Cerbios joins PROVEO™ consortium to pioneer fully integrated ADC manufacture

Lugano, Switzerland: – High-tech Swiss-based CDMO Cerbios-Pharma SA (Cerbios) has announced it is joining Danish and German partners to strengthen the PROVEO™ consortium dedicated to fully integrated end-to-end antibody drug conjugate (ADC) manufacture.

The new PROVEO™ consortium will provide a complete and efficient solution to the market for the process development and full finish manufacture of antibody drug conjugates (ADCs).

Alongside Cerbios, PROVEO includes Denmark’s CMC Biologics A/S, a global leader in clinical and commercial manufacturing of monoclonal antibodies and other therapeutic proteins, together with two German companies, 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, and Oncotec Pharma Produktion GmbH, a world-recognized developer and manufacturer of aseptically produced cytostatic drugs.

Monoclonal antibody production

Within the PROVEO partnership, CMC Biologics will provide monoclonal antibody production, with Cerbios performing process development and manufacture of the cytotoxic drug-linker payload, as well as the conjugation services of the ADC drug substance. Oncotec will provide aseptic fill and lyophilization of the ADC drug product, while IDT Biologika contributes analytical and quality services, supply chain and secondary packaging through to ready-to-deliver final drug product.

These services will be available in early 2017 to complete PROVEO’s full ADC service offering.

Cerbios-Pharma CEO, Dr. Gabriel Haering, commented: “We are pleased to join CMC Biologics and IDT Biologika in the development and production of ADCs.”

Cytotoxic payload and conjugation

“Our extensive experience in the manufacture of cytotoxic drug payloads and conjugation to antibodies will be valuable to clients utilizing the ADC services provided by the PROVEO partnership,” said Dr. Haering.

“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,” he noted.

Cerbios participation in PROVEO was also welcomed by its consortium partners.

“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 Dr. Gustavo Mahler, CEO of CMC Biologics.

End-to-end ADC service

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 all four partners on board, PROVEO now has all necessary competencies, assets and proven experience demanded by the market for end-to-end development and manufacture of complex ADCs, from Drug Substance to Final Drug Product. Additionally, as part of the integrated offering, PROVEO can provide project management, supply chain and quality assurance services.

About Cerbios-Pharma

Cerbios-Pharma SA is a privately held company located in Lugano, Switzerland, that specializes in the development and manufacture of both chemical and biological APIs for its partners worldwide. Cerbios specializes in the development and production of high potency active pharmaceutical ingredients (HPAPIs) in the area of fine chemicals and biologicals.

Cerbios Chemical Division offers exclusive, third party manufacturing services for HPAIs while Biological Division produces monoclonal antibodies, recombinant proteins and pharma probiotics.

Cerbios provides full CMC support to its worldwide 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. Cerbios’ commercial products are marketed worldwide but primarily in Europe, USA, Japan and India.

About CMC Biologics

Danish-based CMC Biologics A/S is a CMO that provides fully integrated biopharmaceutical development and manufacturing solutions to clients globally. The company aspires to lead the CMO sector in customer satisfaction, technical excellence, and quality, under its ‘Right and On Time’ banner.

With three facilities in the USA and Europe, CMC Biologics has proven expertise and capability in delivering custom solutions for the scale-up and cGMP manufacture of protein-based therapeutics for pre-clinical, clinical trials and commercial production.

CMC’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 information at: www.cmcbiologics.com

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. Additionally, IDT provides fill, finish and packaging services for antibodies and proteins. It has expanded its longstanding expertise 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, with sales offices for its own animal health vaccines and biologics product portfolio in Denmark, the Netherlands, France, Spain and Canada. IDT Biologika is part of the Klocke Holding portfolio of companies specializing in contract manufacturing and packaging of pharmaceuticals and cosmetic products.

More information at: www.idt-biologika.com

About Oncotec

Oncotec Pharma Produktion GmbH is a cytotoxics development and manufacturing facility, located and integrated in IDT´s Dessau site. The company, 50% owned by Klocke Holding, is recognized for its specialization in manufacture and development of aseptically produced cytostatic drugs. Oncotec specializes in filling of cytostatic liquids and lyophilisates in vials as well as cytostatic liquids in syringes. Since its foundation in 1997, Oncotec has steadily increased production at Dessau, where it performs manufacturing steps using leading-edge technology production equipment, using state-of-the-art technology and equipment to assure that ADC processing is conducted to highest safety and quality standards.

More information at: www.oncotecpharma.de