Regulatory

  1. 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.

  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. 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.

  5. 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.

  6. Engineering Bacterial Vector-Based Immunotherapies With OS Therapies' Paul Romness and Robert Petit, Ph.D. 10/7/2025

    In this episode of “Better Biopharma,” host Tyler Menichiello is joined by OS Therapies’ CEO, Paul Romness, and chief medical and scientific officer, Robert Petit, Ph.D. The three discuss the development and manufacturing of the company’s lead asset, OST-HER2, a Listeria-based immunotherapy for osteosarcoma.

  7. 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.

  8. 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.

  9. A Straightforward Path Toward Regulatory Compliance & Data Integrity With Your Microbial Testing Systems 11/10/2025

    In this webinar, we will share a variety of strategies for implementing and validating microbial identification systems in the cGMP environment, possible difficulties along the way, and a comprehensive solution that addresses these challenges.

  10. 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.