Featured Articles

  1. Advantages Of Spray-Dried Mannitol In Roll Compaction 4/2/2025

    Pharmaceutical excipients like mannitol enhance formulation stability, flowability, and compressibility, which are crucial for robust tablets. Read how these properties improve patient compliance.

  2. Regulatory Frameworks For mRNA Therapeutics 3/17/2025

    The RNA therapeutics and vaccines market has grown rapidly, driven by siRNA and mRNA technologies. Explore how these advancements are now being applied to cancer vaccines and innovative therapeutics.

  3. Navigating Next-Generation Quality Control Strategies For AAV Testing 3/10/2025

    AAV-based gene therapies, while promising, require rigorous quality control through advanced methodologies to ensure safety, efficacy, and regulatory compliance.

  4. Biologics Technology Transfer Guidebook 2/26/2025

    Explore why technology transfer is a critical component in mammalian biologic drug development and manufacturing with the essential guide to biologics tech transfer that covers key strategies, best practices, and critical considerations.

  5. Multi-Attribute Method Analysis In Biopharmaceutical Development 2/26/2025

    Analytics is a crucial element in biopharmaceutical development and manufacturing. Discover how Multi-Attribute Method (MAM) revolutionizes analytics to enhance quality control and regulatory compliance.

  6. Key Regulatory Considerations For The Next Wave Of Gene Therapies 2/21/2025

    The evolving field of viral vector production, driven by advances in gene and cell therapies, is facing increasing regulatory scrutiny and analytical demands.

  7. What The ICH Q5A Virus Safety Guidelines Mean For Your Cell & Gene Therapy Product 2/19/2025

    Explore Cell & Gene therapy (CGT) products now within scope of the ICH Q5A guidance, technologies that can replace traditional testing strategies, viral clearance studies expected for vector products, and more.

  8. Purity As A Priority: Optimizing Safety Measures For rAAV Therapies 2/11/2025

    Watch to learn how rAAV vectors in gene therapy are addressing manufacturing impurities, risks to patient safety, and analytical methods for detection while aiding sponsors in regulatory compliance.

  9. Limiting Off-Target Effects Of CRISPR-Based Products 2/11/2025

    Find out how to enhance CRISPR gene editing specificity by using Next Generation Sequencing to improve sgRNA quality control, addressing off-target effects and ensuring higher sequence fidelity.

  10. Applying Next Generation Sequencing To Accelerate CGT Product Development 2/11/2025

    Next Generation Sequencing (NGS) revolutionizes gene therapy by enhancing the development and safety of viral vectors like AAV and lentivirus. Discover more about its impact.