Cell and Gene Regulatory

1. Esco IntelliGlove Tester (EIGT) 2/19/2026

   Ensure sterility with wireless glove leak testing. Align with Annex 1 and ISO standards through portable, traceable, and cable-free integrity checks that optimize cleanroom safety and workflows.

2. 0.45 m/s ±20% At Working Position In Closed Sterility Testing Isolators: Requirement Or Convention? 2/19/2026

   Balance compliance and efficiency in sterility testing. Explore how a risk-based approach to airflow and isolator technology aligns with Annex 1 while optimizing contamination control.

3. Esco Pharmaceutical Products Catalogue 2/19/2026

   Secure your process with advanced isolation and airflow containment. From ISO Class 5 environments to cytotoxic safety, these solutions ensure peak protection and global regulatory compliance.

4. Pharma Product Guide 2/19/2026

   Enhance your clinical and pharmaceutical workflows with advanced containment. From ISO Class 5 environments to modular isolation, find scalable solutions to protect integrity and ensure safety.

5. Redefining Glove Integrity Testing: Esco IntelliGlove Tester (EIGT) 2/19/2026
6. Cold Chain Compliance Standards You Should Know About 2/18/2026

   Regulatory frameworks for biopharmaceutical cold chain management are more interconnected than most manufacturers expect — and the gaps between them are where compliance risk lives.

7. Inside Mesoblast's Playbook For Making Allogeneic Cell Therapy Real 2/18/2026

   Mesoblast's Silviu Itescu shares how two decades of rigorous science and manufacturing turned allogeneic MSCs into the first FDA-approved cell therapy while building a scalable platform for inflammatory diseases such as GvHD, back pain, and heart failure.

8. What FDA CRLs Reveal About E&L 2/18/2026

   FDA feedback shows E&L gaps still delay approvals. This preview flags common issues — from unknown compounds to weak tox data — and offers ways to strengthen E&L approaches and cut regulatory risk.

9. U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact 2/18/2026

   Beroe Inc.'s Mathini Ilancheran discusses the 2025 U.S. pharma tariff framework and translates it into actionable procurement and outsourcing responses.

10. Practical USP <1665>/<665> Guide To E&L Risk Assessment 2/17/2026

    A practical USP <1665> and <665> framework helps manufacturers evaluate and manage extractables and leachables risk, supporting quality, safety, and regulatory compliance.