Several contract manufacturers and fine-chemical suppliers took the opportunity to announce capacity expansions and service expansions at Informex, the trade show of custom and batch manufacturers, held last month in Charlotte, North Carolina. Below is roundup of news from the show and following the show.
Almac reported on its new 240,000-square foot North American headquarters, built on 40 acres in Souderton, Pennsylvania, north of Philadelphia, which has full-service, integrated clinical packaging, drug supply-management, and technology solutions to the pharmaceutical and biotechnology industries. The facility complements existing facilities in the United Kingdom.
Almac also 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 received approval from the Italian Medicines Agency (AIFA) for its facility in Burlington, Massachusetts, to manufacture the commercial drug product octreotide for a customer in the European Union. This approval specifically applies to laboratories and manufacturing areas at the company's Burlington facility designed for the production of aseptic and lyophilized vials, affirming the facility's compliance with EU GMP standards.
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.
Carbogen Amcis expanded its service portfolio and capacity for stability studies in compliance with latest guidelines from the International Conference on Harmonization. The company installed new stability chambers at its site in Hunzenshwil, Switzerland and now offers short-term, long-term, accelerated, intermediate, follow-up, and customized tests.
Codexis formed a biocatalysis collaboration with Dainippon Sumitomo Pharma (DSP). Under the agreement, Codexis will supply biocatalysis screening products and services to DSP for use in selected undisclosed therapeutic products in its development pipeline. 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 the InnoSyn route-scouting services of DSM.
Flamma is doubling the production capacity of its non-CGMP facilities in Dalian, China. The company expects the expansion to be completed in 2011 with further expansion by 2013.
The organizers of Informex recognized three companies, Zeon, Novomer, and DSM, for its second annual “Profiles in Sustainability” awards. Fifteen companies submitted projects for consideration by the judging panel, which consisted of representatives from the American Chemical Society’s Green Chemistry Institute, the Society of Chemical Manufacturers and Affiliates, Georgia Institute of Technology, and trade media. The entries were judged on the 12 principles of green chemistry, the commercial scale of the product and process, the uniqueness of the technology, and the magnitude of the product and process. Zeon won the product category for is submission of a high-performance ether solvent, cyclopentyl methyl ether. Novomer won the process category for catalyst technology for enabling the production of certain polymers with carbon dioxde from commodity petrochemical epoxides. DSM was recognized for its corporate commitment to sustainability as a business driver and in pharmaceutical research and development and manufacturing.
Informex 2012 will be held Feb. 14 through Feb. 17, 2012 in New Orleans at the Morial Convention Center.
Johnson Matthey reported on the integration of the biocatalyst offerings from X-Zyme, which the company acquired in July 2010. Johnson Matthey has expanded the biocatalyst offerings into product and service offerings in its catalysis and chiral technologies business. The portfolio from X-Zyme includes enzymatic catalysts for scalable production of highly pure chiral amines and alcohols. The biocatalysts and related technology complement the chemocatalytic technology and related expertise of Johnson Matthey.
Novasep, a supplier of manufacturing solutions to the life-science industry, and instrAction, a provider of chromatographic stationary phases for purification of active pharmaceutical ingredients (APIs), have expanded their global alliance to include the purification of taxanes, a class of anticancer compounds. The collaboration enables Novasep to develop, operate, or supply optimized large-scale chromatography processes for taxane-based APIs and intermediates.
PharmaCore, a contract research and manufacturing organization, announced a new focus on short-term full-time equivalent (FTE) for customers who require custom organic synthesis projects. The PharmaCore Flex-FTE allows customers more flexibility in reaching their project goals through methods other than the provided demonstrated technical package. PharmaCore will provide a quotation based on estimated time, analytical requirements, process development, and other components. If the project goes quickly and is completed before the allotted time frame, the customer pays only for actual time. If changes in analytical requirements prove to require additional time and resources, the customer is consulted and makes the decision on whether or not to proceed. The company also offers long-term FTE projects.
SAFC reported on the completion of its expansion of its Jerusalem, Israel facility, which was completed in 2010. The additional capacity expands SAFC's contract manufacturing capabilities in large-molecule recombinant proteins and small-molecule active pharmaceutical ingredients (APIs) through fermentation, including high-potent APIs and secondary metabolites. The fermentation expansion focuses on niche fermentation of APIs and bulk drugs, producing secondary metabolites, cytotoxins and large-molecule proteins.
ScinoPharm, a provider of active pharmaceutical ingredients (API) and contract research and manufacturing (CRAM) services, will provide commercial manufacturing services for the API vilazodone hydrochloride for the pharmaceutical company Clinical Data’s Viibryd. Viibryd is a new drug entity recently approved by FDA for the treatment of adults with major depressive disorder.