11.05.25 -- Rigorous Safety Monitoring Central To NK Cell Therapy Development

Single-use technology suppliers must align with advanced therapy manufacturers to de-risk manufacturing processes and chemical composition requirements to maintain the safety and efficacy of new treatments.

CGT developers face rising regulatory challenges around potency, stability, and process control. Find out how proactive planning, expert guidance, and early FDA engagement are key to avoiding delays.

Disconnected systems are a leading cause of data integrity violations, which account for over 70% of FDA warning letters globally. Learn why integration is essential for compliance and operational success.

Three essential elements contribute to a repeatable, adaptable regulatory submission process: strategic planning, team engagement, and properly leveraging team experience.

Industry experts share strategies to overcome key barriers in CGT development, from reproducibility to scale-up. Gain practical insights to help teams move faster and more reliably toward commercialization.

Examine disinfectant residue characteristics, impacts, and removal challenges in cleanrooms, as well as the practical requirements for maintaining cleanliness standards and addressing these residues effectively.

Fragmented national regulations for pricing, customs, and reimbursement demand tailored supply chain strategies. Adapting to country-specific hurdles is essential for product integrity and patient access.

This comprehensive presentation offers valuable strategic and operational guidance for navigating the regulatory challenges of conducting gene-modified organism (GMO) trials in Europe.

The quality of non-active ingredients, or excipients, directly impacts product safety and efficacy. See why Excipient GMP is vital for cell culture solutions and how it elevates manufacturing standards.