INSIGHTS ON CELL & GENE REGULATORY ISSUES

• Esco IntelliGlove Tester (EIGT)

  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.

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

  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.

• Esco Pharmaceutical Products Catalogue

  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.

• Pharma Product Guide

  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.

• Redefining Glove Integrity Testing: Esco IntelliGlove Tester (EIGT)
• Cold Chain Compliance Standards You Should Know About

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

• Inside Mesoblast's Playbook For Making Allogeneic Cell Therapy Real

  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.

• What FDA CRLs Reveal About E&L

  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.

• U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact

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

• Practical USP <1665>/<665> Guide To E&L Risk Assessment

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