News in Depth

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

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

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