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After a complete revision of the EU GMP Annex 1, the final version was published in August 2022 and became effective just a few days ago on August 25,…
Proven Process to Optimize Commercial Readiness
John K. Moore, Vetter’s Director of Global Clinical Business Development, shares his biggest takeaways from the event.
A successful tech transfer demands adherence to detail and thorough project management. An experienced CDMO with the respective expertise is essential…
Developing an injectable drug product with known stability limits? Learn how to weigh the pros and cons of reformulation, freezing, and…
A quality expert explains why manufacturing best practices matter to your earliest CTM batches – and how to start aligning with them.
The fill and finish project is a key step on the path to the clinic. Garath Duffy explains how and where to start.
Applying a sustainable mindset can offer a competitive advantage in both the industry and the community.
The Asia Pacific region is reshaping the future of the parenteral drug market. Here’s what that may mean for CDMO partners.
As 2022 takes shape, our industry finds itself at a point few of us expected: the start of a third year in this truly extraordinary era.
See where you need to focus if you’re planning to launch in an autoinjector, pen, or other patient-friendly delivery device.
The Annex 1 of the EU GMP Guide "Manufacture of Sterile Medicinal Products" is considered the most important European regulatory standard for the…