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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, USP Chapter 1032 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.

Accuracy for Assay Performance Data
Accurate, but not precise

Accuracy
Measure of ability to replicate a reference or "target" value.
IntraLab Precision
Precise, but not accurate

IntraLab Precision

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).

Intermediate Precision Data Target 3
Accurate and precise

Intermediate Precision

Measure of repeatability of multiple assays of the same homogeneous sample with different analysts or equipment or on different days.

32454752-data-linear
Linear

Linearity

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

Potency determined with PD-1/PD-L1 Blockade Bioassay 13070mc

Linearity

Linearity Data for PD-1 Bioassay

Repeatability

Repeatability of PD-1/PD-L1 Blockade Bioassay 13071mc

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.