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. 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.

3. In The U.S., Pharmacy-Level Biosimilar Substitution Remains A High Bar 4/20/2026

   Recent changes in the FDA's biosimilarity assessment guidance do not address the other side of the biosimilar coin, interchangeability. Unique to the U.S., pharmacy-level substitution is allowed only when companies clear an additional regulatory hurdle of receiving an interchangeability designation.

4. 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.

5. 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.

6. 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. 

7. 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.

8. 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.

9. 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.

10. 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.