The Approach
Cell therapies are complex and require a strategic plan to ensure a successful Chemistry, Manufacturing and Controls (CMC) execution. Developing the right Analytical Target Profile (ATP) is the foundation of our approach. From assay design to qualification, we work with you to manage the entire lifecycle of analytical development to uphold the consistency and quality of your therapeutic.
Analytical Target Profile
- List of suitable analytical technologies
- Method screening
- Method selection
Assay Development
- Raw material and residual assays
- In-process testing
- Product Characterization and Potency
Clinical Readiness
- Method Qualification for Phase 1/2
- Method validation for Phase 3/Commercial
- Standard method matrix verification
Life Cycle Management
- Data trending
- Continuous improvement
- Surrogate and biomarker analytics
Analytical Development
We develop custom methods tailored to your portfolio assets with efficient transfer of phase-appropriate methods to QC. Further, with Theragent, there is no need to wait for external testing sites to return test results. Our in-house testing, troubleshooting, and investigational capability leads to faster turnaround time for your product.
We offer the following analytical capabilities:
- Viable Cell Count
- Endotoxin
- Mycoplasma
- Sterility/Bioburden
- Microbial ID
- Flow Cytometry
- ELISA (single and multiplex)
- Cell-based assays (cytotoxicity, proliferation, suppression)
- rtPCR/ddPCR
Identity. Purity. Potency. Stability. With our analytical development and in-house testing services, you can rely on us to assure the safety and quality of your product, on-time, every time.