Cook Pharmica LLC

Who We Are

Cook Pharmica, a contract development and manufacturing organization (CDMO), offers manufacturing of cell culture-based biopharmaceuticals. We provide development services, CGMP cell banking and storage, analytical testing, CGMP manufacturing, and stability storage/testing. The current CGMP manufacturing facility has a small-scale train with a capacity up to 250 L that features disposable technologies, and a large-scale train that can support manufacturing needs with two 2,500 L bioreactors.

Our development services comprise cell/strain development, cloning, media optimization, process development, creation of non-CGMP cell banks, analytical development and method validation. Our service portfolio includes development services for formulation/lyophilization, clinical and commercial manufacturing for prefilled syringes/vials, and final packaging.

Major Markets

Cook Pharmica serves the biotech and pharmaceutical industries.

Services Offered

Development Services

• Cell line/strain development
• Clone selection
• Cell line adaptation
• Media optimization
• Process development
• Purification development
• Analytical development
• Preclinical manufacturing

CGMP Mammalian Cell Culture Manufacturing

• Clinical and small-scale commercial manufacturing up to 5,000 L
• Early clinical manufacturing up to 250 L using single-use bioreactor technology
• Multiple disposable bioreactors with capacity up to 100 L
• Cell banking and storage

Additional Services

• QC analytical testing
• Stability testing and storage
• Future parenteral manufacturing services

Cook Pharmica 2009 Brochure

Small-Scale API Manufacturing Fact Sheet