CMC
Chemistry, Manufacturing, and Controls consulting for biologics and small molecules, from process development to commercial manufacturing.
Key Capabilities
- Biologics process development and scale-up strategy
- Analytical method development and validation
- Drug substance and drug product characterization
- CMC regulatory strategy for IND, BLA, and NDA
- Manufacturing site selection and CMO oversight
- Quality systems and GMP compliance guidance
- Stability program design and shelf-life determination
Our Approach
Chemistry, Manufacturing, and Controls is a critical and often underestimated component of drug development. Bionavigen provides expert CMC consulting to help clients develop robust manufacturing processes and analytical methods that support regulatory approval.
Our team has extensive experience with biologics CMC, including monoclonal antibodies, ADCs, recombinant proteins, and cell/gene therapy products. We help clients navigate the complex CMC requirements for these modalities.
We provide strategic guidance on CMC development timelines, resource allocation, and regulatory strategy to ensure that manufacturing and analytical programs are aligned with overall development objectives.