The feature story in this issue centers on the challenges and developments around raw material control for biological products. A main focus is the discussion that took place at a USP workshop on the raw material issues held in April 2021. The story’s three parts delve into: ● FDA views on where the regulatory concerns and expectations lie across the review and inspection continuum ● how the challenges expand in handling raw materials in the CGT context, and ● where biomanufacturers are in using and controlling polysorbates, in particular.
Biomanufacturer Raw Material Control on Regulatory Front Burner as Analytical Power and Formulation Challenges Intensify
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
The feature story in this issue explores the dialogue regulators and industry are having on the key CMC issues that are presenting themselves in the development and review of peptides and oligonucleotides and the approaches and expectations for addressing them. A central focus is the discussion that took place at the USP 2021 peptides/oligonucleotides workshop. The story’s four parts explore: ● recent CMC/regulatory challenges of oligonucleotide drugs ● comparability challenges in crossing over to generics, including insights from recent FDA research ● comparing peptide and oligonucleotide CMC issues, and ● starting material specifications for oligonucleotides.
Manufacturing, Impurities, and Characterization Methods Are Key Regulatory Focal Points for Peptides and Oligonucleotides
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
The four-part IPQ story in this issue explores the current dialogue on the drivers and pathways for a more collaborative, streamlined and globally-minded regulatory approach to medicine/device combination products in Europe and the activity in progress to reach that goal. In focus in the four parts are: ● the EU Pharma Strategy roadmap, comments from industry, and related agency strategies ● culture/structure/process change and global alignment ● HPRA CEO Lorraine Nolan on HPRA and EMA strategy, and ● EMA’s Zaïde Frias and NB/industry perspectives on EU regulatory transformation.
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
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. The two-part feature story in this issue explores how the ICH Q8-12 efforts to evolve the lifecycle regulatory paradigm to be more transparent, internally coherent, knowledge and risk based, continuous improvement and supply friendly, and globally consistent have not yet been realized, and where the deeper solutions to the problems may lie.
The feature story in the April issue explores how regulators and industry are working together to make quality risk management (QRM) a more effective force in improving quality systems and the regulatory communication process at the review and inspections levels. The three parts of the story provide insights from: ● HPRA’S Kevin O’Donnell on the evolution of QRM and the revision now underway of ICH’s 15-year-old QRM guideline Q9, which he is leading ● FDA’s Rick Friedman, also on the Q9 revision Expert Working Group, on advancing aseptic processes through QRM, and ● industry/academia thought leaders on evolving QRM’s relationship with knowledge management across the product lifecycle.