Featured Articles

  1. Strategies For The Development Of Safe And Effective Pediatric Formulations 5/12/2025

    Medicines for infants and children face unique formulation challenges. Learn about the key considerations, including developmental physiology, age specifics, palatability, ease of administration, and precise dosing.

  2. Helpful Biosafety Testing Innovations Where And When You Need Them 4/24/2025

    Monoclonal antibody manufacturing is advancing to boost efficiency, cut costs, and expand access, driven by innovation, demand, and the rise of biosimilars.

  3. Process Analytical Technology In The ADC Bioconjugation Process 4/23/2025

    Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.

  4. De-Mystifying Regulatory Support During Viral Vector-Based Development 4/15/2025

    Navigating clinical trials for viral vector-based cell and gene therapies demands specialized expertise and regulatory insight. Learn how scientific acumen and strategic planning bring innovative therapies from lab to patient.

  5. Tablet Manufacturing Technologies For Solid Drug Formulation 4/2/2025

    Compressed tablets are common oral solid dosages that contain the API and various excipients. Learn about the critical steps in selecting manufacturing methods and excipients to achieve the desired therapeutic effects and stability.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.