Reduced-Method Robustness Testing of Analytical Methods Driven by a Risk-Based Approach

The company will be featuring its sustainable packaging solutions at the event in Paris on Jan. 22–23, 2025.

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

Production is set to take place at Samsung Biologics’ Songdo, South Korea, site, and the agreement will run through December 2030, subject to change.

In this episode of the Drug Solutions Podcast, Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina, discusses the latest analytical tools and their applications in the drug development market.

Contract development and manufacturing organizations (CDMOs) are more critical than ever as the demand for advanced therapies continues to grow. Here are the CDMOs and service providers that are poised to make the biggest impact on the pharmaceutical industry.

In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.