Assay Development
Custom Assay Development Service
Specific diagnostic tests are required for pre-clinical and clinical phases of drug development as well as for patient stratification (companion diagnostics, personalized medicine). For novel protein therapeutics immunoassays are the methods of choice, monitoring concentrations and assessing immunogenicity. In other fields besides human health, such as veterinary, agricultural and environmental, biomarkers are more frequently used as decisive parameters prior to treatment.
MicroCoat provides unique expertise in diagnostic assay development. A broad spectrum of methods, long-lasing experience in assay development and intensive communication with the customer are the cornerstones for successful project execution.
Our assay development service is based on a detailed milestone plan and follows standardized development guidelines along the five project phases:
- feasibility
- development
- verification
- validation
- manufacturing
Project progress is constantly monitored and reported throughout the entire course of a project. All assay development service projects are performed under the rules of ISO and if requested according to IVD regulations. Assay validation can be additionally performed following GLP guidelines.
Assay platforms
Immunological assay platforms
- Sandwich or competitive ELISA in 96- and 384-well plates
- Lateral flow tests strips for on-site testing
- Bead-based assays using magnetic separation
- Customer specific assay platforms
PCR-based analytics
- qPCR Assays including sample preparation
