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.
Optimizing your potency assay with DoE is crucial for assessing a drug’s biological activity. By evaluating variables like drug concentration, time, dilution and effector-to-target ratio, you ensure the assay’s sensitivity, specificity and consistent performance across batches.
Initial Drug Concentration
Directly impacts the assay’s sensitivity, accuracy, and the ability to differentiate between levels of activity.
Time Course
Accurately capture the drug’s dynamic effects and ensure reliable measurement of its potency and efficacy over the intended duration of action.
Dilution Factor
Vital for achieving preventing saturation effects and maintaining the assay within the dynamic range for accurate potency determination.
Effector:Target Ratio
Critical for ensuring the assay’s reliability, as it affects the interaction dynamics and accurately reflects the biological response under various conditions.
To facilitate the development and implementation of functional bioassays in your laboratory, we offer a comprehensive portfolio of reporter bioassays developed and prequalified in accordance with ICH Q6B guidelines.
We provide bioassay qualification services to facilitate downstream validation studies in your laboratory or with a contract research organization (CRO) partner.
Precision
Measure of repeatability of multiple assays of the same homogeneous sample with different analysts or equipment, or on different days.
Linearity
Ability of your assay to provide measured values that are proportional to the concentration of the sample.
Accuracy
Measure of ability to replicate a reference or “target” value.
Robustness
Measure of a procedure’s capacity to remain unaffected by small, deliberate variations in method parameters.
Specificity
Measure of a method to unequivocally assess the analyte in the presence of components.
Developing Bioassays for Qualification and Lot Release of Biologics: A Case Study Using the CD112/CD112R Blockade Bioassay for anti-CD112R Relative Potency Estimation
We support customers through the various stages of biologic drug development in many ways, including product quality documentation to support QC lot release and partnerships with contract research organizations (CROs).
Business Support for Outsourcing Bioassays to CROs
Outsourcing of biologics testing to contract research organizations (CROs) is a growing trend in the biopharmaceutical industry. We support global CROs who offer bioassay services as well as researchers who want to transfer their bioassay to one or more CROs.
Contact us for more information, or to obtain a list of CROs with experience running our assays.
Manufacturing and Quality Systems
Promega functional bioassays and protein characterization products are manufactured in our global state-of-the-art facilities. Over 450,000 square feet of environmentally controlled manufacturing spaces allow flexible bulk manufacture with capabilities for custom automated or semi-automated filling and packaging. We are prepared to accommodate your needs; from bulk production through final product finishing.


Whatever your needs, our team can help you advance your program:
- Optimization
- Qualification
- QC Lot Release