LEVERAGING A TECHNICAL PARTNERSHIP TO DELIVER HIGH TITER BIOLOGICS MANUFACTURING

摘要

Biogen has two of the best legacy manufacture facilities in Research Triangle Park, North Carolina and Hillerod, Denmark, and are able to maintain many well-established partnerships with different companies, who utilize these facilities and work collaboratively to bring many products to market. Biogen not only delivers extraordinary performance in technology transfer, engineering instrumentation, and manufacturing operation, but also has a very strong technical development platform that can generate high biologies titer in the internal and biosimilar programs. Among partnership-based manufacturing experiences, some molecules have high clinical demand but relatively low titer output, which can require high volume and frequency in manufacture capacity; this low output might also require partners to engage more than one CMO and complicate the technology transfer and supply chain. Biogen has thus invested technical development resources in upstream, downstream and analytical development, all working together to develop high titer processes in numerous programs. Regardless of the challenge of multiple different cell lines which originally required different medium and processes, Biogen has shown the ability to successfully triple the titer and maintain comparable product quality in the new development. This collaboration not only utilizes the strength from each side of the partnership, but also exchanges the expertise from technical teams, facilitates technology transfer, enhances the manufacturing support and opens more capacity in the manufacturing facilities for the other programs in need.