Goodwin Biotechnology, Inc., a biological Contract Development and Manufacturing Organization (CDMO) that specializes in bioprocess development and GMP manufacturing of biopharmaceuticals utilizing Mammalian Cell Culture expression systems and Bioconjugation technologies, has partnered with Q Therapeutics, Inc., a clinical-stage developer of novel cellular therapies for central nervous system (CNS) diseases to provide GMP antibodies for manufacture of clinical trial materials. To do so, Goodwin Biotechnology completed Process Development, Scale Up, and cGMP manufacturing of an IgM antibody and an IgM: Ligand…
Monday, July 13, 2015 Daily Archives
Compatibility Assessment of a Model Monoclonal Antibody Formulation in Glass and Blow–Fill–Seal Plastic Vials
PREPRINT October 2015 issue Blow–fill–seal (BFS) technology has been recognized by the industry as an advanced aseptic solution (1–3). Catalent Pharma Solutions has been commercially supplying sterile BFS products to the pharmaceutical industry for decades, primarily in the respiratory and topical ophthalmic markets. Such product formulations range from simple solutions to emulsions with drug substances from classical small molecules to large complex proteins such as biologics. The company also has optimized BFS processes and its Advasept plastic container system for…