Bioassays

As a leader in specialized and complex bioassay development and testing, BioAgilytix combines state-of-the-art cell-based assay facilities with a veteran team of scientists well-versed in the quality and regulatory demands of biological assay development to support customers innovating in the areas of biologics, biosimilars, and biobetters.

BioAgilytix has a proven track record of effectively developing, qualifying and validating a diverse range of bioassays to meet stringent scientific and regulatory demands across numerous industries and disease states.

Use the paragraphs below to learn what a bioassay is, how it can be used to effectively determine concentration and potency of a biological substance, the types of platforms that best support bioassay needs, and how BioAgilytix brings a differentiated level of expertise to the bioassay services we provide.

Our Bioassay Services Include:

Industries We Specialize In:

Here we will outline what a bioassay is, and how a bioassay can be used to effectively determine the concentration and potency of a biological substance. We’ll also discuss the types of platforms that best support bioassay needs and how BioAgilytix brings a differentiated level of expertise to the bioassay services we provide.

What is a Bioassay?

Premier Bioassay FacilityBioassay is a biochemical test that calculates the relative potency of a sample compound to a standard compound. By definition, a bioassay is the “determination of the relative strength of a substance (as a drug) by comparing its effect on a test organism with that of a standard preparation.” Bioassays are used to measure the biological activity and effects of a substance, like a hormone or drug, on a living organism such as a living plant (in vivo) or tissue or cell (in vitro).

Bioassay services are most often employed to determine the concentration or purity of substances including vitamin, hormone, or plant growth factor by measuring their effect on tissue, cells, enzymes, or receptors. The general approach involves measuring the biological response of the live material at several doses, to understand the dose-response relation.

As such, the advantage of the bioassay testing procedure is that it can help determine both the concentration and potency of a sample, which is necessary for regulatory submission and lot release testing of biopharmaceutical products.

How are Bioassays Used?

The primary purposes of bioassays are to measure the pharmacological activity of new or chemically undefined substances, as well as to determine side-effect profiles, including toxicity.

Bioassays are key in determining the potency and stability of a drug substance or product in order to establish its safety and efficacy profile. Today, they are an important component in effectively controlling the quality of biopharmaceuticals for lot release testing and manufacture.

BioAgilytix’s premier GMP laboratory is built to support the full range of bioanalytical requirements, from custom bioassay development to lot release testing, and stability testing under GLP and GMP standards.

The scientists at BioAgilytix are responsible for lead optimization and mechanism-of-action studies that have led to the discovery of several key drugs that are on the market today, as well as a number of promising clinical candidates.

Having supported the bioanalysis of numerous therapeutics now successfully brought to market, we intrinsically know the types of challenges to anticipate in each phase. Our team works proactively to mitigate your risk and to solve problems quickly so you can bring your life-saving innovations to market faster.

Our commitment is to see you succeed! This is what makes BioAgilytix the go-to scientific partner for those seeking to improve patient outcomes with more potent and effective biologic therapeutics across disease states, from research to drug development.

  • Oncology Research and Drug Development – BioAgilytix is working alongside our pharma and biotech customers and colleagues to help lead the change in cancer treatment breakthroughs, looking beyond generic chemotherapies and toward new, more effective personalized approaches. As a bioanalytical CRO specialized in complex drug development efforts, including oncology and immune-oncology studies and trials, we deliver multi-stage bioanalytical services and offer the extensive expertise needed to affect real change.
  • Metabolic Diseases – From discovery through every phase of biologic development, BioAgilytix offers comprehensive bioanalytical support for every stage of your metabolic, obesity, and diabetes drug development and research. Our services are supported by decades of scientific expertise in even the most complex challenges related to bioanalysis of drugs addressing endocrine disorders and metabolic diseases.
  • Autoimmune Diseases – BioAgilytix has extensive expertise in the bioanalytical support needs of autoimmune drug development. By leveraging our team’s veteran insights in autoimmune diseases, our team is set-up to produce successful results in even the most complex autoimmune drug development and research studies.
  • Neurologic Diseases – BioAgilytix leverages veteran insights, gained from decades of real-world experience supporting neurology research studies, to help you successfully navigate scientific and regulatory complexities at every step of development.

BioAgilytix’s premier GMP laboratory is built to support the full range of bioanalytical requirements, from custom bioassay development to lot release testing and stability testing under GLP and GMP standards.

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Bioassay Platforms and Applications

There are a number of innovative technologies and platforms that can be used to help automate bioassay testing processes and yield greater throughput, speed, reliability, and reproducibility.

BioAgilytix leverages a unique breadth of platforms to support the delivery of its bioassay services, including ELISA, MSD-ECL, ProteinSimple ELLA and Flow Cytometry. For a full listing of the technology platforms leveraged by BioAgilytix, click here.

By selecting the platform to optimally support each bioassay’s specific parameters, we are able to perform robust, timely analysis related to:

  • Cell proliferation: Bioassays can be used for accurate assessment of cell number increases as a result of cell growth and division. Cell proliferation is a high-sensitivity indicator of cell stress in intact cell structures.
  • Apoptosis and cell death: These assay can also be used to characterize programmed cell death, and understand the mechanisms of cell death and survival.
  • Signaling and secretion: Bioassays play a role in understanding cellular activities and coordination, and can be used to assess the ability of cells to perceive and respond to their microenvironment.

BioAgilytix’s Bioassay Expertise

With more than half of our scientific staff boasting over 15 years of experience performing complex bioassays – having cultured over 200 cell lines – BioAgilytix leads the industry in the development and testing of cell-based assays to GLP and GMP standards.

We never let a specialized or demanding bioassay requirement stall our customers’ speed of innovation, and work scientist to scientist to solve even the most challenging bioanalytical assay needs with responsive service and seasoned expertise.

Our scientists can help you choose the method that will best support your distinct bioassay parameters. We understand the key considerations that should be assessed as part of your bioassay system selection, and will carefully weigh the advantages and disadvantages of each to select the optimal model.

From supporting scientific breakthroughs or developing novel therapeutic drugs, BioAgilytix has proven our ability to efficiently advance large molecule innovations no matter the complexity of the bioassay demands. Our strategy is driven by quality science that yields quality results.

Whether you’re a leading global company or an organization on the rise, BioAgilytix can supplement your internal resources to extend your bioanalytical capabilities or take them over entirely.

  • Pharmaceutical & Biotech Companies – For years, top pharmaceutical companies and growing biotechnology players alike have relied on the specialized bioanalytical services of BioAgilytix to deliver the results they need to progress their biologic candidates through development. Large molecule bioanalysis holds tremendous promise in the creation of safer, more effective drugs, and our veteran team will help unlock that therapeutic value for your organization and the patients you serve.
  • Agricultural Biotechnology – It goes without saying that the safety of agricultural products, for both humans and the environment, is of paramount concern and should be treated with the utmost care. BioAgilytix is poised to help agricultural biotechnology companies to make crop production and management simpler and more efficient. Every element must be carefully evaluated to assess efficacy against potential risks. BioAgilytix’s field-tested and proven support can assist in overcoming large molecule complexities associated with such bioanalysis to speed time to market of promising agricultural innovations.

Choose Bioagilytix for Your Bioassay Development and Testing

Rely on the scientists at BioAgilytix. We are responsible for lead optimization and mechanism-of-action studies that have supported the discovery of several key drugs on the market today, as well as multiple promising clinical candidates, that can support your unique project requirements. Let us help you bring clarity to the complexities of bioassays in the development of life-changing innovations.


Let us help you bring clarity to the complexities of bioassays in the development of life-changing innovations.

Discuss your project with a Bioassay Expert