Quality/GMPs

Controlling Quality in Aging Facilities

Manufacturing biopharmaceuticals in an aging facility may create quality issues such as equipment breakdown and contamination risks.

Biologic Standards in the Pharmacopoeias: An Update

Awareness of recently implemented—or ongoing—advances by the pharmacopoeias can help biotherapeutic manufacturers remain compliant with current requirements.

GMPs for Sterile Manufacturing of Biologics

The complex nature of biologics creates challenges for GMPs in sterile manufacturing, and the EU’s Annex 1 is making an impact.

Creating a Contamination Control Strategy

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.

Massive Government Spending Bill Tackles Key FDA and Research Issues

December 22, 2022

The Consolidated Appropriations Act for 2023 provides FDA with a $6.6 billion total budget.

FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region

December 20, 2022

FDA has announced that bebtelovimab is not currently authorized for emergency use in any region of the US.

Rising Demand Drives Drug Shortages

December 08, 2022

FDA struggles to track shortages caused by a rise in demand.

ACS-Grade Reagents’ Database Launched

December 02, 2022

The complete online database of ACS Reagent Chemicals is now available.

Controlling Quality in Aging Facilities

December 02, 2022

Manufacturing biopharmaceuticals in an aging facility may create quality issues such as equipment breakdown and contamination risks.

Viral Clearance Studies: Challenges and Beyond

December 02, 2022

The design of viral clearance studies must keep pace with the quickly evolving biologic drugs industry.

Digitalization of Biomanufacturing: A Status Update

December 01, 2022

Digitalization of bioprocessing is slowly bringing benefits to the biopharma industry.

Pandemic and Politics Shaped Pharma and FDA in 2022

December 01, 2022

Health crises, political tension, and budget concerns were major challenges.

Etihad Cargo Achieves IATA CEIV Pharma Recertification for Pharmaceutical Logistics

November 30, 2022

Etihad Cargo is one of the only airlines to hold IATA CEIV Pharma certification globally.