R44GM140750
Project Grant
Overview
Grant Description
Hidef B8: Commercialization and Scaled Production of Defined, Robust, and Cost-Effective Media for iPSCs - Research & Related Other Project Information
Defined Bioscience, Inc.
7. Project Summary
Inconsistency of growth media for cell culture is a significant problem in both industry and academia that has plagued laboratories for decades. In biopharma, cell-based and cell-derived therapies are growing at a tremendous rate and require well-defined, animal-free components to meet FDA and CGMP regulations. It is therefore not surprising that there is an increased need for and adoption of serum-free media for cell culture growth that is attributed to its superior batch-to-batch consistency and reduced risk of unwanted animal/xenobiotic contaminants.
This is particularly critical to human induced pluripotent stem cells (hiPSCs), a rapidly evolving technology with wide research and clinical application. These cells present numerous advantages compared to previous technologies, including human origin, the ability to form multi-class cell systems and tissues, relative ease of production and modification, and functional relevance. Robust and well-characterized protocols are of utmost importance when culturing hiPSCs for downstream applications. High pluripotency, genetic stability, large-scale production, and maintained function all must be kept in mind for hiPSCs.
Yet, despite the array of defined media now available for iPSCs, many of these media fail to satisfy the full needs of hiPSC research, including robustness over multiple passages and experimental needs, low cost, ease of production, weekend-free media changes, and fully defined components. Such traits are critical for robust, consistent, and affordable research in the hiPSC space.
Just this year, our Defined Bioscience team empirically tested common defined media components over a large array of concentrations and combinations, isolating a well-defined recipe with high robustness, efficacy over >100 cell passages, and maintained success in a weekend-free passaging schedule. This media, termed B8 by the lab of Scientific Advisory Board member Paul Burridge, met or exceeded the expectations for a Phase I SBIR development proposal.
Here, we will extend this work to prepare Hidef B8, a formulation of B8 finalized to optimal component concentrations and reduced cost. This optimized formulation will be tested across academic and industrial labs in the United States to confirm robustness and efficacy in streamlined and applied hiPSC culture and methodologies. We intend to make Hidef B8 an affordable, defined media for robust hiPSC culture across high passage numbers and in a weekend-free context, significantly reducing the cost and complexity of hiPSC technologies across the field.
This will enable stable cell culture and a well-characterized starting point for subsequent differentiation and applied hiPSC technology efforts, while simultaneously lowering the barrier of entry for hiPSC development in the field.
Defined Bioscience, Inc.
7. Project Summary
Inconsistency of growth media for cell culture is a significant problem in both industry and academia that has plagued laboratories for decades. In biopharma, cell-based and cell-derived therapies are growing at a tremendous rate and require well-defined, animal-free components to meet FDA and CGMP regulations. It is therefore not surprising that there is an increased need for and adoption of serum-free media for cell culture growth that is attributed to its superior batch-to-batch consistency and reduced risk of unwanted animal/xenobiotic contaminants.
This is particularly critical to human induced pluripotent stem cells (hiPSCs), a rapidly evolving technology with wide research and clinical application. These cells present numerous advantages compared to previous technologies, including human origin, the ability to form multi-class cell systems and tissues, relative ease of production and modification, and functional relevance. Robust and well-characterized protocols are of utmost importance when culturing hiPSCs for downstream applications. High pluripotency, genetic stability, large-scale production, and maintained function all must be kept in mind for hiPSCs.
Yet, despite the array of defined media now available for iPSCs, many of these media fail to satisfy the full needs of hiPSC research, including robustness over multiple passages and experimental needs, low cost, ease of production, weekend-free media changes, and fully defined components. Such traits are critical for robust, consistent, and affordable research in the hiPSC space.
Just this year, our Defined Bioscience team empirically tested common defined media components over a large array of concentrations and combinations, isolating a well-defined recipe with high robustness, efficacy over >100 cell passages, and maintained success in a weekend-free passaging schedule. This media, termed B8 by the lab of Scientific Advisory Board member Paul Burridge, met or exceeded the expectations for a Phase I SBIR development proposal.
Here, we will extend this work to prepare Hidef B8, a formulation of B8 finalized to optimal component concentrations and reduced cost. This optimized formulation will be tested across academic and industrial labs in the United States to confirm robustness and efficacy in streamlined and applied hiPSC culture and methodologies. We intend to make Hidef B8 an affordable, defined media for robust hiPSC culture across high passage numbers and in a weekend-free context, significantly reducing the cost and complexity of hiPSC technologies across the field.
This will enable stable cell culture and a well-characterized starting point for subsequent differentiation and applied hiPSC technology efforts, while simultaneously lowering the barrier of entry for hiPSC development in the field.
Awardee
Funding Goals
THE NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES (NIGMS) SUPPORTS BASIC RESEARCH THAT INCREASES OUR UNDERSTANDING OF BIOLOGICAL PROCESSES AND LAYS THE FOUNDATION FOR ADVANCES IN DISEASE DIAGNOSIS, TREATMENT, AND PREVENTION. NIGMS ALSO SUPPORTS RESEARCH IN SPECIFIC CLINICAL AREAS THAT AFFECT MULTIPLE ORGAN SYSTEMS: ANESTHESIOLOGY AND PERI-OPERATIVE PAIN, CLINICAL PHARMACOLOGY ?COMMON TO MULTIPLE DRUGS AND TREATMENTS, AND INJURY, CRITICAL ILLNESS, SEPSIS, AND WOUND HEALING.? NIGMS-FUNDED SCIENTISTS INVESTIGATE HOW LIVING SYSTEMS WORK AT A RANGE OF LEVELSFROM MOLECULES AND CELLS TO TISSUES AND ORGANSIN RESEARCH ORGANISMS, HUMANS, AND POPULATIONS. ADDITIONALLY, TO ENSURE THE VITALITY AND CONTINUED PRODUCTIVITY OF THE RESEARCH ENTERPRISE, NIGMS PROVIDES LEADERSHIP IN SUPPORTING THE TRAINING OF THE NEXT GENERATION OF SCIENTISTS, ENHANCING THE DIVERSITY OF THE SCIENTIFIC WORKFORCE, AND DEVELOPING RESEARCH CAPACITY THROUGHOUT THE COUNTRY.
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
San Diego,
California
921221937
United States
Geographic Scope
Single Zip Code
Related Opportunity
Analysis Notes
Amendment Since initial award the End Date has been extended from 03/31/23 to 03/31/24 and the total obligations have increased 97% from $760,359 to $1,495,522.
Defined Bioscience was awarded
Project Grant R44GM140750
worth $1,495,522
from the National Institute of General Medical Sciences in May 2021 with work to be completed primarily in San Diego California United States.
The grant
has a duration of 2 years 10 months and
was awarded through assistance program 93.859 Biomedical Research and Research Training.
The Project Grant was awarded through grant opportunity Better Defining Growth Medium to Improve Reproducibility of Cell Culture (SBIR) (R43/R44 - Clinical Trial Not Allowed).
SBIR Details
Research Type
SBIR Phase II
Title
HiDef B8: Commercialization and scaled production of defined, robust, and cost-effective media for iPSCs
Abstract
RESEARCH andamp; RELATED Other Project Information Defined Bioscience, Inc. 7. PROJECT SUMMARY Inconsistency of growth media for cell culture is a significant problem in both industry and academia that has plagued laboratories for decades. In biopharma, cell-based and cell-derived therapies are growing at a tremendous rate and require well-defined, animal-free components to meet FDA and cGMP regulations. It is therefore not surprising that there is an increased need for and adoption of serum-free media for cell culture growth that is attributed to its superior batch-to-batch consistency and reduced risk of unwanted animal/xenobiotic contaminants. This is particularly critical to human induced pluripotent stem cells (hiPSCs), a rapidly evolving technology with wide research and clinical application. These cells present numerous advantages compared to previous technologies, including human origin, the ability to form multi-class cell systems and tissues, relative ease of production and modification, and functional relevance. Robust and well- characterized protocols are of utmost importance when culturing hiPSCs for downstream applications. High pluripotency, genetic stability, large-scale production and maintained function all must be kept in mind for hiPSCs. Yet despite the array of defined media now available for iPSCs, many of these media fail to satisfy the full needs of hiPSC research, including robustness over multiple passages and experimental needs, low cost, ease of production, weekend-free media changes and fully defined components. Such traits are critical for robust, consistent and affordable research in the hiPSC space. Just this year, our Defined Bioscience team empirically tested common defined media components over a large array of concentrations and combinations, isolating a well-defined recipe with high robustness, efficacy over andgt;100 cell passages, and maintained success in a weekend-free passaging schedule. This media, termed B8 by the lab of scientific advisory board member Paul Burridge, met or exceeded the expectations for a Phase I SBIR development proposal. Here we will extend this work to prepare HiDef B8, a formulation of B8 finalized to optimal component concentrations and reduced cost. This optimized formulation will be tested across academic and industrial labs in the United States to confirm robustness and efficacy in streamlined and applied hiPSC culture and methodologies. We intend to make HiDef B8 an affordable, defined media for robust hiPSC culture across high passage numbers and in a weekend-free context, significantly reducing the cost and complexity of hiPSC technologies across the field. This will enable stable cell culture and a well-characterized starting point for subsequent differentiation and applied hiPSC technology efforts, while simultaneously lowering the barrier of entry for hiPSC development in the field.8. PROJECT NARRATIVE Human induced pluripotent stem cell (hiPSC) culture is plagued by poorly defined, inconsistent, and costly media recipes for maintained pluripotency. Our team has developed a formulation, termed B8, that is low-cost, robust, effective at high-passage counts, and is fully defined. This project aims to finalize the B8 formulation to HiDef B8, with increased characterization, low commercialization cost, and a more robust weekend-free usage protocol, for application in hiPSC cell maintenance and differentiation studies.
Topic Code
400
Solicitation Number
PA18-815
Status
(Complete)
Last Modified 10/4/24
Period of Performance
5/17/21
Start Date
3/31/24
End Date
Funding Split
$1.5M
Federal Obligation
$0.0
Non-Federal Obligation
$1.5M
Total Obligated
Activity Timeline
Transaction History
Modifications to R44GM140750
Additional Detail
Award ID FAIN
R44GM140750
SAI Number
R44GM140750-1238755504
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Small Business
Awarding Office
75NS00 NIH NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES
Funding Office
75NS00 NIH NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES
Awardee UEI
H7BMDJBA2DL3
Awardee CAGE
8G7S1
Performance District
CA-50
Senators
Dianne Feinstein
Alejandro Padilla
Alejandro Padilla
Budget Funding
Federal Account | Budget Subfunction | Object Class | Total | Percentage |
---|---|---|---|---|
National Institute of General Medical Sciences, National Institutes of Health, Health and Human Services (075-0851) | Health research and training | Grants, subsidies, and contributions (41.0) | $735,163 | 100% |
Modified: 10/4/24