Fujifilm, Piramal simplify complexities

MORRISVILLE, N.C.—Recognizing a "growing niche in thedevelopment of biopharmaceuticals," Fujifilm Diosynth Biotechnologies in lateOctober entered into a strategic alliance with Piramal Healthcare UK Ltd.,under which the two companies will offer what they call "the seamless contractdevelopment and manufacture" of antibody-drug conjugates (ADCs).

The pair maintains that the deal will allow customers tobenefit from the experience and assets of both organizations, while simplifyingthe supply chain and vendor management relationships, leading to shorter timeto clinic.

For Fujifilm Diosynth Biotechnologies, this alliance is partof an ongoing program to expand its offering in mammalian-basedbiopharmaceuticals. The company recently announced an expansion of its cGMPmanufacturing facilities at its sites both in Research Triangle Park, N.C., inthe United States and Billingham in the United Kingdom.

Pointing to the respective strengths of the alliedcompanies, Fujifilm Diosynth Biotechnologies points out that it is one of theworld's leading providers of contract development and manufacturing servicesfor biopharmaceuticals, while Piramal is a world leader in antibody-drugconjugation. Their combined experience includes work on more than 150 biopharmaceuticals,as well as more than 300 batches of ADCs spanning more than 30 different newchemical entities, including the world's only FDA-approved ADC.

"We started talking in March," recalls Dr. Mark Douglas,director of strategic business development for Fujifilm DiosynthBiotechnologies. "We wanted to extend our business and realized that excitingthings were happening in the ADC space and Piramal was involved in a lot ofthat excitement. We had encouragement from a lot of customers to establish asort of one-stop shop offering, and they really wanted us to give that a go,especially if it was going to be with Piramal."

"From the Piramal perspective, we were just starting to lookat establishing collaborative partnerships with other parts of the ADC supplychain," adds Piramal's Aidan Walker, who is president of Formulations Services."While we had a strong position in conjugation chemistry, we had nocapabilities in biologics or API, for example, and many of our customers hadconcerns about the complexity of the supply chain. They wanted that supplychain simplified, and pairing with Fujifilm achieved that."

Fujifilm Diosynth Biotechnologies touts extensive experiencein the development and manufacturing of recombinant proteins, vaccines andmonoclonal antibodies, among other large molecules expressed in a wide array ofmicrobial, mammalian and insect systems. The company offers a comprehensivelist of services from cell line development, including its proprietary pAVEwaysystem to process development, analytical development, clinical and commercialmanufacturing.

For its part, Piramal Healthcare UK's parent company,Piramal Enterprises, is one of India's largest diversified companies, with apresence in pharmaceutical, diagnostics, healthcare financial services andinformation management sectors.

"We are delighted to combine with Fujifilm DiosynthBiotechnologies to offer a seamless service to customers for the production ofantibody conjugates," Walker noted in the news release announcing the deal."Fujifilm Diosynth Biotechnologies has a long track-record in deliveringsuccessful biologics programs, and this alliance will combine strengths fromboth companies for the benefit of our customers, and ultimately patients."

In the same news release, Stephen Taylor, commercial vicepresident of Fujifilm Diosynth Biotechnologies, said, "This strategic alliancewith Piramal is an important step for us in bringing a new, high-technologyoffering to the marketplace. Our customers will benefit from high quality,consistent material, rapid service and shorter logistical chains, saving timeon the critical path of drug development. Piramal is a recognized world-leaderin this area and we are delighted to be partnering with them."