Alliance will provide an efficient end-to-end solution for the development and manufacture of ADCs
CMC Biologics, a global leader in the clinical and commercial production of monoclonal antibodies and other therapeutic proteins, and IDT Biologika GmbH, a privately held life-science company with 95 years of expertise in the research, development and manufacture of biologics for human and animal health, have formed a strategic collaboration to provide a complete and efficient solution for the manufacture of antibody drug conjugates (ADCs).
Within the collaboration, CMC Biologics will perform process development and produce the bulk monoclonal antibody, and IDT Biologika will offer services including conjugation of the cytotoxic drug to the antibody substance through to the aseptic fill, finish and packaging of the ADC final drug product.
This joint manufacturing solution will provide speed, reliability, quality ADC manufacturing and a simplified supply chain, from DNA to finished drug product, for clinical trials and beyond.
‘The collaboration with CMC Biologics is an important step towards providing full ADC manufacturing services to meet the needs of ADC development and production in this rapidly growing field,’ said Dr Ralf Pfirmann, Chief Executive Officer of IDT Biologika. ‘Our new collaboration enables IDT Biologika to leverage its biologics and cytotoxics capabilities and facilities to provide ADC developers with a highly reliable and efficient solution for early process development through to clinical and commercial manufacturing. We see this as an important undertaking to make a meaningful difference in human health.’
‘We are delighted to be working with IDT Biologika, one of the fastest growing and innovative CMOs in Germany and now in North America,’ said Gustavo Mahler, PhD, Chief Executive Officer of CMC Biologics. ‘We share common values with IDT Biologika, such as a constant focus on manufacturing excellence and dedication to customer service.’