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cGMP 小分子用作辅助试剂

干细胞在再生医学疗法中具有很大的潜力。它们可用于生成细胞,以替代多种疾病(包括创伤、糖尿病和帕金森病)中丧失或不健康的细胞。干细胞治疗中用作辅助试剂的小分子需要安全、可靠、一致、有质量保证,以确保干细胞治疗的安全性。我们的 GMP 小分子根据现行 GMP 指南生产,能够提供上述保证。

GMP Small Molecules

Product Name

Catalog #

Description

CHIR 99021

TB4423-GMP

GSK-3 Inhibitor; WNT pathway activator. Enables reprogramming of human somatic cells into iPSCs

SB 431542

TB1614-GMP

TGF Beta 1 (TGF-β1), ALK4 and ALK7 Inhibitor. Replaces SOX2 in reprogramming of fibroblasts to iPSCs

XAV 939

TB3748-GMP

Tankyrase Inhibitor; inhibits WNT signaling. Promotes cardiomyocyte differentiation from ESCs

Y-27632

TB1254-GMP

Selective ROCK Inhibitor. Increases survival of ESCs and iPSCs undergoing cryopreservation

查看更多 GMP 产品

GMP Protein Bottles

GMP 蛋白

我们致力于为细胞疗法制造商提供一致、安全和可追溯的试剂供应。秉承这种理念,我们供应种类繁多的 GMP 蛋白,包括细胞因子和生长因子。

StemXVivo Media Bottle

GMP 细胞培养基

体外细胞生产中的所有成分都需要可控、可追溯和可扩展,包括培养基和血清。我们的 GMP 培养基生产设施提供现成和定制培养基,可用于进一步生产免疫和干细胞疗法。

 

Cloudz Cell Activation Kit

GMP Cloudz Cell Activation Kits

Cloudz kits are based on dissolvable alginate beads decorated with cell type-specific antibodies. They induce feeder-free activation and expansion of specific immune cell subsets.

GMP Cell Manufacturing and Process Development

We offer process development services for any gene modified therapy, GMP patient processing for Phase I and Phase II clinical trials, and GMP manufacturing of iPSC cell lines.

GMP 小分子资源

手册:开创性细胞和基因疗法解决方案

我们的手册概述了 Bio-Techne 提供的创新产品和服务,帮助推进您的细胞和基因疗法研究。 

海报:使用小分子的干细胞工作流程

我们的干细胞工作流程海报总结了小分子在干细胞工作流程中各种方案中的使用情况,并强调了使用小分子的一些关键优势。

实验方案:关键干细胞方案要点

我们的干细胞方案简图重点介绍了小分子在细胞培养、重新编程和分化过程中代替蛋白或与蛋白一起使用的方法。 

About GMP Small Molecules

GMP small molecules are important in the manufacture of stem cell therapies for translational research and clinical applications, where they are used as ancillary reagents. Ancillary reagents are utilized in the growth and manipulation of stem cells. Although they are not intended to be present in the final cell therapy product, they may influence its safety, so the use of GMP ancillary reagents is advisable. 

The clinical phases of development of any therapy are highly regulated in order to mitigate the risk to patient safety, and this includes the use of GMP ancillary reagents (raw materials) for developing stem cell therapies. Our GMP small molecules are manufactured following relevant sections of ICH Q7 guidelines (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients), which ensures batch-to-batch consistency, traceability from starting material to final product and animal-free production.

View Our Cell and Gene Therapy Resources