CMC Biologics and IDT Biologika Announce a Strategic Collaboration to Manufacture Antibody Drug Conjugates

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 formation of a strategic collaboration to provide a complete and efficient solution for the manufacture of antibody drug conjugates (ADCs).

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Within this collaboration, CMC Biologics will perform process development and manufacture of the bulk monoclonal antibody and 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. 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 through commercial manufacturing. Additional details will be provided at the upcoming DCAT conference in March and initial services will become available to clients in April 2016.

"The collaboration with CMC Biologics is an important step to provide 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 permits IDT Biologika to leverage its biologics and cytotoxics capabilities and facilities, and their unique combination in the business, manufacturing and development portfolio at IDT´s Dessau headquarter site, to provide ADC developers with a highly reliable and efficient solution for early process development through clinical and commercial manufacturing based on our capabilities and experience. 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 the common values with IDT Biologika with a constant focus on manufacturing excellence and a dedication to customer service.”

About ADCs

Antibody Drug Conjugates are a class of therapeutic drugs consisting of a cytotoxic drug linked to a monoclonal antibody that represents one of the fasting growing segments of the pharma and biotech industry. Manufacture of ADCs poses unique and highly complex challenges, requiring clean room biologic and high containment cytotoxic facilities, often involving multiple vendors and providers. CMC Biologics and IDT Biologika will provide a unique complete manufacturing solution for developers of ADCs.

About IDT Biologika

IDT Biologika is an innovative life science company headquartered in Dessau, Germany with extensive expertise in research, development and manufacturing of vaccines, and in addition providing fill, finish and packaging services for antibodies and proteins. It has expanded its longstanding sought-after activity in vaccine development for Phase 1 and Phase 2 clinical projects for the human vaccine market through its recently acquired Rockville, USA facility. The company also operates vaccine development and manufacturing facilities in Riems, Germany and Cambridge, Canada and sales offices for its own animal health vaccines and biologics product portfolio in Denmark, the Netherlands, France, Spain and Canada. IDT Biologika is a portfolio company of the Klocke Holding. The other Klocke portfolio companies specialize in contract manufacturing and packaging of pharmaceuticals and cosmetic products. Klocke Holding also owns a 50 percent stake in Oncotec Pharma Produktion GmbH, a cytotoxics development and manufacturing facility, located and integrated in IDT´s Dessau site. More information can be found at www.idt-biologika.com.

About CMC Biologics

CMC Biologics is leading the industry among CMOs in customer satisfaction, technical excellence, and quality – Right and On Time. With three facilities in the USA and Europe, the Company provides fully integrated biopharmaceutical development and manufacturing solutions to clients globally. The Company has proven expertise in delivering custom solutions for the scale-up and cGMP manufacture of protein-based therapeutics for pre-clinical, clinical trials and commercial production. The Company’s wide range of integrated services includes cell line development, bioprocess development, formulation and comprehensive analytical testing. Clients can also benefit from CMC Biologics’ proprietary CHEF1^® expression system for mammalian production. More detailed information can be found at www.cmcbiologics.com.

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Contact information

IDT Biologika
Peter Kellner
Corporate Communications
+ 49 34901 885 5681
peter.kellner@idt-biologika.de
or
CMC Biologics
Robert Broeze, PhD
SVP, Global Business Development
+1 609-273-3414
bbroeze@cmcbio.com