Regulatory

1. Levers For Streamlining And Optimizing The Biosimilar Process 4/20/2026

   New and more advanced production methods mean biosimilar developers can produce their own versions of commercial drugs with greater efficiency. Levers like cell line engineering and bioreactor controls make it easier to increase productivity. Biologics Consulting Group Principal Consultant Vince Narbut walked through some of the unit operations ripe for optimizing during Bioprocess Online Live: Process Control's Increasing Role In Biosimilar Approval.

2. Process Intensification: Challenges, Trends, And Industry Takeaways 7/1/2025

   Process intensification is here and transforming industries now. Discover how experts and early adopters are tackling challenges and unlocking new efficiencies through sustainable technologies.

3. Master The 2-Point Calibration Process To Maintain Data Integrity 5/19/2025

   Ensure accurate sensor readings with an innovative software by mastering the 2-point calibration process. Learn more about how and why regular calibration supports data integrity and compliance.

4. 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.

5. Building A Comprehensive Control Strategy For Biosimilar Analytics 4/20/2026

   Like many other biologic drugs, building a comprehensive controls strategy for biosimilars starts with defining critical quality attributes (CQAs), said Vince Narbut, a principal consultant at Biologics Consulting Group, during Bioprocess Online Live: Process Control's Increasing Role In Biosimilar Approval.

6. Streamline Production With A Final Filling Single-Use Set 8/7/2025

   Streamline your production with a Final Filling Single-Use Set that installs in under 10 minutes to eliminate cleaning and sterilization while ensuring Annex 1 compliance and full customization.

7. Select Your Best Downstream Process Intensification Strategy 1/7/2026

   Intensified and connected processing can cut costs and eliminate bottlenecks in mAb manufacturing. Discover how to identify the most efficient chromatography methods and future-proof your operations.

8. 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.

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. 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.