Regulatory

1. 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.

2. 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.

3. 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.

4. 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.

5. The Necessity Of Potency Assay Matrices For Complex Proteins 4/20/2026

   For complex proteins, the FDA requires a matrix of orthogonal potency assays. Sponsors must assess all functional activities of a product, especially when the mechanism of action is known.

6. How To Avoid A Biosimilar Comparative Efficacy Study, If Possible 4/20/2026

   Few companies, if any, would ever eagerly volunteer to perform a comparative efficacy study (CES) for their biosimilar candidate. The FDA has been clear all along that compelling a CES remains a tool in its toolbox if the agency believes it's necessary. So what might trigger one, and how can companies avoid it?

7. 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.

8. 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.

9. 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.

10. 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.