Featured Articles

  1. Early Product Characterization De-Risks Biologics Development 6/12/2019

    The relationship between physicochemical profile and biological activity — and how this relationship affects clinical performance — is key to informed decisions, accelerated development, and risk reduction.

  2. 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.

  3. 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.

  4. 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.

  5. 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. Discover how these properties improve patient compliance, especially for children and the elderly.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.