Regulatory

1. Level Up With Product Characterization 3/12/2021

   In the race to bring a new biotherapeutic to market, unexpected obstacles can slow you down or even knock you back a few steps. But with the right information at the right time, and an experienced partner to provide scientific, regulatory, and bioprocessing guidance and support, you can find a smoother, faster path to the finish line.

2. 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.

3. 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.

4. 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.

5. Standards' Role In Biosimilarity Assessment 4/20/2026

   Standards are useful tools for specific purposes, but they represent a one-point target. They do not capture the full range of variability found in reference products on the market.

6. 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.

7. 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.

8. 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.

9. Cell And Gene Therapy Innovations 5/19/2025

   This interview with a pharmaceutical analytics expert discusses key insights into advances in cell and gene therapy and the strategies used to support customers in improving their therapeutic development.

10. 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.