Guest Blog: Introduction to Technology Transfer
Jennifer Shi, Director of GenScript ProBio Antibody Manufacturing Department, talks about technology transfer in biologics manufacturing.
As defined in ICH Q10, the aim of technology transfer is to achieve the commercial objectives of a product by transferring the product and process knowledge between R&D and production, either within one production site or between two production sites. This knowledge contributes to the foundation of bioprocess, control strategies, process validation methods and continuous improvement. Technology transfer occurs throughout the life cycle of biotherapeutics, so it is important for any company.
Usually, the whole process can be divided into four steps. Firstly, our management team will evaluate the feasibility. The feasibility study includes project feasibility, quality agreement, building a technology transfer team and acceptable transfer standard establishment. As the premise of technology transfer, it should be finished before the beginning of project transfer. Plus, adequate information exchange is the basis of a successful technology transfer. After passing the assessment, the sending unit and receiving unit should exchange information and develop the technology transfer plan through analyzing the gap of equipment, consumables, process, and personnel according the collected information. Risk assessment and risk mitigation plan are necessary for a comprehensive technology transfer plan. The third step is technology transfer implementation, including analytical method transfer, process transfer, clean process transfer and successfully performed corresponding engineering batch and validation batch. Finally, we will complete the technology transfer report according to the assessment of similarity of process and comparability of product quality.
At GenScript ProBio, we believe that adequate information exchange at the second step is very important during the whole technology transfer process. Therefore, for full document and information transfer, we pay special attention to several key points. For example, analytical method transfer includes raw materials, in-process control, drug substance and drug product release test method and validation report, list of all analytical equipment, essential reagents and consumables. Development process is also one of our focus, including process development report, process description, batch record, equipment list, essential materials list, CQA assessment, CPP and semi-finished products stability.
In clinical phase II&III, we also take the validation into consideration, including process validation, column lifetime study, transportation validation report, storage validation report, compatibility report of packaging materials and biosafety- related validation report.
Last but not least, the documents required in the transfer process are complicated, so we suggest that the sending unit and receiving unit prepare technology transfer document list in advance and make confirmation according to the list. For example, during the analytical method transfer, the required files includes Reference quality standard and CoA, DS/DP release test SOP, DS/DP release test validation report and DS/DP release test development report.
GenScript ProBio provides GMP clinical manufacturing service for worldwide clients. The technology transfer team has established a comprehensive and refined technology transfer process and has implemented comprehensive risk control in the technology transfer process, which ensures the smooth transfer of customer projects and successful production.