Applications / Regenerative Medicine & Cell Therapy
NovelMatrix resolves the substrate-driven problems faced in iPS cell therapies, CAR-T manufacturing, and organoid culture.
Clinical Pain
Matrigel™ (mouse EHS sarcoma) has well-known compositional variability (Hughes et al. 2010) that is disruptive in GMP manufacturing for iPS cell therapies and regenerative medicine products. PMDA and FDA both expect animal-derived raw materials to be avoided wherever possible, putting incumbents under regulatory pressure.
Trypsin and collagenase strip surface proteins such as CD markers, EGFR and adhesion molecules. For CAR-T and iPS-derived therapies, this degrades potency and complicates release assays. Non-enzymatic harvesting is a long-standing unmet need.
Lymphocytes, T cells and CAR-T cells are natively suspension, which makes live imaging, single-cell analytics and process-control observation difficult. Cell loss and phenotype drift during expansion drive low manufacturing yield.
Organoids and spheroids underlie patient-derived drug screening (PDO) but Matrigel-based protocols are poorly standardized, limiting cross-site reproducibility and daily clinical adoption.
Utility of NovelMatrix
Recombinant production removes virus / prion risks and the traceability problems of animal sourcing. Aligned with FDA Modernization Act 2.0 and PMDA guidance, the GMP transition path is direct.
Cells can be detached without trypsin under defined conditions, preserving CD markers and receptors. Suited to CAR-T and iPS-derived cell therapy release testing.
Natively suspension lymphocytes, T cells, CHO and iPS-derived spheroids can be held in adherent form for live imaging, single-cell observation and location-resolved monolayer culture.
The EGF-like domain on FP2 is designed to engage EGFR → PI3K/Akt, MEK/ERK signaling (the EGF-dependence of intestinal organoid maintenance is established in Fujii et al. 2018 and subsequent work), reducing the need for exogenous EGF and removing a source of growth-factor lot variation.
Future Treatments
By eliminating substrate-driven risk and variation, production bottlenecks for PMDA-bound iPS therapies (RPE, cardiomyocytes, dopaminergic neurons) are eased.
Adherent culture of suspension cells plus non-enzymatic harvest maintains phenotype while reaching higher density, compressing per-patient cost and lead time.
Standardized substrate-enabled organoid culture could turn patient tumor tissue into drug-sensitivity panels within days, supporting personalized oncology decisions.
Kawakami, Y. et al. (2025) Development of the FP121 series: Hybrid proteins mimicking marine adhesive proteins with cell adhesion and proliferation activity , Materials & Design .
View on ScienceDirect →Novelglue (FP121 シリーズ) の基盤論文。細胞接着・増殖活性・スクラッチアッセイ等の一次データを含む。
Fujii, M. et al. (2018) Human intestinal organoids maintain self-renewal capacity and cellular diversity in niche-inspired culture condition , Cell Stem Cell , 23 , pp. 787-793.e6 .
DOI: 10.1016/j.stem.2018.11.016EGF を含むニッチ因子に依存したヒト腸オルガノイド維持条件を示した代表論文。
Hughes, C. S., Postovit, L. M., Lajoie, G. A. (2010) Matrigel: A complex protein mixture required for optimal growth of cell culture , Proteomics , 10 , pp. 1886-1890 .
DOI: 10.1002/pmic.200900758Matrigel の組成の不均一性とロット間変動を定量的に評価。
Aisenbrey, E. A., Murphy, W. L. (2020) Synthetic alternatives to Matrigel , Nature Reviews Materials , 5 , pp. 539-551 .
DOI: 10.1038/s41578-020-0199-8Matrigel 代替としての合成・組換え基材の比較レビュー。
