Qualification & Validation of Assays

One of the greatest challenges a drug producer faces when it comes to ensuring a mAb is suitable for its intended purpose is gathering and providing the appropriate data according to FDA, ICH, and other regulatory bodies. At this point, qualification and validation of the full process and the analytical assays run to support that process become critical, as are the partners supporting the process.

Qualification, also known as characterization or verification, is intended to prove that the assay is fit for purpose and is more of a focus in the earlier development phases, with a cGMP qualified assay required for releasing clinical batches. Validation is critical in the later stages of development, with fully validated assays required during Phase III and submission to the FDA and other regulatory body for approval.

Qualification and Validation of Analytical Testing

Development, qualification and validation of analytical assays is fundamental to producing the highest quality products and bringing them to market efficiently. The BioOutsource team understands the complexities of development, and how they change depending on both the clinical phase and the intended use of the assay method. We tailor our assay development services and provide the data to meet these needs, and assay development is performed using proven statistical approaches or, where appropriate, by applying the principles of Design of Experiment (DoE) with support from our statistical partners and Sartorius data analytics solutions.

A Reliable Qualification and Validation Partner

There are significant differences between performance of simple assays at the candidate selection stage and the performance of GMP lot release assays within a highly regulated QC environment. A true understanding of these requirements, as well as best practice for the clinical phase, is essential to ensure that reliable, fit-for-purpose methods are developed in a cost-effective manner. In addition to our proven and flexible approach, services can be scaled to include generation of a fully characterized GMP-compliant cell bank as needed for specification-setting studies before the formal robustness and validation assessments.

During the specification-setting activities, we evaluate the performance of the assay and its controls to define stringent assay acceptance criteria and select the final assay design. We employ a range of statistical analysis software packages to select the most accurate analysis mechanism and each study validates the Reference Standard for the assay at the start, or during requalification steps. Robustness evaluation criteria are selected based on knowledge of the method, and validation is performed in compliance with appropriate regulations to assess accuracy, repeatability, intermediate precision, assay range, dilutional linearity and specificity. On completion of the GMP potency assay validation, the assay is fit for purpose for the testing of GMP lot release samples.

Efficient Technology Transfer

Technology transfer is a critical step, as the process(es) developed are transferred to the client (or partner) site. In addition to partnering with you to develop, qualify and validate your process, BioOutsource will ease this process by providing training to staff at the transfer site in all aspects of the assay, including all the paperwork and reagents necessary to perform parallel testing that verifies successful technology transfer.

If you have any questions, or would like to know more about our qualification and validation assays, please contact us today.

BioOutsource cGMP Qualification and Validation Assays

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