Services > Assay Development
We offer both assay development and validation services tailored to your product and regulatory needs. In the development phase, we design and optimize analytical methods based on your specific matrix, target analytes, and regulatory framework. This includes selecting suitable technologies (e.g., qPCR, ELISA), establishing performance parameters, and ensuring robustness and reproducibility. Our development process is collaborative and flexible, allowing for iterative refinement and adaptation to your evolving requirements. Once a method is established, matrix validation is required to confirm whether your specific matrix is compatible with one of the analytical methods available in our laboratory. In manufacturer-validated kit systems and processes already implemented in the lab, only selected parameters may need to be verified. For example, in a limit test, it may be sufficient to confirm a pharmacopoeia-defined threshold and demonstrate method robustness across three product batches. If no pharmacopoeial limit exists, a more extensive validation may be necessary, including statistical approaches such as the probit method to determine the LOD95. The scope of validation is often highly product-specific and should be coordinated with the relevant authority. Early alignment helps avoid unnecessary revalidation, costs, and delays. Beyond regulatory requirements, the extent of validation depends on the number of analytical parameters, your desired level of statistical certainty, and your internal quality standards. We are happy to advise you and develop a customized validation plan that fits your needs – from initial assay design to full GMP-compliant implementation.
Many of the methods used in our laboratory are either manufacturer-validated and/or described in the European Pharmacopoeia. For example, mycoplasma testing with the Microsart® ATMP Mycoplasma System (Sartorius Biotech GmbH) has undergone extensive manufacturer validation. The framework for validating such systems is defined by European Pharmacopoeia 2.6.1, and further guidance is provided by the ICH Q2 (R1) guideline “Validation of Analytical Procedures: Text and Methodology”, especially for impurity testing and limit tests.
However, even extensively validated methods often require matrix-specific validation before they can be applied to your product. This requirement is defined by EU-GMP guidelines, as no manufacturer validation can account for every possible production process or matrix. Biotechnological products are frequently unique—even when using the same cell culture medium. Differences in cell type, species, or production processes (e.g., secretion of heterologous proteins, antibodies, or cytokines) can significantly affect analytical performance. Matrix validation also considers factors such as sample transport and storage conditions, which may influence test results. Therefore, even for validated methods, compatibility with your specific matrix must be confirmed. In addition to validation, we offer custom assay development tailored to your product and analytical needs. This includes method design, optimization, and performance characterization using technologies such as qPCR, ELISA, and others. Our development process ensures that your assay is robust, reproducible, and aligned with regulatory expectations. We are happy to support you in both developing new assays and validating existing methods for GMP use. Let us help you define a strategy that meets your scientific and regulatory goals.
Minerva Analytix offers GMP-compliant and rapid biosafety testing using state-of-the-art molecular biology methods to prevent and contain biological contamination in your applications.