Guest Columns

  1. 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.

  2. 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.

  3. How To Approach Tech Transfers And Sponsored Life Sciences Research In An AI Age 3/27/2025

    Two IP attorneys examine the patentability of AI-conceived inventions and share tips for technology transfers and sponsored research in pharma/biotech.

  4. 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.

  5. 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. 

  6. When Conflict Arises With Your CDMO 3/24/2025

    Outsourced Pharma Advisory Board Member Sean Eisenberg details how to handle and overcome conflicts between drug sponsors and CDMOs. This is part one of a two-part dissertation on a subject that, if you outsource, will certainly arise ... if it hasn't already.

  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. The Technologies Propelling GLP-1 Analogues 3/18/2025

    This article delves into the manufacturing and synthesizing technologies used to manufacture GLP-1 drugs as well as the novel drug delivery technologies being used.