cGMP rHu TGF-β 1 Lyophilized

Manufacturing

• Expressed in CHO cells
• Tag-free purification
• Negligible BSE/TSE risk from all components
• All raw materials are compliant, controlled, and traceable under Akron’s Quality Management System (QMS)

Quality

• Relevant cGMP guidelines used in manufacture, testing, and release
• USP <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
• ISO 13485:2016, Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
• ISO/TS 20399-1-3:2018, Biotechnology - Ancillary Materials Present During the Production of Cellular Therapeutic Products

Stability

• Currently on a long-term stability program
• Store at 2-8
• Transport on cold packs

Reconstitution

Reconstitute the lyophilized product with 1 mL of sterile water for injection (WFI). Avoid freeze thaw cycles.

For Use Statement

For research use or further manufacturing use in ex vivo cell therapy applications. This product is not intended for direct in vivo use or for direct clinical use as a drug, therapeutic, biologic, or medical device.

Certificate of Analysis (CoA)
TSE/BSE Statement
Certificate of Origin (CoO)
Safety Data Sheet (SDS)
Product Page

• Appearance
• pH
• Residual Moisture
• Protein Content
• Molecular Weight
• Purity
• Specific Activity
• Biological Activity
• Bacterial Endotoxins
• Sterility

In vivo, rHu TGF-β 1 is produced by many cell types. It helps regulate inflammatory processes and is implicated in autoimmune disease. It also affects stem cell and immune cell differentiation and activation. Akron’s cGMP-compliant rHu TGF-β 1 can be used to promote ex vivo responses from B cells, T cells, macrophages, mesenchymal stem cells (MSCs), induced pluripotent stem cells (iPSCs), and neural stem cells (NSCs).