Featured Bioprocessing Editorial

  1. 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.

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 FDA Draft Guidance On CES Signals More Reliance On Toxicity And PK 11/19/2025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

  3. 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.”

  4. AI Is Not The CMC Revolution You're Looking For, And That's OK 11/18/2025

    Advanced therapy development today is less about big funding, more about frugality. Artificial intelligence unlocks a competitive advantage.

  5. 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    The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products.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.

  6. 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.

  7. Solving The Stem Cell Consistency Conundrum With iMSCs 11/17/2025

    The ability to produce unlimited batches of induced mesenchymal stem cells from a single iPSC cell bank is, perhaps, one of their most alluring features.

  8. Sensitive Critical Starting Materials Need A 'Just-In-Data' Approach 11/14/2025

    Here's a blueprint for transforming the fragmented, high-risk interface between vector and cell therapy platforms into a unified, predictable, and compliant system.

  9. Exploring The Benefits Of Electroporation In NK Cell Transfection 11/14/2025

    Electroporation creates temporary holes in cell membranes for genetic material to slip through. The technique offers some key advantages to viral transduction.

  10. On The Potency Assurance Journey, Travelers Need A Road Map 11/13/2025

    When regulatory expectations change by the phase, the route can be difficult and confusing to navigate for both new and experienced potency investigators.