Regulatory

1. An Efficient And Reliable Way To Digitalize Your Sterility And QC Testing Data 5/2/2023

   Watch to learn about the M-Trace™ Electronic Test Record Software, your digital QC companion for trusted and efficient data recording that automizes and digitalizes your sterility and QC testing data.

2. 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. 

3. 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.

4. 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.

5. 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.

6. 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.

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

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

8. 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.