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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
As the industry prepares for Informex, the trade show of custom and batch manufacturers in Charlotte, North Carolina, a roundup of key recent developments.
Informex, the exhibition of contract manufacturers of active pharmaceutical ingredients (APIs), pharmaceutical intermediates, and fine chemicals, will be held Feb. 7-10 in Charlotte, North Carolina. As the industry gathers next week, below is a roundup of key recent developments from suppliers.
Aescia is investing in a new high-containment facility in Queenborough, United Kingdom. The facility is scheduled to be completed in May 2011. Aesica also is purchasing three manufacturing sites in Germany and Italy from the biopharmaceutical company UCB as announced in late 2010. Aesica is acquiring sites in Monheim and Zwickau, Germany, as well as UCB’s Pianezza, Italy site. The companies also formed a long-term supply agreement.
Almac is expanding its biocatalysis business with a $4-million investment for discovering new biocatalytic platforms and for other research areas. These areas include hyperactivation of biocatalysts to reduce enzyme loadings, drivers for cofactor recycles, and resolving problems with equilibriums. Almac also added a dedicated late-stage customization suite to the company’s commercial facilities. The addition is designed to assist orphan drug and niche product launches in Europe.
AMRI formed a research and licensing agreement with Genentech, part of the Roche Group, for a family of antibacterial compounds discovered from AMRI's research of its natural-products sample collection. Under the agreement, which was announced in January 2011, Genentech will receive an exclusive license to develop and commercialize multiple potential products from AMRI's proprietary antibacterial program, and the companies will conduct research to identify antibacterial agents. AMRI will receive an upfront license fee and research funding, milestone payments, and royalties on product sales.
BioVectra expanded its current good manufacturing practice (CGMP) microbial contract fermentation services at its facility in Charlottetown, Prince Edward Island, Canada. The expansion doubled the company’s capacity to handle clinical-stage projects and was scheduled to be completed in the fourth quarter of 2010.
Codexis, a biocatalysis company, expanded its line of Codex panels with the introduction of Codex screening kits. The screening kits consists of 24 enzymes, which represent two commonly used enzyme classes: ketoreductases and transaminases. In January 2011, Codexis and DSM Pharmaceutical Products, the custom-manufacturing organization of Royal DSM, formed an enzyme supply agreement. The agreement grants DSM rights to use Codexis’ custom biocatalysts and services and secures supply of Codexis enzymes for commercialization of pharmaceutical manufacturing routes developed by DSM’’s InnoSyn route-scouting services.
DSM Pharmaceutical Products, the custom manufacturing organization of Royal DSM, formed a license agreement with the German biotechnology company c-LEcta GmbH, an industrial biotechnology company, for proprietary screening technology. The agreement, which was announced in December 2010, grants DSM rights to c-LEcta’s proprietary alcohol dehydrogenases for enzyme screening programs and development of sustainable manufacturing routes for manufacturing of APIS and intermediates.
Royal DSM also reported in December 2010 that DSM Anti-Infectives formed a joint venture (JV) with the Chinese chemical company Sinochem Group . As part of the JV agreement, Sinochem will take a 50% equity interest in DSM Anti-Infectives for EUR 210 million ($275.7 million) on a cash and debt-free basis. The JV will be headquartered in Hong Kong, and all 2000 DSM Anti-Infectives employees will be part of the new entity. The parties anticipate the closing to take place in the second quarter of 2011.
Fermion, the contract-manufacturing arm of the Finnish pharmaceutical company Orion, is investing EUR 5 million ($7 million) in its plant in Oulu, Finland, to expand its capabilities in high-potency manufacturing. The company conducted a SafeBridge precertification inspection in the third quarter of 2010. The expansion is expected to be operational in early 2012.
Lonza and California Peptide Research (CPRI) formed an agreement to provide peptide manufacturing and development services. CPRI adds geographic diversity to Lonza's existing facilities in Braine-l'Alleud (Belgium), Visp (Switzerland), Nansha (China), and Kouřim (Czech Republic). CPRI’s offering includes milligram- to multi-gram-scale custom synthesis, a variety of catalog products, as well as consulting services and technical support.
In a separate announcement, Lonza formed an agreement with Dalton Pharma Services to provide early-phase chemistry and kilogram-laboratory manufacturing services for small molecules. Dalton offers contract chemistry research, contract analytical services, and chemical synthesis up to CGMP kilogram-scale as well as small-scale fill-finish activities at its site in Toronto, Canada.
Novozymes Biopharma, part of Novozymes, developed and launched a recombinant source of sodium hyaluronate, which is not derived from animal-based raw materials. Sodium hyaluronate is traditionally derived from rooster combs or from strains of Streptococcal bacteria, which may potentially result in safety risks from animal proteins, viruses, or endotoxins, according to the company. Novozymes uses fermentation for producing Bacillus sodium hyaluronate. The product is used in drug formulations and may be used in drug-delivery systems, including nanocarriers, micelles, cross-linked hyaluronic acid molecules, hydrogels, powders, minipellets, implants, sponges, films, and conjugates. Novozymes is constructing a new CGMP facility for its Bacillus -based hyaluronic acid in Tianjin, China. The facility will make pharmaceutical-grade products. Large-scale GMP production is planned for the first quarter of 2011.
Piramal Pharma Solutions, the contract- manufacturing arm of Piramal Healthcare, completed the latest phase of its investment program to increase production capacity for antibody drug conjugates at its facility in Grangemouth, Scotland. The expansion supports the GMP production for the planned launch of a new cancer treatment by an undisclosed US-based biotechnology company in 2011.
Purac is investing EUR 15 million ($21 million) in a new manufacturing facility in the United States for its biomedical polymers. The company’s biopolymers business includes lactide-based polymers such as polylactic acid and lactide/glycolide copolymers. The company currently manufactures biopolymers at its facility in The Netherlands. Construction of the US-based facility will begin in 2011 and is expected to be completed by the end of 2011.
SAFC completed its expansion of its high-potency fermentation capabilities at its facility in Jerusalem. Production was scheduled to begin in October 2010.
Saltigo is considering setting up capacities for manufacturing highly potent APIs at its facilities in Leverkusen, Germany, and Redmond, Washington, according to an Aug. 24, 2010, press release. In October 2010, Saltigo also reported that it will jointly develop processes for the synthesis of APIs and intermediates with Reuter Chemische Apparatebau (RCA). RCA produces chiral substances.