Samsung Biologics, a leading contract development and manufacturing organization and Enzolytics (ENZC), a drug development company committed to commercializing multiple proprietary therapeutics to treat debilitating infectious diseases, announced the signing of a strategic CDMO partnership agreement.
Under the terms of the agreement, Samsung Biologics will provide end-to-end CDMO services from cell line development, clinical drug substance, and drug product manufacturing services to support IND filings for Anti-HIV and Anti-SARS-CoV-2 Monoclonal Antibodies for the treatment of HIV and SARS-CoV-2. In addition, there will be continuing discussions for other Monoclonal Antibodies being developed by Enzolytics.
The Enzolytics protocol offers the opportunity to implement A.I. analysis and provides a platform for creating multiple fully human Monoclonal Antibodies targeting conserved immutable sites on the virus and offering a cure for these viruses. A stable cell line will be manufactured with support from Samsung Biologics' R&D Center in San Francisco. Its related clinical trial materials will be manufactured at Samsung Biologics headquarters in Incheon, South Korea.
“Partnering with Enzolytics reinforces the value of our fully integrated, end-to-end business model, which is designed to meet the unique needs and goals of our biotech clients,” said John Rim, CEO of Samsung Biologics. “We look forward to providing comprehensive services and professional support for the manufacturing of this important class of Monoclonal Antibody therapeutics for the treatment of HIV and SARS-CoV-2, helping to accelerate the process of drug development to IND filing and bring these life-saving products to patients.”
"The collaboration with Samsung Biologics is a significant milestone for Enzolytics' Artificial Intelligence enabled Monoclonal Antibody Platform. We chose to partner with Samsung Biologics because of Samsung Biologics' extensive experience and expertise in developing, producing, and manufacturing Monoclonal Antibodies for Infectious Diseases and Oncology.” said Dr. Gaurav Chandra, Chief Operating Officer Research and Development at Enzolytics. “This partnership marks a pivotal milestone for Enzolytics to significantly advance the clinical development of our universal, durable, broadly neutralizing Monoclonal Antibodies and reduce time to the clinic and offer the much-needed treatment for patients."