jan 08 update

A new £2 million chemical engineering laboratory at the University of Strathclyde in the UK will spearhead an expansion of its activities in biomolecular engineering, with a particular focus on human health, nutrition and finding new ways to generate energy.

Strathclyde has a particular interest in developing new technologies for bioprocessing, and has research programs looking at bioprocess monitoring and control using near and mid infrared technologies, as well as microbial physiology.

The biomolecular engineering department is already working with GlaxoSmithKline on a £2.4m research program looking at applying process analytical technologies (PAT) to biopharmaceuticals development, and has developed links with the UK's National Biomanufacturing Centre in Liverpool, looking at using spectroscopic technologies to guide scale translation.

Meanwhile, the University of Nottingham has also opened new facilities for the study of chemical engineering.

The new department in Nottingham will promote study into 'clean and green' chemistry and engineering and help to bridge the gap between chemistry and chemical engineering. The research facility, called 'Driving Innovation in Chemistry and Engineering' (DICE), has already received around £3.5 million from the Engineering and Physical Sciences Research Council (EPSRC) and will help to develop sustainable technologies and promote awareness of the same among young people.

DICE will aim to promote research in green chemistry/green engineering areas, efficient use of energy, safer chemical products, renewable raw materials, and 'zero-waste' processes to deliver new science and new technology.

Research areas will include new chemical reactions and catalysts, renewable raw materials for use in chemical processes, safer chemical products, new reactor concepts, including structured reactors, multi-functional reactors, across scales from micro to commercial plant, and process analytics and control.

Germany Shows Special Facility in FOYA Category Awards

Germany put in a strong showing as category winners were announced for the fourth annual Facility of the Year Awards (FOYA) recognizing innovation in pharmaceutical manufacturing projects.

Three of the five category winners in the 2008 FOYA program sponsored by the International Society for Pharmaceutical Engineering (ISPE), INTERPHEX and Pharmaceutical Processing magazine were companies located in the German market, albeit in one case with a US parent.

The awards come at a time when pharmaceutical manufacturing costs are under an unusual degree of scrutiny. Despite the growing trend to outsourcing, some market observers suggest the industry is still not paying nearly enough attention to inefficiencies in its cost of goods.

The award for Facility Integration went to Germany's Boehringer Ingelheim Pharma, for a new building constructed at the company's R&D site in Biberach. The aim was to integrate all the major functions of pharmaceutical development in a single unit to promote synergies, optimal communication and seamless co-operation across the relevant disciplines. At the same time, maximum flexibility was needed to enable handling of a broad range of product types, batch sizes, potencies and dosage forms.

Commissioned in January 2006, the resulting 96,840 sq. ft. space encompasses state-of-the-art formulation laboratories, pilot plants for solids and parenterals, GMP facilities to support Phase I-IV clinical trials, and office areas.

Bristol-Myers Squibb (BMS) won the Facility of the Year Award for Equipment Innovation, scooping the prize for the Pharmaceutical Development Center of Excellence created on the US company's campus in New Brunswick, New Jersey. A two-phase approach was taken to adapt an existing building in a way that would allow full implementation of lessons learnt as containment and process automation technology were integrated into the operation.

Phase One consisted of a state-of-the-art Clinical Supply Operations (CSO) expansion facility, including full containment for expanded oral solid-dose activities and, according to BMS, the most flexible clinical-scale continuous barrier line for sterile products in the US. Phase Two built on the technologies in Phase One, adding further processing space and scale to the OSD clinical operation and a new stand-alone Product Technology Center for development scale-up.

IDT Biologika, a German company that performs contract development and manufacturing for new human viral vaccines, was the FOYA winner for Operational Excellence. The company's new Facility for Production of Live Human Viral Vaccines IDT 201 addressed the challenges of incorporating all the relevant operations in a multipurpose facility while avoiding cross-contamination and expensive lead times between manufacturing cycles.

Also foremost among the requirements were disposable technologies, room sterilization procedures and transparency of operations/process flow to satisfy regulatory and client expectations. The result was a total production area of 50,550 sq. ft. encompassing two contained manufacturing lines that allow operations to be segregated for the preparation of cells, virus propagation and virus purification using highly efficient technical systems such as fermenters and robotics. The building has capacity for the development and manufacturing of vaccines for Phase I to III clinical trials, as well as for commercial supply.

The Process Innovation award went to Pfizer Manufacturing Deutschland at Illertissen, Germany, a strategic site in the Pfizer Global Manufacturing network focused on oral solid-dose forms and containment production. Project NEWCON was launched to expand capacity at Illertissen in the face of growing demand for the smoking-cessation medicine Chantix (varenicline) and to accommodate future demand for highly potent compounds.

A novel concept in high-containment manufacturing operations was developed, with the highest possible degree of integrated automation. All the unit operations were located within a single containment module, supported by automation systems without any manual handling. All of the equipment within this module was fitted with suitable barrier technology such as isolators and split-valves.

The related process controls were sited in an adjacent room with links to all automation systems and levels supporting processes such as MES (manufacturing execution systems) and laser-guided transport systems. The facility design meant no operator attendance was needed inside the containment suite, nor was any personnel protection equipment required for routine operations.

Coming up trumps in the Project Execution strategy was the Swiss-based F. Hoffmann La Roche AG. The company built two biotechnology production facilities to expand capacity for its new anticancer drugs, one of them at the Roche site in Penzberg, Germany. This 'Biologics IV' plant was four stories tall and comprised two highly automated production lines, each with three 12,500 litre fermenters and downstream processing, as well as associated laboratory and office space.

The €290 million project was run on an ultra fast-track basis and the new plant was designed, built and brought into operation within three years. The facility is initially being used to manufacture the active ingredient (trastuzumab) for the breast cancer drug Herceptin. Once operating at full capacity, Biologics IV will be able to produce enough active ingredients for another 100,000 Herceptin patients per year.

The overall winner of the 2008 Facility of the Year Award will be announced at ISPE's annual meeting in Boca Raton, Florida on 25-29 October.

India's Shasun Setting up First Facility in North American

The company has taken a long-term lease on a research laboratory at the US site and will scale it to provide active pharmaceutical ingredient (API) services for preclinical and clinical trials to customers in North America.

The process development facility, which will start operating in April 2008, will also offer back-end support to partners in the region for Shasun's growing contract research and manufacturing services (CRAMS) business.

The initiative underlines not only the increasing importance of the North American market to Shasun's spread of activities in pharmaceutical research, development and manufacturing but the company's strategic evolution from a leading manufacturer of core APIs such as ibuprofen towards a one-stop shop for drug multinationals, providing integrated services from discovery through to production of finished formulations.

The plan is to build on this base and operate on full capacity from October 2009.

It complements existing sites for API development servicing preclinical and early-phase clinical trials in the UK and India.

Shasun's UK manufacturing sites in Dudley and Annan - acquired with the custom synthesis business of France's Rhodia Pharma Solutions in early 2006 - include laboratory, kilo lab (intermediate facilities for initial drug scale-up) and pilot plant resources, while the same offering is available from Shasun's Indian facilities in Chennai, Cuddalore and Pondicherry.

Cook Pharmica Announced an $80 Million Expansion to Its Biopharmaceutical Facility in Bloomington, Indiana.

The cash injection will add 80,000sq. ft to the existing site, and with 200 extra jobs will more than double the existing workforce at the site when the expansion is fully completed.

The development will see Cook return to providing formulation, filling and finishing services to the pharma industry, activities that were carried out by parenteral contract manufacturer Cook Pharmaceutical Solutions until its acquisition by Baxter in 2001.

The existing facility will benefit from the addition of two new filling lines and corresponding finishing lines, with plans including one high-speed syringe filling line and one low-medium speed vial filling line with lyophilisation capacity up to 250 sq. ft. Both lines will be kitted out with isolator technology.

Cook's Bloomington site is currently focused on developing and manufacturing mammalian cell-culture based products, but will now be able to offer formulation, filling and finishing services to customers.

The facility will also move into aseptically filled parenteral vial and syringe products such as simple solutions and diutents, suspensions, vaccines, proteins and biologics.

There is a further 600,000 sq. ft of available space on the campus into which the company can move should it continue to expand.

Through the expansion plans, Cook was offered up to $2.2m by the Indiana Economic Development Corporation in performance-based tax credits and up to $100,000 in training grants based on the firm's job creation plans.

Construction work on the expansion is due to start in mid-2008, with completion expected in early 2010.

PPD Opens Central Lab Services in China

Pharmaceutical Product Development (PPD) has initiated central laboratory services in China in response to the country's budding clinical trials scene.

The US-based contract research organization (CRO) has formed an exclusive agreement with Peking Union Lawke Biomedical Development Limited (PUL) that has allowed it to "begin immediately" providing its central lab services to biopharma firms in the country.

The firm currently has other central labs in Brussels, Belgium and Kentucky in the US.

PPD is not the only CRO to have this idea. Its larger rival Quintiles also expanded its Global Central Laboratories and Clinical Development Services units in China (Beijing) earlier this month.

Under PPD's new arrangement, the firm will also operate the new lab services from a base in Beijing, where the country's largest life sciences park is located, having invested in lab equipment on site that is "identical" to that of its other two central labs.

The firm said that its new China central lab will be networked with PPD's in-house computer system and after completing a number of cross-validation and quality assurance measures, it is expected to deliver laboratory data that are "directly combinable."

The company generates two thirds of its sales in the US, but has been conscious of developing its operations beyond US borders since July last year when several analysts expressed concern that the firm was not capitalizing enough on conducting business outside the country. At the end of July, PPD announced it would expand its operations in Scotland and more than double its workforce over the next three years. Several months later, the company announced the opening of site in four new global locations - Copenhagen, Denmark; Sydney, Australia; Lima, Peru and Lisbon, Portugal.

Earlier this month the firm hired a new senior member of management to oversee the company's Phase II-IV clinical operations in Europe, Middle East and Africa (EMEA) and lead its expansion plans in the budding region.

WaferGen Pushes Research with Malaysian Subsidiary

WaferGen has launched a new subsidiary in Kedah, Malaysia, with the express purpose of overseeing research and development of its real-time PCR system.

The Californian firm will use its new base in Kulim Hi-Tech Park, Kedah, Malaysia, to pursue and establish research collaborations with both local universities and government-run research centres. WaferGen's Malaysian arm will also coordinate production of the SmartChip PCR system with a newly signed-up local contract manufacturer called Pentamaster Corporation Berhad.

The new subsidiary’s first task will be to optimize various gene panel assays to be used with the SmartChip system. The assays can be applied in a number of areas, including various disease targets, as well as toxicology and whole-genome analysis. WaferGen will work with the Malaysian Industrial Development Authority (MIDA) and the Malaysian Biotechnology Corporation (BiotechCorp).

Meanwhile, local universities and Malaysia's Genome Research Center will be tapped up to identify new therapeutic biomarkers, which in turn will give the firm new targets for SmartChip and its assays.

MDS Pharma Enters Brazil

MDS Pharma Services is the latest contract research organization (CRO) to branch out into a new and exotic emerging market location, with the establishment of an office in Sao Paulo, Brazil.

The new location will provide late stage clinical trial management services, adding to the nearly two dozen similar offices the firm has already set up in 21 countries throughout Africa, Asia Pacific, Europe, Latin America and North America.

Latin America is of growing importance to the drug development industry, with Brazil - where it is estimated that 645 Phase I-IV clinical trials are currently taking place - followed by Argentina, leading the way for the region. Drug development activity exploded in Brazil between 1995 and 2000, when the country experienced a 1000 percent increase in clinical trial activity.

Meanwhile, global expansion plans are not the only thing on MDS' mind. In late January the company also opened a new Phase I clinic in Arizona - the largest of its kind on the US west coast.

Built to the tune of $25m, the new 300-bed facility more than triples the capacity of the firm's Phase I presence in Phoenix, which combined with a nearby existing unit, totals 420 beds.

Shasun Expands Process Development with U.S. Facility

India's Shasun Chemicals and Drugs is setting up a process development plant in Piscataway, New Jersey, its first ever facility in the North American market.

The plan is to build on this base and operate on full capacity from October 2009.

SAFC Boosts Biologics

SAFC is still on its expansion drive, with yet another multi-million dollar investment announced at the company's niche biologics plant in Carlsbad, California.

The $12m project is further evidence of the Sigma-Aldrich company working to strengthen its presence in the ever-popular biologics arena.

The funds will go towards two fully segregated state-of-the-art viral product manufacturing suites, which will make use of disposable bioreactor technologies and allow SAFC Pharma to increase its viral manufacturing to commercial-scale quantities.

The new facilities will add 8,000 sq, ft. in manufacturing space, with 100L batch production in stirred tank bioreactors and 1,000L batch manufacturing in disposable bioreactors, to the existing 44,000 sq. ft. facility.

The additional capacity should be operational by the second half of 2009, and will also be Biosafety Level 2 compliant, allowing the manipulation of human pathogens.

This is just the latest in a regular stream of capacity expansions and investments that SAFC have announced over the last year or so.

In September 2007, not only did the company announce a $29m investment to expand manufacturing capacity for high-potency biologics at its site in Jerusalem, but also dedicated $10m to increase capacity at its Irish and Swiss plants.

August saw the company's flagship high-potency active pharmaceutical ingredient (HPAPI) site in Wisconsin benefit from a £4.5m refit, with new equipment installed and a further capacity expansion, scheduled for completion during the first quarter of this year.

SAFC's St Louis campus also got a financial boost back in May, with a $16m expansion in manufacturing capacity for biologics, also due to be complete during Q1 2008.

Wyeth Site Rescued by New Start-Up Firm

Wyeth's manufacturing facility in Rouses Point, New York, has been spared the scrap heap, with yesterday's announcement that new pharma player Akrimax has bought up the beleaguered site.

While financial figures for the acquisition were not disclosed, Akrimax received a $2m grant from Empire State Development (an agency encouraging economic investment in the state) and a further $1m was secured through the senate.

The death knell for the Rouses Point facility seemed to ring in October 2005, when Wyeth announced it would be phasing out activities at the plant following a drop in demand for menopause treatment Premarin (conjugated oestrogens), manufactured at the site.

Original plans were to have ceased all operations by the end of this year, but Akrimax had apparently been in discussions with Wyeth regarding the possibility of an acquisition since the closure was announced.

Akrimax only officially formed in 2007, but the acquisition of the Wyeth plant provides it with a large manufacturing facility and an 800-strong workforce, most of who will be kept on at the site.

The plant itself covers around one million square feet in manufacturing and packaging facilities, currently used to manufacture products such as Premarin and Wyeth's anti-depressant drug Effexor XR (venlafaxine).

Under the terms of the agreement, the two firms will work cooperatively over a transition period lasting until the end of 2009. During this time, Akrimax will lease the facility back to Wyeth to allow the firm to continue manufacturing its products while Akrimax begins introducing its own products to the plant.

Akrimax also intends to introduce contract manufacturing services to the facility to produce products for third party customers.

The sale does not include a 12,000 sq. ft. chemical development pilot plant located next to the manufacturing facility. Wyeth intends to continue operations at the chemical development site, as well as at its other New York facilities in Chazy and Plattsburgh.

Young Akrimax develops and manufactures prescription and over-the-counter (OTC)

products in solid (capsule and tablets), semi-solid (creams and ointments) and liquid dosage forms, as well as controlled/sustained release and sterile injectables.

Actavis Snaps Up Pfizer Plant

Icelandic generics firm Actavis is the proud new owner of Pfizer's manufacturing facility in Nerviano, Italy.

The plant, one of numerous sites on Pfizer's chopping block following the company-wide consolidation drive announced early last year, specializes in oncology products and significantly ups Actavis' capacity for cancer therapeutics.

The site is relatively old, originally developed and founded by Farmitalia in 1965, now covering an area approximately 3,228,000 sq. ft. and approved by EU, US and Japanese regulators.

Actavis will continue operations at the site, making use of the 'broad manufacturing capabilities' at the plant to meet anticipated demand for its oncology products, as well as landing an exclusive multi-year agreement to supply cancer therapeutics to Pfizer.

Actavis plans to use the site to develop new products and transfer existing products to the Nerviano site over the next few years, and will liaise closely with the Icelandic firm's Bucharest operations that also develop and manufacture oncology products.

The transaction is expected to be complete by the end of this month, expanding Actavis' network of manufacturing sites to 22 plants in 14 countries.

Actavis has only recently started to bulk up its presence in the Italian market, last month announcing that it had marketed it first own-brand product in the country.

Italy represents the fourth largest European pharmaceutical market served by the company, with the generics market in the country apparently expanding at double-digit rates in recent years.

The addition of a local manufacturing site is therefore likely to help the firm supply this growing market more efficiently, as well as beefing up manufacturing capacity for the company as a whole.

Sartorius Stedim Closes Plant

Processing specialist Sartorius Stedim Biotech announced a cooperation and supply deal with systems manufacturing firm Paul Mueller Company for the US market, with a production facility in Pennsylvania set to close as a result.

Paul Mueller will take over manufacture of stainless steel biopharmaceutical production systems for Sarorius Stedim, with the agreement announced this morning covering the US, Canada, the US Virgin Islands and Puerto Rico.

Effective immediately, the company will be Sartorius Stedim's exclusive North American partner and supplier of stainless steel systems such as fermentors, bioreactors, freeze-thaw systems, crossflow and other filtration systems.

As part of the move to link with Paul Mueller, Sartorius Stedim has announced plans to shut down its existing production facility for stainless steel systems in Bethlehem, Pennsylvania.

The site is relatively new, with the 85,000 sq. ft facility having only opened in October 2004. The plant employed 130 staff when it opened, with the addition of the Pennsylvania site setting Sartorius up as the only fermenter manufacturer in the world to have its own production facilities in the three key markets of North America, Europe and Asia Pacific.

Sartorius merged with French firm Stedim Biosystems just under a year ago, with the combined firm now deciding to focus on its 'customer-specific application engineering' and installation and servicing of its stainless steel systems.

These activities will take place at the company's site in Springfield, Missouri, in close proximity to the Paul Mueller operations. The company will continue to manufacture

processing systems for its European and Asian customers at its facilities in Germany and India.

Paul Mueller operates automated fabrication and machining facilities with approximately one million square feet of manufacturing space dedicated to stainless steel systems for a variety of industries.

Cephalon Closes Eden Prairie Facility

SEC documents filed by U.S. firm Cephalon this week revealed that the company has initiated a restructuring plan, which includes the closure of its Eden Prairie facility.

The restructuring scheme involves transitioning manufacturing activities from the Cima Labs facility in Eden Prairie, Minnesota, to the company's recently expanded site in Salt Lake City, Utah. Certain drug delivery R&D activities currently performed at Salt Lake City will now also be consolidated at Cima's Brooklyn Park facility in Minnesota.

Approximately 90 jobs are likely to go as part of the restructuring, with around 170 net jobs to go at Cima and around 80 net jobs in Salt Lake City.

The estimated pretax costs of the plan are likely to be in the region of $34m - $47m.

Protalix BioTherapeutics Expands in Carmiel, Israel.

The expanded space will triple the firm's current manufacturing space, in anticipation of the potential commercialization of the company's lead product candidate, prGCD, a therapeutic protein for the treatment of Gaucher disease.

BMS Closes another Puerto Rico Plant

Bristol-Myers Squibb (BMS) has revealed plans to close another site in Puerto Rico in its latest cost-cutting move. The company announced it will cease operations at its Barceloneta manufacturing plant by the end of 2008. Around 225 employees will lose their jobs as part of the site closure.

This is the second site on the island that BMS has mothballed in the past few months. In October, the company announced the closure of a plant in the city of Mayaguez that makes cardiovascular and diabetes drugs, a move that will wipe out 400 jobs.

Puerto Rico is one of the world's top five drug-manufacturing hubs, primarily due to its close proximity and trading ties with the US, as well as its low cost base and tax breaks, however, the island has incurred a sting of blows of late as many companies have been scaling back operations.

Pfizer, Schering-Plough, GlaxoSmithKline (GSK), Teva Pharmaceuticals, Watson Pharmaceuticals, Patheon and Wyeth, as well as BMS, have all slashed jobs there in the past couple of years for reasons ranging from cost-cutting measures, to the mothballing of sites due to regulatory concerns. Over 3000 jobs have been eradicated so far.

The pharmaceutical industry is undergoing a transformation phase as it experiences unprecedented patent expirations and financial cut backs. At the same time, the

industry is also moving away from blockbuster drugs towards more targeted therapies and biologics.

Puerto Rico has over 60 solid dose manufacturing facilities.

Additionally, BMS is also planning to mothball over half of its 27 manufacturing facilities during the same period. Its recent actions in Puerto Rico are part of this.

Despite the fact that BMS has earmarked two solid dose facilities on the island for closure, it is investing in two new biologics sites. The firm is spending $220m on creating a centre of excellence for the fill and finish of sterile parenterals, at a site in Manati, and $60m on a centre of excellence for high potency drugs

Invetech Commits to U.S. Market

Australia-based Invetech has committed itself to tackling the US market, opening up its first facility in the country - home of the world's largest drug industry.

The firm said that its new site, located in San Diego, California, will allow it to add US-based custom design, engineering and contract manufacturing services to its capabilities, making its services more amenable to North American clients.

Since 2002 the company has been working to establish a client base in the region. The firm is also currently scoping out new business opportunities in Europe.

Invetech delivers global contract design and development, contract instrument manufacturing and custom automation services to diagnostic, life sciences, drug discovery and pharmaceutical companies.

With Invetech’s other facilities located in Melbourne, Australia, Invetech prides itself on offering a relatively low cost base for its international clients.

Bosch Opens India Packaging Plant

Bosch Packaging has opened a new manufacturing facility in Goa, India, to cater to its growing customer base in the booming emerging market and increase sourcing for its European headquarters.

The packaging machinery division of German technology group Bosch says its new facility covers 28,000 sq. ft. and will make packaging technology equipment for food and pharmaceutical customers in India.

The company already counts several leading multinationals among its key India customers including Pepsico, Cadbury, ITC Foods, Parle, Perfetti, General Mills, Effem, Dehli Flour Mills, Godrej Foods and Monsanto. Last year it sold around 100 machines to the market.

The new Bosch Packaging plant in Goa, which was officially opened last month, employs 80 people and has an initial installed capacity of 120 machines a year, mainly fully automatic form-fill-seal type packaging machines. The firm plans to increase this to 240 machines in three years.

Bosch already has a plant in Bangalore but the Goa plant gives it access to good infrastructure to supply to the rest of India and to leading universities for sourcing talented employees. There is also a good supplier base for assembly of the machines.

In 2006, the Bosch packaging business reported a turnover of approximately €570 million.

Medegen Enters Mexico

California-based Medegen has opened a new facility in Mexico to meet the demand for outsourced contract manufacturing.

Medegen said that it expects the value of the pharma contract manufacturing market to reach $8bn by the end of the year, with the requirement for such services to grow at an annual rate of 10 per cent.

The company's Manufacturing Services unit will occupy the new 42,000-sq. ft site in Tijuana, where it will conduct expanded manufacturing services for the medical device and pharmaceutical industries.

The US Food and Drug Administration (FDA)-compliant facility will also handle the finished goods assembly for Medegen's in-house range of IV therapy products.

Roche Ramps up Biotech

Roche has announced major investments at three of its European sites, continuing its drive to strengthen its position in the biopharmaceutical market.

The Swiss pharma has earmarked CHF430m ($391.6m) to expand capacity at three sites in Germany and Switzerland.

Around CHF280m is going towards beefing up biotech R&D activities at the firm's site in Penzberg, Germany, focusing on the development and production of biopharmaceuticals for oncology indications.

A further CHF150m will be invested in the sites at Mannheim, Germany, and Kaiseraugst, Switzerland, to expand capacity for syringe filling activities for drugs such as anemia treatment Mircera (methoxy polyethylene glycol-epoetin beta), Pegasys (peginterferon alfa-2a) for hep C, and rheumatoid arthritis treatment Actemra.

Although Roche currently operates approximately 17 production sites worldwide, the three sites in Germany and Switzerland were selected following a 'thorough evaluation' of the company's manufacturing activities and 'taking on board local business conditions' at each location.

Currently half of Roche Group's top 10 pharmaceuticals are products of biotech research, accounting for around 45 per cent of the pharma division's total sales. Measured by sales and manufacturing capacity for biopharmaceuticals, the Roche Group claims it is the leading biotech firm worldwide.

In 2004 the company announced a CHF800m investment to establish new biotech production facilities at the site in Penzberg and its Basel, Switzerland plant.

In addition to Basel and Penzburg, the company has biopharmaceutical manufacturing facilities in South San Francisco (US, Genentech), Vacaville (US, Genentech), Oceanside (US, Genentech), Utsunomiya (Japan, Chugai) and Ukima (Japan, Chugai).

New HPAPI Plant for Novasep

Novasep has significantly upped its capacity with a new high potency active pharmaceutical ingredient (HPAPI) plant at its facility in Le Mans, France.

The new €8 million plant has already been installed and validated at the Le Mans facility, part of a €50m investment scheme at the site. According to a company spokesperson, the new plant allows the company to increase HPAPI capacity by around 50 percent.

The new facility has been established in order to meet increasing demand for multipurpose chemistry and purification of HPAPIs in a confined good manufacturing practice (GMP) environment, according to Novasep.

Construction of the facility started at the end of 2006, with the plant able to cater for batches of up to 10kg.

The facility will allow the company to offer additional production capacity for late clinical and early commercial phase quantities manufactured under GMP conditions, following Novasep's plans to offer scale-up services for highly potent materials throughout their lifecycle.

The Le Mans facility is the site of Novasep company Séripharm, the group's HPAPI specialist, with expertise in combining various techniques such as extraction, synthesis and semi-synthesis, preparative chromatography, crystallization and containments for HPAPIs up to Class 5.

The Novasep Synthesis arm of the company has particular expertise in cytotoxic products, and is one of the world's largest producers of paclitaxel and other taxanes.

Codexis Opens Fermentation Facility in Budapest

Codexis will be opening Codexis Laboratories Hungary Kft (CLH) in Budapest. The site will concentrate on fermentation strain development and process technology. CLH will be an expansion of the company’s existing R&D operations in the U.S., Germany, and Singapore.

Teva Acquires CoGenesys

Teva Pharmaceutical Industries Ltd. has entered into a definitive agreement to acquire CoGenesys, Inc. for $400 million cash. CoGenesys is a biopharmaceutical company focused on the development of peptide- and protein-based medicines. CoGenesys was established in 2005 as a division of Human Genome Sciences Inc. (HGSI) with an early drug development focus and became independent in June 2006.

The acquisition is part of Teva's strategic goal to advance in the biogenerics market as it evolves. Teva will gain access to CoGenesys' biotechnology research team, its development technologies (including Albumin Fusion, a novel approach to long acting biopharmaceuticals), and its pipeline, representing a broad spectrum of therapeutic categories. The CoGenesys team includes 70 professionals working in a 48,000-sq.-ft. state-of-the-art facility, in Rockville, MD.

Teva's biotechnology infrastructure currently includes product development and manufacturing in several countries. The company also markets biopharmaceutical drugs outside the U.S.

The transaction is expected to close during the first half of 2008.

AAI Pharma’s Renovation Approved

AAIPharma's sterile manufacturing plant in Charleston, SC received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to produce aseptic and lyophilized products. The approval follows a $1.5 million renovation of the plant and allows for production of products for shipment to countries in the EU. The site previously received FDA approval.

Lonza Expands and Upgrades Manufacturing Facility

Lonza further expands its capacity in the endotoxin detection area by upgrading its manufacturing suite for LAL (Limulus Amoebocyte Lysate) in Walkersville, MD, USA. The site has received approval from the U.S. FDA (Food and Drug Administration) to manufacture kinetic chromogenic lysate1 in the new LAL manufacturing suite. This multi-million USD expansion program included investments in a new high capacity lyophilizer2, new sterile manufacturing facilities, improvements to filling line efficiencies, as well as improvements to infrastructure and supporting systems, ensuring that the Walkersville facility remains at the forefront of regulatory compliance. Other lysate formats will be validated for manufacture in the new manufacturing suite in the near future.

The opening of the new facility now gives Lonza two independent lysate manufacturing suites, allowing continuous manufacturing even when one suite is undergoing maintenance. The new facilities will improve manufacturing consistency, provide larger lot sizes for high volume customers and will ensure ready availability of lysate supply, in line with projected growth plans, for the next 10-15 years.

Venus Remidies Expands Facility in India

Venus Remedies Ltd has inaugurated the sixth and last phase of its Rs 150 crore expansion project, its state of the art and hi-tech and elaborate research facility, "Venus Medicine Research Centre" at its Baddi Campus on January 14, 2008.

bioMérieux Opens a Subsidiary in Algeria

bioMérieux (Euronext: BIM), a world leader in the field of in vitro diagnostics announced its plans to open a subsidiary in Algeria in early 2008. The new subsidiary, based in Algiers, will enhance bioMérieux’s presence in Africa and illustrates the company’s international expansion strategy.

As part of Algeria’s 2005-2009 Healthcare Development Program, the country will create over a hundred healthcare facilities. bioMérieux will provide its expertise in the fight against infectious diseases and contribute to the scientific training of healthcare professionals. In particular, bioMérieux intends to play a major part in protecting patients from healthcare-associated infections in Algeria, drawing on its unique offer in microbiology.

bioMérieux Transfers Certain R&D and Manufacturing Activities to France

bioMérieux (Euronext: BIM) announces the transfer to France of R&D and certain manufacturing activities currently at its Boxtel site in the Netherlands. The transfer will take place gradually until the end of 2009, when this site closes.

All of the molecular diagnostics R&D and manufacturing will be transferred to the Christophe Mérieux Center in Grenoble, for a seamless interface between product development and manufacturing. A new plant will be built on the site to accommodate manufacturing of molecular diagnostic systems.

In parallel, microplate immunoassay R&D, together with the production of raw materials, will be moved to Marcy l’Etoile, the company’s global center of excellence for immunoassays. bioMérieux will communicate where this product line will be manufactured at a later date.

The Pittsburgh Life Sciences Greenhouse Relocates

The Pittsburgh Life Sciences Greenhouse (PLSG), the organization providing capital investments and customized company formation and business growth services to the region's life sciences enterprises, announced that the PLSG has helped Cognition Therapeutics, Inc. (Cognition) make the decision to relocate to southwestern Pennsylvania and has invested $200,000 in the Company. In addition, the PLSG has assisted Cognition in establishing regional operations and has provided connections to additional capital and equipment sources. The Cognition team is occupying office space in the PLSG Incubator and laboratory space on the South Side.

Cognition is an early-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics targeting the toxic proteins that cause the cognitive decline associated with Alzheimer's disease and other degenerative diseases of the human brain.

Center of Molecular Immunology (CIM) was Inaugurated.

CIM is one of the emblematic institutions of Cuba’s biotechnology industry. It is mainly devoted to basic research and the development and production of new products to diagnose and treat cancer, based on the culturing of superior cells from mammals and according to regulations established for good manufacturing practices.

One of the most relevant pieces of news from the Center for Molecular Immunology during 2007 was the approval in the United States of a clinical trial with the Nimotuzumab or CIMAHER monoclonal antibody for the treatment of advanced head, neck, and brain tumors in pediatric patients.

Lanxess Opens New Facility

Lanxess Corp. has established a new site in Redmond, WA, to serve the pharmaceutical business line of its affiliate, Saltigo GmbH (a subsidiary of Lanxess Deutschland GmbH). The site includes offices, labs and technical facilities and provides Saltigo with U.S.-based pharmaceutical operations.

Saltigo plans to use the cGMP facilities of the kilo lab and pilot plant to produce APIs for early clinical testing through to Phase IIa. Timothy Fitzpatrick, former associate director of ICOS Corp., will be manager of the Redmond site, overseeing as many as 25 employees. Lanxess Corp.'s sales team will provide sales and marketing support.

The Redmond site will focus on the early lifecycle phases of APIs, in which substances are initially needed on laboratory and pilot scales. For the production of larger volumes, Saltigo has a portfolio of chemistries and technologies, plus expertise in synthesis optimization and process development, at its production site in Leverkusen, Germany.

Lanxess plans to expand the capabilities of the new site for Saltigo's activities, improving the infrastructure, facilities in the fields of low-temperature synthesis and CGMP kilo production, and optimizing quality

Florida Funds Expansion of Oregon University

In an unprecedented move, Florida has lured a public university in Oregon to the sunshine state with an offer of $118 million to establish a research laboratory there.

Oregon Health & Science University in Portland announced that its Vaccine & Gene Therapy Institute (VGTI) in Beaverton would expand to Port St Lucie in Florida — where government officials are aggressively funding research facilities to spawn a biotechnology industry. It is thought to be the first time that one US state has paid for biomedical research facilities for another state university.

The VGTI, which currently has about 90 staff working for seven principal investigators, expects its facility in Florida to be more than double the size of its Oregon site, which will continue to operate. Florida is providing $60 million for operations over a decade, and local governments will fund infrastructure costs.

Azopharm Opens Cyanta Analytical Laboratories

Azopharma CEO, Phil Meeks, announced the opening of a new Cyanta Analytical Laboratories facility in Maryland Heights, MO. The new 20,000 square foot modern laboratory is equipped with state-of-the-art instrumentation to support pharmaceutical and medical device product development, specifically analytical method development and inhalation/respiratory services. The new facilities have been modified and updated to meet the stringent demands of our pharmaceutical, medical device and biotech customers.

Cyanta Analytical Laboratories provides analytical services to the pharmaceutical, biotech and medical device industries. As part of the Azopharma Product Development Group, Cyanta's services focus on stand-alone analytical projects for pharmaceutical products and medical devices, whether in development or currently marketed. Cyanta services support early to late phase projects including analytical development, method validation, stability testing, extractables and leachables, inhalation development services and analytical support for formulations.

Cyanta Analytical Laboratories along with the Azopharma Product Development Group of companies provides a complete spectrum of product development services for the pharmaceutical, medical device and biotech industries.

All Azopharma PGO facilities are FDA registered and inspected, DEA approved and client audited on a regular basis.

Gulf Pharma Has Facility in UAE

Gulf Pharmaceutical Industries (Julphar) is the first drug company in the UAE to become a truly multinational company with facilities in seven countries and exports to 47 more. The Ras al Khaimah-based medicine manufacturing company has ambitious growth plans including a new biotechnology project to develop crystal insulin for diabetic patients.

Julphar was established in 1980, commercial production started in 1984 and after 23 years, Julphar has become an Arab multinational organization. They now have seven plants and are planning to double this to 14 within the next three years. Julphar has been profitable for the last 15 years.

Julphar has several plants in Ras Al Khaimah and seven new plants are under construction and will be completed in the next three years. With the completion of these projects, Julphar will have 14 plants in the UAE. They are also planning another seven outside the UAE. These plants are located in the MENA and Asia region - Afghanistan, India, Morocco, Sudan, Lebanon, Yemen and Iran.

Kaine Proposes Funds for Higher Education Science Projects

In an effort to bolster the Virginia economy, Gov. Timothy Kaine proposed a $1.65 billion bond package for higher education.

The package, invested over the next five to seven years, will provide facilities for researchers to develop new, cutting-edge technologies and turn them into commercial assets.

Pending approval from the General Assembly and a November general referendum, JMU would receive $96 million for campus construction projects. Among the projects included in the higher education package are the construction of a new biotechnology building and the renovation and expansion of Duke Hall.

The biotechnology building, expected to cost $44.8 million, would be located between the new ISAT Library and the Physics/Chemistry building on the east side of campus. This new structure will contribute to an ever-growing science corridor on that end of the university.

Biodel Plans Manufacturing Facility for Injectable Insulin

Biodel reported plans to build and operate a fill and finish manufacturing facility for its Phase III injectable insulin product. Biodel anticipates that the site will cost under $15 million. The plant, to be located on the campus of Biodel’s headquarters in Danbury, CT, will be available for commercial production in 2009, according to the company. The firm expects that the dedicated production plant will improve margins, provide superior quality control, and better inventory control.

VIAject is Biodel’s lead candidate. It is being developed as a rapid-acting form of injectable human insulin for meal-time use by patients with type 1 or type 2 diabetes.

PerkinElmer Obtains Finnish Site for Genetic Screening Services

PerkinElmer signed a long-term lease for an industrial/office research facility in Turku, Finland. It will reportedly serve as the headquarters for the company’s genetic screening business, which provides solutions for neonatal, clinical, and prenatal screening and diagnostics. A significant portion will also be used for R&D.

The transaction was facilitated through investment firm W. P. Carey & Co. CPA®:14, W. P. Carey & Co.’s publicly held nontraded REIT affiliate, acquired the Turku site for approximately €10 million. The facility is being leased to Wallac Oy, a subsidiary of PerkinElmer.

The acquisition is a follow-on transaction to an approximately €28 million sale-leaseback of an adjacent research and production building that CPA:14 completed with PerkinElmer in 2001. Both properties are located in Turku’s Bio Valley.

Pennsylvania Industrial Development Authority will Help Biotechnology Companies

Mitos Technologies, Mito Molding and Mitos BioSystems, will receive a $642,177 PIDA loan for enhancements to a new facility in Upper Providence Township. The organizations will occupy half of the 40,000-square-foot building, which is currently under construction. All 24 existing employees will be transferred to the new site and 47 new jobs will be created. The Montgomery County Industrial Development Corporation is sponsoring this $2.1 million project.

Medrad Builds New Cleanroom for Disposables

MEDRAD, INC., a worldwide leading provider of medical devices and services that enable and enhance imaging procedures of the human body, celebrated the grand opening of a new manufacturing facility that will produce disposable components for its vascular injection systems. The 120,000-square-foot facility currently employs 70, with potential employment anticipated to reach hundreds of new jobs over the next several years, making it one of the largest single sources of new jobs in Butler County and one of the largest single sources of new manufacturing jobs in Western Pennsylvania.

The facility is located on the former site of a U.S. Steel sintering plant in Victory Road Business Park in Clinton Township, Butler County. It is 30 miles north of Downtown Pittsburgh and about 14 miles from MEDRAD's original sterile disposables operation on Route 910 in Indianola, Pa., which will remain in operation.

The building is also designed to be LEED (Leadership in Energy and Environmental Design) certified. LEED certification requires that a building meet stringent measures and tests of its energy efficiency and environmentally friendly construction through use of natural lighting, biodegradable materials and construction practices that reduce human impact on the site.

At the heart of the new facility is an extensive cleanroom environment in which workers manufacture disposable components used to inject contrast dyes during medical imaging procedures. MEDRAD's disposable products consist primarily of high-pressure, large-volume syringes and injection systems, including specialty tubing, used to inject contrast agents as part of computed tomography (CT), magnetic resonance (MR) and angiography medical imaging scans.

This is the second major MEDRAD facility to open in the last year. MEDRAD celebrated the grand opening of its 125,000-square-foot Global Center in June 2007. The Global Center, in the TECH 21 Research Park in Warrendale, Pa., Allegheny County, houses more than 260 employees in Corporate Services, Corporate Compliance, Sales/Customer Support and Corporate Operations.

In addition to the new disposables plant and its Global Center, MEDRAD operates two other local facilities. Its Indianola facility, on Rt. 910 in Indiana Township, Allegheny County, houses MEDRAD's Computed Tomography (CT), Cardiovascular (CV) and Magnetic Resonance (MR) Strategic Business Units, as well as its Innovations group and the original sterile disposables manufacturing operation. The company's Heilman Center, in RIDC Park, O'Hara Township, Allegheny County, houses its electromechanical manufacturing, equipment service and Multi-Vendor Service operations. In total, the company employs over 1,700 employees worldwide, about 1,200 of them in Western Pennsylvania.

Vettrer Recieves Japanese Certification

Japan's Ministry for Health, Labor and Welfare has given Vetter Pharma-Fertigung GmbH & Co. KG the go-ahead as a foreign manufacturer for the Japanese pharmaceutical market. Vetter, a world leader in aseptic filling of pre-filled injection systems, received certification in the categories "drug, sterile product," "drug, packaging, labeling and storage" and "medical device, sterilized medical device." According to Japanese authorities, official approval is needed for any company looking for partnerships as a contract manufacturer with Japanese pharmaceutical and biotech companies seeking to sell drugs in the local market.

The certificates demonstrate that Vetter meets the specific Japanese quality and safety standards as a foreign manufacturer. From now on, Japanese pharmaceutical and biotech companies wanting to offer their drugs on their domestic market can take advantage of the services offered by the Ravensburg-based company. Vetter already partners with international customers to manufacture pre-filled injection systems for the Japanese market. Partnering with Japanese pharmaceutical and biotech companies also represents a major building block in the future growth potential of the company, which has a headcount of over 1,900 spread over several locations.

Vetter Pharma Fertigung GmbH & Co. KG of Ravensburg, Germany, has started the construction of a new facility for visual inspection and secondary packaging. Vetter, the leading manufacturer of aseptic prefilled application systems, will be adding the new building close to Ravensburg Vetter South (RVS), its existing state-of-the-art facility. The approximately 20-million-euro expansion will create more than 200 new jobs.

The facility will be operating by the end of 2008.

In addition to its RVS location, the company has two other aseptic production facilities in the region. Vetter fills all common injection systems for international pharmaceutical and biotech companies. All of the company's facilities are autonomous and can be used for mutual back-up.

Merck Hands US Active Pharmaceutical Ingredient Manufacturing Facilities Over

The closure of the sale of the facility, located in Riverside, Philadelphia, was announced by the purchaser, PRWT Services.

The divestment is the latest in a series of fat trimming exercises being undertaken by Merck since November 2005, when it first announced plans to slash its workforce by 11 per cent (around 7,000 employees), closing five factories and three manufacturing facilities in the process. The cost-cutting measures were designed to save the firm up to $4bn by 2010.

Under PRWT's new ownership, the site, which makes antibiotics, has been set up as a new wholly-owned subsidiary and renamed Cherokee Pharmaceuticals, although it will continue to carry out business as usual and retain the 400 existing Merck employees.

WuXi PharmaTech, China's Contract Research Giant, Gaining Biologics Capabilities and a Base in the U.S.

The firm has agreed to pay $151m for US-based AppTec Laboratory Services in addition to taking on $11.7m of AppTec's debt. The transaction already has the approval of all required parties and is expected to close in the first quarter of 2008.

AppTec offers contract testing, research and development, and biologics manufacturing services from FDA-registered facilities in Philadelphia and Atlanta and WuXi PharmaTech said its chemistry services will be complemented by AppTec's biologics testing and manufacturing capabilities to create a "broader and deeper scope of services".

In addition, the firm said that AppTec brings "established customer relationships with many leading pharmaceutical, biotech and medical device companies in the US and around the world". A company spokesperson indicated that further acquisitions may be on the cards in the near future.

With its global expansion plans it may also be planning to take on the US-based contract research organizations (CROs) who are setting up operations and/or establishing business partnerships in China and in doing so, encroaching on its market share.

China has been actively trying to create a name for itself in the preclinical arena and is fast becoming a popular destination to outsource preclinical work, which is often highly specialized, difficult to perform and costly. According to a recent Bloomberg report, WuXi Pharmatech, China's largest preclinical services provider, will this year overtake Pfizer, the world's largest pharmaceutical company, in the number of chemists it employs - currently the number sits at 2100.

The annual cost of a Chinese scientist is around $30,000 a year.

CMC Puts Down US Roots

Acquisition of ICOS Biologics Operation Gives CMC a U.S. FootprintCMC Biopharmaceuticals A/S, a Copenhagen, Denmark-based provider of contract biomanufacturing services, has acquired the biologics development and manufacturing operation that Eli Lilly and Company gained when it purchased ICOS Corporation in January 2007. The operation, which will be known as CMC ICOS Biologics Inc., is located in Bothell, WA, and is responsible for developing and manufacturing therapeutic proteins for early clinical trials. The financial terms of the deal were not disclosed.

The new facility officially expands the Danish company's operations into the U.S

As a part of the agreement, CMC will retain the existing 127 employees working at the biologics facility in Bothell, Washington.

New Projects in Mississippi

The University of Mississippi Medical Center and Baptist Medical Center are in the middle of major expansions, while Central Mississippi Medical Center and St. Dominic/Jackson Memorial Hospital completed projects in the last few years.

UMC leads the list with $66 million in projects, including a new hospital that opened in late 2006 and expansion of the Guyton Building by nearly 100,000 square feet.

When finished, the larger Guyton Building will offer greater capabilities in researching cardiovascular physiology, psychiatric neuroscience and microbiology/immunology, said David Dzielak, UMC's associate vice chancellor for strategic research alliances.

Construction is scheduled to be completed this summer and open in September.

The medical center also is scheduled to get $7.3 million in federal funding for a biotechnology research center.

Also, Baptist Medical Center is adding a 205,000-square-foot tower to the hospital's west side. It will feature cardiovascular and women's services. The hospital's fourth floor is being expanded to include a neonatal intensive care unit. Construction is scheduled to be finished by October.

Baptist Health Systems also has plans to turn about 15 acres east of the hospital between Fortification, Poplar, North State and Jefferson streets into a mixed-use area with retail, medical office and residential space.

St. Dominic has ongoing upgrades, but the last major expansion was the opening of Dominican Plaza in late 2005. The plaza houses a medical office that includes wellness and outpatient centers.

In 2007, Central Mississippi Medical Center introduced a host of features to its facility. They include a joint center for people recovering from knee or hip surgery and several pieces of state-of-the-art medical equipment.

Scripps, Torrey Pines Poised to Expand

Scripps Florida grew to 232 scientists and technicians in 2007, but it could begin to make great strides in 2008.

The research center is crammed into temporary quarters at Florida Atlantic University's Jupiter campus, but scientists hope to move into Scripps' three permanent buildings in October.

Universities to Spend $60 Million in Federal Funds

Several Mississippi universities are beginning the year with plans to spend roughly $60 million in federal funding, much of which is dedicated to construction and continuing research projects.

The money is part of a $512 million omnibus bill Congress approved.

The University of Mississippi will use $7.3 million to begin construction on the Mississippi Biotechnology Research Park on 20 acres. The award would be used on the first building, a 50,000-square-foot structure that could be finished in three to four years and house lab and office space for start-up biotechnology companies.

The completed park is expected to cost $50 million to $75 million.

With its $7.3 million, Mississippi State will expand its Thad Cochran Research, Technology and Development Park with a 30,000 square-foot building. The multipurpose structure is expected to house 10 to 15 smaller companies. Construction could begin as early as March or April.

Developed in 1990, MSU's research park houses multiple, research-based companies, some of which are the product of the school's research. University of Southern Mississippi was awarded $7.5 million for its marine aquaculture facility. The school will construct a building at its Gulf Coast Research Laboratory in Ocean Springs.

USM got an additional $1.98 million to finish and equip a research lab at the school's Innovation and Commercialization Par, just north of the Hattiesburg campus.

Jackson State University was awarded $4.72 million to continue research at the Center for Defense Integrated Technology, said Gordon Skelton, director for the Center for Defense Integrated Data.

Merck & Co. Sells Manufacturing Facility to PRWT

PRWT Services is establishing a presence in the life science market through the acquisition of the Cherokee chemical manufacturing plant in Riverside, PA, from Merck & Co. Cherokee also entered into a five-year supply agreement with Merck for an estimated value of $100–200 million annually.

The Cherokee plant is an API manufacturing facility of products/antibiotics for humans and animals. The facility will be a part of subsidiary, Cherokee Pharmaceuticals.

PRWT intends to make considerable capital investments in the Cherokee plant to support the growth of the business and increase the number of jobs available in the local community. All 400 employees working at the plant will be offered jobs and are expected to transfer their employment from Merck to PRWT.

McIlvaine Company,

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