Large-scale Purification of GMP Chimeric Antibodies

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 (B is-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"  IC: United Therapeutics Corp.NIH Ref. No.: E-291-2014Advantages: Cost effective means of removing impurities to produce GMP grade chimeric antibodies for regulatory approval.Applications: Large scale manufacturing of chimeric monoclonal antibodiesDevelopment Status: ClinicalUpdated On: Nov 13, 2018Provider Classifications: Publications: Patent Application: 14/809,211PCT/US2015/042241Patent Authority: USLicensing Contacts: Lead Inventor: Inventor IC: United Therapeutics Corp.United Therapeutics Corp.NCINCINCINCIInventor Lab URL: https://frederick.cancer.gov/...
Source: NIH OTT Licensing Opportunities - Category: Research Authors: Source Type: research