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A Novel First-in-class 3D Printing Technology for Advanced Manufacturing of Complex Vaccine Formulations against Influenza and Emerging Infectious Diseases

Award Number: R01FD007456
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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PROJECT SUMMARY: Vaccination is known to be the most effective strategy to manage the spread and deleterious impact of various infectious diseases including the most recent emerging, coronavirus disease 2019, COVID-19. Recombinant protein subunit vaccines have demonstrated promising results for immunization against infectious diseases recently. These vaccines are manufactured through recombinant DNA technology in which the gene fragment that encodes the production of the recombinant protein is introduced to a host cell as an expression system. The genetically engineered cells can proliferate and produce a high amount of the protein of the target which can be separated and purified in the succeeding steps. The recent progress in genetic tool development to manipulate the microorganisms and utilization of mammalian cell lines in biopharmaceutical manufacturing have projected the global protein markets to reach $228.4 billion by the end of this year. However, this industry is still overloaded with processes that lack flexibility and process controls or integration needed for continuous or on demand production capacity. There is no biomanufacturing system that can produce recombinant proteins through a single-step continuous manufacturing process. So, due to the high demand for vaccines all over the world, there’s an immense need for highly efficient yet inexpensive technologies. Yeast expression systems such as Pichia pastoris (P. pastoris) can be used as an expression host cell which offers numerous advantages over traditional systems including high growth rate, easy genetic manipulation process, high yield protein expression, performing eukaryotic post-translational modifications, appropriate protein folding and protein secretion in the external medium and easy purification process.In this project we will utilise a novel Sprayed Multi Adsorbed-particle Reposing Technology (SMART 3D printing technique to produce biocompatible Pluronic (F127)-bisurethane methacrylate (F127-BUM) polymers based microcarrier immobilised with P. pastoris which can be used in large-scale fermentations for production of recombinant proteins. Our SMART technology meets the requirements for recombinant proteins manufacturing such as ease of scale-up, correct protein folding, and short post-production processing. It also has the potential to improve agility, flexibility, cost, and robustness in the manufacturing processes for complex protein-based biologics.Additionally, in contrast to other particulate fabrication techniques, SMART can incorporate live cells during the single-step microparticle formulation process. This technology can easily host further ancillary processes such as ultra-low temperature freezing print bed (-80oC or lower), fibre optic probes for the inline monitoring of critical product quality attributes (CQAs) such as viscosity, content uniformity and stability, making it accessible to industry in the near term with a robust control strategy. Our SMART will be implemented in a continuous setup to manufacture dry powder bioengineered P. pastoris encapsulated F127-BUM microcarriers to produce recombinant proteins for infectious diseases such as vaccines against Epstein-Barr virus (EBV) and influenza vaccines.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	UNIVERSITY OF MISSISSIPPI	113 FALKNER	UNIVERSITY	MS	38677	LAFAYETTE	USA	Food and Drug Administration Research	001	4	3/4/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$498,119
2024	2023	UNIVERSITY OF TEXAS AT AUSTIN	110 INNER CAMPUS DR	AUSTIN	TX	78712	TRAVIS	USA	Food and Drug Administration Research	000	3	3/4/2024	NON-COMPETING CONTINUATION	-$498,119
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $498,119 )
2023	2023	UNIVERSITY OF TEXAS AT AUSTIN	110 INNER CAMPUS DR	AUSTIN	TX	78712	TRAVIS	USA	Food and Drug Administration Research	000	3	9/8/2023	NON-COMPETING CONTINUATION	$498,119
														Subtotal = $498,119

Issue Date FY: 2022 ( Subtotal = $498,728 )
2022	2022	UNIVERSITY OF TEXAS AT AUSTIN	110 INNER CAMPUS DR	AUSTIN	TX	78712	TRAVIS	USA	Food and Drug Administration Research	000	2	9/1/2022	NON-COMPETING CONTINUATION	$498,728
														Subtotal = $498,728

Issue Date FY: 2021 ( Subtotal = $498,189 )
2021	2021	UNIVERSITY OF TEXAS AT AUSTIN	110 INNER CAMPUS DR MN 13	AUSTIN	TX	78712	TRAVIS	USA	Food and Drug Administration Research	000	1	9/21/2021	NEW	$498,189
														Subtotal = $498,189

Grand Total All Awards = $1,495,036

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A Novel First-in-class 3D Printing Technology for Advanced Manufacturing of Complex Vaccine Formulations against Influenza and Emerging Infectious Diseases

Award Number: R01FD007456

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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