BioOutsource

BioPotency

BioPotency assays are a regulatory requirement for the release of product and for the stability assessment of the product. Due to the unique issues that are presented by these techniques BioPotency assays can represent one of the major investments in the development of a biologic. There are potentially a huge number of issues surrounding the use of these types of assays in a GMP release setting. Choosing the right partner for the development and operation of one of these assays is critical, BioOutsource scientists have a wealth of experience in a number of techniques and can advise on the best route for developing an assay, specific for your product.

The ICH Q6B guideline – “Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological products” provides the following comments concerning the assay type that should be chosen:

“A valid biological assay to measure the biological activity should be provided by the manufacturer”

“Mimicking the biological activity in the clinical situation is not always necessary”

“Correlation between the expected clinical response and the activity in the biological activity should be established”

The complexity of the structure and function of many biotechnology-derived products necessitates a wide range of analytical procedures to adequately characterise the product. Physiochemical tests have a limited value with regard to the characterisation of biologics. Therefore, the development and analysis of products using biological assays that measure the ability of a material to elicit a function are essential to successful product development. Bioassays based on cells will exhibit an inherent variability due to the nature of living cell cultures. Therefore it is necessary to design assays that can reduce variability as much as possible whilst enabling statistically valid measures of potency to be made. These assays require the use of statistical analysis to analyse and report the potency and therefore a clear understanding of the requirements is essential at the offset.

Assay Development

BioOutsource can develop assays specific to our Client’s requirements, transferring assays directly from our Clients or provide pre-existing, established assays. We would normally recommend the establishment of a dedicated client cell bank for the project. We can produce, characterise and store dedicated cell banks used for Bio-Potency release assays. Increasingly there is no international standard available to support the testing of product. We therefore will assist in the characterisation of “in-house” standard and create a specification to produce a compliant reference standard for your assays.Potency assays in BioOutsource are validated to a standard package for accuracy, linearity, precision, range, limit of detection (LOD), limit of quantification (LOQ), repeatability, and assay related robustness that meets ICH and regulatory acceptance. Assay performance, including control and reference standard performance is routinely monitored.