WTVAWCBI

Key Takeaways Revised recommendations address manufacturing-source submissions, immunogenicity-related testing, impurity thresholds,...

Key Takeaways A distributed “hub-and-spoke” operation could register as one establishment, reducing administrative friction while improving FDA...

Automation and digitalization work together in the digital plant. Automation—using machines rather than people to perform tasks—offers benefits...

In April 2016, in the guidance document Pharmaceutical Quality/Manufacturing Standards (CGMP) Data Integrity and Compliance With CGMP, FDA began...

FDA announced on Sept. 17, 2021 that the US District Court for the Middle District of Florida entered a consent decree of permanent injunction...

AstraZeneca announced on Sept. 21, 2021 that they will be investing $360 million into a new manufacturing facility that will produce small...

The European Union’s good manufacturing practice (GMP) guide for sterile products, Annex 1, has been under review for some time, with the...

FDA announced on May 11, 2021 that it has made the final version of the International Council for Harmonisation of Technical Requirements for...

FDA published M9 Biopharmaceutics Classification System-Based Biowaivers on May 11, 2021 to support biopharmaceutics classification of drug...

Through the partnership, Univercells will introduce the intermediate capacity scale-X carbo system, which includes a fixed-bed bioreactor and...