CMC Biologics and IDT Biologika Collaborate on ADC Manufacturing

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PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-04-06-2016, Volume 11, Issue 4

Collaboration will provide for unified development and manufacture of antibody drug conjugates.

CMC Biologics, a clinical and commercial manufacturer of monoclonal antibodies and other therapeutic proteins, and IDT Biologika GmbH, a contract research, development, and manufacturing service provider of biologics for human and animal health, announced in February 2016 the formation of a strategic collaboration to manufacture antibody drug conjugates (ADCs).

CMC Biologics will perform process development and manufacture of the bulk monoclonal antibody. IDT Biologika will perform services from conjugation of the cytotoxic drug to the antibody substance through to the aseptic fill, finish, and packaging of the ADC final drug product. Initial services will become available to clients in April 2016.

The joint manufacturing efforts will provide speed, reliability, quality ADC manufacturing and a simplified supply chain, from DNA to finished drug product, for clinical trials and beyond through commercial manufacturing, the companies report in a press statement.