US Pharma MarketingAs cell therapies scale and CDMOs cut staff, tacit manufacturing know-how can be lost in tech transfer, raising risks for quality and scale-up. As of 2022, over 86% of biopharma companies outsource at least some activities. While this helps mitigate risks and accelerate timelines, it also necessitates technology transfer, where tacit knowledge is lost. “Technology transfer occurs repeatedly across the lifecycle: from CMC development to first GMP clinical supply, and further down to commercial scale, between manufacturing sites and even post-approval when capacity, network or process/method changes are required, with appropriate comparability and regulatory support,” said Ryan Chen, director of…
Technology transfer enables the movement of documented processes and knowledge from one unit, such as R&D, a pilot plant or an existing manufacturing site, to another, such as an internal site, CMO or CDMO. However, tacit knowledge, expertise that can’t be written down, is often lost in the process. As of 2022, over 86% of…
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Source: Drug Discovery & Development