The goal of this STTR Phase II collaboration between Purdue University and bioVidria, Inc. is to commercialize disruptive new technology for protein chromatography and then maximize its impact by serving the fastest growing segment of the pharmaceutical industry: protein drugs. The product is a reversed phase chromatography column that uses silica particles of only 500 nm in diameter, thereby significantly increasing resolution and sensitivity in protein separations. Slip flow is what enables high flow rates with such small particles. The primary market opportunity is the analysis of the heterogeneity of bioengineered drugs based on monoclonal antibodies. These drugs offer high target specificity, e.g., toxicity directed at the tumor. The problem to be solved is that monoclonal antibodies can undergo intra- and inter-molecular disulfide scrambling during storage, which causes immunogenicity in patients. The proposed slip-flow column will uniquely resolve and isolate these scrambled versions, enabling rational design of formulations to reduce immunogenicity. The Phase I research focused on protein and peptide separations in packed capillaries, demonstrating ten-fold narrower zones and a ten-fold flow enhancement from slip flow. The Phase II research will focus on scaling up to develop packed stainless steel columns of 2.1 mm in diameter. The scale-up will allow customers to use these columns with current commercial instruments, which is essential for serving the pharmaceutical industry.
The Specific Aims of the Phase II proposal are to 1) optimize the process for packing 500 nm particles into stainless steel columns, 2) develop a scalable process to make bonded phases with negligible silanol activity, and 3) develop separation methods for resolving products of disulfide rearrangement of monoclonal antibodies for all three types of antibody platforms. We enlist three major companies to provide samples: Genentech (IgG1), Pfizer (IgG2) and Eli Lilly (IgG4).

Agency
National Institute of Health (NIH)
Institute
National Institute of General Medical Sciences (NIGMS)
Type
Small Business Technology Transfer (STTR) Grants - Phase II (R42)
Project #
2R42GM106580-02
Application #
8782084
Study Section
Special Emphasis Panel (ZRG1-IMST-L (11))
Program Officer
Edmonds, Charles G
Project Start
2013-08-01
Project End
2016-07-31
Budget Start
2014-08-15
Budget End
2015-07-31
Support Year
2
Fiscal Year
2014
Total Cost
$500,996
Indirect Cost
Name
Biovidria, Inc.
Department
Type
DUNS #
808276237
City
Tucson
State
AZ
Country
United States
Zip Code
85747