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GEN News Highlights : Oct 24, 2012

Partnership Offers Seamless ADC Development and Manufacturing

Fujifilm Diosynth Biotechnologies and Piramal Healthcare in the U.K. are pooling their expertise to offer what they claim is a seamless contract development and manufacturing service for antibody drug conjugates (ADCs). Diosynth is a global contract development and manufacturing business for biopharmaceuticals. Piramal has specialist expertise in the ADC field.

Diosynth says the partnership is part of an ongoing program to expand its capabilities in the field of mammalian-based biotherapeutics. “This strategic alliance with Piramal is an important step for us in bringing a new, high-technology offering to the marketplace,” states Stephen Taylor, commercial vp. “Our customers will benefit from high-quality, consistent material, rapid service, and shorter logistical chains, saving time on the critical path of drug development.”

Piramal’s Pharma Solutions CMO business offers a full range of API and formulation services, and specialist expertise in ADCs that spans process development, optimization, and characterization, to preclinical and toxicology batch preparations. The company also offers GMP manufacture for clinical and commercial-scale, together with analytical and bioanalytical method technology transfer, development and validation, stability study design and execution for bulk substances and finished drug products, and full QA and regulatory support. The firm has experience with a range of ADC platforms and major conjugation chemistries for linking proteins, peptides, and oligosaccharides to antibodies.