Guest Columns

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. FDA Draft Guidance On CES Signals More Reliance On Toxicity And PK 11/19/2025

    The technology to measure alternative metrics is vastly improved. Now, FDA joins other regulators in deprioritizing comparative efficacy studies for biosimilars.

  8. Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations 11/18/2025

    A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”

  9. Phages As A Pharmaceutical: New EMA Guidance On Antimicrobial Drug Development 11/17/2025

    The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products. Rising antimicrobial resistance has renewed interest in bacteriophages to fight pathogens.

  10. How To Improve Sponsor–CMO Collaboration Around Digital Deviations 11/17/2025

    Digital strategies and standardized data models cut manual work, boost accuracy and speed of information sharing, and build trust between sponsors and CMOs.