Acceptable Analytical Practices for Dissolution Testing of Poorly Soluble Compounds

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

Calquence (acalabrutinib) plus bendamustine and rituximab reduced risk for disease progression or death by 27% compared with the current standard of care, according to a phase III trial.

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.