Biologics Assay Development and Services
Our bioassay development and services can help to accelerate your biologic drug discovery and development workflow. These comprehensive services include new assay development, modification of existing assays, bioassay optimization and qualification, biologic drug profiling and custom cell manufacturing.
mAb Therapeutics
Potency Assay Development
- Genetic reporter bioassays
- PPI bioassays
- CRISPR engineering
- Genetic reporter bioassays
- PPI bioassays
- Primary cell assays
- Genetic reporter bioassays
- PPI bioassays
- Master Cell Banks (MCB)
- Thaw-and-Use Cells
T Cell Therapy
TCR Discovery
- TCR functional assays
- Target cell killing assays
- CRISPR engineering
- Target cell killing assays
- Cytokine bioassays
- Target cell killing assays
- Target cell killing assays
- Master Cell Banks (MCB)
- Thaw-and-Use Cells
Gene Therapy
Potency Assay Development
- Genetic reporter bioassays
- PPI bioassays
- CRISPR engineering
- Viral delivery (e.g. AAV)
Vaccines and Antiviral mAb
Assay Development
- Neutralizing Ab Function
- PsVLP bioassays
- Antibody Fc Function
- ADCC/ADCP target cells
- ADCC/ADCP reporter bioassays
- PBMC ADCC bioassays
- Target cell killing assays
- Lumit® Immunoassays
Veterinary/Animal Health
Vaccine Assay Development
- Neutralizing Ab Function
- Antibody Fc Function
- Genetic reporter bioassays
- PPI bioassays
- Primary cell assays
- Genetic reporter bioassays
- PPI bioassays
- Master Cell Banks (MCB)
- Thaw-and-Use Cells
Assay Development
New Assay Design
Developing a bioassay to measure the activity of biotherapeutic candidates is a complex process that can be challenging for many laboratories. It is essential to design an assay that reflects the true mechanism of action of the drug candidate. Further, the assay must be qualified and evaluated over time to ensure maximum precision, accuracy, linearity and robustness. Our team of experts has deep experience developing potency bioassays for a wide variety of drug mechanisms of action.
Modification of Existing Bioassays
Sometimes, your research may require modification of an existing bioassay. For example, you may need to express a target receptor exogenously or knock out a receptor or signaling molecule to adapt an existing bioassay for your needs. Using a variety of technologies, we can modify our comprehensive line of existing bioassays to meet your needs. Other applications may require tailoring the assay for use in different species, such as in veterinary research.
Drug Profiling and Characterization
Our profiling services use customer-provided biologics (such as monoclonal antibodies or CAR-T cells) to generate data with our existing bioassays. These services use our portfolio of immunotherapy bioassays, PBMC ADCC bioassays, HiBiT® Target Cell Killing assays, Lumit® immunoassays, PsVLP bioassays and more.
Bioassay Qualification
Critical attributes of functional bioassays are defined in ICH and USP guidelines; these include specificity, accuracy, precision, linearity, range and robustness. 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 also provide bioassay qualification services to facilitate downstream validation studies in your laboratory or with a contract research organization (CRO) partner.
Learn more about bioassay qualification.
Our team supports customers through the various stages of drug development in many ways, including product quality documentation, business support to enable global CROs, and scientific and technical support.
Learn more about QC lot release.
Bioassay Optimization & Qualification Services Milestones
Developing Bioassays for Qualification and Lot Release of Biologics: A Case Study Using the CD112/CD112R Blockade Bioassay for anti-CD112R Relative Potency Estimation
Custom Cell Manufacture
Consistent and reliable cell manufacturing is essential for developing and validating cell-based potency bioassays for biologic drugs. In particular, the creation and characterization of cell banks are critical processes to ensure the quality of the final product. We offer custom, bulk manufacture of cryopreserved and quality-controlled thaw-and-use cells to simplify your workflows and enable maximum assay reproducibility.