Executive Summary
Quality agreements and technology transfer can significantly impact advanced therapy timelines. In this expert-led webinar, QA leaders discuss practical approaches to structuring sponsor–CDMO quality agreements, reducing tech transfer risk, and embedding quality risk management across the cell and gene therapy lifecycle. Watch to gain actionable insight into maintaining GMP compliance while accelerating development.
Key Takeaways
– What a robust quality agreement should include
– Reducing risk during technology transfer and validation
– Applying quality risk management (QRM) in advanced therapies
– Strengthening regulatory alignment through structured QA collaboration
About This Webinar
Cell and gene therapy programs require rigorous quality oversight from early development through commercial manufacturing. Poorly defined quality agreements, unclear role delineation, or reactive risk management can introduce compliance gaps and delay technology transfer.
In this discussion, quality leaders share practical frameworks for structuring sponsor–CDMO quality agreements that evolve with program maturity. The session explores how early QA involvement in technology transfer and validation improves timeline predictability and reduces operational risk.
Panelists also address data-driven quality risk management (QRM), cross-functional communication, and global regulatory considerations across advanced therapy programs. Real-world examples illustrate how structured quality systems strengthen partnerships, improve decision-making agility, and support consistent GMP compliance.
This webinar offers actionable guidance for organizations seeking to embed proactive quality governance into cell and gene therapy development.
Who Should Watch This Webinar?
– QA and regulatory leaders in advanced therapies
– CMC teams preparing for technology transfer
– Sponsors partnering with a CDMO – Operations leaders overseeing GMP compliance
Watch the full webinar to explore practical QA strategies and real-world examples.
Watch nowAbout the speakers
Dr. Luciana Mansolelli
Chief Quality Officer
Dr. Luciana Mansolelli serves as our Chief Quality Officer at Minaris Advanced Therapies, bringing over 29 years of global leadership experience in quality, development and manufacturing for advanced therapies, including biologics, medical devices and cutting-edge cell and gene therapies. She has a proven track record of building robust quality systems, driving operational excellence and guiding teams through complex regulatory landscapes. She has extensive experience working with global health authorities and non-governmental bodies on drug development, manufacturing and commercial compliance, as well as legal frameworks across multiple GxP disciplines and products. Dr. Mansolelli leads our global quality strategy, ensuring the highest standards are met across all programs and sites.
Dr. Mansolelli’s career includes global senior leadership positions at Johnson & Johnson Innovative Medicine and Novartis. Earlier in her career, she served as Director of QA for Novartis, leading R&D quality and compliance at Eurofarma and Hexal do Brasil. She began her career as a production supervisor at Boehringer Ingelheim.
Dr. Mansolelli holds a Doctor of Pharmacy from Universidade Estadual de Maringá and an MBA from Fundação Getulio Vargas.
Audrey Chang, PhD
CMC Advisor at Minaris Advanced Testing
Dr Chang has over 28 years of government and industry experience in conducting biological product testing and in managing laboratories. Audrey earned her Ph.D. at the Johns Hopkins University in Biology, and after a post doc at the FDA, joined BioReliance where she held various positions of increasing responsibilities. Prior to joining Minaris Advanced Therapies, Audrey was VP of QC at Vigene BioSciences which was acquired by Charles River Laboratories. In her current role, Audrey provides technical solutions and support to clients for both traditional biologics and novel modalities. Audrey has always had a passion for driving innovative products to commercialization and is happy to bring her experience to the testing division at Minaris Advanced Therapies.