Gyrolab® Custom Assay Services

Gyrolab Custom Assay Development Service

If a ready-to-use assay is needed for your biologic development program, we can provide a fully qualified assay using a rigorous assay development process. We ensure the best assay conditions and assay performance for your Gyrolab immunoassay, and our efficient assay development service can expedite time to assay validation for your biotherapeutic development program.

Multi-Phase Custom Assay Development Process:

A multi-phase process is followed for assay development, incorporating checkpoints after each step to evaluate results and confirm proceeding to the next step.


The assay development process is customized for each project, and might include the following steps:



Phase 1 Feasibility
Phase 2
Assay Development
Phase 3
Assay Qualification
Phase 4
Assay Transfer


After each phase, a consultation is held for a decision to: 

  • Continue according to the plan
  • Modify the assay development plan
  • Discontinue the assay development project

Adding checkpoints limits the risk of large investments of time or fees, and you are involved in every phase of the assay development process. By breaking the assay development into phases, we ensure communication points for feedback and approval along the assay development path.


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