White Paper

Best Practices For Biopharmaceutical Technology Transfer: Facility Fit And Process Gap Assessments

By Ken Green, Head of MSAT, Samsung Biologics, and Anthony Newcombe, Senior Director of Project Management, Samsung Biologics

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During a long, complex journey of drug discovery with many specialized activities involved, technology transfer is an intrinsic part of the successful development, manufacturing, and commercialization of a product. Biopharmaceutical technology transfer requires careful planning and evaluation to meet project timelines for scale up and GMP manufacture.

Technology transfers inherently involve a number of technical, as well as logistical challenges as manufacturing processes that have been developed at small scale must be transferred and manufactured compliantly to GMP standards with commercial scale in mind. Even with the application of a platform manufacturing process and standardized procedures, facility and equipment capabilities at the intended GMP manufacturing site must be carefully considered together with a structured approach to technology transfer including risk assessment for phase appropriate manufacturing.

Furthermore, accelerated technology transfer timelines required to manufacture biologics to address specific unmet medical needs, such as the development of neutralizing antibody therapies for the treatment of COVID-19, may require an expedited assessment of facility and process fit. Alternate raw materials or equipment may need to be considered as soon as possible depending on the impact of supply shortages and lead times. An expedited technology transfer program may reduce the time needed to manufacture products at commercial scale, but as a result traditional process development timelines may not be possible.

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