Under the leadership of Mai-Britt Zocca, Ph.D., IO Biotech is advancing novel, immune-modulating cancer therapies targeting IDO (indoleamine 2,3-dioxygenase). Though promising, the target fell out of favor after some high-profile misses — most notably Merck's Phase 3 failure with pembrolizumab in 2018. On the Business of Biotech podcast, Dr. Zocca shares how their approach differs from previous attempts. Listen now and subscribe so you never miss an episode.
The FDA will issue a Form 483 for noncompliance in the software validation GxP environment, mostly due to data integrity failures, inadequate written procedures, deficiencies in investigations, and substandard laboratory controls.
Part 1 of this two-part series began to compare the environmental impact of biopharma continuous manufacturing with batch manufacturing. In this article, the author considers process efficiency, single-use technology, and facilities requirements.
By Fran L. DeGrazio,West Pharmaceutical Services, Inc.
As the benefits of delivering biologic drugs as part of a combination product platform are realized, this self-administration trend will continue to grow. From a regulatory perspective, the use of a risk-based approach is foundational.