News in Depth

A more powerful analytical toolbox is allowing industry and regulators to better understand how biotech product manufacturers can improve the control strategies for the raw materials they are using. However, there are still significant knowledge and control gaps, and experts from industry, regulatory agencies, and pharmacopeias are actively sharing insights on how best to fill them.

Part I: Biotech Regulator Vantage Point on Raw Material Control

Part II: The Added Challenges of Materials Management for CGTs

Part III: Biomanufacturer Use and Control of Polysorbates

A confluence of forces is intensifying the pressure on and opening pathways to the reform of drug/device combination product regulation in Europe, with legislative changes and strategic priority needs at issue.

Part I: EU Pharma Strategy Roadmap, Comments from Industry, and Related Agency Strategies

Part II: Culture/Structure/Process Change and Global Alignment

Part III: HPRA CEO Lorraine Nolan on HPRA and EMA Strategy

Part IV: EMA’s Zaïde Frias and NB/Industry Perspectives on EU Regulatory Transformation

The pressing need during the COVID-19 pandemic to accelerate product development and rapidly accommodate the shifting manufacturing and distribution demands has shed strong light on the constraints in the existing quality regulatory framework and the pathways to reducing them.

Part I: Industry Quality Leaders on the Global PAC Regulatory Problem and Solutions

Part II: Evolving the Quality Regulatory Paradigm at the Global Level

Regulators and industry are sitting down together to mine their experience and map out some clearer directions and expectations about what is needed to empower quality risk management (QRM) in improving the pharmaceutical quality system (PQS) and the industry/regulatory communication process at the review and inspection levels.

 

Part I: ICH Q9 Revision Lead O’Donnell on the Evolution of QRM

Part II: FDA’s Rick Friedman on Advancing Aseptic Processing through QRM

Part III: Industry/Academia Thought Leaders on the Evolving QRM/KM Relationship

This four-part story explores the significant impact of the pandemic during 2020-2021 on the CMC review processes for vaccines and biotherapeutics at FDA, EMA and Japan’s PMDA in their efforts to support accelerated product development and review, while assuring that quality standards are met and the ongoing non-COVID-related workload addressed.

 

Part I: EMA Perspective

Part II: FDA CBER Perspective

Part III: FDA CDER Perspective

Part IV: Panel Discussion Among US, Europe, and Japan Regulators

Academia and industry are collaborating more intensely on addressing 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.

Part I: NIIMBL’s Engagement with Academia on Workforce Development Needs

Part II: ISPE Workforce of the Future Traction at UMBC and UC Davis

Part III: Keck Institute’s Behrens on Biopharma Talent Needs and KGI/Industry Partnering

Part IV: Xavier’s Phillips on Sharable Quality and Regulatory Science Curriculum

Part V: CASSS Panel on Opening Up Biopharma Career Pathways

Part VI: European and Global Workforce Development Collaborations

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.”