Bioassay Qualification
Bioassays are critical for elucidating and confirming drug MOA during discovery, and measuring drug potency and stability during the later phases of drug development and manufacturing.
Critical attributes of functional bioassays are defined in ICH and USP guidelines and include specificity, accuracy, precision, linearity, range and robustness. To facilitate the development and implementation of functional bioassays in your laboratory, we offer:
- Reporter bioassays developed and prequalified in accordance with ICH Q6B guidelines.
- A portfolio of cell viability assays with demonstrated use for biologics characterization and validation for QC lot release.
- Bioassay qualification services to facilitate downstream validation studies in your laboratory or with a CRO partner.
Assay Performance Data
Accuracy and precision are critical assay parameters for the qualification of potency bioassays. Accuracy is a measure of how close results are to a target or reference value. Precision is a measure of repeatability. Promega bioassays and developed and prequalified according to ICH guidelines for accuracy and precision to ensure that they meet the performance criteria necessary for use in drug potency and stability studies.
Measure of ability to replicate a reference or "target" value.
Measure of repeatability of multiple assays of the same homogeneous sample under the same operating conditions over a short time (same analyst; same lab; same day).
Measure of repeatability of multiple assays of the same homogeneous sample with different analysts or equipment or on different days.
Ability of your assay to provide measured values that are proportional to the concentration of the sample.
Representative Data
The bioassay prequalification data below was generated using the PD-1/PD-L1 Blockade Bioassay and an anti-PD-L1 blocking mAb.
Potency
Linearity
Repeatability
The Value of Bioassays in a Biologics Drug Development Workflow
In their 2015 BioProcess International article, "Building a Robust Biological Assay for Potency Measurement" Jing Shi and Marian McKee note:
"An important aspect of bioassay design and development is to ensure that the final assay is robust enough to measure manufacturing consistency and is correlated with clinical outcomes. To achieve that, a bioassay requires continuous development and refinement throughout a biologic’s life cycle."
In this article Shi and McKee discuss considerations for building a reliable, reproducible cell-based potency bioassay that will be suitable as a current good manufacturing practice (CGMP) release test.
Related Resources
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