Roundup of Informex 2010

Contract manufacturers of active pharmaceutical ingredients (APIs) and intermediates unveiled capacity and service expansions at Informex, the exhibition of custom manufacturers, which was held in San Francisco last month. Below are some highlights from the show.

Albemarle (Baton Rouge, LA) formed a partnership with PharmaCore (High Point, NC) to provide manufacturing capabilities to PharmaCore customers with projects requiring high-volume capacity. Albemarle’s custom-manufacturing capabilities include a network of manufacturing assets in South Haven, Michigan; Tyrone, Pennsylvania; and Orangeburg, South Carolina.

Almac (Craigavon, United Kingdom) will be opening two new laboratories as part of the group’s new $120-million North American headquarters in Souderton, Pennsylvania. The laboratories will offer analytical support services and a solid-state chemistry service supporting the development of APIs from invention to launch.

In formulation news, Almac added an Xcelodose 600S precision powder microdosing system to its product-development capabilities for preclinical and early-phase clinical supply of material produced by current good manufacturing practices (CGMP). The Xcelodose 600S (Capsugel, Peapack, NJ) is a powder microdoser and automated encapsulator that has the ability to fill formulations or APIs directly into capsules with a high level of accuracy. The system also includes an Xcelohood system that provides containment when filling capsules with APIs of high or unknown toxicity.

Alphora Research (Mississauga, Ontario, Canada) recently completed $2 million in expansions to support its API-development capabilities. The expansions increased capacity for CGMP manufacturing of APIs at the kilogram scale, improved process-chemistry research and analytical services capacity, and increased the size of the company’s facility to 40,000 ft ² .

AMRI (Albany, NewYork) announced that it has acquired Excelsyn (Holywell, UK), a provider of contract chemical-development and manufacturing services, for $19 million in cash. Excelsyn has 60 employees and generated revenue of $15 million in 2009. The acquisition includes a kilo laboratory, pilot plant, and large-scale manufacturing facilities in North Wales.

Ash Stevens (Detroit, MI) was recently honored for achievement in environmental, health, safety, and security (EHS&S) performance. At the annual dinner of the Society of Chemical Manufacturers and Affiliates (SOCMA), the US-based trade association representing custom manufacturers, in December, Ash Stevens received two Silver Awards for its commitment to performance improvements in EHS&S Planning and Operations as well as Employee Training and Engagement. Those are two of the five core principles of SOCMA's ChemStewards program, which ensures compliance and continuous improvement in the area of EHS&S performance. The 2009 SOCMA Awards captures EHS&S activities during calendar 2008. The awards are based on an individual facility's achievements toward meeting and exceeding one of the core principles of the ChemStewards program.

The Pharma Ingredients and Services business unit of BASF (Ludwigshafen, Germany) formed a partnership with GEA Niro (Soeborg 
Denmark), which will allow BASF to make CGMP spray-drying tests and pilot productions of APIs at GEA Niro’s pharmaceutical test station for spray drying in Copenhagen.

BioVectra (Charlottetown, Prince Edward Island, Canada) recently signed agreements with Sandoz Inc. (Princeton, NJ), the US-based generics arm of Novartis (Basel, Switzerland), for Sandoz to commercialize and market the abbreviated new drug application (ANDA) for docetaxel for injection, the generic version of the anticancer drug Taxotere. BioVectra reached commercial marketing and supply agreements with Sandoz to extend specific marketing rights within the United States. The ANDA was filed in June 2009.

Carbogen Amcis (Bubendorf, Switzerland) inaugurated its new high-potency API facility at the site of its parent company, Dishman Pharmaceuticals and Chemicals (Ahmedabad, Gujarat, India), in late January. The facility’s large-scale capacity (currently up to 1600 L) will be capable of producing multi-metric ton quantities of high-potency APIs (as low as 3). The new facility complements Carbogen Amcis’s high-potency API facilities in Bubendorf.

Codexis (Redwood City, CA), a biocatalysis company, has formed a strategic partnership with the contract manufacturer Dishman Pharmaceuticals and Chemicals that covers the use of Codexis’s proprietary biocatalysis technology for the manufacture of building blocks, intermediates, and APIs for innovator-drug companies. The alliance will enable Codexis to offer production of intermediates and final APIs using its biocatalysis technology.

In a separate deal, Codex also signed a biocatalysis agreement with the contract manufacturer Ampac Fine Chemicals (Rancho Cordova, CA), which specializes in high-energetic chemistry and other custom synthesis.

The private equity group Aurelius (Munich) has agreed to buy Isochem (Paris), the fine-chemicals unit of the French chemicals company Groupe SNPE (Paris). Isochem is a provider of fine chemicals, including phosgene derivatives. Isochem has four manufacturing sites in France and one in Kazincbarcika, Hungary.

Novasep (Pompey, France) and the pharmaceutical company Provepharm (Marseille, France) announce the successful validation by Novasep of a CGMP manufacturing process for Proveblue (methylthioninium chloride), a methylene-blue-based API. Methylene blue is widely used as a dye in therapeutic and diagnostic applications, but Provepharm says its Proveblue is the first grade of methylene blue that is compliant with the European Pharmacopoeia and International Conference on Harmonization requirements. The product also complies with the European Medicines Agency’s guideline on specification limits for residues of metal catalysts, according to the company.

Optima Chemical Group (Douglas, GA), an affiliate of Charkit (Norwalk, CT) has agreed to purchase and license select lithium products from FMC Lithium (Charlotte, NC). The lithium products that will now be available through Optima include lithium aluminum hydride and lithium borohydride.

Reaxa (Manchester, UK), a company specializing in pharmaceutical metal catalyst and scavenging technology, has successfully completed scale-up of its nickel EnCat immobilized catalyst in preparation for bulk-scale production of high-volume intermediates and APIs. Nickel EnCat is an immobilized nickel catalyst that traps catalyst species in a porous polymer bead, thereby helping to prevent product and wastestream contamination and facilitating handling and scale-up.

Ricerca Biosciences (Concord, OH) announced on Feb. 10, 2010 that it has agreed to acquire the discovery and preclinical business of MDS Pharma Services, which has facilities in Bothell, Washington; Lyon, France; and Taipei, Taiwan. Ricerca’s headquarters will remain in Concord, Ohio. The proposed transaction between the two companies is subject to customary regulatory and closing conditions. The transaction is expected to close within the next two months.

SAFC (St. Louis, Mo) provided a roundup of its recent investments in API production. The company has announced investments totaling $90 million in the past two years to expand its API production and biologic products. In 2009, the company announced a $30-million investment at its Madison, Wisconsin, site, to expand capacity for commercial-scale high-potency manufacturing. Completion is scheduled for the end of the first quarter of 2010. The new facility consists of two 100-L CGMP suites, another suite containing two 2000-L, reactors, and a further site containing two 4000-L reactors. SAFC also completed a $4.5-million investment in Madison to increase CGMP pilot-plant and large-scale kilogram laboratory high-potency API capacity. In. St. Louis, Missouri, the company recently commissioned a suite for producing high-potency API conjugates.

SAFC is also investing $29 million to expand its large-scale production of bacterial and fungal fermentation-derived biologic high-potency APIs. The 50,000-ft² facility will focus on the production of secondary metabolites, cytoxins, and large-molecule proteins. The facility is scheduled for completion in the first half of 2010.

SAFC also recently invested $12 million to expand its viral-product manufacturing facility in Carlsbad, California. The new suites added 8000 ft² of manufacturing space and enables 100-L batch production in stirred-tank bioreactors and 1000-L batch manufacturing in disposable bioreactors. The expansion also included the addition of an 7000- ft² laboratory complex.

ScinoPharm (Shan-Hua, Tainan County, Taiwan) is constructing a new plant on a 66,670-m² site in Changshu, Jiangsu Province, China, for initially producing GMP-grade pharmaceutical intermediates and later will be equipped to handle API production. The plant, which will also include a research and development center, is scheduled to be fully operational by 2011.