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.
Design-Based Development Paradigm for Cell/Gene Therapies Will Significantly Reduce Costs, Timelines and Regulatory Concerns, AGT CEO Galvin MaintainsAugust 27, 2020
The more efficient, design-based development paradigm for cell and gene therapies, coupled with their therapeutic power, will dramatically reduce manufacturing and testing costs and timelines and significantly alter the regulatory dynamics, American Gene Technologies CEO Jeff Galvin affirmed in his plenary presentation at the PDA annual meeting held virtually in late July.
Synthesis and Analysis Advancements Are Unleashing the Potential of Peptides and Oligos, Spurring CMC Regulatory DialogueJuly 23, 2020
Advancements in synthesis and analysis technologies are helping unleash the therapeutic potential of peptides and oligonucleotides, spurring the dialogue on how the CMC/quality regulatory expectations, guidance and standards should keep pace.
USP Convention Meets Virtually in May 2020 to Review Upcoming Priorities, with Both 200-Year Legacy and Current Pandemic in FocusJuly 16, 2020
In May 2020, the USP Convention (USPC) met virtually to review how its central role in advancing public health has evolved during the broad sweep of its 200-year history on the one hand, while assessing its response to the pressing needs of the COVID-19 crisis now dominating the healthcare field on the other.
The urgency of delivering a vaccine for COVID-19 in previously unattainable timeframes and volumes is throwing the spotlight on the expanded role next-generation sequencing (NGS) needs to play to avoid the time delays and other limitations of in vivo/animal testing.
PART II: Sanofi Pasteur and Ghent University Experience with NGS [CLICK HERE]
PART III: A Decade of Regulator/Industry Collaboration on NGS [CLICK HERE]
PART IV: Stakeholder Engagement Begins on ICH Q5A Revision [CLICK HERE]
PART V: Effort to Reduce Animal Testing for Vaccines Includes Global Health Fund Support for NGS [CLICK HERE]
NIIMBL Progress Includes Partnership with Biophorum on Buffer Mixing and Global Health Fund with Gates FoundationMay 15, 2020
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is partnering with the industry consortium BioPhorum to develop a more streamlined, cost-effective, and resource-conserving way of addressing the buffers used in biopharmaceutical manufacturing.
Top FDA Drug Compliance Concerns during 2019 Included OTCs, Supply Chain Information Flow, Compounding, and Genotoxic ImpuritiesApril 16, 2020
Over-the-counter (OTC) drugs – from raw material supply through product manufacturing and distribution – remained a central concern at the FDA Center for Drug Evaluation and Research (CDER) Office of Compliance (OC) during 2019.
Existing Accelerated CMC, Advanced Manufacturing, and Inspection Initiatives are Supporting Regulators in Pandemic Response, FDA’s Cruse Explains in Recent Field Office UpdatesApril 7, 2020
Initiatives that the major regulatory agencies have been advancing to help address the CMC and technology challenges of developing complex medicines under accelerated timelines are creating a critical foundation for responding to the current coronavirus pandemic.
IPQ’s five part series is exploring the need for: ● a more qualified-for-purpose excipient toolbox that can help address the formulation, quality, and manufacturing challenges posed by a new generation of medicines, and ● a regulatory process that can better accommodate novel excipients.
PART I: FDA’S Novel Excipient Program Proposal and Stakeholder Comments
PART II: IPEC/IQ Thought Leaders on the Novel Excipient Drivers
PART III: Subcutaneous Biotherapeutics, Pediatrics, and Delayed Release
PART IV: USP Initiatives Supporting Novel Excipient Development
PART V: Assessing and Managing Excipient Risks
US/EU MRA Implementation, US Congressional Hearings, and Industry Surveys Shed Light on Global GMP Inspection Challenges and Collaboration OpportunitiesJanuary 15, 2020
During the past decade, industry and regulators around the world have been heavily focused on addressing the daunting challenges of assuring the quality of medicines across an increasingly globalized supply chain.
IPQ’s meeting schedule through September includes:
CASSS Capillary Electrophoresis Symposium (Sep. 13-16)
PDA Manufacturing & Quality Conference (Sep. 14-16)
CASSS Mass Spectrometry Symposium (Sep. 21-24)
PDA Data Integrity Workshop (Sep. 22-23)
ASGCT Policy Summit Agenda (Sep. 22-24)
ISPE Biotechnology Conference and Workshop (Sep. 22-24)
Xavier Health Combination Products Summit (Sep. 23, 24, 30, & Oct. 1)
PDA/FDA Joint Regulatory Conference (Sep. 27-29)
IPEC Excipient World Conference and Expo (Sep. 27-29)
DIA Accelerating CMC Workshop (Sep. 28-30)
ISPE Facilities of the Future Conference (postponed to Feb. 2022)