01.07.21 Facility Engineering, Design, And Construction Tips For Up-Start Biotech Companies
This report helps small and emerging biopharma companies make more informed CMO decisions, and helps CMOs optimize operational and marketing strategies to better accommodate this segment. Findings are based on 93 service encounters from 42 respondents involved in outsourced small molecule API projects in the past 18 months. Learn more here.
Featured Editorial
By Herman F. Bozenhardt and Erich H. Bozenhardt
Fledgling biotech companies are financially fragile, and they can ultimately become controlled by demanding fund managers. Those who manage facility engineering, design, and construction for these companies must adjust their thinking and employ some new tactics to document all costs and impacts, reduce schedules, and maintain quality.
Bridging The Connectivity Gap Between Traditional Sensors And Single-Use Systems
By Julie Stiller, Application Development Manager, David Koechlein, Application Development Manager, and Derek Pendlebury, Global Sales Director, Colder Products Company
Critical process parameters (CPPs) are the key variables in the pharmaceutical manufacturing process that are most likely to affect the quality attributes of a biological product. CPPs must be monitored and controlled throughout the various stages of production. For example, in the production of recombinant proteins, the cell culture expansion and production steps require continuous real-time monitoring and control. Any deviations in CPPs from the historical data gathered during the process development steps could negatively impact cell growth and, therefore, product yield. They can also potentially affect the drug’s overall safety and efficacy. The most common CPPs measured are pH, dissolved oxygen, capacitance, and biomass. Another