News in Depth

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

The pandemic experience and the increasing expectations of regulators regarding supply chain visibility and risk-management are driving forces for incorporating more third-party auditing of excipient suppliers into user quality management systems.

In her new role as FDA’s Principal Deputy Commissioner, Janet Woodcock will be able to continue her strong contribution to the effort in the US and around the world to make drug and biologic regulatory processes as supportive as possible of manufacturing innovation.

FDA’s Knowledge-aided Assessment and Structured Application (KASA) and related Product Quality/CMC (PQ/CMC) initiatives have been laying some important conceptual and information technology (IT) groundwork for the ICH effort now underway to revise its M4Q guideline on the quality component of the Common Technical Document (CTD).

Part I: The Advancing Knowledge-aided Assessment Component of KASA

Part II: Bringing Biologics into the KASA System

Part III: The Progress of FDA’s PQ/CMC Initiative

Part IV: The Goals of Accumulus Synergy in CMC Data IT and Regulatory Communication

Part V: The Drivers for Revising ICH M4Q and Evolving the CMC Regulatory Process

Key focal points in the European GMP arena include revisions to guidance, new veterinary medicine regulations, and adapting assessment/inspection processes to enable manufacturing through the COVID pandemic, foster international collaboration, and address point-of-care manufacturing.

Part I: Update on EMA GMP-related Activities

Part II: MHRA Innovation Pathway and Proposal for Point-of-Care Regulatory Framework

Part III: Insights from Europe and ICMRA Regarding Onsite Inspection Alternatives

The emerging biotech product modalities and their complex analytical challenges and needs have led USP and the European Pharmacopoeia to adapt their standard-setting approaches and work collaboratively with stakeholders internationally in setting and pursuing priorities.

Part I: Update on USP’s Evolving Role and Current Initiatives In the Biologics Arena

Part II: European Pharmacopoeia and FDA Join USP in Focusing on Particulate Control

The leaders of industry’s major COVID vaccine efforts have been sharing their insights at recent conferences on: ● how their companies managed to address the daunting development, manufacturing, and supply chain challenges involved in delivering a vaccine in unprecedented speed during a pandemic, and ● the lessons that can be garnered from that experience in moving forward.

Part I: Implementing the Pfizer/BioNTech mRNA Vaccine Development Plan

Part II: New Digitalized Facility as Springboard for Moderna’s mRNA Vaccine

Part III: Oxford University/AZ Partnership for Global Adenovirus Vaccine Access

Part IV: J&J’s Experience in Handling the Supply Chain Challenges

Part V: Novavax’s Approach to Assuring Comparability for its Protein-based Vaccine

Part VI: Inter-Company Panels at DIA and ISPE Meetings on Vaccine Experience

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