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IPQ Monthly Update – March 2021 in Review

IPQ Monthly Update – March 2021 in Review

The March issue provides a wealth of insights shared by FDA, EMA and PMDA biotherapeutic and vaccine regulators on the challenges, opportunities, and learnings as they have sought to support the accelerated product development and review called for by the pandemic, while assuring that CMC/quality standards are met and keeping up with their non-COVID-related workload. Included are updates on the guidances and other quality-related initiatives impacting vaccines and biotherapeutics that have been forthcoming during the first quarter of 2021.

IPQ Monthly Update – February 2021 in Review

IPQ Monthly Update – February 2021 in Review

The issue focuses on how academia and industry are collaborating to address the pressing needs in biopharma workforce development, in recognition of the challenges of keeping pace with the rapidly evolving process and product technologies and the cross-functional understanding and skills needed to support them. The six-part coverage explores the dimensions of these challenges and the collaborations that are being formed and strengthened to address them.

IPQ Monthly Update – January 2021 in Review

IPQ Monthly Update – January 2021 in Review

Drawing attention in the January issue are: ● how the research, technologies and partnerships that have been gelling in recent years made possible the rapid development of a coronavirus vaccine in 2020 ● how USP has intensified its focus on supply chain vulnerabilities and vaccine/treatment development to help support the pandemic response, and ● FDA’s ongoing progress in improving the usefulness and user-friendliness of its inactive ingredient database (IID).

Latest Improvements in FDA’s Inactive Ingredient Database Include Change Log and Use of Maximum Daily Exposure

FDA’s latest efforts to improve the functionality of its Inactive Ingredient Database (IID) include a quarterly log to track changes in the records and the use of the term “maximum daily exposure” (MDE) in lieu of “maximum potency.”

Recent Technology and Partnership Advances Made Possible Precision and Speed of Vaccine Response to Pandemic, NIAID’s Graham Stresses at CASSS WCBP Conference

The precision and speed of COVID-19 vaccine development was made possible by recent R&D advancements and a strengthened network of public-private partnerships, NIH National Institute for Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VCR) Deputy Director Barney Graham affirmed in his keynote presentation at the opening session of the CASSS Well-Characterized Biotechnology Products (WCBP) conference in late January.

Pandemic Intensifies USP’s Focus on Supply Chain Vulnerabilities and Vaccine Development

Improving understanding of supply chain vulnerabilities and providing support for vaccine development and delivery are two focal points of the USP effort to help address the pressing challenges that the COVID-19 pandemic has brought to the fore regarding the availability of quality medicines.

IPQ Monthly Update – November/December 2020 in Review

IPQ’s attention during November and December remained centered on the impact of the COVID-19 pandemic. In focus in the two stories in the issue are: ● insights from European experts on the myriad of complex issues that have to be addressed in getting the vaccines from manufacturers into the arms of the billions of people around the world that will need to receive them, and ● how the internal operations and external communication processes among pharmacopeias, industry and regulators are being adapted and collaboration expanded.
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