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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 |
|---|---|---|
|
TB4423-GMP |
GSK-3 Inhibitor; WNT pathway activator. Enables reprogramming of human somatic cells into iPSCs |
|
|
TB1614-GMP |
TGF Beta 1 (TGF-β1), ALK4 and ALK7 Inhibitor. Replaces SOX2 in reprogramming of fibroblasts to iPSCs |
|
|
TB3748-GMP |
Tankyrase Inhibitor; inhibits WNT signaling. Promotes cardiomyocyte differentiation from ESCs |
|
|
TB1254-GMP |
Selective ROCK Inhibitor. Increases survival of ESCs and iPSCs undergoing cryopreservation |
查看更多 GMP 产品
GMP Cloudz Cell Activation Kits
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
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
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
Serum-Free and Animal-Free Cell Culture
Increase the consistency of your cell cultures as you approach translational studies for regenerative medicine and cell therapy programs. Adopting these media will
- Reduce variability in media composition
- Simplify compliance with regulatory guidelines
- Simplify comparability testing for raw material changes
Background Information
What is the difference between RUO and GMP small molecules?
We manufacture our GMP (current Good Manufacturing Practice) small molecules according to relevant sections of ICH Q7 guidelines. They can be categorized in the risk tier 2 classification (low risk, well characterized materials with intended use as ancillary reagents, produced in compliance with GMP) of USP <1043>. Our RUO (research use only) products, like those of other suppliers, are categorized in the risk tier 3 classification (moderate-risk materials not intended for use as ancillary reagents) of USP <1043>.
Each vial is weighed to a precise amount. We also carry out microbiological testing on our GMP small molecules, specifically endotoxin and bioburden testing.
Explore our Certificate of Analysis Finder Tool.
Are GMP small molecules animal-free?
Yes. We ensure that our GMP small molecules are animal-free.
Can GMP small molecules be used as therapeutics?
No. Our GMP compounds are intended for use only as ancillary reagents for the further manufacture of advanced therapy medicinal products (ATMP), such as stem cell therapies.
Watch our webinar on the Challenges of Analyzing ATMPs.
Why has Bio-Techne developed a GMP product line?
As stem cell therapies are now entering the clinic, there is a requirement to use GMP compounds as ancillary reagents to ensure the safety and suitability of the stem cell therapy product. By introducing a GMP product line, Bio-Techne is fulfilling its commitment to provide the life science community with the latest and most relevant reagents available, to make new discoveries possible.
