Newsletter | February 1, 2024

02.01.24 -- A New Year's Resolution Suggestion For The FDA


2024 PDA CDMO Partnership Workshop

Unlock success in the pharmaceutical and biotech industry by attending the 2024 PDA CDMO Relationship Management Workshop, 28-29 March, in Long Beach, CA. Gain invaluable insights into optimizing critical partnerships with CDMOs. Learn how to streamline communication, enhance project oversight, navigate regulatory complexities, and control costs effectively. Discover best practices for supplier selection and risk mitigation. Learn more and register today!


A New Year’s Resolution Suggestion For The FDA

Many pharma and biotech companies have continuing compliance problems when getting inspected by our friends at the FDA. In this article, this industry observer with almost 50 years of experience shares some New Year's resolution wishes for the FDA, and, by extension, industry members can consider the list as the foundation for sustainable quality in your operations.


Optimizing The Formulation For A Monoclonal Antibody

An emerging biotech company sought help developing a formulation for a monoclonal antibody. Examine the solution that delivered an optimized formulation within an aggressive timeline and budget.

Survival Kit For Quality Regulations: A Closer Look At Lyo Packaging

Explore primary packaging considerations aligning with ICH principles to ensure sustainable compliance and vial container closure systems for product development and commercial manufacturing needs.


Next-Generation Sequencing For Biologic Production And Safety