MilliporeSigma | October

MilliporeSigma | October 30, 2025 11:00 EDT | Virtual 

Join MilliporeSigma on October 30 to hear Featured Speakers Manjula Aysola, MilliporeSigma, and Alison Armstrong, MilliporeSigma, discuss "Navigating Regulatory Complexities Along the Cell and Gene Therapy Lifecycle: From Raw Materials to Release". Register for this free opportunity by October 28.

Location:
Virtual via Zoom

Register Now for October MilliporeSigma Webinar

Attendance and Substitution Policy

CASSS reserves the right to withdraw, replace, add, or substitute presenters, speakers, and other guests without notice. Entry into the conference is at the sole discretion of CASSS and CASSS reserves the right to refuse entry to anyone for any reason.

Navigating Regulatory Complexities Along the Cell and Gene Therapy Lifecycle: From Raw Materials to Release

Cell and gene therapies (CGTs) represent a transformative frontier in medicine, offering the potential to treat, cure, or even prevent diseases at their genetic origin. These therapies harness the power of living cells and genetic engineering to restore or modify biological function, with applications spanning rare genetic disorders, cancer, and chronic conditions. Although CGTs are shaping the future of medicine, their development and manufacturing lifecycles are complex and rapidly evolving. This webinar will explore and discuss current manufacturing technologies, including platform-based approaches that offer scalability and consistency, while highlighting critical watch-outs such as variability in raw materials, process control challenges, and the impact of early-stage decisions on long-term product quality. Attendees will gain insights into how technology choices influence not only production efficiency but also regulatory compliance and clinical success. The session will also provide a global regulatory update, including new FDA guidelines on raw and starting materials and recent changes in guidelines from other jurisdictions with a focus on viral safety. A deep dive into viral safety strategies will address upstream risk mitigation, downstream viral clearance techniques, and how newer technologies such as next generation sequencing can be implemented in quality control testing. Finally, the webinar will examine regulatory hurdles associated with cross-border release testing, offering practical strategies for navigating international requirements and ensuring product safety and compliance across markets.

Manjula Aysola
Senior Regulatory Consultant
MilliporeSigma

Manjula Aysola is a senior regulatory consultant in the global regulatory management team. She is an expert on regulatory requirements for quality control of biopharmaceuticals including cell and gene therapies. She contributes to industry working groups developing best practice guides and white papers on varied topics.

With the organization for over 16 years, Manjula led several R&D projects for bioreactor process development and cell culture media evaluations for stem cell therapies. She was previously with Millennium Pharmaceuticals focused on oncology target and biomarker discovery. Manjula earned her MS degree in genetics from Clemson University in Clemson, USA.

Alison Armstrong
Sr. Director, Scientific Regulatory Consulting
MilliporeSigma

Dr. Alison Armstrong is the global head of the scientific and regulatory consultancy team. She was appointed to Senior Director, UK Development Services in 2009 and established a client facing technology management team in 2015. This team is responsible for scientific and regulatory advice and fully supports clients.

Alison Armstrong has authored several articles on trends in biosafety testing and is a member of regulatory taskforce groups related to rapid technologies. She is an invited speaker at global conferences. Armstrong holds a PhD in Molecular Virology from the University of Glasgow.