CMC and Regulatory Considerations for CRISPR Therapies
Learn how Synthego helps you prepare for a successful IND submission
Discover the essentials of CRISPR therapies with our concise guide to the Chemistry, Manufacturing, and Controls (CMC), Critical Quality Attributes (CQAs), and the Common Technical Document (CTD).
Shifting from experimental phases in the lab to the clinical stage involves a variety of obstacles, encompassing both scientific barriers and regulatory complexities. One of those obstacles is the IND submission. Learn the basics of CRISPR therapies with our easy-to-follow guide covering Chemistry, Manufacturing, and Controls (CMC), Critical Quality Attributes (CQAs), and the Common Technical Document (CTD). Discover how the CMC details all the steps to make CRISPR therapies, ensuring they're safe, effective, and of high quality. Find out what CQAs are - key features of a product that need strict control for top quality. Finally, understand the CTD, a must-have document format for submitting medical product info to regulatory agencies.
This flyer provides a simplified overview, making it the perfect starting point for those new to the field of CRISPR-based therapeutic development.
Download the flyer now!