USA flag logo/image

An Official Website of the United States Government

High Precision Bioassay Using Robotics and Statistics

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
75595
Program Year/Program:
2005 / SBIR
Agency Tracking Number:
RR021296
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
LANSKY CONSULTING, LLC
LANSKY CONSULTING, LLC 257 South Union St BURLINGTON, VT 05401
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2005
Title: High Precision Bioassay Using Robotics and Statistics
Agency: HHS
Contract: 1R43RR021296-01
Award Amount: $99,784.00
 

Abstract:

DESCRIPTION (provided by applicant): Cell culture bioassays are perceived as laborious and imprecise even after substantial development efforts. These bioassays are used broadly in the biotechnology industry to measure protein or vaccine products in development 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 accounting for group effects (caused by multi-channel pipettes). In addition, the 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. We propose a modern standardized approach to cell culture bioassay using statistical design and analysis linked to laboratory robots, which will address randomization, location effects, serial dilution, and grouped dilution. The larger program goal is to build a turnkey cell culture bioassay system using statistical software and a laboratory robot. The work described in this proposal will use 1) standardized designs and analysis, 2) linear or nonlinear mixed split- or strip-plot models for bioassay analysis, 3) recent developments in laboratory robotics that make randomization practical (both hardware and software), and 4) new code for modeling serial dilution error (developed under EPSCoR funding, Lansky 2004). The combination of methods, once developed, should reduce the coefficient of variation from high single digits or substantially higher to low single digits, reducing the need for replication by a factor of four to ten or more. 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.

Principal Investigator:

David M. Lansky
8028650155
DAVID@LANSKYCONSULTING.ORG

Business Contact:


8028650155
Small Business Information at Submission:

Lansky Consulting, LLC
Lansky Consulting, Llc 308 Pine St Burlington, VT 05401

EIN/Tax ID: 710903133
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No