly and head of the new West Coast site.

"We in the scientific community have only scratched the surface of what is possible for biologic drug design, and collaborations such as this taking place at our new center will help lead to the next generation of biotechnology-based treatments for patients."

Work at the new biotechnology center is mostly focused on discovering, engineering and conducting Phase I and II clinical trials on potential biologic medicines, with an emphasis on cancer, diabetes and autoimmune diseases, areas of medicine that hold potential promise for biologic drug development.

Autoimmune diseases are diseases in which the immune system attacks the body's own tissues; examples include rheumatoid arthritis, psoriasis and multiple sclerosis. Recently, Lilly established a new therapeutic platform dedicated specifically to discovering and developing potential new therapies for autoimmune diseases. Of the five molecules that Lilly currently has in its in clinical pipeline for autoimmune diseases, three are humanized antibodies that were designed and engineered by scientists now based at the Lilly Biotechnology Center -San Diego: IL-23 antibody (LY2525623), slated to enter Phase II development for psoriasis within the next few months; IL-1b antibody (LY2189102), for which, in Q3 of this year, a Phase II trial was begun for type 2 diabetes; and IL-17 antibody (LY2439821), in Phase II development for rheumatoid arthritis and psoriasis.

"We want to continue this positive innovation trend in autoimmunity, cancer, diabetes, as well as other diseases for which there is an unmet need," says Bumol. "In doing so, we are leveraging our deep therapeutic expertise, as well as our small molecule and biotech capabilities."

The Lilly Biotechnology Center is located within a 450,000-foot facility known as Campus Pointe, which was developed, and is owned and managed, by Veralliance Properties of San Diego. Veralliance has partnered with Prudential Real Estate Investors on the development. Lilly is leasing approximately a quarter of Campus Pointe from Veralliance.

Campus Pointe is in the final stages of review to become California's first LEED (Leadership in Energy and Environmental Design)-certified Core and Shell facility at the Platinum level. The Platinum certification, if granted, would mean that the building has met the highest level of criteria set by the U.S.

Green Building Council for environmental responsibility through site sustainability, water efficiency, energy usage and indoor environmental quality, and material utilization.

"There are currently 11 LEED-certified Core and Shell Platinum projects worldwide, but none in California," says Tom Lunneberg, principal of Innovative Energy Solutions, a consulting firm specializing in energy efficiency for commercial buildings and headquartered in Carlsbad, California. "Campus Pointe could become the first Platinum Core and Shell project in California, and would be one of only eight in the United States."

Environmentally-responsible features of Campus Pointe include:

Renewable energy production through use of solar array.
Optimal indoor air quality through enhanced HVAC commissioning and

carbon dioxide monitoring

Water-saving features, including low-flow fixtures, reclaimed water for

both landscaping and the building's cooling system, and drought-tolerant landscaping

Renovation of an existing building (vs. building a new one) and use of

recycled materials in the process. Also, many of the site's existing trees were preserved in the

re-development.

Certified, renewable wood products throughout.

In addition, Campus Pointe has parking for hybrid vehicles and is immediately accessible to public transportation.

New Cancer Center on Microenvironment and Metastasis at Cornell

The National Cancer Institute (NCI) has funded the new Center on the Microenvironment and Metastasis, which will be headquartered at Cornell. The center will focus on using nanobiotechnology and other related physical science approaches to advance research on cancer.

"Our center will be organized to unravel cancer's complexity -- using methods derived from the physical sciences and engineering -- to further understand how cancer travels through the human body," said Harold Craighead, Cornell's C.W. Lake Professor of Engineering, director of Cornell's Nanobiotechnology Center, and the principal investigator and director of the new center. "The research may help identify new drug possibilities to inhibit metastasis and tumor growth."

The new center is one of 12 new research centers across the nation announced Oct. 26 by the NCI. Cornell's grant is for $13 million over five years.

Cornell will serve as the lead institution in a partnership with Weill Cornell Medical College in New York City and the University at Buffalo. Barbara Hempstead, professor of medicine and co-chief of the Division of Hematology and Medical Oncology at Weill Cornell Medical College, will serve as the senior co-investigator.

Nationally, the 12 centers will bring a new cadre of theoretical physicists, mathematicians, chemists and engineers to the study of cancer. During the initiative, the Physical Sciences-Oncology Centers will take new, nontraditional approaches to cancer research by studying the physical laws and principles of cancer; evolution and evolutionary theory of cancer; information coding, decoding, transfer and translation in cancer; and ways to de-convolute cancer's complexity.

Cornell's center will focus on three key projects:

Examining physio-chemical transducers and their role in tumor angiogenesis, led by Claudia Fischbach-Teschl, Cornell assistant professor of biomedical engineering, and Vivek Mittal, associate professor of cardiothoracic surgery at Weill Cornell;
Physical and chemical cues in tumor cell migration, led by Cynthia Reinhart-King, Cornell assistant professor of biomedical engineering, and Paraskevi Giannakakou, associate professor of pharmacology in medicine at Weill Cornell; and
Adhesion of tumor cells in the vascular microenvironment, led by Michael King, Cornell associate professor of biomedical engineering, and David Nanus, professor of medicine and urology and co-chief of hematology and medical oncology at Weill Cornell.

Gail M. Seigel, assistant professor at University at Buffalo's Center for Hearing and Deafness, also serves on the team.

Ultimately, through coordinated development and testing of novel approaches to studying cancer processes, the network of centers is expected to generate new bodies of knowledge, and identify and define critical aspects of physics, chemistry and engineering that operate at all levels in cancer processes.

NCI is part of the National Institutes of Health.

Deerland Opens New Lab for Enzyme Development in Georgia

Deerland Enzymes has opened a new laboratory that gives it greater capabilities in R&D, quality assurance, application development and technical support – and a restricted area for working on top secret projects.

Deerland Enzymes started out in 1990 as an enzyme trading company, and has since morphed into an international trading company and enzyme manufacturer. Based in Kennesaw, GA, it works with customers from the conceptualization of a product right through to final formulation and, where needed, contract manufacturing.

The new lab, which includes expanded work stations and new equipment, is intended to help it work with customers at every stage.

But working in such a competitive market also means it has to ensure its customers’ secrets are secure. This led it to corner off an area of its lab facility and make it accessible to privileged people working on confidential product developments.

CEO Scott Ravech said this ensures “the highest level of safety and security when it comes to protecting [customers’] intellectual properties".

Another aspect the company is emphasizing is quality testing abilities.

“With more stringent analytical requirements needed to support GMP certification and FDA compliance, companies must assume the responsibility of being able to provide accurate and on-time testing necessary to support the needs of the customers,” said John Deaton, lab testing and quality control manager.

The enzymes Deerland makes are used by a broad slate of industries, including food, nutritional supplements, brewing, distilling and animal feed, starch, textiles, waste treatment, paper and pharmaceuticals.

The food enzymes market has benefited greatly from innovation in recent years, according to Leatherhead International’s 2008 Food Additives Report. It cites enzymes which extend the shelf-life of baked goods or imitate meat and cheese flavorings in a wide range of prepared dishes as driving growth in the marketplace.

The Freedonia Group predicts market value for food and beverage enzymes will grow six percent annually to $1.5bn in 2013.

Between 1998 and 2008 the average annual growth rate was 16 per cent, however.

The Sbarro Health Research Organization Dedicated a New Biotech Research Center

The Sbarro Health Research Organization dedicated a new Biotech Research Center on the campus of Temple University in Philadelphia.

The SHRO genetic translational research center includes 20,000 square feet of wet and dry labs, offices, a medical library, and workspaces for visiting scientists, and is located at Temple's Biology-Life Sciences Building.

SHRO expects to add 20 new research positions to its 60 researchers and 10 administrative staff members.

SHRO was founded in 1993 by Mario Sbarro, the founder of the Sbarro restaurant chain, and Professor Antonio Giordano of Temple University and Director of the Temple University Center for Biotechnology at the College of Science and Technology. The organization receives financial support from the Commonwealth of Pennsylvania and operates through a partnership with Temple University.

Protofab Engineering Unveils New Class 10,000/ ISO 7 Cleanroom

Protofab Engineering, Blainec, MN, recently unveiled the newest edition to their rapidly expanding facility—a Class 10,000/ISO 7 Cleanroom. This innovation was fueled by a growing number of requests from Protofab’s customers. Eager to accommodate his customers, Protofab VP John Nelson says, “Continuously innovating our processes and service offerings is key to meeting the needs of our customers big and small. We’re extremely excited about this new addition to our facility because it opens up a whole new market for us to explore.” The addition of this cleanroom to Protofab’s facility allows them to offer these extended services:

The ability to work with customers to develop unique manufacturing and assembly processes.

Northwestern to Start $13.6 Million NCI Center

Northwestern University has won a $13.6 million grant from the National Cancer Institute to establish a center that will study the roles genes play in cancer, Northwestern said.

The five years of funding will go to start the Northwestern Physical Sciences-Oncology Center (PS-OC), one of twelve centers around the country that bring together biology and the physical sciences in an effort to develop therapies and diagnostics for cancer.

"Our center will be studying the regulation and expression of genes in both normal health and development and in cancer," Northwestern Professor and Principal Investigator Jonathan Widom said in a statement.

The interdisciplinary PS-OC is a joint effort between the Chemistry of Life Processes Institute and the Robert H. Lurie Comprehensive Cancer Center at Northwestern.

The research will focus on how genetic and epigenetic information is encoded and decoded in cancer cells, and will involve nanoscale and atomic scale studies, computational biology, mathematical modeling, and other disciplines.

"By bringing a fresh set of eyes to the study of cancer, these new centers have great potential to advance, and sometimes challenge, accepted theories about cancer and its supportive microenvironment," NCI Director John Niederhuber said.

"Physical scientists think in terms of time, space, pressure, heat, and evolution in ways that we hope will lead to new understandings of the multitude of forces that govern cancer — and with that understanding, we hope to develop new and innovative methods of arresting tumor growth and metastasis," he added.

The center also will involve collaborators at the University of Chicago, Children's Memorial Hospital, The California Institute of Technology, and the Weizmann Institute.

The PS-OC will include five project areas, with each focusing on different aspects of the storage and expression of genetic information, and each project will integrate molecular and cell biology methods with ideas from the physical sciences.

REST OF WORLD

Sandoz Expands Manufacturing Site in Germany

Sandoz completed an expansion to its Aeropharm production facility in Rudolstadt, Germany. The facility will enhance their manufacture of inhalation products. Sandoz invested $69-million in the expansion, which is expected to create 65 jobs. Sandoz is the world's second largest producer of generic drugs.

Schott Uses New Vials for Bio-Drugs

Schott begins commercial scale production of its TopLyo vials in a bid to meet growing demand for packaging solutions for freeze-dried bio-drugs.

At present, up to 50 per cent of drugs in development include biomolecular elements such as proteins, polysaccharides and carbohydrates, and the market is expected to grow considerably in the coming years.

Unlike traditional small-molecule pharmaceuticals which are fairly robust, biomolecular drugs can be highly sensitive to changes in temperature and atmospheric conditions, usually requiring that they must by lyophilized for shipment.

However, while freeze-drying solves stability issues, this type of processing can increase the tendency of drugs to adhere to the interior surfaces of vials in which they are packaged, resulting in high-levels of overfilling and wastage.

Schott’s new TopLyo vials, showcased at AAPS 2009 last week, are coated with smooth 40nm thick hydrophobic layers designed to prevent adherence as company spokesman Gary Waller explained.

“Basically this is a combination of two process, the lyophilized bottom process that we’ve matched up with our plasma impulse chemical vapor deposition (PICVD) coating on the inside surface…”“

Waller also told in-PharmaTechnologist that the primary market for TopLyo is any type of biopharmaceutical for which attachment and absorption to vial surfaces during production has hitherto been a problem.

Schott began commercial-scale mass production of TopLyo at its manufacturing facility in Muellheim, Germany on November 8 and estimates that the plant will produce up to six million units a year.

The vials, which are also designed to withstand sterilization processes and heat treatments of up to 300ºC, are currently available in 2ml and 10ml versions although Schott plans to roll-out a 6ml version later this year.

Galenix Joins DSM

French drug delivery specialist Galenix has named DSM’s pharmaceutical products unit as its manufacturing and co-marketing partner as it continues efforts build its global presence.

The deal will see Dutch chemicals giant DSM act as preferred commercial-scale producer of Galenix’ range of delivery and bioavailability enhancement platforms; which include the Minextab, Mucolys and Microgix excipient technologies.

Galenix has sought to grow its offering in the lucrative US pharmaceutical market since late 2004 when it set up a business office in New York and the DSM is the latest stage in that expansion plan according to CEO Jerome Besse.

He explained that: “The [partnership] fits with our strategic intention of expanding service offerings to the North American market, and also with DSM's expansion of sales and marketing focus in Europe."

Pieter de Geus, DSM’s senior VP of R&D was equally positive about the accord, suggesting that: "[The] innovative drug delivery technologies enhance our offering in the field of pharmaceutical development services.

The firms will also work on business development and co-marketing for both Galenix’ development and clinical services offering and DSM’s contract pharmaceutical manufacturing, process development and scale-up expertise.

DSM Pharmaceuticals’ president, Hans Engels, said that: "The alliance brings out the best of both parties. Combining innovative formulations with flawless transition into commercial products creates an attractive value proposition for any drug company."

Pfizer to Close 6 Research Facilities

Less than a month after buying Wyeth, drug giant Pfizer Inc. has mapped out a new structure for its research and development operations.

The plan will bring the closure of six of their 20 research facilities, reorganize and consolidate others, and cut the jobs of up to 2,000 scientists and laboratory technicians.

The two executives heading the combined research operation told The Associated Press exclusively that integrating and reorganizing the two companies' laboratories will boost research productivity and save money as well.

In addition, Pfizer will eliminate about 35 percent of the 16 million square feet of research space it now has around the world.

"We have really built the very best from the two companies," Martin Mackay, president of research and development for traditional medicines such as pills, said in an interview.

Major sites being consolidated include a sprawling Wyeth facility in Collegeville, a suburb of Philadelphia, which will keep manufacturing but have most of its research division shifted elsewhere, and a large facility in the St. Louis suburb of Chesterfield, Mo. That site is being sold back to its original owner, Monsanto Co., for $435 million, and Pfizer will keep a small research group there under a lease agreement. About 600 of the 1,000 Chesterfield jobs will be cut, but some workers will get transfer offers.

Mackay would not specify the total number of people who would lose jobs, but said it would be in line with the 15 percent of total staff Pfizer plans to cut.

"We essentially will have a portfolio up and running on the diseases that we care about this year," said Mackay.

That's an unusually fast transition for an already-huge company that just completed one of the industry's biggest deals ever, giving it a combined work force of about 129,000 people.

In afternoon trading, Pfizer shares rose 43 cents, or 2.5 percent, to $17.39.

CTI Buys German Research Staffing Firm CRS

The deal will combine Hamburg-based CRS’ late-stage trial offering with CTI’s existing range of contract research services that operate from its offices in Frankfurt, Germany.

Speaking shortly after the acquisition was announced CTI CEO Timothy Schroeder, explained that firms’ respective focuses are a good match and should create a firm European base for growth.

“The primary therapeutic focus of CRS has been immunology and oncology, which complements our critically ill population expertise well.

Schroeder also said: “CTI also looks forward to maintaining and developing the business relationships CRS has established and maintained for nearly a decade through its operations across Europe.”

CTI also plans to set up a new regional office in Southern Germany sometime over the next few months, but did not provide any further details.

The firm also recently boosted its presence in the biostatistics and outcomes research field with the establishment of a new dedicated consulting office in Raleigh, North Carolina.

Company president Lynn Fallon explained that: “With CTI’s focus on the critically ill patient population we are seeing an increasing number of FDA mandated REMS programs from our sponsors.

Merrion Pharmaceuticals Opens Dublin Facility

Merrion Pharmaceuticals (Dublin, Ireland) opened a new facility in Dublin, Ireland. The 29,500-ft2 pharmaceutical facility includes 6000 ft2 of offices, a 6500-ft2 formulation process development area, a Class D cleanroom, 21 processing rooms, 4000 ft2 of analytical laboratories, a development laboratory, a feasibility laboratory, and 2100 ft2 of warehouse space.

Germany OK's Novartis Swine Flu Vaccine from Cells

Novartis AG it has received regulatory approval in Germany for a new swine flu vaccine produced using cell cultures instead of egg-based methods.

Novartis described the approval as a "milestone" and said it is pursuing registration of the vaccine, marketed under the name Celtura, in other major countries, including Japan and Switzerland.

With demand high because of the pandemic, companies are trying to find a more efficient way of producing swine flu vaccine than the slow method of cultivating seed virus in chicken eggs.

The new cell-based technology has previously been licensed in Europe for the production of the seasonal flu vaccine, Novartis said.

"Our modern cell culture technology can enable a faster start-up of vaccine manufacturing, offering the ability to respond more quickly to future pandemic threats", Andrin Oswald, chief executive of Novartis' Vaccines and Diagnostics division, was quoted as saying.

Celtura is currently only produced in Marburg, Germany. The U.S. government has awarded Novartis a $487 million contract to build a second production site in North Carolina, which is expected to be up and running by 2011 or 2012.

ScinoPharm Breaks Ground for Changshu API Plant

ScinoPharm, a global supplier of active pharmaceutical ingredients (APIs), has commenced construction of a new plant on a 66,670 square meter (717,369 sq. ft.) site. The facilities, located in Changshu, Jiangsu province in China, will include a R&D centre and production plants fully compliant with U.S. and international GMP standards. The Changshu plant, slated to be fully operational by 2011, will be used for the production of GMP grade pharmaceutical intermediates initially, and later be equipped to handle API production. China's market for better quality APIs has grown considerably, and local formulation companies are encouraged to utilize APIs from companies having DMFs filed in advanced countries.

"The new site is part of ScinoPharm's long-term strategy to bolster its presence in China. Additional manufacturing and R&D facilities will complement our existing experience in selling quality APIs in regulated markets. The Changshu plant will serve as a launching pad for the rapidly expanding Chinese pharmaceutical market as well as a backup site to our customers," said Dr. Jo Shen, President and CEO of ScinoPharm.

"The Changshu facilities will help ScinoPharm's vertical integration with high quality intermediates, and will ensure final API products are of the highest quality and safety, yet at lower costs," added Dr. Hardy Chan, Executive Vice President and CSO of ScinoPharm.

ScinoPharm's investment in Changshu will also address the increasing number of multinational companies shifting their drug development research and clinical trials to China.

"They need supporting companies, like ScinoPharm, that are beyond medicinal chemistry companies and are knowledgeable about clinical API development, has experience handling FDA inquiries, and also inspections," commented Dr. Chan.

This expansion augments its current CMP manufacturing facility in Taiwan and allows the company to further support customer needs with a wide range of cost-competitive development and manufacturing solutions. ScinoPharm's current China operations include two research and development bases in Kunshan and Shanghai.

Single Vaccine Supplier Decision in Canada

Fears that countries would close borders to key pharmaceutical exports in a pandemic drove Canada's decision to award its pandemic flu vaccine contract to the only company that makes the product in this country, people who were involved in pandemic planning at the time say.

The need for a made-in-Canada vaccine supply was considered paramount to those doing the planning; they had already seen access to limited global supplies of vaccine and drugs dry up during two previous pandemic scares.

"There are very few flu (vaccine) manufacturers in the world. The big ones are just in a few countries. And so there was concern about any of those countries wanting to restrict export of their vaccine," says Dr. Susan Tamblyn, considered by some the mother of Canada's pandemic plan and a long-time fixture in international pandemic preparedness efforts.

Canada pioneered the now-widely used system of advance purchase agreements for pandemic vaccine when the then government of Prime Minister Jean Chretien signed the pandemic vaccine contract in 2001.

The 10-year contract, worth then $323,522,500, was awarded to Shire BioChem, a British company that had a flu vaccine manufacturing plant outside Quebec City. The contract went with the plant when it was sold in 2004 to ID Biomedical and in 2005 to GlaxoSmithKline.

As part of the contract, Shire was guaranteed 75 per cent of Canada's seasonal flu vaccine purchase. The $323 million figure included the cost of the annual seasonal flu vaccine.

The move angered vaccine giant Sanofi Pasteur, which used to share Canada's market 50-50 with Shire. But Sanofi does not have flu vaccine production capacity in Canada.

Under the contract, Shire was required to maintain a constant supply of enough eggs to make pandemic vaccine whenever the need arose. At the time manufacturers didn't need and didn't keep a year-round supply of eggs.

The contract was the envy of many countries and was quickly emulated. The United States, for instance, signed advance purchase agreements with five companies, though most of the U.S. supply is made offshore.

"We got sort of two types of reactions, I think, when we first announced this," says Tamblyn, who is retired but still serves as an occasional consultant to the Public Health Agency of Canada.

"One was that it was very visionary — and that was definitely recognized. The other was just a little bit of concern."

The concern, she says, related to the fact that the move put out into the open something other countries knew but didn't want to acknowledge — if a pandemic broke out, borders would probably close to key pharmaceutical exports.

It had happened before.

In 1976, during the infamous swine flu scare, the U.S. would not allow exports of swine flu vaccine. Canada's supplier at the time was U.S.-based and Canada's delivery did not come.

Eventually, Canada managed to buy some vaccine from Australian manufacturer CSL, because Australia did not plan a mass vaccination program.

In 1997, global supplies of antiviral drugs evaporated overnight when it was discovered a bird flu virus — H5N1 — had infected a number of children. It had previously been thought bird viruses could not infect humans without adapting first in an intermediary animal like a pig.

The world thought it was on the brink of a deadly pandemic. There were only two antiviral drugs on the market at the time, amantadine and rimantadine, and suddenly they couldn't be bought for love nor money.

"The world supply just disappeared overnight," Tamblyn says. "A few countries grabbed for themselves. They placed immediate orders."

"The parallel there would be that one would expect the same thing to happen with vaccine."

Chief Public Health Officer Dr. David Butler-Jones has recently said Canada would probably look at diversifying its supply base when the pandemic contract expires in 2011.

But more suppliers doesn't guarantee better supply with notoriously finicky flu vaccine, says Dr. Marie-Paule Kieny, head of the World Health Organization's vaccine research initiative.

"All the manufacturers have had delays. And some countries have two, three or one and they are also having delays," Kieny notes. "So you might have had more than one manufacturer but not have more vaccine available to start with."

"This is not a GSK Canada problem. The production yield is a problem with all the manufacturers."

And flu expert Dr. Allison McGeer says there was probably discussion about getting a back-up supplier after one of the manufacturers, Chiron (now owned by Novartis) failed to deliver more than 40 million doses of seasonal flu vaccine to the U.S. in 2004 because of a contamination problem.

But Canada was already spending a lot of money on one pandemic contract and there was no way of knowing if a pandemic would even occur in the life of the contract. Besides, McGeer says, there remained the issue that vaccine made outside of Canada couldn't be counted on.

"People might have felt that having vaccine production that was out of the country, that kind of contract might not be worth much during a pandemic," says McGeer, head of infection control at Toronto's Mount Sinai Hospital.

"I mean it's fine in this pandemic, people probably would have honored it. But in other pandemics, it might not have (been). If vaccine was being produced in the U.S. or France, it might not have mattered that we had a contract."

Monsanto Opening Beijing Genomics, Biotech Center

Monsanto said that it will open a research center in Beijing that will focus on collaborations with Chinese research institutions in plant biotechnology and genomics research.

The agricultural biotech firm said that the Monsanto Biotechnology Research Center in Zhongquancun will conduct early-stage genomics and bioinformatics research and it will be the base for collaborations with Chinese scientists.

Monsanto also recently agreed to collaborate with Huazhong Agricultural University in a gene discovery and biotech research agreement.

"The establishment of the center will have a key role in further strengthening our collaboration, and speeding up commercialization and marketing of new technology," Qifa Zhang, a scientist at Huazhong, said in the statement.

MDS’ Central Labs Becomes Clearstone Central Laboratories

MDS’ Central Labs has been rebranded as Clearstone Central Laboratories following its acquisition by Czura Thornton, which is looking to expand the business and that of Chiltern, a CRO also owned by the investment company, into new geographies, according to its co-founder.

Czura Thornton acquired Central Labs from MDS for an initial $8m (€5.4m) as part of the contract research organizations (CRO) restructuring efforts. Having acquired Clearstone, Czura Thornton is planning on expanding its geographic reach and service offering, according to Nick Thornton.

Speaking to Outsourcing-Pharma, Thornton, co-founder of Czura Thornton, explained that India and Latin America are possible locations for new Clearstone sites. He added that setting up in India would be helped by Chiltern’s presence in Mumbai and that the CRO may also expand.

Thornton intends to develop a “symbiotic relationship” between Chiltern and Clearstone. One aspect of this is that the organizations may establish offices in countries where the other has a presence, drawing on their expertise and local knowledge to ease the process.

Consequently, in addition to Clearstone’s potential expansion into India and Latin America, Chiltern may set up in Beijing, China and Singapore. Clearstone already has operations in these locations and Thornton believes they would be interesting locations for Chiltern to set up in.

Thornton confirmed that Clearstone and Chiltern will remain separate entities but that a close relationship could be beneficial to both companies. In addition to the geographic possibilities Thornton envisages the companies making use of each others’ infrastructure and expertise.

Furthermore, Chiltern will recommend Clearstone to its clients that need lab services, and vice versa, to drive business and fulfill Thornton’s goal that the companies “take advantage of each other’s strengths". Thornton added that Clearstone will look to build strong relationships with other CROs.

New service areas

The first goal at Clearstone is to work on the “stability, consistency and quality of operations”, which Thornton believes are already of a high standard but can still be improved.

Clearstone will then look at expanding its service offering and Thornton expects investments to be made in biomarker capabilities. Oncology is another area of focus and this may be supported by the establishment of a centre of expertise.

By making these expansions Thornton hopes to grow Clearstone’s top line. This is the primary goal post-takeover and consequently Thornton expects to keep Clearstone’s current facilities operational, although regarding cutbacks he said “never say never”, adding that “there may be some fine tuning”.

Building on current capacity should strengthen Clearstone’s position in the sector, which Thornton believes follows the growth of the clinical trial market and is showing signs of recovery after several quarters with “soft demand”.

Penn Completes Phase One of Tredegar, Wales, Plant Expansion

Welsh contract services firm Penn Pharmaceuticals has reorganized its transport and delivery infrastructure in the first phase of a £12m (€13.3m) expansion at its facility in Tredegar.

A company spokesperson told Outsourcing-Pharma that the £315K expansion, which was supported by a grant from Welsh Assembly Government’s investment fund, "[has improved] access for delivery, generated car parking and enabled future building by flattening the land.

"Penn are in essence focusing on developing the manufacturing capability and enhancing their ability to work with difficult to handle highly potent molecules."

COO Darren Hassey said that extension of the site by some 2,400sqm (25,824 sq. ft.) will provide a number of logistical benefits.

“By altering the externals of the site and moving the delivery and collection points we have in turn altered the internal factory processes, ensuring the smooth flow of people, process and materials."

Company CEO Peter George said that: “Heavily investing in our Tredegar site…strengthens our commitment to the local community and as a leading Welsh company we will endeavor to payback the Assembly Government’s faith in us by driving sustainable growth and employment."

Penn first announced its expansion programs in March and said that the move could create up to 155 new jobs at the site in the Tafarnaubach Industrial Estate over the next five years.

Prior to that, in May 2008, Penn bolstered its clinical trial supplies distribution capabilities seven-fold with the addition of 7,000 sqm (75,320 sq. ft.) of temperature controlled storage and distribution capacity.

In related news, Penn announced that it has spent £350,000 on a new inventory management system at its facility in a bid to become a "client partner, rather than a supplier."

The new technology integrates real-time bar coding with what Penn describes as a customer portal that, it claims, makes it one of the first contract manufacturing organizations (CMO) in Europe to provide customers with the ability to track products and inventory remotely.

Hassey suggested that: "Our investment in this new customer portal...increases visibility for customers wishing to track their order status, materials disposition and third-party courier logistics."

Novartis to Invest $1.25 Billion in Two New Facilities in China

Novartis is to plough $1 billion into the construction of a new Novartis Institute for BioMedical Research in Shanghai (CNIBR) and another $250 million into a global technical center for APIs in Changshu, China.

The five-year Chinese investment plan will involve moving and expanding Novartis’ existing CNIBR, which is situated in Zhangjiang High-tech Park, to a new campus in Shanghai. Once completed, the new facility is expected to be Novartis’ third largest R&D center worldwide, behind its facility in Cambridge, MA, and headquarters in Basel, Switzerland.

Activities at the new CNIBR will span analytics and biomarkers, in vivo pharmacology, protein production, characterization and scale-up screening, chemistry and proteomics, along with genomics and imaging. The facility will employ an estimated 1,000 R&D staff compared with the 160 R&D associates at the current CNIBR site.

The $250 million investment in a new global technical center for APIs in Changshu, meanwhile, will be used to establish complementary activities focused on technical R&D and manufacturing. By locating both activities at a single site, Novartis hopes to enhance API process development and operational efficiency.

The company believes its investments in China will extrapolate to new drugs for patients both in China and in other countries. “We are pleased to contribute to the Shanghai government’s aim to establish the city as the premiere R&D center for China’s bio-medicine industry by 2012,” comments Daniel Vasella, Ph.D., chairman and CEO.

The Chinese government recently announced it will spend some $124 million over the next three years to bolster the nation’s health system, Novartis points out. The government also aims to make affordable, basic medical services available to its entire population by 2020. Novartis aims to support this health reform by sharing knowledge and best practices.

IRB Schulman Sets Up Canadian Operation

US IRB Schulman Associates has opened an office in Canada in response to growing customer demand for clinical trial review services in the country.

The new unit, located in Toronto, will offer the usual range of independent review board (IRB) services as well as a French-speaking support service for clinical programs conducted in the country.

According to the firm’s website provincial regulations prevent it from providing oversight for research sites in Alberta, Saskatchewan and Newfoundland and Labrador.

In addition, Schulman is not able to review research sites in Nova Scotia that are located in the Capital District Health Authority’s (CDHA) jurisdiction.\

Quintiles to Open Phase I Site in ‘Experimental Medicine’ Hub

Quintiles is collaborating with Guy’s and St Thomas’ NHS Foundation Trust and King’s College London to establish a 30 bed Phase I site which will help meet demand for early-stage research conducted in patients.

Eddie Caffrey, senior vice president (VP), global phase I, Quintiles, explained that the rise in biologics and therapeutics focused on targets only found in those with a disease have seen pharma, and some regulatory agencies, request trials in patients.

This shift in pharma’s pipeline played a role in Quintiles expanding and formalizing its relationship with Guy’s and St Thomas’. Quintiles has a long relationship with the hospital, using its expertise on occasions, and it will now have a facility on the 14th floor of Guy’s in London, UK.

Caffrey added that there is a “huge interest” in clinical research at the hospital fuelled by a “real desire” to cut the time it takes for molecules to get to patients, which fits with Quintiles goals.

To further this target Quintiles is setting up near to Guy’s and St Thomas’ and King’s College London’s good manufacturing practice (GMP) pharmacy and the Biomedical Research Centre’s (BRC) new Faculty of Translational Medicine, which is due to launch on December 2.

Robert Lechler, VP Health, King’s College London and director of King’s Health Partners, said the goal is to “create a powerful ‘experimental medicine’ hub” that can “harness the expertise of our world class scientists and clinicians to drive new discoveries in medicine and clinical treatment”.

It is hoped that this concentration of infrastructure and expertise will drive forward the translation of science onto the wards, from ‘bench to bedside’, to help shorten the time it takes molecules to reach patients.

Quintiles will use the facility to conduct trials in healthy volunteers and patients. It is due to be completed in early 2010 and builds on Quintiles global Phase I capacity. On a local level the site expands on Quintiles’ existing facilities in Newcomen Street, London, UK.

The facility will cover all therapeutic areas but the nature of the products pharma wants to trial in patients means drugs for certain targets, such as respiratory diseases and arthritis, may be tested more frequently at the site, according to Caffrey.

Icon Plans for Site at Hospital

Icon is currently planning to occupy over a third of the 100,000 sq. ft. redeveloped hospital in Manchester, UK, which is due to open in 2012 and will become a flagship site for the CRO.

Andrew Copestake, vice president and general manager, Europe at Icon Development, explained the market factors that led to Icon entering into a deal with the hospital.

Firstly, the incident at Northwick Park, UK, where some trial participants suffered multiple organ failure, has led to clients requesting studies are performed on hospital grounds, according to Copestake.

Since the incident the Medicines and Healthcare products Regulatory Agency (MHRA) has implemented new accreditation, increasing safety measures, but Copestake believes there is still a perception among clients that a hospital location is beneficial.

Consequently Icon entered into the deal with Manchester Royal Infirmary (MRI) and has established a good relationship, and geographic proximity, to the accident and emergency ward.

The contract research organization (CRO) also intends to work closely with MRI’s investigators and the hospital’s nurses and technicians may spend time at Icon’s site.

By taking these measures Copestake believes Icon will become an integrated part of the hospital, not just a tenant, which will potentially benefit the partners, as well as clients and patients.

The second primary driver behind the deal is pharma’s desire to perform Phase I trials in patients, as well as healthy volunteers. By performing translational medicine Icon can give clients early indications of the efficacy and safety of a product in people with the illness.

Several CROs are bolstering their capacities in this area, including Quintiles which entered into a similar partnership with a hospital to establish a translational research facility in London, UK.

Copestake believes the UK government is encouraging the National Health Service (NHS) to reach out to partners in industry to ensure its work has commercial applications and this has helped the CROs set up the deals.

The relocation in 2012 is part of a two phase deal that will initially see Icon occupy a 34-bed translational research facility in the grounds of MRI.

Icon moves into the site, which has been built to its specifications, next year but will hand it over to MRI when it takes a planned 35,000 sq. ft. of the main redevelopment in 2012. At this point Icon will also move its operations at Skelton House, Manchester, to the redeveloped site.

The project is a “major development” for Icon and after its completion it will look to build on its success. Copestake added that the UK has a great reputation for clinical trials and Icon now has a partner that shares its research agenda.

In June Icon entered into a similar collaboration between industry, academia and the National Health Service (NHS) to establish a purpose built translational medicine facility in Manchester, UK.

Caffrey believes the two deals indicate that the NHS is open to this sort of relationship and the Association of the British Pharmaceutical Industry (ABPI) leant its support to the Icon deal, saying it is the type of collaboration it is seeking to encourage.

Novotech Opens Facility in Malaysia

Novotech says its new “management hub” in Kuala Lumpur, Malaysia will serve as a base for expansion in the booming Asia-Pacific contract research sector.

The contract research organization (CRO), which already has operations in India and Korea, said that, in addition to Malaysia, the facility will manage operations in Singapore, Thailand and the Philippines.

In common with almost all CROs that expand anywhere, Novotech said that improving access to potential study participants was a motivation for the expansion.

However, for Novotech the need is particularly pressing given that the firm landed contracts for 23 multi-centre Ph II and III trials in June, all of which are due to take place between now and 2014.

Although details of the specific contracts have not been released, Novatech did confirm that they were with major US and European organizations in a range of therapeutic fields including oncology, CNS disorders and cardiovascular disease.

CEO Alek Safarian stressed the regions large, ethnically diverse population as a benefit explaining that, in particular, it will help Novatech meet growing drug industry demand for cost effective research.

“A sizable patient population, transparent regulatory environment, time zone compatibility with the Australian headquarters and Government and clinical sector support for research all make the region very attractive.”

Safarin also said that the expansion fits with its efforts to generate more than half of its contract research revenues for operations outside Australia in the next three to five years.

The Kuala Lumper office is due to be fully operational in the next few months with the other new regional offices scheduled to open before the end of the year.

Novavax Opening Indian Vaccine Plant

Novavax says its new Indian vaccine plant will be operational in four months with sufficient capacity to help meet local demand for seasonal influenza vaccines.

The new plant will be run by CPL Biologicals (CPLB), Novavax’s joint venture (JV) with India’s largest privately-held drugmaker company Cadila Pharmaceuticals.

Novavax, Inc. announced today that CPL Biologicals Pvt. Ltd., the new joint venture between Cadila Pharmaceuticals in India, has begun construction of a state-of-the-art manufacturing facility that will be used to produce pandemic and seasonal influenza vaccines. CPL Biologicals will utilize Novavax's virus-like particle (VLP) vaccine technology to produce commercial-scale quantities of VLP-based influenza vaccines using Novavax's innovative disposable manufacturing solution. The CPL Biologicals facility is expected to be operational within four months and should be capable of producing over 60 million doses annually at full capacity. This facility will also be used to produce other novel vaccines being developed by CPL Biologicals, based on Novavax's VLP vaccine technology.

When operational in February, the 25,000 sq. ft. facility will have capacity to make up to 60m doses of influenza vaccine a year using Novavax’s virus-like particle (VLP) manufacturing technology.

The virus-like particle (VLP) cell-culture technology, which mimics the structure of a wild type virus to elicit an immune response but is unable to replicate, cuts production time to a fraction of that required using traditional egg-based manufacturing methods.

In time, the manufacturing facility will also make vaccines for other indications being developed by CPLB, using the VLP platform.

John Trizzino, senior VP of Novavax’ international and global alliances, who will also serve as interim CEO of the JV, explained that Cadila is providing 100 per cent of the financial support for the plant.

“We anticipate creating capacity for CPL Biologicals to sell influenza vaccines in India and at the same time become a potential supplier to Novavax for sale of vaccines in other markets where Novavax maintains commercial rights.”

Trizzino went on to say that the partnership model, coupled with the short time in which the plant will be made fully operational, demonstrates the efficiency and scalability of the VLP platform and the role it can play in address demand for influenza vaccine.

“Moreover the construction of this… facility is consistent with Novavax’ strategy to establish regional partnerships with…. manufacturing capabilities that allow our VLP influenza vaccines to be licensed, manufacturing and sold throughout the world.”

Novavax showcased the capability of its VLP technology with the opening of its first vaccine manufacturing plant in the US in May last year.

The 5,000 sq. ft., $5m facility, in Rockville, Maryland, served as both a pilot plant for manufacture and as a promotional platform for the technology and for Novavax’ partnering plan. Recent events suggest that the approach is paying off.

In July for example, Novavax’s technology was selected by the Spanish government for the country’s first vaccine manufacturing facility in a collaboration between the Ministry of Health and Novavax licensee Rovi Pharmaceuticals.

In addition to Ravi and Cadila, Novavax also works with GE Healthcare on implementation of the VLP technology and is likely to sign other agreement as concerns about the lack of H1N1 vaccine continue to grow.

Novavax and CPL Biologicals Break Ground on New Influenza Vaccine Manufacturing Facility in India.

Supram Begins Construction of Pharmaceutical Manufacturing Plant in Ireland

Supram Limited, formed by French pharmaceutical company Les Laboratoires Servier (Neuilly-sur-Seine, France) to develop a new active pharmaceutical ingredients plant in County Kilkenny, Ireland, has had its planning application upheld on appeal by the Irish national planning appeals board, An Bord Pleanala. Site preparation is well under way.

The French firm has had a major presence in Ireland for some time in Arklow, where the company operates as both an Irish HQ and secondary pharmaceuticals-production unit.

The Supram unit will include a major six-story development, including four floors dedicated to active pharmaceutical ingredient (API) production, with a multi-product production area comprising clean-area facilities and support utilities in a 6,363-square-metre (68,465 sq. ft.) development.

A site study for the plant began in 2006. Servier originally evaluated a site in Waterford, but eventually settled on the Industrial Development Belview site in County Kilkenny. A joint venture between Technip (OTC:TKPPY) (Paris, France) and DPS Engineering Limited (Dublin, Ireland) is providing design-build services for the $182 million project. Completion is scheduled for June 2011.

Carmat Opens Cleanroom in Velizy, France

CARMAT SAS, a Young Innovative Company (YIC) developing the world's most advanced artificial heart announced the inauguration of its cleanroom facilities in the presence of Valérie Pécresse, France's Minister for Higher Education and Research.

TitleSanofi-Aventis Joins Minsheng in OTC Market Manufacturing

Sanofi-Aventis has signed a joint venture agreement with Minsheng Pharmaceutical Group of Hangzhou to exploit the country’s booming OTC vitamin and mineral market.

China’s OTC market is predicted to become the world's second largest OTC market in 2010, according to Olivier Charmeil, Sanofi-Aventis' senior vice president for pharmaceutical operations in Asia/Pacific and Japan. The JV is in-keeping with the pharma giant’s plan to establish joint ventures rather than create R&D facilities in China.

The move marks Sanofi-Aventis entrance into China's OTC market, currently valued around $10.3 billion, and projected to experience double-digit growth over the next five years.

Money Approved for New Systems Biology Ireland Research Center

Ireland's government has agreed to spend €14.8 million ($21.8 million) over the next five years to establish the Science Foundation Ireland Centre for Science, Engineering & Technology in Systems Biology, a new research center to be led by University College Dublin and its Conway Institute.

The center will employ 69 people and focus on systems biology, the mapping of interactions between the elements of a biological system and the building of models intended to accurately reproduce that system’s behavior. The new research center is also being supported through industry partners that include Ark Therapeutics, Hewlett Packard, Servier, Agilent Technologies, Siemens Ireland, and Protagen.

The new center, also called Systems Biology Ireland, "should greatly assist the [Industrial Development Agency] to attract further high-end foreign direct investment, and also allow Irish SMEs to grow," Ireland's minister for science, technology and innovation, Conor Lenihan, said in a statement.

Systems Biology Ireland "is working with a range of industry partners to develop new technologies for biomedical research," the statement also said.

Nycomed Invests in Russian Plant

Nycomed will invest $110 -million in a production plant near Yaroslavl, Russia. The facility will produce medicines for the local populations. Construction is scheduled to start in 2010 and the company expects production in 2014 with approximately 150 employees. The site will be designed to manufacture liquid sterile products, ampoules and vials, as well as small molecule pills. Liquid production includes solution preparation, washing of ampoules, sterilization, filling, and inspection. Solid production will encompass all stages from mixing and granulation through compression and coating.

Lonza Opens Plant in Nanjing, China

Lonza celebrates the completion of another strategic project in China with the opening of the new Microbial Control Formulations Plant in Nanjing. This new state-of-the-art facility strengthens the leading position of Lonza in the Microbial Control market and adds important capacity and capabilities to their Microbial Control offering. Nanjing is located in China’s eastern Jiangsu province which is ideally suited to service a majority of our Microbial Control Customers.

The new plant is focused on the manufacturing of formulations but is capable of manufacturing quaternary compounds as well. The plant fully complies with the Chinese Ministry of Health regulations and is a US EPA registered site. The plant will manufacture registered formulations for the hygiene, water treatment and materials protection industries. The plant is supported by microbiology, application and analytical labs along with regulatory services which will enable the production of customized formulations as well as Lonza formulated products. Lonza has an expansive portfolio of over 1000 internationally registered formulations.

“We are happy to have completed this strategic expansion project for our Microbial Control business on time and on budget. With the new facility in Nanjing we have significantly expanded our capacity and advanced our position in this critical market.”, comments Jeanne Thoma, Head of Lonza Microbial Control. “The design of our facility allows us great flexibility to manufacture formulated products using a wide range of active ingredients to meet our customer’s requirements.”

Lonza’s Microbial Control business is a global provider of products and services to the Hygiene and Preservation, Materials Protection and Water Treatment industries. Lonza’s Microbial Control business is dedicated to help protect the health & welfare of humans, animals, plants, and products.

UK News

GlaxoSmithKline plc (NYSE:GSK) (GSK) (Middlesex, England) has started a project to upgrade facilities in Montrose for the production of Relenza, a drug that alleviates flu symptoms.
AstraZeneca plc (NYSE:AZN) (London, England) has begun developing a research and development Bioscience Centre site in Alderley Park, Cheshire.
Novartis also has begun a project for production of the API for its Tekturna hypertension treatment at its Grimsby plant.

Recent developments in Ireland:

Schering-Plough Corporation (NYSE:SGP) (Kenilworth, New Jersey) has started a project for the development of carpoule-filling facilities in its Brinny biotechnology plant near Cork. A major sterile project at the same site is also under consideration, but may be reconsidered in light of the forthcoming merger with Merck, Sharpe & Dohme, a division of Merck & Company, Incorporated (NYSE:MRK) (Whitehouse Station, New Jersey).
The Irish Development Agency is understood to be actively seeking pharma/biotech companies for its Dundalk biotech park development.

Novartis Expands in Liverpool, UK

Novartis Vaccines, a division of Novartis AG (NYSE:NVS) (Basel, Switzerland), has begun a fast-track project with PM Group, an Irish engineering company, to build a facility for swine flu vaccines at Novartis' Speke plant in Liverpool. The project is progressing alongside other projects associated with increasing the production of seasonal flu vaccines at the site.

Micromeritics has New European Headquarters in Germany

The particle measurement machine maker opened its new base, which is in the Avantis Science Park near Aachen. In addition to corporate offices house at the 500 sqm (5,380 sq. ft.) facility, the site also serves as the base for Micromeritics’ contract laboratory analysis operations.

In a press statement, company regional manager Tom Hustings explained that: "Micromeritics feels it can better serve its customer base across central Europe by locating at the border triangle where Germany, the Netherlands, and Belgium meet."

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