Cook Pharmica is a full-service biopharmaceutical contract manufacturer located in Bloomington, IN. Cook Pharmica’s mission is to provide process development, flexible manufacturing, and comprehensive analytical services to the global biotech community; enabling its partners to bring their life-saving discoveries to patients. And with the recent announcement of its expansion into parenteral contract manufacturing, Cook Pharmica will serve the industry as a complete one-source solution.
The current API manufacturing facility was designed to support clinical and small-scale commercial products and features two 2,500-L stainless steel bioreactors. The facility’s design incorporates disposable technologies, segregated production rooms, innovative wall pass-throughs, and unidirectional flow of operators, and equipment and supplies to reduce the risk of contamination. An additional small-scale CGMP API manufacturing train provides up to 250 L capacity in disposable bioreactors.
Cook Pharmica’s development group offers a variety of mammalian and microbial development services, such as cell line or strain development, clone selection, cell line adaptation, media optimization, process development, purification development, analytical development, and preclinical manufacturing.
Additional contract services offered are analytical and microbial testing, CGMP cell banking and storage, stability testing and storage, and regulatory assistance with submissions.
In early 2010, Cook Pharmica will offer parenteral contract manufacturing capabilities including syringe and vial filling and finishing. This expansion demonstrates Cook Pharmica’s commitment to expand its services to meet the needs of customers and the biotech industry. The fill–finish expansion will include the same levels of transparency provided in API manufacturing operations. Clients will have the opportunity to monitor projects through secure internet webcams positioned to give full visibility at each stage of production.
Let Cook Pharmica change your view on outsourcing.