REGULATORY ARTICLES
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![mammlian-cell-lines-GettyImages-1690936576]( "FDA's New Flexible CMC Framework For CGT")
FDA's New Flexible CMC Framework For CGTThe FDA is rethinking CMC oversight for cell and gene therapies, prioritizing science‑based justification over rigid validation models. Learn how this lifecycle‑focused approach could reduce burden.
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![GettyImages-1440940383-chemical-bonds-3d-structure]( "Flow Chemistry For Contemporary Isotope Labeling")
Flow Chemistry For Contemporary Isotope LabelingGain insight into how late‑stage exchange and flow‑based methods enable efficient access to labeled molecules for pharmaceuticals, mechanistic studies, and analytical applications.
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![Pharmaceutical-regulations-GettyImages-1423114910]( "Navigating The Regulatory Space To Biosimilar Approval")
Navigating The Regulatory Space To Biosimilar ApprovalThe biosimilar patent cliff is reshaping pharma, creating unprecedented opportunities for biotech and CDMOs. Explore expert regulatory support that can help you navigate this shift with confidence.
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![Lab Mouse-GettyImages-1459570569]( "FDA Leading The Decline Of Animal Testing")
FDA Leading The Decline Of Animal TestingThe gold standard practice of conducting animal studies for evaluating toxicity, pharmacodynamics, and immunogenicity is being challenged by innovative alternatives – New Approach Methods (NAMs).
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![GettyImages-1788431592-patent-application-desk-glasses-pen-paper]( "The Patent Cliff Looms – Design Your Biosimilar Approach Accordingly")
The Patent Cliff Looms – Design Your Biosimilar Approach AccordinglyIn your pursuit of developing a high-quality biosimilar, think strategically. Consider what type of biologic your team’s expertise can support and which is needed most in your target market.
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![GettyImages-1411630763 Wooden Judge Gavel On A Table]( "Revolutionizing Drug Discovery: The Rise Of Fashionable Models")
Revolutionizing Drug Discovery: The Rise Of Fashionable ModelsAs a result of advancements in research technology, "fashionable models" such as organoids and organs-on-chips (OoCs) have been developed. Explore organoid and OoC technologies in detail.
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![GettyImages-1168902334 FDA]( "Emulate Endorses The FDA Modernization Act Of 2021")
Emulate Endorses The FDA Modernization Act Of 2021Learn why removing the mandate for animal testing would enable faster, more efficient, and more humane drug development, all while benefiting both patients and the pharmaceutical industry.
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![Medical scientists analyzing research-GettyImages-1413600685]( "Developing A Comprehensive Regulatory Approach For LNP Drugs")
Developing A Comprehensive Regulatory Approach For LNP DrugsThe path to regulatory approval for LNPs demands carefully considered strategies. By adopting proactive and strategic approaches, developers can overcome regulatory hurdles on the path to approval.
REGULATORY VIDEOS
On this week's episode of the Business of Biotech, five-time public company CFO and seven-time public company board member Allan Shaw talks about why FDA decision-making feels less predictable, and how that uncertainty is reshaping clinical trial strategy, investor behavior, and the innovation ecosystem.
Qualification is not a one-and-done activity in regulated environments. Learn when requalification is required and how lifecycle-based testing helps ensure equipment performance and compliance.
On this week's episode of the Business of Biotech, we speak with Dr. Sarfaraz Niazi, Ph.D., about how biosimilar regulations have taken shape, from early FDA uncertainty to citizen petitions, lawsuits, and guideline changes.
On episode 125 of Cell & Gene: The Podcast, Host Erin Harris talks to Halloran Consulting Group's Monika Swietlicka to discuss how the FDA is increasing flexibility in cell and gene therapy development without lowering evidentiary standards, emphasizing a risk-based, holistic approach.
REGULATORY ARTICLES. APP NOTES, CASE STUDIES. & WHITE PAPERS
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![mammlian-cell-lines-GettyImages-1690936576]( "FDA's New Flexible CMC Framework For CGT")
The FDA is rethinking CMC oversight for cell and gene therapies, prioritizing science‑based justification over rigid validation models. Learn how this lifecycle‑focused approach could reduce burden.
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![GettyImages-2183428971-lab-cleanroom]( "Industry Innovators: APAC's Sharp Advanced Therapeutics Edge")
APAC is rapidly advancing its role in the global therapeutics landscape, fueled by faster development models. Learn how this momentum is reshaping expectations for innovation and commercialization.
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![GettyImages-1440940383-chemical-bonds-3d-structure]( "Flow Chemistry For Contemporary Isotope Labeling")
Gain insight into how late‑stage exchange and flow‑based methods enable efficient access to labeled molecules for pharmaceuticals, mechanistic studies, and analytical applications.
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![GettyImages-1413607446-vial-syringe-liquid-scientist-glove]( "Your Biosimilar, Your Journey")
With many blockbuster drug patents set to expire by 2030, the market is ripe for biosimilar developers to stake their claim. To succeed, they must be strategic and compliant.
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![GettyImages-2148124393 DNA]( "A Risk-Based Approach To Plasmid DNA And mRNA Process Development")
Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.
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![GettyImages-1435391920-cell-culture-development-well-plate]( "Cell And Gene Therapy In Conversation")
Industry experts share strategies to overcome key barriers in CGT development, from reproducibility to scale-up. Gain practical insights to help teams move faster and more reliably toward commercialization.
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![Pharmaceutical-regulations-GettyImages-1423114910]( "Navigating The Regulatory Space To Biosimilar Approval")
The biosimilar patent cliff is reshaping pharma, creating unprecedented opportunities for biotech and CDMOs. Explore expert regulatory support that can help you navigate this shift with confidence.
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![GettyImages-1087219526-scientist-computer-screen-compliance-sterilization]( "Zero To Final Fill: How HUGEL Implemented Its First Single-Use Lines")
As regulations tighten, biomanufacturers are adopting single-use tech to boost compliance, reduce labor, and streamline fill-finish operations from the ground up.
REGULATORY SOLUTIONS
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![sterisart thumb]( "21 CFR Part 11 Compliance Checklist For A Universal Pump")
This checklist provides a detailed look at the requirements of 21 CFR Part 11 and highlights how the Sterisart® Universal | Gen 4 - Advanced supports your efforts to meet these regulatory demands.
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![sterisart 2 thumb]( "Sterility Testing For A Connected Era")
This pump combines state-of-the-art hardware with sophisticated, user-friendly software to offer compliant, paperless documentation and reporting.
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![Getty Images-823447656-vector-viral-lab-AAV-cell-development]( "Global Experts In Nanotechnology And Drug Particle Engineering")
Discover the nanoparticle engineering, formulation and GMP manufacturing services that can drive forward your market success and unlock the power of “small."
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![Egnyte Gxp]( "GxP Compliance Software For Life Sciences (21 CFR Part 11)")
Accelerated GxP and 21 CFR Part 11 compliance without disrupting your existing workflows.
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Choosing the right document management platform comes with daunting responsibility: compliance, usability, and adoption to name a few. We created this Buyer’s Guide to provide you with a tangible framework to evaluate varied solutions and, ultimately, identify one or more that meet your specific use case.
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Life sciences organizations face more pressure than ever to run efficient, uninterrupted manufacturing production at the lowest possible cost. To stay compliant with government regulations, quality and manufacturing organizations must precisely follow Good Manufacturing Practices (GMP) standardized processes and maintain an associated document control process that adheres to those requirements.
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![Aseptic Filling GettyImages-1087219366]( "Drug Product Fill Finish And Formulation Solutions")
Formulation and aseptic filling solutions are crucial at every stage of development. Consider a manufacturing partner who can address every challenge on the path from pre-clinical programs to commercialization.
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![GettyImages-1400218353-eco_environment_city_green_sustainable]( "Small Is Powerful, Small Is Green")
As the pharmaceutical industry innovates and evolves, learn more about how Nanoform can play a critical role in empowering your company's journey to net zero.
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Quality & Manufacturing organizations in Life Sciences companies are facing more pressure than ever to run efficient, uninterrupted production at the lowest possible cost, while meeting stringent safety, quality, and regulatory standards.
