Featured Articles

  1. Collaborative Bioprocessing: Next-Gen mAb Downstream Manufacturing 9/23/2024

    Explore the bioprocessing template, operational paradigm, and the complexities of qualifying an advanced, highly automated bioprocessing train designed for the production of mAbs and other biologics.

  2. The Role Of Extractables Data In The Adoption Of Single-Use Systems 8/29/2024

    Explore guidance for evaluating single-use systems for extractables and leachables, and learn how supplier-provided single-use system extractables data can save both time and resources.

  3. Accelerating ADC Clinical Development Timelines 8/28/2024

    For ADC developers, obtaining the desired payload can be a challenge, as their synthesis is more complex than most other small molecules. Learn about a more efficient approach to payload synthesis.

  4. What Do You Need To Do To Qualify A Single-Use Assembly? 8/28/2024

    Learn about the implementation of single-use technologies, single-use user requirement specifications, and best practices for single-use qualification, including quality and regulatory documentation.

  5. Optimizing Virus Bank Manufacturing 8/16/2024

    Gain insight into two cases where clients were enabled to overcome obstacles during virus bank manufacturing.

  6. Regulatory Considerations For Excipients Used In Lipid Nanoparticles 8/15/2024

    Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

  7. Scaling Up The Learning Curve For Large-Scale AAV Manufacturing 7/26/2024

    The complexity of manufacturing AAV products, coupled with the challenges linked to controlling their costs, underscore the importance of improving the efficiency and scalability of these processes.

  8. Accelerating Bulk Harvest Release Testing With A PCR-Based Solution 7/3/2024

    Adventitious agent testing is frequently a bottleneck in downstream processing. Discover a PCR-based solution for manufacturing processes using CHO cells and animal origin-free components.

  9. How To Accelerate And Enhance ADC Therapies 6/24/2024

    Learn how payloads and advanced payload intermediates can expedite drug development and elevate ADC therapies, and explore ADC payloads, payload intermediates, and solubility-enhancing technology.

  10. Make More Lentivirus And Make It Right The First Time 6/14/2024

    Discover how you can achieve higher titers and robust yield with an optimized, end-to-end lentivirus platform, designed to maximize production and quality for the success of your cell or gene therapy.