San Diego, CA, United States
San Diego, CA, United States

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The present invention relates to the stabilization of one or more metabolically-active cell in a blood sample at ambient temperatures. In particular, formulations, compositions, articles of manufacture, kits and methods for substantially stable storage of one or more metabolically-active cell in a blood sample at ambient temperatures are provided.


Patent
Biomatrica | Date: 2013-08-13

Compositions and methods are disclosed for substantially dry storage at ambient or elevated temperatures of biological samples such as nucleic acids, proteins and cells in a form from which the samples can be substantially recovered, using a dissolvable or dissociable dry storage matrix comprising a borate composition and a stabilizer as disclosed, such as any of a number of zwitterionic stabilizers.


Patent
Biomatrica | Date: 2013-12-20

Described herein are stabilized polymerase compositions comprising a polymerase and an polymerase stabilizing agent, such as a non-detergent zwitterionic stabilizer or a cationic ester disclosed, for use in nucleic acid amplification or nucleic acid sequencing. Compositions are provided for the stabilization of one or more polymerases in a single stabilized liquid formulation. Also disclosed are methods for making and using stabilized polymerase compositions and kits for nucleic acid amplification and sequencing comprising the stabilized polymerase compositions provided.


Compositions and methods are disclosed for substantially liquid, gel, suspension, slurry, semisolid and/or colloid storage of biological samples following admixture with the herein disclosed storage composition, permitting substantial recovery of biological activity following storage without refrigeration. In certain embodiments, unfractionated blood or tissue samples may be stored without refrigeration for weeks, months or years in a form that permits recovery of intact DNA, RNA or protein components following the storage period.


Patent
Biomatrica | Date: 2014-06-13

The present invention relates to stabilization of cells at ambient temperatures. More particularly, the present invention relates to formulations, compositions, kits and methods that allow dehydration and rehydration of cells and dramatically increased recovery of functional cells after dry storage at room temperature.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 140.17K | Year: 2015

DESCRIPTION provided by applicant HIV genotyping reagents require cold shipping and storage Many of the resource limited settings where these reagents are used have unreliable and costly cold chain transport and storage In this proposal we will modify the reagents in the HIV PanGroup M Genotyping Assay HIV PMGA to allow for ambient temperature shipping and long term storage The first aim of this proposal is to develop and optimize formulations to dry and store all of the reagents in module of the HIV PMGA The second aim will test the lead formulations from aim for their limit of viral RNA detection and the third aim will verify te sequence accuracy of samples processed using the modified kit In the end this project will develop multiple formulations that will allow the long term ambient temperate storage of the HIV PMGA reagents that retain their genotyping efficacy PUBLIC HEALTH RELEVANCE HIV genotyping is an important tool to monitor HIV drug resistance in ART programs This proposal will stabilize the RTPCR and PCR reagents in the CDC HIV PanGroup M Genotyping Assay so they can be shipped and stored at ambient temperature These stabilized reagents will be a more reliable and cost efficient strategy for HIV genotyping in resource limited settings


Grant
Agency: Department of Defense | Branch: Army | Program: SBIR | Phase: Phase I | Award Amount: 99.66K | Year: 2012

The objective is to develop approaches are sought for sample preservation of nucleic acids from blood products or other sample for storage at room temperature conditions. The goals of the project are to: 1) determine preferable tissue for nucleic acid archiving; 2) investigate sample collection protocol, processing, of the selected tissue; and 3) initially define key potential aspects of storage conditions for preservation of nucleic acids. In addition, we will develop a completely integrated ambient temperature workflow from collection, transport to storage to avoid any cold-chain handling. This complete ambient workflow can be achieved through the integration of advanced thermo-stability products currently in Biomatrica's product development pipeline. The overall objective is the development of workflow which protects nucleic acids, in particular RNA from degradation during collection to sample archiving and determine its feasibility for large scale implementation.


Compositions and methods are disclosed for substantially liquid, gel, suspension, slurry, semisolid and/or colloid storage of biological samples following admixture with the herein disclosed storage composition, permitting substantial recovery of biological activity following storage without refrigeration. In certain embodiments, unfractionated saliva samples may be stored without refrigeration for weeks, months or years in a form that permits recovery of intact DNA following the storage period.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 150.00K | Year: 2013

Whole blood remains the cornerstone specimen type used in molecular analysis. Changes in the DNA, RNA, protein, peptide, metabolic, and blood cell analyte levels during pre-analytic specimen handling between collection and eventual molecular analysis impacts testing accuracy and delegitimizes any conclusions drawn from the results. The specific aim of this research is to develop stabilized blood collection devices which effectively preserve analytes at their collection levels, and allow for cold-chain independent shipping and storage. It accomplishes this through the utilization of biostability compounds which stabilize and protect the analytes. What is unique and noteworthy about our proposal is that these particular biostability compounds not only protect soluble analytes such as plasma proteins, but appear to act on the entire cellular fraction, including whole cells and the analytes associated or contained within them. In essence, the biostability compounds arrest the entire blood specimen in its post-collection state, and in a form which is compatible with all downstream molecular analysis. The proposed research will result in the, selection of performance-validated biostability compounds which can be incorporated into standard blood collection tubes or self-draw blood collection devices.


Grant
Agency: Department of Defense | Branch: Army | Program: SBIR | Phase: Phase II | Award Amount: 730.61K | Year: 2014

The projects objective is the development of a scalable all ambient temperature biological sample workflow preserving the nucleic acids for molecular analysis. This ambient workflow can be developed for large scale blood collection, transport and long-term archiving without the use of costly and unreliable cold-chain management, using commercially available biopreservation products. Since the completion of the human genome project in 2001, nucleic acid (DNA and RNA) based analysis has proven to be the most powerful diagnostic tool currently available to create actionable prediction of human health and understand and prevent disease development. The complexity of the human genome requires large sample populations to increase the predictive value of genetic analysis. Large scale archiving of population and/or patient specimens is the key to create this knowledge base. The pioneering work of Biomatrica over the past decade in the field of chemical biomaterial preservation at room temperature has allowed low cost alternatives to unreliable cold chain management. In Phase I we successfully demonstrated the power of chemical ambient preservation of nucleic acids throughout the workflow from blood sample collection and transport to the reliable storage of nucleic acids. We demonstrated that a) diagnostic analysis can be performed after storage in the ambient biopreservation products, b) the integrity of the DNA and RNA are pristinely maintained using ambient preservation c) the workflow is scalable from collection to archiving at lower costs and higher reliability than the current cold chain-based workflow. The Phase II development will result in the integration of proven commercial products into a highly scalable process, with the integration of automation equipment, the establishment of Standard Operating Procedure (SOPs) and an optimized workflow that reduces operational costs. The automated methods can be directly implemented for blood sample processing and archiving of nucleic acids in a routine setting.

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