Analytical Development

Developing analytical methods to make your process a well characterized one.

Analytical methods are essential tools in cell therapy manufacturing. They are necessary to gauge and control raw materials, the manufacturing process, and the final product. Our scientists will help develop the right methods specific to your needs – and we will advise you if your requirements are not yet fully refined. Whether your product is autologous or allogeneic, put our analytical development experience to work to ensure that your process is a well characterized one.

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.