Featured Editorial

  1. Allogeneic Cell Therapy Is Still Learning What Biology Will Allow 7/14/2026

    Allogeneic cell therapy is advancing through smarter donor selection and manufacturing control, showing how biology, process design, and product consistency drive success.

  2. On The Ground At BIO 2026: Johanna Kaufmann, Ph.D., On The Oncology Modality Puzzle 7/10/2026

    At the 2026 BIO International Convention, Bioprocess Online caught up with Johanna Kaufmann, Ph.D., CSO at Deck Bio, a company developing multi-targeted T-cell engagers for solid tumors.

  3. BIO 2026: Modernizing The FDA And Bolstering The Workforce 7/10/2026

    Bioprocess Online's chief editor, Tyler Menichiello, shares his key takeaways from the 2026 BIO International Convention in San Diego.

  4. Transforming Computer System Validation In The Life Sciences Industry 7/10/2026

    Regulators acknowledge how traditional CSV methods fail to meet modern demands for speed and flexibility. The scene is changing in favor of smarter, leaner validation.

  5. BIO 2026: Crowley On Competing With China And Modernizing The FDA 7/8/2026

    Exclusive coverage from John Crowley's press conference at the 2026 BIO International Convention in San Diego.

  6. Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis 7/8/2026

    Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.

  7. Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program 7/7/2026

    In this third and final article of this series, let's take a closer look at what a well-constructed Annex 1-compliant program looks like at each stage, from gap assessment through governance.

  8. An Open-Source Modeling Tool For Suspended Continuous Lyophilization 7/7/2026

    Building on a continuous suspended-vial lyophilization workflow, process developers can model critical variables before doing physical experiments.

  9. Essential CMC Elements For A Therapeutic Secretome 6/30/2026

    Noveome Biotherapeutics's Larry Brown, Sc.D., explains the regulatory and CMC challenges behind the company's novel secretome therapy, ST266.

  10. Mapping Early-Phase Supply Chain Bottlenecks That Doom Pipelines 6/30/2026

    Many sponsors miscast preclinical development as an unglamorous step between discovery and the clinic. Here's how the consequences may lead to irrevocable losses.