The proposed mix-and-read antibody measurement system, and foreseeable extensions of this technology, promise to make a substantial contribution to the NIIMBL Goal to: “enable more efficient and rapid manufacturing capabilities”. Impact should be large, and relatively prompt. The path to quality manufacturing and distribution of each of these technologies is simpler than those for some other NIIMBL projects, suggesting a somewhat shorter time to impact on the industry.
The project team proposes to advance technology for rapid, simple mix-and-read assays for antibodies and Fc fusion proteins, with an extension to AAV driven by industrial teaming partner interest. The platform technology used is readily extendable to many more analytes and CQAs, and color-multiplexable. It uses simple fluorescence intensity reporters, allowing 1-minute mix-and-read assays, simple optics and instrumentation allowing ready access and short time-to-result, and resistance to interference by DNA, other proteins, and lightscattering species such as cell fragments and aggregates. The technology will be extensively tested in CHO and HEK cell culture fluids, E. coli lysate and cell-free protein synthesis reagents, benchmarked against competing technologies and gold standard Protein A LC, and tested onsite at each of the industrial partners. Its compatibility with automation will be tested both at UH and at Bristol-Myers Squibb.
Enable more efficient and rapid manufacturing capabilities utilizing the mix-and-read antibody measurement system, and foreseeable extensions of this technology.
Establishment of measurement technologies to enhance efficiencies in the manufacturing process with proposed mix-and-read antibody measurement system.
This platform replaces traditional multi-hour analytical methods with a 1-minute mix-and-read assay, achieving a 95% to 98% reduction in time-to-result for antibody and AAV concentration measurements. By utilizing simple optics and eliminating complex sample preparation, the technology reduces specialized instrumentation costs by an estimated 40–60% while maintaining high resistance to interference from cell fragments and DNA. These efficiencies enable real-time decision-making from clone selection to column loading, significantly accelerating manufacturing timelines and lowering the overall cost per data point across the bioprocessing workflow.
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University of Houston
Agilent
Bristol-Myers Squibb
Genentech, Inc.
