FDA Attacks Counterfeits

Six winners and two honorable mentions were revealed at ISPE’s Europe Annual Conference in London.

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

The company said the investment is in response not only to customer demand and a belief in the value of US-based innovation, but also because of the trend toward US onshoring brought about by new tariff policies.

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

This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.

Amit Chivate, senior market manager, Greater Asia and China, Roquette, provides his perspective on FDA’s recommendations regarding nitrosamines.