Newsletter | September 17, 2020

09.17.20 -- What You Need To Know About Process Characterization And Validation

Process Characterization And Validation For Biologic Processes

Using a risk-based approach to generate an appropriate control strategy will help ensure your product meets characterization and validation requirements, enabling timely approval and launch to market.

Process Characterization: Ready For The FDA? (Webinar)

This webinar discusses process characterization basics, including information on what’s optional vs. what’s required. Learn why process characterization is important and how to speed up the process.

Managing Demand Uncertainty In Biologics Production

To forecast demand, a company must factor in its estimate of the size of future sales, the timing of the launch, the dosage of the product, its strategy for building its market, and a host of other variables. Variations in any one of those factors can lead to drastically different demand scenarios. Read more to learn how to manage this uncertainty.

Solutions To Today’s Biomanufacturing Challenges

Biopharmaceutical companies take on a lot of risk developing new large molecule drugs. With more complex molecules in development, changing capacity needs, uncertain forecasts, and increased competition, the market demands flexibility and innovative approaches to address today's new challenges.