Shownin Biotech offers customized services based on your scientific research needs in somatic cell reprogramming and other associated realms. Our expertise extends to crafting customized hiPSC solutions, catering specifically to patients with genetic diseases.
Empowered with our non-integrative reprogramming technology, we are able to transform diverse human somatic cells into research-grade induced pluripotent stem cells (hiPSC). These hiPSC mirror the distinctive morphology and gene expression of human embryonic stem cells (hESCs), with untransformed karyotypes and the capability to form three germ layers in vitro and in vivo.
The human cell research and development center at Shownin Biotechnologies Co., Ltd. was constructed in compliance with current Good Manufacturing Practice (cGMP) standards. Our facilities include 1000 m2 clinical-grade cell laboratory (B+A level), 1000 m2 scientific research-grade cell laboratory (C+A level), 220 m2 space for laboratory animal barrier environment (C level) , 350 m2 molecular biology laboratory and other R&D and manufacturing platforms. The R&D center boasts state-of-art cell product research, development, production, and quality inspection equipment, underpinning a comprehensive and standardized quality management system. Shownin Biotechnologies Co., Ltd. has achieved success in generating a range of research- and clinical-grade hiPSC cell lines. These cells, spanning healthy and disease-specific variants, find applications in diverse research realms – from in vitro disease modeling to drug screening, testing and animal transplantation experiments.
At Shownin Biotechnologies Co., Ltd., we adhere to rigorous quality standards across every stage of service, encompassing preparation, identification, storage, packaging, logistics and more. This commitment ensures that we meet our customers’ scientific research requirements while guaranteeing the repeatability and reliability of subsequent experiments.
The morphorlogy of hiPSC colonies during reprogramming
A, B, C: peripheral blood reprogramming-hiPSC clone formation stage and hiPSC clone morphology after expansion. Scale bar: 200μm.
Project content and delivery standards
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Project |
Introduction |
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Tissue Source |
We recommended Peripheral blood, also accept other tissues (such as fibroblasts) |
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Preparation Process |
Preparation of hiPSC cell lines using non-integrated reprogramming method |
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hiPSC |
No foreign gene insertion |
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Culture Conditions |
Both reprogramming and hiPSC culture are carried out in a culture system with clear chemical composition，the hiPSC quality is stable and the differentiation potential is complete. |
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Delivery |
Deliver 3 hiPSC clones for one donor, 2 tubes of cryopreserved cells (>2x106cells / tube) / clone |
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Period |
3-6 months |
Delivery standards
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Project |
Introduction |
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Donor Screening |
AIDS, Syphylis, Hpatitis B, Hepatitis C were negative |
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Cytological detection |
Cell morphology, cell growth, cell number and cell viability |
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Cell surface marker |
SSEA4 + / TRA-1-81 +, Flow cytometry |
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Pluripotency cell markers |
OCT4/NANOG, qRT-PCR |
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Exogenous gene detection |
PCR detection of vector sequence |
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Genomic stability |
Karyotype analysis |
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Microbiology and endotoxin detection |
Bacteria, fungi, mycoplasma and endotoxin were negative |
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Identity |
Documentation that somatic cells and derivative iPSCs are genetically identical |
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Identification of cell differentiation potential |
Teratoma test (optional), which detects tissue differentiated from the three germ layers |