cGMP rHu Insulin
Pharmaceutical level raw material for cGMP manufacturing.
See why everyone is choosing Akron growth factors.
Akron’s Recombinant Human Insulin (rHu Insulin) product is manufactured following all relevant cGMP guidelines for ancillary materials and is supported by a Type II Master File (MF), which can be referenced by the FDA during your drug or biologic application process. The amino acid sequence of Akron’s rHu Insulin is identical to native human insulin, and extensive physicochemical characterization studies have demonstrated comparable quality attributes relative to commercially available injectable human insulin products, including Novolin® R.
Akron’s rHu Insulin is a 5.8 kDa recombinant protein expressed in Pichia pastoris. The mature protein consists of two peptide chains, the A chain containing 21 amino acids and the B chain containing 30 amino acids, linked by two interchain disulfide bonds for a total of 51 amino acids. The protein is manufactured and purified in a pharmaceutical facility without the use of histidine tags or nickel affinity chromatography. Validated analytical methods and product specifications aligned with the USP Human Insulin monograph are used for product release, including identity, purity, endotoxin, and total viable count testing.
Active Substance
- Negligible BSE/TSE risk from all raw material components
- Raw materials are qualified, controlled, and fully traceable under Akron’s Quality Management System (QMS)
- Extensive physicochemical characterization and demonstrated comparability to commercially available injectable human insulin products, including Novolin® R
Manufacturing
- Type II eCTD MF (#027051) on file with FDA
- Tag-free pharmaceutical processing without affinity tags or nickel chromatography
- Kilogram-scale production capacity
Quality
- Relevant cGMP guidelines used in manufacture, testing, and release
- USP <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
- EP 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products
- ISO 20399:2022, Biotechnology - Ancillary Materials Present During the Production of Cellular Therapeutic Products
- High Purity, Low Endotoxin - Endotoxin and Total Viable Count testing per USP
Stability
- 36-month shelf life
- Store at -20 °C
- Ships on dry ice
- Protect from light
Reconstitution
Reconstitute the lyophilized product in 0.05N HCl to create a stock solution between 1-10 mg/mL. Further dilutions at concentrations ≤1 mg/mL may be prepared using aqueous solutions such as PBS, saline, culture medium, or Water for Injection (WFI). Adjust to neutral pH with NaOH, as needed. Store aliquots at -20 °C and avoid repeated 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.
Each lot is released using validated analytical methods and product specifications aligned with the USP Human Insulin monograph.
- Identity
- Purity
- Potency
- Impurity Profiling
- Residual Process Contaminants
- Endotoxin
- Bioburden
Insulin is one of the most well characterized proteins in history. It was the first protein hormone to be discovered, the first protein to be fully sequenced, and the first protein to be synthesized with recombinant technology. In vivo, insulin’s primary function is the regulation of glucose metabolism. It stimulates cells to uptake glucose, inhibits glucose production in the liver, inhibits the breakdown of lipids and proteins, and enhances the synthesis of proteins. It is produced by beta cells in the pancreatic islets and its mis-regulation is responsible for the widespread disease diabetes mellitus.
Aliquot Sizes & Formats
Lyophilized (100 mg) Cat. # AK9844-0100
