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Growth and Advancements in Fill/Finish
Leveraging automation advancements can help improve efficiency in aseptic processing.
Changes and Trends in the Outsourcing Landscape
Quality Considerations in Changing Excipient Providers
January 15, 2024
Harmonization of global regulations fosters innovation and ensures quality medicines.
Boehringer Ingelheim is investing €120 million (US$131 million) into its Koropi, Greece site to expand production for new therapeutics.
FDA is anticipating how AI may advance manufacturing and improve supply chain security.
The SD File format offers benefits for KASA and cheminformatics to support regulatory submissions.
Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.
This paper explores the relationship between investing in pharmaceutical manufacturing risk reduction and meeting business objectives.
Recent research and perspectives shed light on an opportunity to better connect risk and knowledge through improved integration of systems.
As innovation accelerates, pharmaceutical regulators continue their path of maintaining proportion, balance, and restraint.
January 11, 2024
Pluri has launched PluriCDMO, a new contract development and manufacturing organization business that will offer cell therapy manufacturing services.
Regulators from around the world will gather to help shape the mRNA and RNA therapeutics landscape at an exceptional April 2024 Washington, D.C. convocation.