Da Yu Protein Sciences – CMC Consulting
Our CMC Consulting services span all phases and areas of Biologics development. We work directly with your team to address the most critical areas in your CMC program.
IND Readiness - We can assist your team with the submission of their initial IND CMC package to regulatory agencies.
- Review Overall CMC Strategy
- Phase-Specific Testing Strategies
- Specification Strategies
- Reference Material Preparation
Analytical Development - The analytical control strategy is the linchpin to a successful CMC program. Towards this end, we can work with your team to establish a control strategy in line with current regulatory expectations.
- Release and Stability Testing Strategies
- In Process Testing Strategies
- Assay Development, Qualification, Validation
- Analytical and Biophysical Characterization Strategies
- Comparability Testing
Formulation Development – It is critically important to have a stable formulation that meets the Targeted Product Profile (TPP) early in development to avoid additional comparability studies and potential clinical bridging studies later in development. We collaborate with your team to manage the risks associated with formulating your protein product.
- Preformulation Strategies
- Stability-Indicating Assays
- Stability Programs – Real Time, Accelerated, Stressed
Compliance - We can assist your team with implementing phase-specific compliance with current GMPs to ensure your program’s readiness for advancement.
- Support CRO and CMO Assessment and Oversight
- Audit Preparedness - PAI Review and Readiness
- Process and Analytical Validation Strategies and Review
- Equipment Qualification and Validation
- Quality Manual and System Assessment
Information on the regulatory and compliance requirements for CMC Biologics development can be obtained on our Useful Links page.
Organizations interested in discussing our CMC Consulting services further are welcomed to Contact Us.