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With technology transfer, expertise is essential

With technology transfer, expertise is essential

As with any complex and intricate action involving high-quality GMP-conforming clinical manufacturing, detailed planning and reliable execution within time and budget is required. Numerous steps and challenges including strict regulatory requirements and extreme attention to detail are critical for a successful transfer. Because multiple partners and sites are involved, the best approach is often working with a skilled partner with considerable experience in transferring aseptic manufacturing processes, necessary systems, routine and management skills.

The choice of a skilled outsourcing partner is critical to ensuring the successful transfer of a drug product. Because every transfer is associated with its own set of issues, its complexities should never be underestimated. Be certain that the company offers a detailed gap analysis and has significant experience and analytical methods for process design and development. The execution of Risk Analysis requires experts to identify the relevant degree of detail. Its success is largely dependent on the skill and performance of individuals assigned to the project as well as the experience of the transferring team. Be certain that the appropriate individuals are involved from the start.