Manufacturing and Bioprocessing – Chemical
2019 PharmSci 360
Tapan Sanghvi, PhD, MBA
Vertex Pharmaceuticals, Inc.
Boston, Massachusetts
Continuous Process Verification (CPV) methodology has been implemented at Vertex for validating drug products manufactured using continuous processes. The use of advanced manufacturing utilizing in-line, on-line, and/or at-line measurements generates a substantial amount of data, which allows a comprehensive understanding of process performance and variability during the development stage of the product lifecycle.
Execution of process development on the same equipment as is used commercially allows significant product development data to be leveraged for Process Validation (PV). Furthermore, our Quality by Design (QbD) approach to product development along with a collection of significant amounts of in-process data during development and clinical batches manufactured on our continuous manufacturing line allows a comprehensive CPV approach to process validation. Our validation strategy, which prospectively states the relevance of development and clinical manufacture to demonstrate commercial process understanding and which may justify fewer than 3 PV batches, will be presented.