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Reducing a major cost burden of therapeutic cell manufacturing by selectivelyremoving toxic culture byproducts to allow recycling of media

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41GM140787-01A1
Agency Tracking Number: R41GM140787
Amount: $224,453.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 400
Solicitation Number: PA20-265
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-09-20
Award End Date (Contract End Date): 2022-07-19
Small Business Information
151 10TH ST
San Francisco, CA 94103-2604
United States
DUNS: 080199257
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 Emily Hopewell
 (813) 451-5967
Business Contact
Phone: (615) 403-0861
Research Institution
United States

 Nonprofit College or University

ABSTRACT:The tremendous cost of cell-based therapies manufacturing is the significant threat to the success of
cell/gene therapy treatments. The cell culture medium alone can contribute to around 30-40% of the Cost of
Goods (COGs). This is because, the current cell culture methods require frequent and complete media
replacement in order to remove toxic metabolites from culture. This practice of completely replacing the medium
with fresh medium adds significant expense and contributes to unnecessary waste. Restoring nutrient, osmotic,
and pH balance need not require replacement of the entire culture medium volume. At production scale, some
version of medium recycling will be required to reduce waste and overall cost of manufacturing. The aim of the
current study is to develop a cost-effective media filtration system using coconut-shell derived activated carbons
(CS-AC) that can selectively remove two important toxic metabolites such as lactic acid and ammonium from
cell culture medium. With such filtration system, metabolic waste products can selectively be removed, non-
metabolized components like buffers, and growth factors can be retained, and the depleted nutrients like sugars
and amino acids can be replenished as they are consumed by the cells. Determining the level of recycling that
is achievable by this filtration technology for each component of the culture medium requires a significantly more
complex analysis informed by empirical data from spent medium analysis.The ultimate goal of this study is to utilize this filtration technology and develop a commercial grade
single-use filtration device by embedding the AC into cellulose matrix or neutral-grade resins. The application of
the new filtration device to remove toxic metabolites from spent culture medium will transform the current
approaches being investigated for COG reduction during cell based therapeutic manufacturing. Such a filtration
system holds a great promise for affordable cell/gene therapy treatment possibilities, and is expected to have a
strong economical impact on clinical medicine.Narrative:
The study deals with design and development of a filtration technology for depleting toxic metabolites
from spent culture media. The filtered media with growth supporting factors will be recycled back to the
culture, potentially eliminating frequent culture media changes and reducing the COG for cell/gene
therapy manufacturing. The ultimate goal of this study is to utilize this filtration technology and develop
a commercial grade single-use filtration device.

* Information listed above is at the time of submission. *

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