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Technology transfer is an intrinsic part of the development & manufacturing life cycle of a pharmaceutical product. Undertaking a comprehensive facility fit and gap assessment as part of the technology transfer permits timely evaluation of any equipment or process gaps and reduces last minute surprises that may result in costly delays to biopharmaceutical development programs.
A close partnership with transparent communication of risks, sharing information and alignment on expectations between sending and receiving sites are essential.
- The primary purpose of the facility fit assessment is to identify the gaps between the existing process design and associated controls with the intended manufacturing site capabilities. The selection of materials, process aids, consumables and their associated testing requirements may also be time constraints. The global sourcing of raw materials may also be impacted by other events, such as the current COVID-19 pandemic, which has a huge impact on vendor lead times. This may require an evaluation of the current existing supply chains within the network.
- The second step of a facility fit assessment is to evaluate potential risks and challenges associated with technology transfer and identify remediation actions that may be required to ensure the process will consistently produce product of the required quality. Risk mitigation strategies are generally proportional to the potential risk to product quality or process performance. In cases where high risks gaps cannot be easily mitigated, additional controls are considered. An assessment of risk pre- and post-remediation is recommended to document the impact of proposed changes to address the specific gaps identified.
- Finally, an assessment of the regulatory CMC impact of the facility fit and gap assessment should be considered based on the intended countries and licensing strategy for product distribution from the new manufacturing site. Additionally, any environmental or health and safety risks should be evaluated to ensure that there are no potential issues that could impact scale-up and large scale manufacturing.
A successful and seamless technology transfer requires extensive experience and know how. It’s imperative to initiate the facility fit as a priority when initiating technology transfer to avoid unexpected delays and additional cost later that could impact the manufacturing schedule.