# CGMP Compliant Closed Cell Culture System for Reproducible De-differentiation of human somatic cells into iPSCs

> **NIH NIH R44** · BIOPICO · 2021 · $617,592

## Abstract

CGMP Compliant Closed Cell Culture System for Reproducible De-differentiation of human
somatic cells into iPSCs
Abstract
The advancement of iPSC-based personalized cell therapies is currently hindered by the challenges in the
biomanufacturing of therapeutic cells. Despite approaches that have made the derivation, growth and
differentiation of iPSCs more efficient, there remains significant variability in reprogramming efficacy,
genomic integrity and developmental potential of iPSCs derived from patient tissue samples. These
variabilities include lot-dependent or technician-dependent differentiation efficiency, bacterial or fungal
contamination risks, CO2 or O2 concentration level stresses during cell maintenance, high costs or cross-
contamination risks with centralized biomanufacturing facility and requirement of cGMP criteria or regulatory
compliance. The difference of iPSCs derived from the same sample in their in-vitro growth characteristics
and their inability to re-differentiate into the desired tissue type will cause serious problems in therapy. The
further advance of iPSC-based personalized medicine is currently limited by the difficulty to generate iPSCs
for large populations and at an affordable cost. Therefore Biopico Systems Inc will solve such challenges by
developing an automated cGMP Compliant Closed Cell Culture System for reproducible de-differentiation
of human somatic cells into iPSCs. To commercialize Biopico's “CellsMX” system, optimization of closed
media exchange system and integration of customized mRNA/ media formulation front-end for
reprogramming will be performed in this Phase II research. The CellsMX system will provide quality
assurance to the customers for mass production under cGMP guidelines, as operating license are issued to
biological entities along with how cells are produced, tested, and released for therapeutic use. Further, even,
if a large number of patients need iPSC-based personalized cell therapies, under CellsMX closed system,
patient cells are not cross-contaminated and the system can be deployed at the point of care avoiding high
costs and risks associated with the transportation, logistics, tracking, and recording. While patient-specific
iPSC strategy's reduction of immunologic stimulus will drive the initial market segment for the CellsMX
system, Biopico will develop a suite of products for several of such therapeutic culture processes.

## Key facts

- **NIH application ID:** 10239244
- **Project number:** 5R44GM139413-02
- **Recipient organization:** BIOPICO
- **Principal Investigator:** John Collins
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $617,592
- **Award type:** 5
- **Project period:** 2020-09-01 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10239244

## Citation

> US National Institutes of Health, RePORTER application 10239244, CGMP Compliant Closed Cell Culture System for Reproducible De-differentiation of human somatic cells into iPSCs (5R44GM139413-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10239244. Licensed CC0.

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