Our track record has proven our ability to effectively develop, qualify, and validate 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.
By defintion, 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.” They are used to measure the biological activity and effects of a substance, like a hormone or drug, on a living organism such as a live 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.
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.
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There are a number of innovative technologies and platforms can be used to help to 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 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:
With more than half of our scientific staff boasting over 15 years of experience performing complex bioassays – having cultured over 200 cell lines – BioAgiltyix 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.
Just a few of our bioassay services include:
We are also able to develop and validate custom bioassays in line with all relevant regulatory guidelines and recommendations.
Rely on the scientists that were responsible for lead optimization and mechanism-of-action studies that supported the discovery of several key drugs on the market today, as well as multiple promising clinical candidates, to support your unique project requirements.
Let us help you bring clarity to the complexities of bioassays in the development of life-changing innovations.
See how we apply our specialized large molecule expertise to help solve your bioanalytical challenges.
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