Inside INFORMEX: Evaluating the Market for Contract API Manufacturing - Pharmaceutical Technology

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PharmTech Europe

Inside INFORMEX: Evaluating the Market for Contract API Manufacturing
Contract API manufacturers and fine-chemical producers roll out capacity and service expansions.

Pharmaceutical Technology
Volume 36, Issue 4, pp. 132-134

Acquisitions and partnerships

Some contract API manufacturers also recently expanded to support biopharmaceutical development and manufacturing. For example, SAFC reported on its recent $350-million acquisition of BioReliance, a provider of global biopharmaceutical testing services, from Avista Capital Partners. BioReliance provides biologic, specialized toxicology, and animal-health testing to pharmaceutical, biopharmaceutical, diagnostics, and other life-science companies.

BioReliance employs more than 650 people and is headquartered in Rockville, Maryland, with additional operations in Glasgow and Stirling, Scotland, and sales offices in Tokyo, Japan, and Bangalore, India. The acquisition complements SAFC's industrial media position, and its CompoZr zinc finger nuclease technology is synergistic with BioReliance's toxicology and animal-health services operations for the development of new assays, cell lines, and animal models, according to the company.

Carbogen Amcis recently acquired Creapharm Parenterals, a subsidiary of France-based Creapharm Group and a CDMO specializing in liquid, semisolid, and injectable aseptic dosage forms. Creapharm Parenterals employs 16 specialists and operates a GMP manufacturing site in Riom, France.

Solvias and RohnerChem reported on their partnership for custom research and manufacturing services, which was announced in October 2011. The preferred but nonexclusive partnership provides services from route scouting to commercial manufacturing. Solvias brings expertise in chemical, analytical and solid-state development, and RohnerChem brings experience in scale-up and commercial-scale custom synthesis of complex, small-molecule fine chemicals and APIs.

Key capabilities from Solvias include high-throughput screening methods, which have been used in asymmetric homogeneous catalysis, CX-couplings, racemate resolutions, carbonylations, hydroformylations, biocatalysis development, and various other transformations. Solvias' solid-state development group also is equipped to assist in developing crystallization processes, perform polymorphism studies, and provide guidance in the development of the best solid form for an API. After process optimization, which can be performed either at Solvias' or at RohnerChem's kilo laboratories, commercial quantities can be manufactured at RohnerChem facilities.

In January, evocatal, a biocatalysis provider, and RohnerChem formed a strategic partnership in biocatalysis with evocatal providing its biocatalysis experitse and RohnerChem manufacturing expertise.

Service expansions

BASF has opened an industrial biotechnology and microbiology research center in Tarrytown, New York. The company uses biotechnological methods to produce products such as vitamins, enzymes, pharmaceutical intermediates, and specialties for the personal care, food and feed industries. One focus of the research laboratory work is to develop more efficient and resource-conserving production processes. The use of metabolic engineering, or the targeted modification of metabolism, is used to enhance the efficiency of the microorganisms used in these production processes. The laboratory also will be used to develop bacterial biofilms.

DSM reported on InnoSyn, a route-scouting service that supports R&D as well as implementation of economical and scalable routes. The service offering includes consulting, route scouting, biocatalyst/catalyst screening, prefeasibility studies, full feasibility studies, mini-plant campaigns, and support in transfer and implementation. Various technical packages are provided for biocatalysis, homogeneous catalysis, organic chemistry and process R&D and continuous chemistry (i.e., microreactor technology).

Neuland Laboratories, a contract manufacturer of APIs, intermediates, and peptides, launched a new mobile app version of its GuarD project-management system. GuarD was developed to support customers' participation in project planning and real-time tracking. GuarD uses the principles of critical-chain project management, which emphasizes resource availability and flexibility to maintain project timelines. GuarD allows for a detailed project plan that is viewable in an online template to provide a customer progress of its project, information on the latest task updates, expected time of completion, and other information important to the project.

Patricia Van Arnum is a executive editor at Pharmaceutical Technology, 485 Route One South, Bldg F, First Floor, Iselin, NJ 08830 tel. 732.346.3072,


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