News

Rest assured, we are monitoring and successfully mitigating potential challenges due to ongoing supply chain disruptions to deliver material consistently to our customers. Learn more.

Promega's Cookie Policy

We use cookies and similar technologies to make our website work, run analytics, improve our website, and show you personalized content and advertising. Some of these cookies are essential for our website to work. For others, we won’t set them unless you accept them. To find out more about cookies and how to manage cookies, read our Cookie Policy.

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.

biologics-icons-mab-therapeutics

mAb Therapeutics
 


Potency Assay Development
  • Genetic reporter bioassays
  • PPI bioassays
  • CRISPR engineering
Drug Profiling
  • Genetic reporter bioassays
  • PPI bioassays
  • Primary cell assays
Bioassay Qualification
  • Genetic reporter bioassays
  • PPI bioassays
Made-to-Order Cell Manufacturing
  • Master Cell Banks (MCB)
  • Thaw-and-Use Cells
biologics-icons-t-cell-therapy

T Cell Therapy
 


TCR Discovery
  • TCR functional assays
  • Target cell killing assays
  • CRISPR engineering
Potency Assay Development
  • Target cell killing assays
  • Cytokine bioassays
Drug Profiling
  • Target cell killing assays
Bioassay Qualification
  • Target cell killing assays
Made-to-Order Cell Manufacturing
  • Master Cell Banks (MCB)
  • Thaw-and-Use Cells
biologics-icons-gene-therapy

Gene Therapy
 


Potency Assay Development
  • Genetic reporter bioassays
  • PPI bioassays
  • CRISPR engineering
Lumit™ Immunoassays
  • Viral delivery (e.g. AAV)
biologics-icons-vaccines-and-antiviral

Vaccines & Antiviral mAb


Assay Development
  • Neutralizing Ab Function
  • PsVLP bioassays
  • Antibody Fc Function
  • ADCC/ADCP target cells
Antibody Profiling
  • ADCC/ADCP reporter bioassays
  • PBMC ADCC bioassays
  • Target cell killing assays
  • Lumit™ Immunoassays
biologics-icons-vet-and-animal-health

Veterinary/Animal Health


Vaccine Assay Development
  • Neutralizing Ab Function
  • Antibody Fc Function
mAb Assay Development
  • Genetic reporter bioassays
  • PPI bioassays
  • Primary cell assays
Bioassay Qualification
  • Genetic reporter bioassays
  • PPI bioassays
Made-to-Order Cell Manufacturing
  • 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.

18092ma-w2

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
biologics-milestone-1
biologics-milestone-2
biologics-milestone-3

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.

Do you have questions? Our Biologics Drug Discovery team has answers!