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10 BioPharm International ® Manufacturing and Facilities eBook 2023 www.biopharminternational.com Manufacturing: Tech Transfer r un seamlessly. Figure 1 shows a n exa mple of a technolog y transfer plan standardization. To en- able an accelerated production timeline, CDMOs should have manufacturing processes built that take speed into consideration and with essential factors optimized before manufacturing begins— all to prevent possible delays. DP must meet strict reg u lator y r u les a nd must comply w it h a sept ic process standards as well as the claim of sterilit y on ever y dr ug product batch. A CDMO that has carefully built its manufacturing process to accelerate timelines will incorporate: • Media fills: media fill, or aseptic process simu- lation, assessments are authored by DP opera- tions and reviewed by quality assurance to en- sure routine and non-routine interventions (that may be included per a client process). Based on the assessment, the number of media fills will be determined either within a bracketing ap- proach. One client process-specific media fill is typically required to meet regulatory submission requirements, or conversely, three media fills if the process transferred is determined to be out- side of the bracketing approach. It is critical to ensure equipment is routinely maintained to prevent equipment failure or damage that could directly impact product quality and production efficiency. Any new equipment introduced into the filling process will be evaluated for possible inclusion in the media fill process. • Flexible capacity: a CDMO should have f lexible capacity and services that can support projects t hat may requ i re v ia ls of va r ious si zes (e.g., from 2 mL to 100 mL) for successful and timely production. A more f lexible and adaptable ap- proach to drug development and manufacturing can help ensure the unique needs of a project are evaluated and addressed as they arise, pre- venting delays that could impact timelines. In addit ion, dur ing t he t ra nsit ion f rom clin ica l FIGURE 1. An example of a technology transfer plan standardization. MPS is master project schedule. PFD is process flow diagram. QRA is quality risk assessment. PHA is preliminary hazard analysis (process gap assessment). FMEA is failure mode an effects analysis. PCS is process control strategy. SOP is standard operating procedure. MBR is master batch record. PPQ is process performance qualification. Overall Tech Transfer Plan Tech Transfer Agreement MPS, Scope Document, Project Workbook Initial Knowledge Transfer (PFD, Spec, etc) QRA Report (PHA) Stage 0 Engineering Run Protocol Material Specification Sample Master Plan Process Validation Master Plan QRA Report (FMEA) PCS, SOP, MBR (Draft) Stage 1 Engineering Run Cleaning Validation Plan Cleaning Validation Media Fill Protocol Media Fill PCS, SOP, MBR (Final draft) Stage 2 Engineering Run Report Cleaning Validation Report Shipping Qualification Analytical Method Qualification QRA Report (Approved) PCS, SOP, MBR (Approved) Stage 3 Kick Off PPQ Tech Transfer Protocol Validation Report Development, Validation, Verification Study Visual Inspection Qualification Media Fill Report Purchase Order Sterilization Validation Report Tech Transfer Summary Report Tech Transfer Change Control Bill of Material Before ER Before PPQ FIGURE IS COURTESY OF THE AUTHORS.