Commercial Tech transfer: An opportunity for process and product improvement

While many CDMOs see technology transfer as a complex process that often goes wrong, we see it as a way to capture an advantage. In fact, we believe that when planned for and executed correctly, tech transfer can lower manufacturing costs and improve process robustness and efficiency.

Complete process validation in accordance with regulatory and cGMP guidelines is essential to the establishment of a reliable high-quality commercial supply. This includes:

  • Process validation with critical parameters
  • Validation of analytical assays
  • Hold time studies
  • Stability studies at required ICH conditions
  • Container shipment studies
  • Release testing
  • CMC documentation in CTD format

While technology transfers are commonly viewed as part of the normal course of business, at Thermo Fisher Scientific, we see them as an opportunity to use our integration and efficiency to give clients a strategic and financial advantage. When your transfer is urgent, we can execute it quickly and effectively to minimize interruption to your product supply.

In 2017, we successfully completed 185 technology transfers, with 44 for drug substance, three for development and 138 for commercial projects. In all cases, we are driven by your deadlines, flexible in our approach and determined to get your tech transfer right the first time, every time. It is with this approach we won the European Outsourcing Award for Most Effective Technical Transfer in 2008, 2010, 2011 and 2012.

We pride ourselves in our tech transfer experience and accuracy. Contact us to discuss a potential tech transfer for your project.

Download our whitepaper, “Technology Transfers: Reaping Rewards, Reducing Risks”