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Development of Cell Culture Inserts and 3D In Vitro Tissue Models Utilizing Novel Electrospun Scaffolds

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44ES034681-01A1
Agency Tracking Number: R44ES034681
Amount: $884,718.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: R
Solicitation Number: PA22-176
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-05-17
Award End Date (Contract End Date): 2025-04-30
Small Business Information
200 Homer Avenue, Unit 1P
Ashland, MA 01721-1717
United States
DUNS: 131658739
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (508) 881-8860
Business Contact
Phone: (508) 881-8860
Research Institution

Tissue culture inserts that utilize film-based microporous membrane scaffolds are key components of in vitro
tissue models that are used as alternatives to animal testing. However, insert scaffold technology has not
significantly advanced in nearly 30 years. Currently available film-based insert scaffolds are only 2-dimensional
(2D), and are excessively rigid compared to natural extracellular matrix. These 2D scaffolds are not well-suited
for production of complex in vitro 3-dimensional (3D) tissue models. Electrospinning technology can produce
novel scaffolds that better replicate natural 3D extracellular matrix and overcome limitations of currently available
scaffolds. In Phase I-equivalent preliminary work, we produced 3D electrospun scaffolds and developed
manufacturing processes for attaching these scaffolds to high-throughput screening (HTS) Transwell® tissue
culture inserts. We also demonstrated the feasibility of utilizing the 3D electrospun scaffold Transwell® products
for producing organotypic in vitro models of full-thickness human skin and bronchial tissues. These tissue models
have improved physiological relevance and functionality compared to currently available models, and are needed
as alternatives to animal testing. The goal of this revised Direct Phase II SBIR proposal is to further develop and
commercialize these novel electrospun scaffold inserts and organotypic culture models. Aim 1 will utilize 3D
electrospun scaffold inserts to develop full-thickness human skin models consisting of human keratinocytes and
human dermal fibroblasts. Aim 2 will utilize the 3D electrospun scaffold inserts to develop full-thickness human
bronchial airway models consisting of human bronchial epithelial cells and human pulmonary fibroblasts. The
tissue models will be produced in 24- and 96-well HTS Transwell® scaffold plates, as well as individual 6-, 12-
and 24-well Transwell® scaffold insert formats. The models will be produced without the use of animal-derived
extracellular matrix, and will be the only full-thickness in vitro skin and airway tissue models commercially
available as HTS 24- and 96-well formats. The tissue models will be characterized for barrier integrity,
morphological appearance and function, and intra- and inter-lot reproducibility. Validation of the models for
several regulatory accepted assays including assessment of skin irritation and phototoxicity, and assessment of
airway toxicity of tobacco products, will provide key opportunities for immediate commercial use of the scaffold
products and models. Commercial products that will result from this project include individual Transwell® scaffold
inserts as well as 24- and 96-well HTS Transwell® scaffold plates that will be marketed as stand-alone products
to allow researchers to produce any type of tissue models using their own cells and media. Tissue model kits for
producing human skin and bronchial models that would include HTS Transwell® electrospun scaffold plates
together with pre-qualified cells and culture medium and production protocols could also be offered through
partnerships. A conservative market penetration of 1% (global market for insert products, in vitro tissue models
and non-animal in vitro screening assays rt$1.5 billion) would result in annual revenue exceeding $15 million.

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

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