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Quantifiable Nanoparticle Characterization using TEM

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
96500
Program Year/Program:
2010 / SBIR
Agency Tracking Number:
RR028166
Solicitation Year:
N/A
Solicitation Topic Code:
NCRR
Solicitation Number:
N/A
Small Business Information
NANOIMAGING SERVICES, INC.
11099 North Torrey Pines Rd, Suite 250 LA JOLLA, CA -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2010
Title: Quantifiable Nanoparticle Characterization using TEM
Agency: HHS
Contract: 1R43RR028166-01
Award Amount: $193,829.00
 

Abstract:

DESCRIPTION (provided by applicant): Characterization of nanoparticles and biologics is a critical step in the development of important new pharmaceutical therapeutics as, in many cases, preclinical characterization is the rate-limiting phase of the commer cialization process. Nanoparticle therapeutics poses unique challenges for characterization that require an interdisciplinary approach in which several orthogonal methods are required to provide a complete picture. Cryo-electron microscopy, with its unique capability for providing exact visual information of size, shape, morphology, and aggregation of a sample in its natural hydrated state, is a powerful additional tool in the armamentarium of characterization techniques applied to nanoparticles. NanoImagin g Services, Inc. was established in 2007 in order to provide cryoEM imaging services specifically focused on the characterization of biologics and nanoparticles. Over the past 18 months it has become clear that there is a critical need for more quantitativ e analysis of multiple cryoEM images. The images must be processed, analyzed and evaluated with the goal of providing numerical data that can be used for assessing the characteristics of the samples and comparing these characteristics to the results obtain ed from other orthogonal methods. Quantitation is critical for assessing lot-to-lot comparisons, quality assurance and control, monitoring samples over time, and when providing data to the regulatory agencies. Here we request support to undertake a 6 month study to determine the feasibility of developing several quantitative characterization protocols that are designed to address specific needs in the research and development of new biologics and nanoparticles as therapeutics. Specifically we will develop q uantitative tools to characterize particle morphology and aggregation state and test and validate the methods using a number of samples of high interest as pharmaceutical therapeutics. PUBLIC HEALTH RELEVANCE: Arguably two of the fastest growing sec tors of the biopharmaceutical industry are the production of biologics as therapeutic agents and nanoparticles as drug delivery vehicles. There is considerable evidence that the physical properties of biologics and nanoparticles is tightly linked to their functional behavior and may thus be a determining factor in the biodistribution, safety, and efficacy of the pharmaceutical product. Cryo- electron microscopy, with its unique potential for providing quantitative information of size, shape, morphology, and aggregation of a sample in its natural hydrated state, is a powerful additional tool in the armamentarium of characterization techniques applied to nanoparticles.

Principal Investigator:

Joel D. Quispe

Business Contact:

Clinton Potter
cpotter@nanoimagingservices.com
Small Business Information at Submission:

NANOIMAGING SERVICES, INC.
NANOIMAGING SERVICES, INC. 10931 N TORREY PINES RD, STE 108 LA JOLLA, CA 92037

EIN/Tax ID: 120863030
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No