cGMP rHu SCF Lyophilized

Active Substance

• Negligible BSE/TSE risk from all sub-components for all media components
• Low Endotoxin (< 1 EU/µg)
• High Purity (≥ 97%)

Manufacturing (sub)

• All raw materials are compliant, controlled, and traceable under Akron’s Quality Management System (QMS)
• Yeast expression system
• Tag-free purification

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

• 36-month shelf life for 100 µg (AK9879-0100
• 18-month shelf life for 1 mg (AK9879-1000)
• Store at -20 °C
• Transport on cold packs

Reconstitution

AK9879-0100: Reconstitute the 100 µg lyophilized product in 0.2 mL of sterile water.
AK9879-1000: Reconstitute the 1 mg lyophilized product in 0.5 mL of sterile water.

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
• Specific Activity
• Purity (Non-Reducing SDS-PAGE)
• Purity (Reducing SDS-PAGE)
• Purity (HPLC)
• Host Cell Derived Proteins
• Bacterial Endotoxins

In vivo, SCF is critical to the regulation of hematopoietic stem cells (HSCs) and plays a key role during fetal development. Akron’s cGMP-compliant rHu rHu SCF can be used to promote the ex vivo expansion of HSCs and various hematopoietic progenitor cells.