Guest Columns

  1. Contamination Control Strategies In Low Bioburden Biologic Drug Substance Manufacturing 12/15/2025

    How do manufacturers apply a contamination control strategy in a non-sterile world, particularly at a low bioburden biologic drug substance manufacturing site? How can Annex 1 apply?

  2. What 2025 FDA Warning Letters Tell Us About GMP Compliance 12/15/2025

    This analysis identifies key compliance trends and regional disparities by examining the 2025 U.S. FDA warning letters issued to drug product manufacturers posted between Jan. 1 and Dec. 9, 2025.

  3. Ask The Pros — The Latest In Upstream HCP Mitigation 12/15/2025

    We asked leading experts how upstream interventions can reshape HCP control. Here’s what they shared. Answers have been edited for clarity.

  4. Unpacking The EU's Mutual Recognition Agreements For Pharma 12/12/2025

    MRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.

  5. The Module Type Package Wants All Your Equipment To Start Talking 12/11/2025

    A forthcoming ISPE guide uses case studies to aid in the design of plug-and-play process skids with implications for every step in the manufacturing process continuum.

  6. Why Your MVP And Its Evolution Matters To Manufacturing 12/8/2025

    Minimum viable product is one of the most important inputs to developing a manufacturing process. It defines essentials that matter to the people who make the product.

  7. TFF Offers Ideal Anaerobic, GMP Conditions For LBP Concentration 12/8/2025

    When configured correctly, TFF provides the gentle processing environment and oxygen protection required for strict anaerobes.

  8. Ask The Pros — The Latest In HCP Monitoring 12/4/2025

    Established methods focused on counting all HCPs indiscriminately. Now, a new wave of sophisticated monitoring offers clearer impurity profiles.

  9. An End-To-End Automated HTP Platform For Cell Line Optimization 11/20/2025

    Bristol Myers Squibb's high-throughput stable CHO platform produces high-titer, high-quality material in a fraction of the conventional timeline.

  10. Here's What You Need To Know About The Access Consortium Pathway 11/20/2025

    Five nations are collaborating on a work-sharing program to reduce regulatory duplication in drug development.