BIO From The Editor and Guest Columns

  1. Alternatives To Testing Sterility In Cell- And Tissue-Based Products 3/28/2025

    Testing depletes precious product, and regulators increasingly support using other methods if they're backed by robust validation data.

  2. Embracing Turnkey And Outsourced Quality Management In Biopharma 3/28/2025

    In-house quality management systems often struggle to keep pace. Many organizations are adopting turnkey and outsourced quality management solutions to ensure compliance and enhance efficiency.

  3. Impressions And Takeaways From BPI West 2025 3/27/2025

    Editor Tyler Menichiello reviews the most compelling topics and sessions from this year's BioProcess International U.S. West.

  4. Questions You And Your New CDMO Might Be Asking 3/27/2025

    One expert who has been on both sides of contracting relationships explores common questions you could — or should — be asking before signing up with a new manufacturer.

  5. Using Digital Shadows To Reinforce Downstream Modeling 3/26/2025

    This model class transfers real-time information in one direction, and it can help bridge the gap between digital model and fully functioning digital twin.

  6. The Importance Of Primary And Secondary Drying And Their Impact On Lyophilization 3/25/2025

    For parenteral formulations, biologics, and vaccines, the lyophilization process's primary and secondary drying stages require precise control of temperature, vacuum, and duration. 

  7. Counting The Steps To Decentralized Personalized Therapy Manufacturing 3/21/2025

    AltruBio's CEO has a rough map of the steps to distributed cell therapy manufacturing. She discusses the path and some of the obstacles we'll need to clear first.

  8. Upskilling Your Quality Team For The AI Revolution In Pharma 4.0 3/21/2025

    While AI systems offer advanced capabilities for data analysis, process optimization, and quality assessments, your quality team must first be proficient in interacting with them.

  9. 3 Strategies For mAb Manufacturing: How Do You Choose? 3/19/2025

    As cost and supply come under more scrutiny, there are primarily three scaling strategies for mAb manufacturing that can be leveraged, each with its own set of pros and cons.

  10. A Practical Guide To Defining Priority Data In MES 3/17/2025

    Manufacturing execution systems (MES) play a crucial role in pharma/biotech, but MES platforms face the challenge of identifying the critical data that should be prioritized for supporting effective operations.