Introduction to Technology Transfer

This activity introduces the key principles of technology transfer in bioproduction, explaining the industrial challenges related to scale-up, site change, or lifecycle phase transition. It presents the main stages of the process—preparation, implementation, and validation—the success criteria (quality, cost, timelines), as well as structuring documents such as the control strategy and the transfer master plan.

This activity presents the GARAMP method (Gap Assessment, Risk Assessment and Mitigation Plan), used to anticipate discrepancies between the sending and receiving units during a technology transfer. It details the steps of gap identification, risk evaluation (using tools such as FMEA), and the development of a remediation plan, in alignment with regulatory frameworks such as ICH Q9.

This activity explores the key steps involved in the preparation and implementation of a technology transfer: qualification of raw materials, equipment, and critical utilities, manufacturing documentation, personnel training, analytical validation, and execution of the first technical batches. It highlights the necessary conditions to ensure process reproducibility at the receiving unit.

This activity presents the foundations of process validation (PPQ) and comparability studies, which are essential to demonstrate that the product resulting from the transferred process remains compliant in terms of quality, safety, and efficacy. It describes the three stages of validation—design, qualification, and continued verification—and details the analytical methods used to assess comparability.