Industry Insights

  1. Maintaining CQA's As Manufacturing Process Scale From 2D to 3D 6/23/2022

    We discuss critical process parameters that may be utilized to control for CQAs in 3D bioreactor systems and the comparability of CQAs and functional attributes between hMSCs manufactured in 2D planar culture vs. 3D bioreactor culture.

  2. 4 Questions To Ask Your Fill/Finish Partner

    Reducing risk while maximizing API volume is critical during the fill/finish phase of biopharmaceutical manufacturing. To ensure safety and quality, partner with an experienced fill finish provider.

  3. AI Performance Management In Biologic And Drug Development 3/7/2025

    Life cycle maintenance is essential in AI-driven drug development. Regulators recommend continuous updates to AI models to monitor and adjust for data pattern changes.

  4. ASTM International Pharmaceutical Cleaning Standards: Current Status And Future Direction 1/2/2025

    This article provides an update on the progress of the science-, risk-, and statistics-based ASTM International Cleaning Standards: published standards, work currently underway, and how you can get involved.

  5. CDMO Partnerships In Early Development Aren't Always The Best Choice 12/7/2022

    This article looks at the needs and challenges biotech organizations face during the manufacture of therapies, how they can reduce cost, and how establishing — or not establishing — partnerships with CDMOs can help get their therapies to patients faster.

  6. Achieving Flexibility In RNA Drug Manufacturing With Microfluidics 11/21/2023

    RNA manufacturers need flexible processes and technology. They need to manufacture high-quality RNA in small quantities and scale up. Modular, and more specifically, modular microfluidics equipment makes that easier. This discussion takes stock of the current state of modular equipment for RNA manufacturing.

  7. Cell Line Development: Reducing Timeline To IND Submission 4/5/2022

    Learn how to streamline your development timeline and align your project for timely Biologics License Application (BLA) and Investigational New Drug (IND) submissions.

  8. Software Validation Keeps GxP Systems Current, Speeds Up Time-To-Market 2/2/2024

    Requirements to maintain a GxP environment mean researchers must conduct software validation on any updated software so it continues to meet users’ needs.

  9. Human Performance In Biopharma Operations — Your Problem Isn't Error 11/9/2020

    Part 1 of a two-part roundtable discusses key drivers for human performance improvement, lean manufacturing and human performance programs, and perspectives on human performance in the context of the rapid scale-up and production of COVID-19 therapeutics and vaccines. 

  10. What Drug Manufacturers Should Know About Operational Readiness 6/4/2025

    Moving beyond last-minute checklists, true Operational Readiness is about intentionally building success into your facility’s DNA. Discover the foundational elements that enable a smoother and safer startup.