Guest Columns

  1. Struggling With GxP Systems? There's A DAP For That 4/2/2025

    A typical life sciences enterprise now has 500+ software applications. A digital adoption platform (DAP) is an overlay to help with user adoption, like an advanced version of the MS Word "paperclip" assistant.

  2. Risk Management Planning: Be Prepared When Disaster Strikes 4/1/2025

    Few life sciences companies are ready for a disaster, particularly a cyber one. Key factors include an integrated approach to cyber preparedness and risk planning, a dedicated team, and more.

  3. AI Model Cards Make Function And Risk Easier To Understand 3/31/2025

    AI doesn’t follow predefined logic like traditional software. Here's a tool, including a downloadable template, to answer critical compliance questions quickly.

  4. Amgen's Deep Learning Approach To Vial Inspection 3/31/2025

    The company is testing how artificial intelligence can help bring down the number of false rejections caused by factors like glare on the glass or bubbles in the vial.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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. 

  10. 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.