This technology is a method for purifying a biologic composition, comprising diafiltering the biologic composition into a composition comprising phosphate buffered saline (PBS) to obtain a purified composition. The method is particularly useful for removing one or more impurities from the biologic composition, such as bis(2-hydroxyethyl)amino-tris(hydroxymethyl)methane (Bis-tris).The technology is directed to large scale manufacturing of Chimeric 14.18 (Ch14.18) monoclonal antibodies. Ch14.18 is an anti-GD2 monoclonal antibody and has been described in Gillies et al., Journal of Immunological Methods 125:191-202 (1989) and US Patent 5,541,087.
FDA/EMA approved Chemistry, Manufacturing and Controls (CMC) large scale manufacturing to produce GMP grade chimeric antibodies. See FDA Press Release: "FDA approves first therapy for high-risk neuroblastoma"
- Large scale manufacturing of chimeric monoclonal antibodies
- Cost effective means of removing impurities to produce GMP grade chimeric antibodies for regulatory approval.
David A. Meh (United Therapeutics Corp.), Timothy Atolagbe (United Therapeutics Corp.), Mark Farquharson (NCI), Samir Shaban (NCI), Mary Koleck (NCI), George Mitra (NCI)
- U.S. Provisional: U.S. Provisional Patent Application Number 14/809,211, Filed 25 Jul 2015
- PCT: PCT Application Number PCT/US2015/042241, Filed 27 Jul 2015