Industry Insights

1. Expert Q&A: What A Submission-Ready E&L Strategy Really Looks Like 4/14/2026

   Underestimating E&L risks can delay approvals. A risk‑based, product‑specific approach — supported by strong analytics and toxicology — helps teams identify issues early and move forward with confidence.

2. What FDA CRLs Reveal About Method Validation 4/14/2026

   FDA rejection letters reveal validation failures are structural, not technical. Weak lifecycle oversight, robustness, and documentation continue to delay approvals despite clear guidance.

3. What FDA CRLs Reveal About CCIT 4/14/2026

   FDA rejection letters show common CCIT gaps — low sensitivity and incomplete validation. Spotting these trends helps teams strengthen integrity testing and avoid approval delays.

4. Understanding And Implementing USP <665> For Single-Use Systems 4/14/2026

   New expectations for single-use systems require structured risk assessment and extractables testing. As compliance deadlines near, practical guidance aligns science, knowledge, regulatory readiness.

5. From Bench To Approval: Smart IVBE Strategies For Complex Drugs 4/10/2026

   In vitro bioequivalence can replace clinical studies for complex products when well designed. Clinically relevant, risk-based methods under realistic conditions show site-of-action equivalence.

6. Cell-Based Bioassay eBook: The Definitive Guide To Getting Potency Testing Right 2/27/2026

   Our free 26-page e-book is here to help, offering clear explanations, practical strategies, and regulatory insights to guide you in creating robust, compliant CBBAs that keep your programs on track.

7. NGS Adoption For Viral Safety: From Experimental Tool To Regulatory-Endorsed Standard 2/26/2026

   Once viewed as an exploratory tool, NGS is now emerging as a robust, regulatory-endorsed method for ensuring viral safety in biological medicinal products.

8. USP <665> Becomes Official On May 1, 2026. Are You Ready? 2/24/2026

   With USP <665> becoming official on May 1, 2026, proactive preparation is essential to ensure compliance and prevent delays, regulatory observations, or supply chain disruptions.

9. 21% Of CGT Clinical Holds Stem From CMC Issues. What Does This Tell Us? 2/23/2026

   Cell and gene therapy (CGT) trials account for nearly 40% of all clinical holds reported by the NIH, with over 21% caused by CMC issues, often delaying approvals by over 6 months.

10. What Defines Excellence In CMC Analytics? 2/21/2026

    In this podcast, our Chief Scientific Officer, Daniel Galbraith, shares candid insights into what separates operational vendors from true scientific collaborators.