Potency Assay Services
Industry Challenge: Potency
Active immunotherapy, including cancer vaccines, offers exciting prospects to direct the body’s own immune responses to resolve localized or systemic disease. Antigen processing is central to active immunotherapy (Figure 1), whether the approach seeks to elicit cytotoxic T-lymphocyte (CTL) responses to treat cancer and intracellular pathogen infection, or if the goal is to induce T-cell anergy, removing T-cell subsets responsible for damaging autoimmune responses. These technologies break new ground on a number of fronts, including product manufacturing and release testing. For product release and stability indicating tests, the identity, purity and strength of each lot are measured using assays standard to the industry. However, measurement of product potency, of critical importance to regulatory authorities, has proven quite difficult to characterize. The insufficiency of measuring antigen expression, coupled with the lack of reproducibility associated with cell-based assays, complicates quality assurance efforts and highlights the need for assay standardization. The inability to reproducibly measure the potency of active immunotherapy poses a significant hurdle with regards to regulatory approval – delaying product realization and potential returns.
The Receptor Logic Solution
Receptor Logic offers a solution to quantitatively and reproducibly measure the potency of active immunotherapies through the use of its proprietary T-Cell Receptor mimic monoclonal antibodies (TCRms) which recognize specific MHC-peptide complexes with avidities similar to the best CTL lines classically used in activity assays (Figure 5).
The impressive specificity of TCRms coupled with their ability to recognize validated disease biomarkers, in the form of discrete MHC-peptide complexes, empower these tools to augment and/or replace T-cell based assays. Assays employing TCRms can measure over five orders of magnitude of specific MHC-peptide complexes (including less than 40 complexes per cell). Further, TCRms facilitate product development by:
- Assisting lead antigen validation
- Correlating antibody reactivity with T-cell function
- Substituting TCRm assays for T-cell-based approaches
- Demonstrating lot-to-lot consistency for released drug substance
- Testing product stability
Please contact us and we will provide a complete description of services offered and explore how Receptor Logic's TCRm technology may assist your product development efforts.