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Quantitative Characterization ff Submicron Aggregates for Antibody TherapeuticsAward last edited on: 7/29/13
Sponsored Program
SBIRAwarding Agency
NIH : NCATSTotal Award Amount
$1,402,868Award Phase
2Solicitation Topic Code
-----Principal Investigator
Bridget CarragherCompany Information
NanoImaging Services Inc
4940 Carroll Canyon Road Suite 115
San Diego, CA 92121
San Diego, CA 92121
(888) 675-8261 |
info@nanoimagingservices.com |
www.nanoimagingservices.com |
Location: Single
Congr. District: 52
County: San Diego
Congr. District: 52
County: San Diego
Phase I
Contract Number: 1R43RR028166-01Start Date: 4/1/10 Completed: 3/31/11
Phase I year
2010Phase I Amount
$193,829Public Health Relevance:
Arguably two of the fastest growing sectors 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.
Thesaurus Terms:
Address; Antibodies; Appearance; Behavior; Biodistribution; Biologic Products; Biological Agent; Biological Products; Cancers; Characteristics; Chemicals; Communicable Diseases; Complex; Cryo-Electron Microscopy; Cryoelectron Microscopy; Data; Development; Development And Research; Disease; Disorder; Drug Delivery; Drug Delivery Systems; Drug Targeting; Drug Targetings; Drugs; Electron Cryomicroscopy; Goals; Image; Industry; Infectious Disease Pathway; Infectious Diseases; Infectious Diseases And Manifestations; Infectious Disorder; Link; Lipids; Malignant Neoplasms; Malignant Tumor; Marketing; Measures; Medication; Methods; Methods And Techniques; Methods, Other; Metric; Moab, Clinical Treatment; Modeling; Monitor; Monoclonal Antibodies; Morphology; Pharmaceutic Preparations; Pharmaceutical Agent; Pharmaceutical Preparations; Pharmaceuticals; Pharmacologic Substance; Pharmacological Substance; Phase; Prevention; Process; Production; Protocol; Protocols Documentation; R & D; R&D; Safety; Sampling; Sampling Studies; Services; Shapes; Techniques; Testing; Therapeutic; Therapeutic Agents; Time; Viral Vaccines; Virus; Viruses, General; Visual; Biopharmaceutical; Biotherapeutic Agent; Commercialization; Cryoem; Design; Designing; Disease/Disorder; Drug/Agent; Imaging; Interdisciplinary Approach; Interest; Malignancy; Mathematical Algorithm; Nano Imaging; Nano Particle; Nanoimaging; Nanoparticle; Neoplasm/Cancer; Particle; Physical Property; Pre-Clinical; Preclinical; Public Health Relevance; Quality Assurance; Research And Development; Tool; Visual Information
Phase II
Contract Number: 9R44TR000182-02Start Date: 00/00/00 Completed: 00/00/00
Phase II year
2012(last award dollars: 2013)
Phase II Amount
$1,209,039Public Health Relevance:
Aggregation in antibody therapeutics is a topic of increasing concern in the biopharmaceutical industry, because these aggregates are believed to play an undesirable role resulting in adverse health effects to patients; as a result, there is increasing pressure from the U.S. Food and Drug Administration to develop quantitative characterization tools for submicron aggregate particles in biopharmaceutical drug products. Our technology applies high-throughput molecular microscopy to identify and quantify sub-micron protein aggregates in antibody therapeutics. These new analytical methods will contribute to the armamentarium of analytical techniques aimed at helping reduce costs and improve safety and efficacy of antibody therapeutics.
Public Health Relevance Statement:
Aggregation in antibody therapeutics is a topic of increasing concern in the biopharmaceutical industry, because these aggregates are believed to play an undesirable role resulting in adverse health effects to patients; as a result, there is increasing pressure from the U.S. Food and Drug Administration to develop quantitative characterization tools for submicron aggregate particles in biopharmaceutical drug products. Our technology applies high-throughput molecular microscopy to identify and quantify sub-micron protein aggregates in antibody therapeutics. These new analytical methods will contribute to the armamentarium of analytical techniques aimed at helping reduce costs and improve safety and efficacy of antibody therapeutics.
Project Terms:
Address; Algorithms; analytical method; Antibodies; Autoantigens; Automation; B-Lymphocytes; Biological; Biological Products; Biotechnology; Client; Collaborations; Colorado; Complex; Computer software; Consultations; cost; cost effective; Data; Data Analyses; Data Collection; Descriptor; design; Detection; Development; drug efficacy; Drug Formulations; Drug Kinetics; Ensure; Face; falls; Fee-for-Service Plans; financial incentive; Freezing; Generations; Health; Housing; humanized antibody; Image; imaging modality; Imaging technology; Immune response; immunogenicity; Immunoglobulin G; improved; Industry; innovation; instrument; Joints; Marketing; Measures; method development; Methodology; Methods; Microscopy; Molecular; molecular imaging; monomer; Morphology; particle; Particulate; Patients; Peer Review; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Play; Preparation; pressure; Process; protein aggregate; protein aggregation; Publications; Reporting; research study; Resolution; Role; Safety; Sampling; Scientist; Seeds; Services; Shapes; software development; Specimen; Stress; submicron; Techniques; Technology; Therapeutic; Therapeutic antibodies; Therapeutic Monoclonal Antibodies; therapeutic protein; tool; Translations; United States Food and Drug Administration; Universities; Validation; Virus; virus morphology; Work;