Featured Bioprocessing Editorial

  1. Lessons In Quality From Sanofi's Plai.qa 11/24/2025

    The platform orchestrates data to evaluate site maturity and performance and provide recommendations for improvement.

  2. The Promise And Paradox Of QbD 11/24/2025

    The difference between QbD as burden and QbD as advantage lies in critical thinking supported by structure — a hierarchy of metrics, toolsets, and tailored platforms.

  3. The Future of Biotech Outsourcing: Essential Skills for Program Managers 11/24/2025

    The next generation of program managers who liaise with contract manufacturers needs an expanded skillset to thrive.

  4. Hidden Sensitive Data Liability: Why Legacy Web Forms Put Life Sciences Organizations At Critical Risk 11/21/2025

    Many life science organizations collect sensitive data through outdated web forms, exposing companies to critical vulnerabilities, data breaches, regulatory penalties, and more.

  5. A Hierarchy Of Metrics Brings Strategy Into Biopharma's Daily Work 11/21/2025

    Information now flows faster than organizations can think about it, and without deliberate structure, decision-making becomes reactive rather than reflective.

  6. 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.

  7. 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.

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 FDA Draft Guidance On CES Signals More Reliance On Toxicity And PK 11/19/2025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

  9. 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.”

  10. 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.