InDevR is a biotechnology company that develops advanced life science instrumentation and assays for analysis of viruses and other microorganisms as well as protein detection and characterization, with product focus on Virus Quantification and pathogen detection/identification. InDevR Inc. is a privately held, woman-owned small business located in Boulder, Colorado, USA. Wikipedia.
InDevR | Date: 2012-06-12
Methods for the quantification of influenza HA proteins and anti-influenza antibodies for the fields of vaccine-related protein quantification, potency determination, and efficacy evaluation are provided. According to the technology, quantification is achieved by providing capture agents attached to an array in a series of decreasing concentrations. Serial dilutions of a reference material also may be introduced. The reference material within each solution binds to the capture agents on the array and is labeled with a label agent capable of producing a detectable signal used to construct a calibration curve. A target material of unknown concentration is introduced to a separate identical array, and the target material binds to the capture agents and also is labeled by a label agent to produce a detectable signal. The calibration curve based on the reference material is then utilized to determine the concentration of the target material without the need to perform replicate experiments.
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 2.40M | Year: 2008
DESCRIPTION (provided by applicant): This Phase II Advanced Technology SBIR [PA-06-134] proposal is in response to NIAID's Notice of High-Priority Influenza Research Areas [NOT-AI-05-013]. In order to provide health officials with the tools required to eff iciently combat a pandemic strain of influenza, it is essential that rapid and cost-effective methods for vaccine production be developed. The proposed instrument is specifically designed to provide a rapid count of the number of intact viruses per unit volume in liquid. While optimization of vaccine production methods is an example application for which the number of intact viruses is a valuable measurement, the time and cost savings of virus enumeration within minutes, rather than days, is anticipated t o have substantial impact on several other virus-related fields. Support for that outlook is provided by the excellent group of collaborators we have been able to assemble during the Phase I efforts, including scientists from two large vaccine manufacturer s (MedImmune and Novartis), a small cutting-edge vaccine manufacturer (Protein Sciences Corporation), a biological reagents company (Microbix Biosystems, Inc.), a diagnostics company (Quidel Corporation), and a College of Medicine (at Baylor). All Phase I objectives were achieved and in many cases exceeded. During Phase II efforts we will i) design and construct an advanced prototype Virus CounterTM and develop automated methods for instrument parameter setup; ii) evaluate instrument performance in comparis on with standard methods such as plaque assays, fluorescence focus assays, transmission electron microscopy and real-time quantitative PCR, iii) optimize the Virus CounterTM and assay for utility in vaccine production, and iv) conduct beta-site testing of the instrument. PUBLIC HEALTH RELEVANCE: In order to provide health officials with the tools required to efficiently combat a pandemic strain of influenza, it is essential that rapid and cost-effective methods for vaccine production be developed. T he proposed instrument is specifically designed to provide a rapid count of the number of intact viruses per unit volume in liquid. While optimization of vaccine production methods is an example application for which the number of intact viruses is a val uable measurement, the time and cost savings of virus enumeration within minutes, rather than days, is anticipated to have substantial impact on several other virus-related fields.
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 597.13K | Year: 2008
DESCRIPTION (provided by applicant): Our objective is to develop a commercially viable influenza diagnostic for rapid and simultaneous screening of clinical samples for influenza A and B type and important subtypes. The advantages of the proposed approach over existing polymerase chain reaction (PCR) methods for influenza viruses stem from the use of a single gene segment for identification of both type and subtype. The target for the proposed work, the matrix gene segment, is known to be robustly amplified and more conserved than the traditional hemagglutinin gene (HA) target. The initial commercial niche for the developed product will be state and local public health laboratories. While state health labs currently receive clinical samples for typing and su btyping, the cost of subtyping by the gold standard of viral isolation and hemagglutination inhibition test is prohibitive. Currently, most health labs rely on a fluorescence-based immunoassay to screen for H3 or H1 viruses, with no confirmation of the n euraminidase subtype and no current capabilities for emerging viruses. Those labs that utilize real-time reverse transcription PCR (RRT-PCR) assays must rely on the mutation- susceptible HA gene for partial subtyping and must conduct individual tests for e ach HA subtype. The proposed product would serve as a means to improve and broaden surveillance efforts at state and local levels in the US, as well as in regional labs worldwide, by providing a rapid and cost-effective means to simultaneously screen for t ype (A and B) and certain subtypes, specifically, current human-adapted influenza viruses (A/H3N2 and A/H1N1) and A/H5N1. This new surveillance tool would be used in place of existing immunoassays and singleplex HA targeted RT-PCR based assays but is not d esigned to replace viral isolation methods and sequencing, which are necessary for a more complete understanding of influenza viruses. Specific Aim 1 will capitalize on the recent discovery that the matrix gene segment of influenza's viral genome c an provide both type and subtype information for influenza viruses. The hypothesis to be tested is that a small set of M gene segment specific primers pairs (5) for RT-PCR can be designed to selectively detect A/H3N2, A/H1N1, A/H5N1, and B viruses. Specifi c Aim 2 will focus on systematic optimization of multiplex conditions for RT-PCR. In Specific Aim 3, promising primer sets that satisfy the criteria for success with initial samples will be validated in a blind study of 300+ patient samples acquired over a t least two flu seasons by a variety of sampling methods, including nasal swab, nasal wash, and nasopharyngeal aspiration. In Phase 2 we will engineer a system for automated sample handling, including extraction and RT-PCR amplification, followed by rapid separation and detection of PCR products by a fast chromatographic method. Post-PCR separation and detection is anticipated to provide superior accuracy and sensitivity relative to multiplex RRT- PCR with no added time to the overall assay. The mot ivation for the proposed work is the tremendous impact influenza viruses have on human and animal health and the need for rapid, inexpensive tools for strain surveillance. The intent is to provide state and local public health laboratories with the ability to affordably and rapidly screen patient samples for influenza type and subtype using the highly reliable and conserved matrix gene segment as the identification target.
InDevR | Date: 2016-04-20
Influenza vaccine potency assays and reagents related thereto; kits for quantifying influenza hemagglutinin from seasonal vaccine strains.
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 600.00K | Year: 2012
DESCRIPTION (provided by applicant): There is a tremendous need for new analytical methods to enhance vaccine research and development, ultimately allowing the production of safe and efficacious vaccines in less time at less cost. For example, it is well known that for splt vaccines one step in the process that can be rate limiting is protein quantification and potency determination. The FDA approved gold standard potency assay for influenza hemagglutinin protein based vaccines is single radial immunodiffusion (SRID). SRID is a time and labor intensive assay, often requiring 2-3 days to complete and a minimum of 6 hours hands on time by well trained analysts. While the reference reagents are provided at no cost by the Center for Biologics Evaluation andResearch (CBER), additional materials must be purchased and the entire assay prepared and validated by each vaccine producer. Often vaccine producers experience long delays, sometime months, in receiving reference reagents. Even with reference materials inhand, the wait for results can be days for each round of clone assessment prior to moving forward in development. As is widely acknowledged, the overall result is a time-consuming and inefficient vaccine development process. Here we propose two new quantitative, multiplexed analytical methods based on cost-effective low density microarrays. Both assays are based on a Titer on Chip approach that will streamline vaccine potency measurements by substantially reducing time to result, eliminating inter-laboratory variations associated with assay preparations, and reducing reagent cost. One proposed assay relies (Specific Aim I) on monoclonal antibodies that are universally responsive to hemagglutinin subtypes for influenza (e.g., H1, H3, H5). The other proposed assay (Specific Aim II) relies on universal sialic acid glycoproteins that bind hemagglutinin to achieve rapid HA protein quantification without the need for strain specific antibodies. We believe that Titer on Chip has the long term potential to revolutionize influenza vaccine potency determination. PUBLIC HEALTH RELEVANCE: There is a tremendous need for new analytical methods to enhance vaccine research and development, ultimately allowing the production of safe and efficacious vaccines in less time at less cost. Here we propose two new quantitative, multiplexed analytical methods based on cost-effective low density microarrays. We believe that Titer on Chip has the long term potential to revolutionize influenza vaccine potency determination.