Cell culture techniques have, and will continue to, significantly contribute to many of areas of biomedical science and research that will benefit humans and animals. In most cases, the supplementation of minimal culture media with animal-derived products, e.g., animal serum, is essential for proper cell growth. Serum is the centrifuged fluid component of either clotted or defibrinated whole blood taken from domestic cattle. It provides hormone factors for cell growth and proliferation and provides all of the essential factors needed for maintaining a favorable growth environment. Among several common animal sera, fetal bovine serum (FBS) has been the most widely used and is viewed as a critical reagent for the success of current scientific research and discovery. Despite its widespread use, FBS has a number of well-appreciated problems; it is heterogeneous, with great variety from lot to lot, and is frequently contaminated with things like endotoxins, mycoplasma, bacteria, and/or viruses. Variability and contamination significantly affect the reproducibility of experiments and the safety of products. Better quality control methods are needed to eliminate and detect the presence of serum contaminants, especially from large batches of serum and in a high-throughput manner. In response to this need, Ceres Nanosciences, Inc. has devised a solution leveraging its innovative and proprietary Nanotrap technology, which consists of customizable hydrogel microspheres that have widespread applicability in other fields for separating, targeting, stabilizing, and enriching target analytes from biofluids. Based on supporting proof-of-concept data and through three specific aims, Ceres proposes a Phase I SBIR to evaluate the feasibility of using Nanotrap particles to improve the extraction and detection of common contaminants from serum, and to investigate the integration of Nanotrap technology into a scalable, higher-throughput workflow that is able to be used with large- batch volumes of serum. If successful, the application of this technology could significantly impact the way serum is produced by: accelerating the processing time needed to satisfy regulatory requirements; improving the ability to detect and remove contaminants; and streamlining the workflow between serum collection and sale. This work would then also improve the overall quality of serum being used by the industry, thus helping to improve this essential resource for all applications of cell and tissue culture.

Public Health Relevance

Cell culture techniques have, and will continue to, significantly contribute to many of areas of biomedical science and research that is of benefit to humans and animals. In most cases, the supplementation of minimal culture media with animal serum is essential for proper cell growth, but there are high degrees of variability and contamination between different batches of serum that can significantly affect the reproducibility of experiments and the safety of products. This Phase I SBIR work by Ceres Nanosciences, Inc. will test the feasibility of a solution leveraging its innovative and proprietary Nanotrap technology, which consists of customizable hydrogel microspheres that have proven to have widespread applicability in other fields for separating, targeting, stabilizing, and enriching target analytes from biofluids. If successful, the application of this technology could significantly improve the overall quality of serum being used by the industry, thus helping to improve this essential resource for all applications of cell and tissue culture.

Agency
National Institute of Health (NIH)
Institute
National Institute of General Medical Sciences (NIGMS)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43GM135943-01
Application #
9906315
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Krepkiy, Dmitriy
Project Start
2020-02-01
Project End
2020-10-31
Budget Start
2020-02-01
Budget End
2020-10-31
Support Year
1
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Ceres Nanosciences, Lllp
Department
Type
DUNS #
011762701
City
Manassas
State
VA
Country
United States
Zip Code
20110