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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,…
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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…
12/09/2022
Developing an injectable drug product with known stability limits? Learn how to weigh the pros and cons of reformulation, freezing, and…
09/06/2022
A quality expert explains why manufacturing best practices matter to your earliest CTM batches – and how to start aligning with them.
08/23/2022
The fill and finish project is a key step on the path to the clinic. Garath Duffy explains how and where to start.
07/11/2022
Applying a sustainable mindset can offer a competitive advantage in both the industry and the community.
05/17/2022
The Asia Pacific region is reshaping the future of the parenteral drug market. Here’s what that may mean for CDMO partners.
04/28/2022
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.
03/16/2022
See where you need to focus if you’re planning to launch in an autoinjector, pen, or other patient-friendly delivery device.
12/14/2021
The Annex 1 of the EU GMP Guide "Manufacture of Sterile Medicinal Products" is considered the most important European regulatory standard for the…
10/20/2021
