An Overview of the Validation Approach for Moist Heat Sterilization, Part II

The new lab will be used to develop and scale innovations for the production of medicines and to help secure the supply chain.

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

Teva’s investigational monoclonal antibody, TEV-53408, has been designed for use in adults with celiac disease, for which a strict and lifelong gluten-free diet is currently the only treatment.

Both companies viewed the early end to the PIVOT-PO trial as a positive development, with GSK saying it would work with US regulatory authorities to move the treatment forward in 2025.