6th Gene Therapy Analytical Development & CMC Summit
Twelve gene therapies have been approved by the FDA to date to treat a variety of diseases, including the first ever gene edited therapeutic. The CMC package required to effectively demonstrate safety and efficacy of increasingly complex gene therapy products to regulators needs to keep pace.
The 6th Gene Therapy Analytical Development & CMC Summit will unite 250+ analytical development, CMC, QC, and process development experts to showcase innovative analytical and process development methods, assess their readiness, and ultimately guarantee safety, quality, efficacy, and consistency of gene therapies to regulators.
Join your peers this July to:
- Understand how to transition your potency assay from early to late-stage
- Explore how NGS methods can better inform your genome titers
- Accurately measure partials in your samples
- Produce contaminant-free and high yield vector batches at scale
Secure your place here or get in touch with the team – info@hansonwade.com