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UNIVERSITAET FUER BODENKULTUR WIEN
WIEN, 1180
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Subcontracting experience
1 record from government sources. Past participation is not evidence of current teaming interest.
| Role | Agency | Description | Vehicle | Obligated | Action date | Period |
|---|---|---|---|---|---|---|
| Subcontractor | Department of Health and Human Services | OPTION 11C: 0258-A474-4612
DEVELOPMENT OF A TAG-LESS RNA DOWNSTREAM PURIFICATION PROCESS AND ASSISTANCE IN OPTIMIZING AN AFFINITY-BASED RNA DOWNSTREAM PURIFICATION PROCESS
THE UNIVERSITY OF NATURAL RESOURCES AND LIFE SCIENCES, VIENNA WILL AID IN THE BIOPROCESS DEVELOPMENT OF A NOVEL RECOMBINANT INFLUENZA VIRUS NEURAMINIDASE. THIS PROTEIN IS INTENDED TO BE USED AS A SUBUNIT VACCINE. RECOMBINANT NEURAMINIDASE (RNA) WILL BE PRODUCED IN INSECT CELLS, USING THE BACULOVIRUS SYSTEM, AT MOUNT SINAI AND/OR EXPRESSION SYSTEMS. DR. LINGG€„¢S TEAM WILL DEVELOP A DOWNSTREAM PROCESS (DSP) FOR HIGHLY PURE RNA USING TWO STRATEGIES. FIRSTLY, AN ALREADY EXISTING POLY-HISTIDINE-TAG BASED DSP WILL BE OPTIMIZED TO ENSURE A ROBUST PROCESS WITH A YIELD SUFFICIENT TO SUPPORT PHASE I CLINICAL TRIAL PRODUCTION AT EXPRESSION SYSTEMS. SECONDLY, A NOVEL DSP THAT DOES NOT RELY ON THE POLY-HISTIDINE-TAG, WILL BE DEVELOPED.
TASK 1: OPTIMIZE AFFINITY-BASED PROCESS
THE CURRENT AFFINITY-BASED PROCESS UTILIZES POLY-HISTIDINE TAGGED RNA WHICH CAN BE PURIFIED USING IMMOBILIZED METAL AFFINITY CHROMATOGRAPHY. WHILE THE PROCESS PRODUCES RNA OF SUFFICIENT PURITY, IT SUFFERS FROM LOW SCALABILITY DUE TO LACKING ROBUSTNESS OF THE PROCESS. PROTEIN LOSSES DURING COLUMN WASH STEPS WERE OBSERVED. THE AFFINITY CHROMATOGRAPHY STEP WILL BE OPTIMIZED USING VARIOUS STRATEGIES AND AN ARRAY OF ANALYTICAL TOOLS TO MONITOR THE CONCENTRATION OF PRODUCT AND CRITICAL IMPURITIES.
OPTION 11D: 0258-A475-4612
DEVELOPMENT OF A TAG-LESS RNA DOWNSTREAM PURIFICATION PROCESS AND ASSISTANCE IN OPTIMIZING AN AFFINITY-BASED RNA DOWNSTREAM PURIFICATION PROCESS
THE UNIVERSITY OF NATURAL RESOURCES AND LIFE SCIENCES, VIENNA WILL AID IN THE BIOPROCESS DEVELOPMENT OF A NOVEL RECOMBINANT INFLUENZA VIRUS NEURAMINIDASE. THE WORK ON THIS OPTION WILL BE AS FOLLOWS:
TASK 2: DEVELOP TAG-LESS PROCESS
A CONVENTIONAL DSP FOR THE PRODUCTION OF RNA WITHOUT AFFINITY TAG WILL BE DEVELOPED USING STATE-OF-THE-ART BIOCHEMICAL ENGINEERING METHODS. THE PROPOSED PROCESS WILL CONSIST OF SEVERAL UNIT OPERATIONS, NAMELY CLARIFICATION USING DEPTH FILTRATION, VIRAL INACTIVATION, CONCENTRATION USING ULTRAFILTRATION, CAPTURE USING ANION-EXCHANGE CHROMATOGRAPHY, POLISHING USING AN ORTHOGONAL CHROMATOGRAPHY METHOD, FORMULATION USING ULTRAFILTRATION/DIAFILTRATION AND VIRUS FILTRATION.
PROCESS DEVELOPMENT WILL BE SUPPORTED BY MECHANISTIC MODELS AND AN ARRAY OF ANALYTICAL TOOLS FOR MASS BALANCES OF PRODUCT AND IMPURITIES ACROSS UNIT OPERATIONS. SCALABILITY PARAMETERS OF ALL UNIT OPERATIONS WILL BE DETERMINED TO ENSURE SEAMLESS PROCESS TRANSFER FOR SUPPORT OF PHASE II CLINICAL TRIALS AND BEYOND. 0258-A474-4612 / 0258-A475-4612 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: NY Parent award description: THIS CONTRACT WILL SUPPORT COMPONENT A OF THE COLLABORATIVE INFLUENZA VACCINE INNOVATION CENTERS (CIVICS) PROGRAM TO DESIGN AND EVALUATE INNOVATIVE INFLUENZA VACCINE APPROACHES, BASED ON PRINCIPLES OF INFLUENZA IMMUNITY, THAT ACHIEVE DURABLE, ROBUST View parent award on USAspending | — | $459,164 | Jul 15, 2024 | — – — |
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