Chemistry, Manufacturing, and Controls (CMC) play a critical role in transforming a promising molecule into a commercial-grade therapeutic product.
Manufacturing Strategy
We are initiating GMP (Good Manufacturing Practice) manufacturing of our main components. This involves extensive work in characterization and formulation development.
Quality & Manufacturing
Precision, Compliance, and Scalability at Every Stage
Supply Chain
We are focused on establishing a robust supply chain, identifying partners capable of producing our molecule at a commercial grade.
Quality by Design
Our approach emphasizes “quality by design,” ensuring development work is done right the first time. This principle, aligned with FDA guidelines, helps build a solid database and avoid costly delays later in the development cycle.
Operational Readiness
We are building the necessary operational infrastructure to support future clinical trials and eventual commercialization.
Partnerships
Our partnership with Celito provides cohesive expertise in critical areas, including Quality and G&A Infrastructure.