Regulatory

1. Fill And Finish: Your Final Step Is Our First Priority 12/9/2025

   Fill and finish demands precision, compliance, and adaptability. Learn how flexible solutions and expert support can help you overcome complexity, reduce risk, and ensure quality in this final step.

2. US GMP (21 CFR 820) Manufactured Oligos For Preclinical Research 10/18/2023

   Learn why Custom cGMP Oligos should be considered to ensure oligo products meet the strict standards of MDx, LDTs, and preclinical research.

3. 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.

4. A CDMO Perspective: Bioprocess Automation And Data Management 11/5/2025

   Watch this video to understand data management and process automation challenges across single-use bioprocessing applications from a CDMO leader, Paul Jorjorian, VP and GM of Pharma Services at Thermo Fisher Scientific.

5. Developing Antibodies To Block Neuroinflammation With MindImmune's Stevin Zorn, Ph.D. 10/20/2025

   In this episode of "Better Biopharma," host Tyler Menichiello is joined by MindImmune's president and CEO, Stevin Zorn, Ph.D. They discuss the development of the company's lead candidate, MITI-101, a monoclonal antibody designed to prevent peripheral immune cells from entering the brain and driving neuroinflammation linked to Alzheimer's disease.

6. 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.

7. 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. 

8. 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.

9. Platforming And The Future Of Standardized Manufacturing Chassis 4/20/2026

   Platforming downstream processes offers efficiency gains, while upstream processes are standardizing on high-intensity perfusion or fed-batch. Robust analytical data allows for modern efficiencies like single-use systems.

10. 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.