01.28.26 -- Single-Use Standards Are Maturing, But The Process Remains King

Minimizing endotoxin contamination is vital to protect patients from harmful reactions. Delve into the benefits of low-endotoxin products designed for contamination prevention to avoid needing contaminate removal.

This playbook provides a concise yet comprehensive roadmap for navigating Europe’s multifaceted regulatory environment when conducting gene therapy trials involving GMOs and CDx.

The EU GMP Annex 1 revision, which went into effect in August of 2023, requires a detailed Contamination Control Strategy. Learn how it impacts global manufacturers, RABS use, and personnel procedures.

Discover how to implement a validated, broad-spectrum qPCR workflow that covers over 250 species, ensuring both regulatory compliance and accelerated speed-to-market for your clinical-grade products.

Listen to these critical lessons from FDA 483 observations and Warning Letters to proactively address common GMP cleanroom compliance failures and build an inspection-ready facility.

Sterile manufacturing is key to patient safety and future innovation. Adhering to the rigorous standards set by the EMA's Annex 1 requires strategic, risk-based compliance for facility design and process.

Explore how a modular AAV8 platform enables scalable, GMP-ready gene therapy manufacturing with reproducible outcomes, streamlined tech transfer, and adaptability across serotypes.

Read how a comprehensive investigation and systems-level bio-decontamination strategy successfully eliminated persistent mold contamination in a vaccine manufacturing facility's high-risk area.