06.18.25 -- Bridging Development And Regulation In CGT With Halloran Consulting Group's Monika Swietlicka

Eurofins ensures Annex 1 compliance through robotic isolators, PUPSIT, contamination control strategies, and rigorous training for aseptic sterile fill-finish of early-phase clinical products.

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

In this presentation, expert speakers provide an in-depth exploration of the essential validation and regulatory strategies for Immunohistochemistry (IHC).

Overcoming barriers to gene therapy development requires continued innovation in manufacturing processes, harmonized regulatory approaches, and outcome-based pricing models.

Explore how the FDA's Real-World Evidence framework helps integrate real-world data into drug approval, improving efficiency, while ensuring data reliability and regulatory compliance.

Become equipped with the tools and strategies needed to strengthen your calibration efforts and better position your organization for success in regulatory audits.

Watch to explore the relationship between a Contamination Control Strategy (CCS) and the development of a robust cleaning and disinfection program for cleanroom environments.

For vector-based therapeutics, testing for replication-competent viruses is crucial but prolongs release times. Which tools can help developers and manufacturers be confident in their CGT products?

The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.