PROVEO Partnership Expands with Addition of Cerbios-Pharma and Oncotec Pharma for the Manufacture of ADCs

CMC Biologics A/S, a global leader in clinical and commercial manufacturing of monoclonal antibodies and other therapeutic proteins, and IDT Biologika GmbH, a privately-held life-science company with a 95 year history of expertise in research, development and manufacture of biologics for human and animal health, announced the addition of Cerbios-Pharma SA (“Cerbios”) and Oncotec Pharma Produktion GmbH (“Oncotec“) to PROVEO, their strategic collaboration for providing a complete and efficient solution to the market for the process development and manufacture of antibody drug conjugates (“ADCs”).

Within the PROVEO partnership, CMC Biologics provides monoclonal antibody production, and Cerbios performs process development, manufacture of the cytotoxic drug-linker payload, and the conjugation services of the ADC drug substance. Oncotec provides aseptic fill and lyophilization of the ADC drug product, and IDT Biologika performs analytical services, supply chain and secondary packaging through to ready-to-deliver final drug product. These services will be available in early 2017 and will further complete PROVEO’s full ADC service offering.

“We are pleased to join CMC Biologics and IDT Biologika in the development and production of ADCs,” said Gabriel Haering, PhD, CEO of Cerbios. “Our extensive experience in the manufacture of cytotoxic

drug payloads and conjugation of antibodies will be valuable to clients utilizing the ADC services provided by the PROVEO partnership. Our approved Safebridge Category 4, GMP facility in Lugano was designed to accommodate the complex processes needed for production of very potent active ingredients including cytotoxics like ADCs.”

“Cerbios brings two decades of experience working with highly potent cytotoxic compounds and will provide a valuable addition to the ADC services offered by our PROVEO partnership,” said Gustavo Mahler, PhD, CEO of CMC Biologics.

Dr. Ralf Pfirmann, CEO of IDT Biologika, added, “We will leverage Cerbios’ experience with cytotoxic payloads to round out the ADC services that we offer to our clients. We are also pleased to bring our sister company, Oncotec, into the PROVEO partnership, which will further strengthen the team and provide essential drug product expertise and capacity.”

With the addition of these partners, PROVEO now has all necessary competencies, assets and proven experience that are urgently needed by the market for the development and manufacture of complex ADCs, from Drug Substance to Final Drug Product. Additionally, as part of the integrated offering, PROVEO provides Project Management, Supply Chain System, and Quality Systems for its clients.