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Manufacturing biopharmaceuticals in an aging facility may create quality issues such as equipment breakdown and contamination risks.
Awareness of recently implemented—or ongoing—advances by the pharmacopoeias can help biotherapeutic manufacturers remain compliant with current requirements.
The complex nature of biologics creates challenges for GMPs in sterile manufacturing, and the EU’s Annex 1 is making an impact.
January 01, 2023
A CCS provides significant benefits to the industry and helps with holistically understanding contamination controls, says Siegfried Schmitt, vice president, Technical at Parexel.
December 22, 2022
The Consolidated Appropriations Act for 2023 provides FDA with a $6.6 billion total budget.
December 20, 2022
FDA has announced that bebtelovimab is not currently authorized for emergency use in any region of the US.
December 08, 2022
FDA struggles to track shortages caused by a rise in demand.
December 02, 2022
The complete online database of ACS Reagent Chemicals is now available.
The design of viral clearance studies must keep pace with the quickly evolving biologic drugs industry.
December 01, 2022
Digitalization of bioprocessing is slowly bringing benefits to the biopharma industry.
Health crises, political tension, and budget concerns were major challenges.
November 30, 2022
Etihad Cargo is one of the only airlines to hold IATA CEIV Pharma certification globally.