R01FD007456
Project Grant
Overview
Grant Description
A novel first-in-class 3D printing technology for advanced manufacturing of complex vaccine formulations against influenza and emerging infectious diseases - 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 utilize a novel sprayed multi adsorbed-particle reposing technology (SMART) 3D printing technique to produce biocompatible Pluronic (F127)-bisurethane methacrylate (F127-BUM) polymers based microcarrier immobilized 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 (-80°C or lower), fiber 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.
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 utilize a novel sprayed multi adsorbed-particle reposing technology (SMART) 3D printing technique to produce biocompatible Pluronic (F127)-bisurethane methacrylate (F127-BUM) polymers based microcarrier immobilized 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 (-80°C or lower), fiber 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.
Awardee
Funding Goals
TO ASSIST INSTITUTIONS AND ORGANIZATIONS, TO ESTABLISH, EXPAND, AND IMPROVE RESEARCH, DEMONSTRATION, EDUCATION AND INFORMATION DISSEMINATION ACTIVITIES, ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS), BIOLOGICS, BLOOD AND BLOOD PRODUCTS, THERAPEUTICS, VACCINES AND ALLERGENIC PROJECTS, DRUG HAZARDS, HUMAN AND VETERINARY DRUGS, CLINICAL TRIALS ON DRUGS AND DEVICES FOR ORPHAN PRODUCTS DEVELOPMENT, NUTRITION, SANITATION AND MICROBIOLOGICAL HAZARDS, MEDICAL DEVICES AND DIAGNOSTIC PRODUCTS, RADIATION EMITTING DEVICES AND MATERIALS, FOOD SAFETY AND FOOD ADDITIVES. THESE PROGRAMS ARE SUPPORTED DIRECTLY OR INDIRECTLY BY THE FOLLOWING CENTERS AND OFFICES: CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER), CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH), CENTER FOR VETERINARY MEDICINE (CVM), CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN), NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH (NCTR), THE OFFICE OF ORPHAN PRODUCTS DEVELOPMENT (OPD), THE CENTER FOR TOBACCO PRODUCTS (CTP), AND OFFICE OF REGULATORY AFFAIRS (ORA), AND THE OFFICE OF THE COMMISSIONER (OC). SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAMS: TO STIMULATE TECHNOLOGICAL INNOVATION, TO ENCOURAGE THE ROLE OF SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION BY MINORITY AND DISADVANTAGED PERSONS IN TECHNOLOGICAL INNOVATION. FUNDING SUPPORT FOR SCIENTIFIC CONFERENCES THAT ARE RELEVANT TO THE FDA SCIENTIFIC MISSION AND PUBLIC HEALTH ARE ALSO AVAILABLE.
Grant Program (CFDA)
Awarding Agency
Place of Performance
University,
Mississippi
386771848
United States
Geographic Scope
Single Zip Code
Related Opportunity
Analysis Notes
Amendment Since initial award the End Date has been extended from 08/31/24 to 08/31/25 and the total obligations have increased 200% from $498,189 to $1,495,036.
The University Of Mississippi was awarded
Project Grant R01FD007456
worth $1,495,036
from Center for Biologics Evaluation and Research in September 2021 with work to be completed primarily in University Mississippi United States.
The grant
has a duration of 4 years and
was awarded through assistance program 93.103 Food and Drug Administration Research.
The Project Grant was awarded through grant opportunity Enhancing Innovations in Advanced Manufacturing Technologies for Vaccines against Influenza and Emerging Infectious Diseases (R01) Clinical Trials Not Allowed.
Status
(Ongoing)
Last Modified 10/25/24
Period of Performance
9/1/21
Start Date
8/31/25
End Date
Funding Split
$1.5M
Federal Obligation
$0.0
Non-Federal Obligation
$1.5M
Total Obligated
Activity Timeline
Transaction History
Modifications to R01FD007456
Additional Detail
Award ID FAIN
R01FD007456
SAI Number
R01FD007456-361664924
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Public/State Controlled Institution Of Higher Education
Awarding Office
75FDA1 FDA OFFICE OF ACQUISITIONS AND GRANTS SERVICES
Funding Office
75DKKB FDA CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
Awardee UEI
G1THVER8BNL4
Awardee CAGE
4B836
Performance District
MS-01
Senators
Roger Wicker
Cindy Hyde-Smith
Cindy Hyde-Smith
Budget Funding
Federal Account | Budget Subfunction | Object Class | Total | Percentage |
---|---|---|---|---|
Salaries and Expenses, Food and Drug Administration, Health and Human Services (075-0600) | Consumer and occupational health and safety | Grants, subsidies, and contributions (41.0) | $996,847 | 100% |
Modified: 10/25/24