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ICH Q3D Implementation Continues with Workshops, Research, and Guideline and Pharmacopeial Revisions

More sensitive and selective methodologies have facilitated the identification and quantification of elemental impurities (EIs) in pharmaceuticals and the movement away from the old heavy metal analytical tests to the newer risk-based assessment strategy of ICH Q3D.

Part I: Role of PQRI/FDA Workshop in Q3D Implementation Dialogue

Part II: Regulatory Experience and Perspectives in Implementing Q3D

Part III: Pharmacopeial Harmonization with ICH Q3D

Part IV: Outcomes of PQRI Study on Variability in Elemental Impurity Analysis

Strengthened European Regulator Support for Advanced Technologies Includes New EMA Quality Innovation Group

The experience of the pandemic has underscored the criticality of assuring that regulatory processes keep pace with innovation in the manufacturing and control arena and has spurred the efforts that were underway in Europe to assess the issues involved and implement the adaptations needed to address them. The three parts of the IPQ story review the progress of these efforts.

Part I: Europe’s Focus on CMC Innovation and Agile Regulation

Part II: Innovation Issues Explored at CASSS CMC Forum in Europe

Part III: MHRA’s “New Era in Regulation”

EMA Toolbox on CMC Flexibilities has been Evolving to Incorporate Industry Input and Learnings from the Pandemic

EMA’s “toolbox guidance on scientific elements and regulatory tools to support quality data packages” for priority medicines targeting unmet medical needs, released in April 2022, reflects extensive stakeholder input and will evolve further as experience and learnings from the pandemic are evaluated.

Developed as an outcome of the 2018 joint EMA/FDA workshop on quality support to Priority Medicines (PRIME) and Breakthrough Therapy (BT) designated products, the guidance outlines the tools available in the EU to address the challenges in generating robust quality packages under accelerated conditions. It is applicable to small molecules, biological/biotech products, and advanced therapy medicinal products (ATMPs).

The guidance was drafted, consulted on, and revised throughout the COVID pandemic.

Part I: EMA Perspective on its Toolbox Guidance and OPEN Initiative

Part II: Industry View on Efficiency Tools and CMC Flexibility Learnings from COVID

Part III: Panel Discussion on Effective Tools for the Future

CBER’s Advanced Technologies Program Growing Stronger with Increased Funding, Expertise, and Collaboration

CBER’S Advanced Technologies Program (ATP) is being strengthened through the expansion of internal and external funding, scientific and regulatory expertise, and collaborative support through the CBER Advanced Technologies Team (CATT). As part of its efforts to promote the adoption of advanced manufacturing, CATT has joined with CDER’s Emerging Technologies Team (ETT) to form the Center for the Advancement of Manufacturing Pharmaceuticals and Biopharmaceuticals (CAMPB). The Office of Regulatory Affairs and other centers are also expected to participate in the center’s activities.

mRNA-LNP Vaccines Spur Global Dialogue on Nanomaterial Standards and Regulatory Approaches

The successful development of mRNA-lipid nanoparticle (LNP) vaccines to address the COVID-19 pandemic has highlighted the power of nanoparticle-based formulations in producing safe and efficacious medicinal products.

Part I: Pfizer/BioNTech Lipid Challenges with mRNA-LNP COVID Vaccine

Part II: FDA’s Novel Excipient Review Pilot Program and Nanomaterials Guidance

Part III: USP’s Draft Guideline and Other Efforts on mRNA Vaccine Quality

Part IV: The EDQM Nanomedicines Dialogue and WHO on Regulating mRNA Vaccine Quality

Part V: Potency Assays for mRNA-LNP Vaccines

NASEM-Led Study for FDA is Helping Drive Industry/Regulator Agenda on Innovation Needs

An FDA-commissioned study carried out through the National Academies of Sciences, Engineering, and Medicine (NASEM) is helping drive the industry/regulator agenda on advancing innovation in pharmaceutical manufacturing.

PART I: The NASEM Study and FDA Reflections

PART II: Existing Mechanisms to Enable Innovation

PART III: Challenges and Opportunities

PART IV: The Path Forward

Pandemic Experience Showcases the Potential for Faster Innovation, More Collaboration, and Workplace and Operations Modernization

The potential for faster innovation, and the power of collaboration and workplace and operations modernization are emerging into high relief as the assessment of the pandemic experience continues to deepen. Among recent venues where industry and regulators have come together to explore these themes was the February ISPE Facilities of the Future Conference. Focused on the dialogue that took place there, the IPQ story that follows is divided into three parts:

PART I: The Evolving Landscape of Pharmaceutical Operations

PART II: Government-Industry Collaboration in This and Future Pandemics

PART III: Reducing the Cost of Vaccine Manufacturing for Broader LMIC Access

Progress in Addressing Impurity Challenges in Focus at USP’s 2022 Peptide/Oligo Workshop

The progress in understanding and addressing the challenges of impurities was a key focal point of this year’s USP Therapeutic Peptides and Oligonucleotides Workshop, held virtually on February 28, March 2 and March 4, 2022.

PART I: US and European Regulator Perspective on the CMC Challenges of Oligonucleotides

PART II: USP Standards Development Efforts for Peptides and Oligos

PART III: Peptide and Oligo Analytical, Manufacturing and Raw Material Considerations