KBI Biopharma
Watch the Tech Talk to see how KBI's Cell-Based Assay Team effectively reduces the number of plates necessary for method development, enabling the generation of a reliable cell-based potency method in a shorter amount of time while using less material.
In the contract laboratory environment, the time constraint is ever-present and works against both the contract lab and the client or sponsor. This is especially true for the cell-based potency testing teams, where the assays have an infinite number of variables ranging from optimal growth conditions to the generation of the ideal titration curve to accurately measure any effect on the targeted mechanism of action. To overcome this ever-present hurdle, the Cell-Based Assay Team at KBI utilizes a titration curve modeling tool to effectively predict the cellular response to an agonist or antagonist.
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About Our Process
In consultation with the client, our first step is to determine an assay to observe any potential effect, either synergistic or inhibitory, to utilize the mechanism of action in question to develop an assay to accurately determine the potency of the drug substance or drug product. These assays can vary from a reporter gene assay, cell proliferation assay, cell toxicity assay, binding assay, or chemokine/cytokine release assay.
Once a base assay is agreed upon, a titration curve of the drug substance/drug product is generated to cover a wide range of concentrations/amounts of the drug product or drug substance to ensure a maximum and minimum signal is obtained for the assay in question. As soon as the basic titration curve is generated and a curve is obtained, the four parameter values from the resulting titration curve are utilized to aid our team in focusing in on a titration curve.
The goal is to have a titration curve that will effectively produce a clear upper and lower asymptote and numerous points along the slope of the curve. In addition to developing a titration curve containing all of these essential features, this tool will help to observe the potential shift of the curve at the extreme ranges of the assay (e.g., 50% and 150% of the nominal signal) to avoid losing either the upper or lower asymptote at the extreme ranges of the assay.
Utilization of this tool has reduced the number of plates necessary for method development from 15-20 to 4-8, not only enabling the KBI Cell-Based assay team to effectively generate a reliable cell-based potency method in a shorter amount of time and utilizing less material. This allows the KBI Cell-Based Assay team to meet client timelines while maximizing the utilization of valuable client material.
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If you are interested in learning more about KBI’s work in process development, you can reach out to our team.