Featured Articles

  1. 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.

  2. 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.

  3. Monitoring Microbial Contamination Of Mammalian Cell Cultures 2/21/2025

    Mammalian cells are widely used to produce complex processed molecules. Explore a system that effectively detects microbial contamination in mammalian cell cultures and utilizes a newly formulated lysis buffer.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Adapting A Hybrid Analysis For AAV Characterization 2/11/2025

    Gain insights into utilizing hybrid long-read and short-read sequencing to analyze adeno-associated virus capsids to enhance biosafety testing and genome assembly while achieving high identity mapping.

  9. Building Local Biomanufacturing Capacity In South Africa 2/11/2025

    Biovac evolved from a vaccine supplier to a biopharmaceutical innovator, providing a blueprint for expanding Africa's vaccine manufacturing capacity. Gain valuable insights from their journey.

  10. Bridging Clinical And Commercial Needs 1/29/2025

    Discover how viral vector CDMO services can provide a solution to streamline gene therapy development, balancing clinical and commercial needs, to reduce delays and costs.