Sartorius, 1010-050, CellGenix® rh IL-7 (GMP Grade)

Top Features for Recombinant Human Interleukin-7:
Optimal use for expansion of CAR-T Cells and differentiation of iPSC's into T cells
ADCF Level 2
High purity to ensure the safety of your process
Available in two different grades (Preclinical and GMP grade)

CellGenix® Recombinant Human Interleukin-7 (IL-7) is an animal-derived component-free product. It is produced in a dedicated animal-free GMP facility. IL-7 is used in the cell and gene therapy space for the ex vivo expansion of genetically modified T cells, such as CAR T cells, and differentiation of induced pluripotent stem cells (iPSCs) into T cells. It is in addition used to differentiate cord blood derived hematopoietic stem cells (HSCs/CD34+) into natural killer cells (NK cells).
GMP grade: CellGenix® Recombinant Human IL-7 is produced following applicable GMP guidelines and allows for the safe use in accordance with USP Chapter <1043>, Ph. Eur. General Chapter 5.2.12 and ISO 20399:2022.
CellGenix® GMP cytokines are provided with documented evidence of purity, potency, consistency and stability. In combination with our expert regulatory and technical support this will help simplify your raw material qualification and validation efforts.
Expiry: ≥ 6 months from date of shipping.
We have submitted Drug Master Files (DMFs) to US Health Authorities to support our customers’ regulatory activities. These Master Files can be cross-referenced through Letters of Authorization (LOAs) in Marketing Authorizations, IND, BLA, NDA, ANDA or other DMF applications. Please submit your Authorization Request via the form above.
Preclinical grade: Designed to meet the demands of translational research, CellGenix® Preclinical cytokines are ideal to bridge the gap between the lower quality of research grade and the higher costs of GMP grade materials.
Expiry: 3 years from date of shipping
For the exact expiry date and the batch specific activity, please refer to the Certificate of Analysis on the My Sartorius Portal.
Safety Data Sheets (SDSs) are available on request.

Specifications
Applications:
Application Area: Cell & gene therapy; Immunology
Cell Type: T Cells; ESC/iPSC; NK Cells
Intended Use: For further manufacturing use

Biological Information:
Activity: 70 – 220 x 106 IU/mg

Compliance Information:
GMP Compliance: This product was manufactured in accordance with applicable Good Manufacturing Practice (GMP) guidelines.
Origin: Animal-Component Free
Quality Grade: GMP

Features:
Carrier-Protein Free: Yes

Physicochemical Information:
Endotoxin: ≤ 0.025 EU/µg
Expression System: E. coli
Formulation: Lyophilized from 200 µL of a 0.2 µm-filtered solution containing 25 mM sodium phosphate, 150 mM sodium chloride and 0.1 % polysorbate 20, pH 7.4

Product Information:
Brand: CellGenix®
Package Type: Vial
Size: 50 µg

Sterility/Purity:
Delivery Condition: Sterile
Purity: ≥ 97%

Weight:
Molecular Weight (kDa): 18.3 kDa