Written by Modality Solutions
Posted on: November 10, 2020
“Our sponsorship and workshop at the BMWS20 support our continued commitment to helping the global biopharmaceutical industry collaborate on new approaches to similar challenges,” said Modality Solutions President Gary M. Hutchinson. “It’s our mission to share our cold chain validation best practices that will help industry leaders understand the changing industry standards and how to integrate risk management processes with validation best practices to ensure compliance, quality, and product integrity.”
Modality Solutions is a sponsor and session panelist at the Biomanufacturing World Summit (BMWS20) Nov. 16-17, 2020 virtual conference.
Gary M. Hutchinson and Daniel J. Littlefield will present “Transport Simulation Testing of Your Therapy: A Better Approach Than ‘Real World’ Shipping Tests.”
During the session, attendees will take away valuable information, including:
- Accelerated, sequential testing (e.g., ASTM, ISTA) is no longer acceptable by the FDA for drug product testing.
- Real-world testing cannot test the “worst-case” edges of your operating space.
- Real-world testing in the post-COVID-19 world will be difficult and expensive.