Regulatory

  1. 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.

  2. Criticism Of FDA's Limited Proof-Of-Principle Ignores The Full Breadth Of Biosimilar CQA Understanding 4/20/2026

    Critics say adalimumab and trastuzumab, two of the most well-characterized antibodies on the market and each with their several approved biosimilars, provide a limited basis for proof of principle. During Bioprocess Online Live: Process Control's Increasing Role In Biosimilar Approval, panelists agreed that the full body of evidence includes approved biosimilars with diverse mechanisms of action and complex glycostructures.

  3. Platforming And The Future Of Standardized Manufacturing Chassis 4/20/2026

    Platforming downstream processes offers efficiency gains, while upstream processes are standardizing on high-intensity perfusion or fed-batch. Robust analytical data allows for modern efficiencies like single-use systems.

  4. 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.

  5. A CDMO Perspective: Bioprocess Automation And Data Management 11/5/2025

    Watch this video to understand data management and process automation challenges across single-use bioprocessing applications from a CDMO leader, Paul Jorjorian, VP and GM of Pharma Services at Thermo Fisher Scientific.

  6. 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.

  7. Facing NASH Therapeutic Skepticism With 89bio's Rohan Palekar 8/9/2023

    The non-alcoholic steatohepatitis (NASH) therapeutics market has proven to be an 11/10 on the difficulty scale. Despite billions of big biopharma dollars invested in therapeutic development, and a few close calls, no therapeutics has yet reached the finish line.

  8. Simplifying Bioprocess Data Collection 2/17/2023

    Centralized bioprocess data collection and aggregation lowers the risk of data loss during any manual retrieval process. Discover a solution that helps you meet data storage and reporting requirements.

  9. Strategies To Reduce Regulatory Risks In Gene Therapy 5/15/2020

    Learn how to mitigate regulatory risk for your gene therapy process.

  10. Fill And Finish: Your Final Step Is Our First Priority 12/9/2025

    Fill and finish demands precision, compliance, and adaptability. Learn how flexible solutions and expert support can help you overcome complexity, reduce risk, and ensure quality in this final step.