Recent clinical successes in cell therapy and gene therapy have shown how fast this field is advancing. While the clinical outcomes are leading the developments in this field, the chemistry, manufacturing, and control (CMC) are struggling to meet development needs, global regulatory compliance and timelines.
The intricacies of these advanced therapies represent many challenges. From cell source to the final product, sponsors are continuously addressing gaps to improve the product quality and deliver a safe and efficacious product. In this webinar, we will focus on the main CMC challenges in cell and gene therapy development in the EU and US and their integration as part of the overall product development.
Key takeaway message:
Present specific quality considerations for cell and gene therapies
Identify and take into account the CMC challenges during product development in order to minimize CMC hurdles
Provide insight on commonalities and differences between EU and US
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