Regulatory

  1. How Is U.S. Policy Reshaping Global Biomanufacturing Operations? 2/5/2026

    In this opening segment from the Bioprocess Online Live event, “Protecting Bioprocessing Operations and Supply Chains In A Turbulent Economy,” panelists Adam Golin, Jon Lindbloom, and James Sapirstein speak candidly about how U.S. tariffs are affecting the global operating environment.

  2. Process Intensification: Challenges, Trends, And Industry Takeaways 7/1/2025

    Process intensification is here and transforming industries now. Discover how experts and early adopters are tackling challenges and unlocking new efficiencies through sustainable technologies.

  3. Executive Roundtable: Cell Therapy Predictions For 2025 And Beyond 12/17/2024

    In this executive roundtable discussion, Bioprocess Online editor Tyler Menichiello is joined by CEO, co-founder, and president of Ossium Health, Kevin Caldwell, CSO of FibroBiologics, Hamid Khoja, Ph.D., and president and acting CEO of Triumvira Immunologics, Rob Williamson. The panelists share their predictions and thoughts on the industry’s direction heading into 2025. They cover manufacturing trends (noting opportunities for improvements in cell therapy manufacturing), AI adoption, regulatory concerns, and the potentially challenging funding environment ahead. 

  4. MES Apps Built For Speed And Seamless Integration 12/9/2025

    Digitize bioprocess workflows to achieve consistent, paper-free execution that deploys up to 66% quicker than traditional MES with a cloud-based, no-code platform built for single-use bioprocessing.

  5. Comparing Biosimilars To Drifting Reference Product Data 4/20/2026

    First-time biosimilar developers might be surprised to find significant lot-to-lot quality attribute shifts in their reference product.

  6. Master The 2-Point Calibration Process To Maintain Data Integrity 5/19/2025

    Ensure accurate sensor readings with an innovative software by mastering the 2-point calibration process. Learn more about how and why regular calibration supports data integrity and compliance.

  7. The ICH Q5A Revision, Its New Scope And Guidance 12/1/2022

    Learn about the ICH Q5A revision addressing viral safety of biotechnology products derived from cell lines of human or animal origin that was recently published for public comment.

  8. Building A Comprehensive Control Strategy For Biosimilar Analytics 4/20/2026

    Like many other biologic drugs, building a comprehensive controls strategy for biosimilars starts with defining critical quality attributes (CQAs), said Vince Narbut, a principal consultant at Biologics Consulting Group, during Bioprocess Online Live: Process Control's Increasing Role In Biosimilar Approval.

  9. Levers For Streamlining And Optimizing The Biosimilar Process 4/20/2026

    New and more advanced production methods mean biosimilar developers can produce their own versions of commercial drugs with greater efficiency. Levers like cell line engineering and bioreactor controls make it easier to increase productivity. Biologics Consulting Group Principal Consultant Vince Narbut walked through some of the unit operations ripe for optimizing during Bioprocess Online Live: Process Control's Increasing Role In Biosimilar Approval.

  10. A Straightforward Path Toward Regulatory Compliance & Data Integrity With Your Microbial Testing Systems 11/10/2025

    In this webinar, we will share a variety of strategies for implementing and validating microbial identification systems in the cGMP environment, possible difficulties along the way, and a comprehensive solution that addresses these challenges.