Four Major Milestones Of Tech Transfer

Successful technology transfer in biopharmaceutical manufacturing requires careful coordination across several key stages, beginning with the replication of existing processes and thorough documentation review. Ensuring that process steps are feasible and target outcomes achievable is critical in the early stages. Additionally, identifying and addressing process gaps through risk-based assessments is essential, particularly when considering long-term scalability and compliance with GMP regulations. Readiness evaluations play a crucial role, focusing on material sourcing, equipment validation, and ensuring sufficient skilled personnel. Once gaps are mitigated and readiness is confirmed, the execution phase involves verifying the ability to produce consistent, high-quality products that meet established specifications.

Learn how to master the key stages of technology transfer to ensure a smooth, compliant, and efficient transition from process replication to successful product execution by reading the full article below.