Welcome
Agile Biologics Consulting LLC
Navigating the CMC challenges of bringing therapies to patients.
Biologics CMC Consulting Services
Welcome to the Agile Biologics Consulting website. After working in the biotech industry for over 30 years I became a consultant to help companies navigate the CMC challenges of bringing therapies to patients. Explore this site to learn about biologics CMC and how I can help your company succeed.
Why CMC is Critical for Emerging Biologics Companies
With an average cost of over $10M, advancing a novel biologic product from discovery through early-stage clinical trials is often the most significant expense for an emerging biologics company.
Biologic products are inherently complex and often challenging to manufacture. This must be balanced against FDA regulatory requirements and a rapidly evolving regulatory landscape. Without careful planning and oversight, these create a significant risk of cost overruns, timeline delays, and regulatory approval issues.
Biologics CMC Has Many Unexpected and Significant Risks
Many executives are unaware of the CMC development and manufacturing challenges that can significantly affect the success of their company. Download this CMC risk guide to learn more.