A critical challenge is emerging in cell therapy manufacturing: tacit knowledge — the unwritten, experience-based expertise that makes a process work — is frequently lost during technology transfer from R&D to contract development and manufacturing organizations (CDMOs). This problem is intensifying as CDMOs cut staff, eroding the institutional memory needed to replicate complex biological processes reliably.
Technology transfer is the formal movement of documented procedures and know-how between units, such as from a pilot plant to a manufacturing site. However, according to a report cited by Drug Discovery & Development, over 86% of cell therapy companies faced tech transfer difficulties as of 2022, with tacit knowledge gaps being a primary culprit. Unlike explicit instructions, this expertise resides in experienced scientists and operators who may not be part of the transfer process.
The stakes are high for a field racing to scale from boutique production to commercial volumes. Lost know-how can delay approvals, increase batch failures, and raise costs — at a time when the industry is already under financial pressure. CDMO workforce reductions compound the risk, as departing staff take critical process insights with them.
Industry leaders are exploring solutions such as extended on-site training, digital knowledge capture tools, and structured mentorship programs. But these measures require investment that many cash-strapped developers and manufacturers are reluctant to make.
A counterargument holds that automation and closed-system manufacturing platforms can reduce reliance on human expertise, potentially making tacit knowledge less essential over time. However, these systems themselves require deep process understanding to design and validate, suggesting the challenge has no quick fix.