Ruby Casareno
Biologics CMC Consultant Self-Employed
Ruby Casareno, PhD is an independent Biologics CMC Consultant with over 25 years of experience building and leading cross‑functional teams across the biotechnology industry. She specializes in end‑to‑end biologics development, including process and analytical development, scale‑up, tech transfer, CMC strategy, and regulatory Module 3 support. Ruby has contributed to multiple commercial and more than 20 clinical programs and is known for her hands‑on, practical approach to advancing drug development from early stages through commercialization.
Seminars
As more companies emerge and pivot to enter the field of ADC development, understanding analytical and CMC principles, requirements, and timelines is vital to advance to IND and stay competitive
in a busy biopharma ecosystem.
Designed for ADC biotech C-level, CMC, analytical and quality leaders currently in discovery stage, don’t miss this workshop to learn the CMC roadmap and accelerate your ADC development from gene to IND.
Workshop highlights include:
- Outlining and optimizing the CMC timeline to achieve clinical supply readiness and enable patient dosing immediately upon IND allowed-toproceed
- Navigating the process development activities and delving into cell line development, biologic design, linkerpayload and conjugation
- Detailing the core principles of analytical development and specifications
