Get updated on the progress of the science-, risk-, and statistics-based ASTM International Cleaning Standards: published standards, work currently underway, and how you can get involved.
By Peter H. Calcott, Ph.D., FRSC, president and CEO, Calcott Consulting LLC
FDA's CDER recently issued a draft guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics. This article provides a summary and analysis.
When migrating data in a GMP setting, verifying every record is impossible. A well-structured sampling approach can mitigate the risks and help with a smooth transition.
Gain insight into the exciting developments in continuous manufacturing, and learn how leveraging this innovative technology can help improve manufacturing processes and discover new clinical candidates.
In the age of digital transformation, AI is no longer optional. Discover how to successfully integrate AI into your organization's operations for a competitive edge.
