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Large-scale Purification of GMP Chimeric Antibodies

The National Cancer Institute seeks partners to license or co-develop an FDA/EMA-approved Chemistry, Manufacturing and Controls (CMC) large-scale manufacturing process for the production of GMP-grade chimeric antibodies.
NIH Reference Number
Product Type
  • GMP Manufacturing, Chimeric Monoclonal Antibodies, Unituxin™, Neuroblastoma
Collaboration Opportunity
This invention is available for licensing and co-development.
Description of Technology

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

Potential Commercial Applications
  • Large scale manufacturing of chimeric monoclonal antibodies
Competitive Advantages
  • 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)

Development Stage
Patent Status
  • 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
Therapeutic Area
Tuesday, November 13, 2018