02.11.26 -- Disciplined CGT Will Win On 2026 Regulatory Flexibility

Explore these strategies to calibrate testing scope to risk, optimize execution workflows, and reduce operational burdens without compromising quality standards or safety compliance.

Navigate the FDA's gene therapy guidelines with advanced risk assessment strategies. Optimize gene editing and ensure regulatory alignment for safer, more effective therapies.

Key challenges in emerging cell therapies include finding new antigens, reducing variability, and standardizing processes. Hear from experts about opportunities for growth and response to solid and liquid tumors.

Strict GMP guidelines are meant to mitigate risks and establish quality standards. Understand how advanced equipment design can ensure safety and effectivity in complex, sterile cell and gene manufacturing.

Learn how validated testing, strict sourcing, and regulatory guidance help minimize endotoxin contamination risks and support reliable therapeutic development in advanced medicinal products.

Discover how rapid molecular methods of cell therapy testing like qPCR for mycoplasma, sterility, and lentiviral quantification are key to accelerating product release and timely treatment delivery.

Companies still relying on paper-based manufacturing are falling behind. Examine how digital transformation boosts efficiency and reduces errors in this essential shift toward smarter operations.

Ease your compliance concerns with these insights to maintaining a cleanroom facility that remains safe for your workers, and where the therapeutics they produce remain safe for patients.

Oversight in 2026 requires adaptability as AI, consent standards, and regulatory changes challenge sponsors and IRBs to balance ethics with innovation through proactive planning and collaboration.

Residual host cell DNA monitoring is vital in biologics manufacturing. Learn how digital PCR offers unmatched sensitivity and precision to ensure compliance with strict safety standards set by global regulatory agencies.