The key objective of the transfer is to run the manufacturing process at the receiving site with no or minimal changes from the original process developed at the sending site. Therefore, most of the responsibilities lie with the technology-receiving site. This makes the technology transfer of a biopharmaceutical manufacturing process challenging and any deficiency in technology transfer results in serious loss of time and resources. Although a transferred process should ideally remain the same as the original, in practice the process always undergoes some adaptation at the receiving site, mostly due to the difference in equipment between the sending and receiving sites as well as the need for scale-up of the entire process. The success of technology transfer relies primarily on the adaptability of the production process itself as well as communication between sending and receiving sites. A systematic transfer methodology provides the best chance of a successful technology transfer. This presentation will deal with some of these challenges and how to implement a successful transfer.
Sarel Chen Tov is expert in design and construction of API, Pharma and Biotech projects to FDA / EMEA standards and has near 20+ years of experience. During the years he obtained a unique expertise in efficient and innovative plant design to suit the business case, optimize Capex and Opex providing the client a competitive edge in the marketplace. He is globally renowned name in Pharma & Biotech industry for his expertise in Process & Layout Designs, scale-up and Technology Transfer.