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 ModernizationJune 23, 2022
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
Pandemic Experience and Supply-Chain Risk Management Expectations Increase Attention on Excipient GMP Third-Party AuditingMay 1, 2022
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.
Janet Woodcock and Jeff Baker will Continue to Play Key Manufacturing Innovation Roles in New FDA and NIIMBL PositionsFebruary 28, 2022
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 KASA and Related PQ/CMC Initiatives on Improving CMC Data Structuring and Sharing Will Help Support ICH M4Q RevisionFebruary 17, 2022
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 GMP Focal Points in Europe Include Guidance Revisions, New Vet Regulations, and Adaptive Assessment/Inspection ApproachesJanuary 12, 2022
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
USP and Ph. Eur. Initiatives in the Biologics Arena Continue to Bear Fruit; FDA Joins the Pharmacopeias in Upgrading Particulate GuidanceDecember 28, 2021
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
COVID Vaccine Industry Project Leaders Are Sharing Insights on How the Daunting CMC Challenges Were AddressedNovember 18, 2021
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
Biomanufacturer Raw Material Control on Regulatory Front Burner as Analytical Power and Formulation Challenges IntensifySeptember 9, 2021
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
Manufacturing, Impurities, and Characterization Methods Are Key Regulatory Focal Points for Peptides and OligonucleotidesAugust 9, 2021
The manufacturing process, the control of impurities – in the starting materials, the API and the drug product – and the analytical methods for characterization are focal points for regulators during CMC reviews of both synthetic peptide and oligonucleotide (oligo) therapeutics.
Part I: Recent CMC/Regulatory Challenges of Oligonucleotide Drugs
Part II: Comparability Challenges in Crossing Over to Generics
Part III: Comparing Peptide and Oligonucleotide CMC Issues
Part IV: Starting Material Specifications for Oligonucleotides
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
Pandemic Urgencies Highlight Constraints in Manufacturing Change Regulatory Paradigm and Where Adjustments Are NeededMay 11, 2021
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 Are Exploring with Industry How to Strengthen Quality Risk Management Practices, with Revision of ICH Q9 a Key Focal PointApril 29, 2021
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
Regulators Share Pandemic’s CMC Impact at CASSS Japan Forum; Guidance Output Continues Apace in Q1 2021April 1, 2021
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/Industry Collaboration Intensifies on Addressing the Pressing Needs in Biopharma Workforce DevelopmentMarch 18, 2021
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
Latest Improvements in FDA’s Inactive Ingredient Database Include Change Log and Use of Maximum Daily ExposureFebruary 9, 2021
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 ConferenceFebruary 2, 2021
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.
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.
The pandemic is prompting all of those involved in medicine production, regulation, and standards-setting to take a hard look at their operations for how they can be: ● adapted to continue being productive and address the pandemic exigencies, as well as ● potentially improved on a longer-term basis. It is also significantly deepening communication and cooperation channels.
Part I: EDQM Pandemic Actions Continue Apace in Fall 2020
Part II: Pharmacopeia, Regulator and Industry Expert Panel Explores Pandemic and Nitrosamine Communications
Part III: Second Panel Focuses on Pandemic Organizational Impacts and Key Learnings
Part IV: EDQM and Ph. Eur. Evolution Addressed by Leaders Keitel and Vielle
COVID Vaccine Global Distribution Challenges Explored by Bio Supply Management Alliance (BSMA) Panel of European ExpertsDecember 3, 2020
A panel of leading experts, assembled virtually for the 2020 Bio Supply Management Alliance (BSMA) Europe symposium on November 12, seized on the analogy of a Formula One race pitstop in assessing the expertise, cooperation, and timing that will be needed for successfully delivering COVID-19 vaccinations.
Pandemic Stresses Increase FDA Attention on Risk Management Plans for Drug Shortage Prevention and MitigationNovember 15, 2020
The stresses of the COVID pandemic on the drug supply chain have thrown a spotlight on the importance of risk management plans (RMPs) in preventing and addressing drug shortages.
USP’s Global Efforts to Strengthen Standards and Accelerate Innovation for Biologics Include ICH EngagementNovember 9, 2020
Direct engagement in the ICH guideline development and revision process is helping USP prioritize its related compendial standard setting, revision, and harmonization efforts, and, in turn, enriching ICH awareness of the pharmacopeial standards and approaches that can help inform its guidelines.
CBER Director Marks Traverses the Complex COVID-19 Vaccine/Therapy Regulatory Landscape at FDLI’s Annual ConferenceOctober 13, 2020
At the 2020 annual conference of the Washington, D.C.-based Food and Drug Law Institute (FDLI), held virtually on October 6-8, Center for Biologics Evaluation and Research (CBER) Director Peter Marks provided valuable insights on the difficult terrain that the regulators at CBER have to navigate to reach their goal of making effective vaccines and therapeutics for COVID-19 available as efficiently as possible.
Stronger Unapproved Stem-Cell Enforcement Accompanies FDA Center for Biologics’ Cell and Gene Therapy Advancement EffortsSeptember 14, 2020
Over the last few years, FDA has ramped up its efforts to protect the public from unapproved and potentially dangerous stem cell products, while striving to create a regulatory framework and approach that is as supportive as possible for the advancement of the entire cell and gene therapy (CGT) field.