Industry Insights

  1. How AI Could Clear Logistics Roadblocks Limiting Patient Access To CGT 4/23/2026

    Patient access often gets mischaracterized solely as a cost and pricing issue. A discussion among industry leaders reaches a deeper, more complex conclusion.

  2. ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-Based Decisions 2/28/2023

    The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.

  3. Building Training Programs And User Controls That Last Beyond Go-Live 3/31/2026

    Validation success doesn’t guarantee audit readiness. When training fades, compliance risk grows quietly. Learn how post-go-live gaps surface and how programs prevent findings before auditors do.

  4. How Your Stainless-Steel Column Is Like A French Press 1/10/2023

    Understanding how purification columns help operators to better conceptualize the process enables greater understanding and troubleshooting.

  5. An Overview Of Fluorescent Dyes 6/8/2023

    Expand your knowledge on the basic principle in fluorescence microscopy, immunofluorescence, FITC and TRITC, Cyanines, DNA staining, and more.

  6. Synthetic Oligonucleotides: Regulatory, Analytical & Manufacturing Considerations 5/28/2021

    In early March 2021, more than 300 professionals in regulatory, industry, and academic roles attended the USP's virtual Workshop on Therapeutic Peptides and Oligonucleotides. Building on regulatory considerations and control strategies, the workshop explored innovative techniques being used to analyze synthetic oligonucleotides, ensure quality, and reduce waste. 

  7. Enabling Greater Digitization And Data Integration 9/6/2023

    Establishing an integrated, tailored data management strategy is core to getting the cell line development journey right.

  8. What You Need To Know About Continuous Processing 2/1/2018

    There is a lot of interest around continuous biomanufacturing, but could a hybrid of batch and continuous unit operations be the best solution for your process train?

  9. Resistance Or Defiance? The FDA And The 11th Circuit Spar Over Statute On Orphan Drug Statutory Exclusivity 2/23/2023

    Last September, the 11th Circuit Court of Appeals sided with a challenge to the FDA’s long-standing interpretation of the Orphan Drug Act by broadening the scope of orphan drug exclusivity under step one of the Chevron legal analysis. But the FDA has pushed back.

  10. MTP And "The Ballroom Concept": Agile Manufacturing For Pharma 4/14/2026

    Modular automation is reshaping manufacturing by enabling faster changeovers, reduced downtime, and built‑in compliance. Learn how the “ballroom” approach helps teams adapt to shifting demand.