Earlier this week, at the start of 7th World ADC in San Diego, CA, Danish CMC Biologics, a global leader in clinical and commercial manufacturing of monoclonal antibodies and other therapeutic proteins, and Germany based IDT Biologika, 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 headquartered in Dessau, Germany, announced that the Cerbios-Pharma, located in Lugano, Switzerland, and Oncotec Pharma Produktion to join PROVEO™, a strategic collaboration set up to provide a complete and efficient solution for the process development and manufacture of antibody-drug conjugates.


“…the addition of these companies to the PROVEO partnership gives us all necessary competencies, assets and proven experience that are urgently needed by the market for the development and manufacture of complex antibody-drug conjugates…”


Each of the in PROVEO partnering companies will have a specific role in the development an manufacturing of ADCs.

CMC Biologics, which has three facilities in the USA and Europeprovides 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.

MabPlex
 

Proven Expertise
CMC Biologics’ proven expertise, benefiting the PROVEO partnership, is delivering custom solutions for the scale-up and cGMP manufacture of proteinbased therapeutics for pre-clinical, clinical trials and commercial production.

cmc-biologics-strategic-adc-alliance
Figure 1.0: Strategic collaboration in the PROVEO Partnership. Courtesy: © CMC Biologics A/S. Used with Permission.

“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 accomodate the complex processes needed for production of very potent active ingredients including cytotoxics like ADCs, Haering added.

“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,” added Gustavo Mahler, PhD, CEO of CMC Biologics.

“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,” Dr. Ralf Pfirmann, CEO of IDT Biologika, further added.

One of the key specialties of Cerbios is that the company provides full CMC support to its world-wide partners, including the supply of cGMP clinical batches, registration/validation material and commercially manufactured APIs. Paramount to this is the ability to supply all of the technical documentation and support necessary for a successful registration.

The collaboration with Oncotec, which specializes in filling of cytostatic liquids and lyophilisates in vials as well as cytostatic liquids in syringes, is, according the initiators, also of paramount importance . The state-of-the-art technology and equipment assures that ADC processing is conducted with the highest safety and quality standards.

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 intergrated offering, PROVEO provides Project Management, Supply Chain System, and Quality Systems for its clients.


Note: IDT Biologika is a portfolio company of the Klocke Grupp. The other Klocke portfolio companies specialize in contract manufacturing and packaging of pharmaceuticals and cosmetic products. Klocke Holding also owns a 50% stake in Oncotec Pharma Produktion.