By Robert Hendrix, Staff Engineer, Systems Design, Single-Use Technologies; Kathryn Barnes, Process Improvement Manager, Production Chemicals and Services; Joe Gallo, Associate Product Manager, Production Chemicals and Services; Julie Bray, Production Support Services Senior Manager, Pharma Services; Adam Goldstein, Sr. Director, Research and Development Collaborations, Single-Use Technologies; Thermo Fisher Scientific
Accelerate development and manufacturing in the era of SARS-CoV-2
To meet the urgent demand for SARS-CoV-2 vaccines and therapeutics in the shortest possible timeframe, many companies are designing their scale-up processes in parallel with Phase III clinical trials, redefining the risk tolerance for everyone involved. To satisfy commercial requirements for expedited scale-up, the molecule can no longer dictate the technology transfer process into the manufacturing facility.
Shifting the focus from optimizing an individual process to an entire biomanufacturing workflow requires companies to adopt a new mindset and consider new ways of doing business. Success can be achieved by concentrating on three key activities: reviewing capabilities, assessing your risk tolerance, and identifying additional resources to accomplish your goals.