Regulatory

  1. In Biosimilar Analytical Development, Is A CQA Ever Not Critical? 4/20/2026

    The word "critical" implies a binary signal. The attribute is either existentially important or it's not.

  2. Streamline Production With A Final Filling Single-Use Set 8/7/2025

    Streamline your production with a Final Filling Single-Use Set that installs in under 10 minutes to eliminate cleaning and sterilization while ensuring Annex 1 compliance and full customization.

  3. Faciliflex Cleanroom Module For Therapeutic Drug Manufacturing 1/4/2021

    The Faciliflex Module is a transformational new concept in designing cleanrooms for the production of lifesaving therapeutics.

  4. When And How To Implement Process Intensification 10/3/2025

    Explore when to intensify your processes, what challenges to expect, and how to prepare for a successful transition with expert insights to help guide your strategy and ensure smoother implementation.

  5. Creating Technical Debt When Experimenting With 3D Printed Parts 7/29/2026

    Companies need mature validation paradigms to recognize if and when it's time to transition from a prototype 3D printed part to a sustainable version, likely through a vendor-validated part.

  6. The Burden Of Proof Has Shifted To Analytics For Biosimilar Approval 4/20/2026

    The FDA's recent and stunning declaration that comparative analytical assessments (CAA) are generally more sensitive than clinical efficacy studies (CES) shows the great degree in which the agency is leaning on analytics rather than clinical data when considering 351(k) applications for biosimilars.

  7. Training AI Models 9/17/2024

    In this segment from the Bioprocess Online Live, “A Realistic Look At AI/ML In Biomanufacturing,” panelists talk about what makes a good AI model and highlight considerations for training these models.

  8. Closing The Data Package Gap For In-House 3D Printed Parts 7/29/2026

    Vendor supplied single-use components come with mostly-complete data packages. That luxury doesn't exist when you make your own parts using a 3D printer.

  9. 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.

  10. How To Avoid A Biosimilar Comparative Efficacy Study, If Possible 4/20/2026

    Few companies, if any, would ever eagerly volunteer to perform a comparative efficacy study (CES) for their biosimilar candidate. The FDA has been clear all along that compelling a CES remains a tool in its toolbox if the agency believes it's necessary. So what might trigger one, and how can companies avoid it?