Cook Pharmica LLC is a biopharmaceutical contract manufacturer of mammalian cell-culture products. Cook Pharmica’s mission is to provide process development, flexible manufacturing and analytical services to the global biotech community; enabling its partners to bring their life saving discoveries to patients. Founded in 2004, Cook Pharmica is a privately held, wholly-owned subsidiary of Cook Incorporated.
The award-winning CGMP manufacturing facility was designed to support clinical and small-scale commercial products. Within the manufacturing area are two (2) 2,500L, one (1) 600L stainless steel bioreactors, and disposable bioreactors ranging in size up to 100L. The facility’s design incorporates disposable technologies, segregated production rooms, innovative wall pass-throughs and uni-directional flow of operators, equipment and supplies to reduce the risk of contamination.
Cook Pharmica’s development group offers a variety of mammalian and microbial development services, such as: cell line/strain development, clone selection, cell line adaptation, media optimization, process development, purification development, analytical development and pre-clinical manufacturing.
Additional contract services offered are analytical and microbial testing, CGMP cell banking, stability storage and testing, and regulatory assistance with submissions.
In February 2008, Cook Pharmica announced an $80 million expansion into parenteral formulation, filling, and finishing, targeted to be online in early 2010. The expansion will include syringe, liquid and lyophilized vial filling and finishing, formulation development and will utilize isolator technology. The addition of these services will enable Cook Pharmica to be a full-service contract manufacturer in one location.
Centrally located in Bloomington, Indiana, Cook Pharmica offers a new level of transparency by giving clients the opportunity to monitor projects when away from the facility through secure Internet webcams positioned to give full visibility at each stage of production. Cook Pharmica is committed to maintaining strict compliance to regulatory agency guidelines and CGMP procedures as well as providing the highest levels of quality assurance and quality control in all functions of our facility.