11.19.25 -- Navigating Regulatory Frameworks For Allogeneic CAR-NK Control Strategies

With continuously evolving gene therapy regulations and guidance and limited time during development for testing, here are four points to consider when planning product-release testing of your gene therapy product.

New sterile manufacturing rules require major changes to cryovial filling. Ensure compliance by adopting better "first-air" protection, minimizing human contact, and using 100% dose checks.

Effective isolator cleaning is crucial for vapor phase hydrogen peroxide (VPHP) decontamination. Proper tools, techniques, and training ensure sterility, and regulatory compliance.

Explore the critical aspects of GMP-grade raw materials in cell and gene therapy manufacturing, including contamination control, aseptic strategies, quality systems, supply chain security, and regulatory compliance.

Efficient hcDNA removal is vital for therapeutic safety and compliance. Discover how salt-active enzymes support high-salt purification workflows to help manufacturers meet strict regulatory standards.

Don't let facility limitations hinder your life sciences innovation. Learn essential conceptual design principles for transforming alternative spaces into efficient, regulatory-aligned cleanroom environments for critical processes.

Implementing the EU GMP Annex 1 requires a holistic, evolutionary Contamination Control Strategy built on standardization, data analytics, and continuous improvement for a zero-defect mindset.

Every batch in Cell and Gene Therapy is a personalized mission—where quality must be flawless, timelines are tight, and variability is constant. See why CGT demands a new quality paradigm.

Implement strategies to reduce unplanned downtime and keep your biomanufacturing on track with a checklist that covers maintenance, monitoring, and contingency planning to enhance reliability and resilience.

A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).