High Precision Bioassay Using Robotics and Statistics

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$453,075.00
Award Year:
2007
Program:
SBIR
Phase:
Phase II
Contract:
2R44RR021296-02
Award Id:
75595
Agency Tracking Number:
RR021296
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
LANSKY CONSULTING, LLC, 257 South Union St, BURLINGTON, VT, 05401
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
140695771
Principal Investigator:
DAVID LANSKY
(802) 865-0155
DAVID@LANSKYCONSULTING.COM
Business Contact:
MATTHEW LANSKY
() -
david@lanskyconsulting.com
Research Institution:
n/a
Abstract
DESCRIPTION (provided by applicant): Abstract Cell culture bioassays are often laborious and imprecise even after substantial development efforts. These bioassays are used broadly in the biotechnology industry to measure protein or vaccine products in deve lopment and for lot release. Imprecise assays and slow assay development contribute to slow product development. Common practice in cell culture bioassay ignores statistical and regulatory guidance by failing to utilize proper randomization and not account ing for group effects (i.e.; as caused by multi-channel pipettes). In addition, lack of attention to location effects within the assays, combined with simplistic analyses of assay data, compromise the precision and efficiency of cell culture bioassays. Lan sky Consulting LLC will develop a standardized approach to cell culture bioassay using laboratory robots followed by modern statistical analysis. This combination will address the need for randomization, location effects, serial dilution, grouped dilution, and multiple sources of variation in assay response. The work described in this proposal will demonstrate the performance gains associated with: 1) standardized designs (including designs that require robots for randomization), 2) linear and nonlinear mix ed split- or strip-plot models for bioassay analysis, and 3) advances in implementation of this modern standardized approach to bioassays. The precision gains from the combined package of modern bioassay methods will be shown to reduce the need for sample replication by an order of magnitude or more. Both simulated data and long-term lab experiments with bioassays will be used. The benefits of these new methods include lower assay costs, rapid application to new assay systems, and easy access to best practi ces in design, implementation, and analysis. Most importantly, by building a turnkey robotic and analysis bioassay system, this level of assay performance will be made broadly available to the biotechnology industry as well as to non-profit researchers. Pr oject Summary Narrative Bioassays are critical measurement systems for both development and lot release of pharmaceutical protein and vaccine products. Easy access to high performance bioassays will enable faster and better informed development of biotechn ology products. Improved bioassay technology will bring unique, important protein and vaccine products to market more quickly to address pressing medical needs.

* information listed above is at the time of submission.

Agency Micro-sites


SBA logo

Department of Agriculture logo

Department of Commerce logo

Department of Defense logo

Department of Education logo

Department of Energy logo

Department of Health and Human Services logo

Department of Homeland Security logo

Department of Transportation logo

Enviromental Protection Agency logo

National Aeronautics and Space Administration logo

National Science Foundation logo
US Flag An Official Website of the United States Government