Manufacturing and Bioprocessing – Biomolecular
2019 PharmSci 360
Robert Di Scipio
Skyland Analytics
Niwot, Colorado
Life Science manufacturing data management has become increasingly difficult with advancements in biotech and “precision” cell and gene therapies. These challenges are compounded by the near-universal reliance on CDMOs for process development and manufacturing operations and a growing “data gap” between R&D and commercial manufacturing. Concurrently, regulatory scrutiny into data integrity is at an all-time high.
This session will explore best practices for managing data across global development and manufacturing networks in order to meet compliance, business and analytical requirements.