(68e) Technology Transfer of Pharmaceutical Freeze-Dried Sterile Liquid Manufacturing - A Case Study

A pharmaceutical freeze-dried sterile injectable liquid has been produced at the same manufacturing site for the past 40 years. This unique product has never been commercially manufactured at any other site since its inception. Since manufacturing at the current site is being discontinued, production needs to be transferred to a new site. Initial experimental attempts to transfer the current process to the new site have been unsuccessful. Although the manufacturing processes at both sites are very similar, transfer of the freeze-drying cycle has been problematic. The physical form of the freeze-dried product at the new site has not been comparable to the current site and has not met acceptance criteria. Since the new site will be the only site for worldwide production, the new manufacturing process needs to be harmonized (demonstrating that the new process yields final drug product equivalent to the currently marketed product). Process equivalence is also important to demonstrate for the required FDA and multinational filings before the new site can be approved. This paper discusses the key challenges of transferring the freeze-drying cycle and lessons learned during the technology transfer process.