Sartorius, 20802-0500, CellGenix® GMP SCGM

Optimized, xeno-free, serum-free medium
Serum-free expansion of low numbers of isolated human hematopoietic stem and progenitor cells (HSCs/CD34+ cells)
Highly efficient for the expansion and cultivation of human natural killer cells (NK cells) and human cytokine induced killer cells (CIK cells)
Manufactured in accordance with applicable GMP guidelines

CellGenix® GMP Stem Cell Growth Medium is an optimized, xeno-free medium used for the serum-free expansion of low numbers of isolated human hematopoietic stem and progenitor cells (HSCs/CD34+ cells). In addition, CellGenix® GMP Stem Cell Growth Medium is proved to be highly efficient for the expansion and cultivation of human natural killer cells (NK cells) and human cytokine induced killer cells (CIK cells).
Please access the Certificate of Analysis on the My Sartorius Portal.
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.

Specifications
Applications:
Application: Clinical ex vivo use
Application Area: Cell & gene therapy; Immunology; Stem cell biology
Cell Type: HSC; NK Cells; CIK Cells

Biological Information:
Functional Assay: Expansion of human CD34+ cells

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

Components:
Phenol Red Indicator: With Phenol Red

Features:
Serum Free: Yes

General Specifications:
pH Range: pH 7.2 – 7.5

Physicochemical Information:
Adherence/Suspension: Adherent/Suspension
Endotoxin: ≤ 1 EU/ml
Osmolality: 290-350 mOsm/kg H2O

Product Information:
Brand: CellGenix®
Package Type: Bottle

Sterility/Purity:
Delivery Condition: Sterile
Mycoplasma: Not detectable

Volume:
Volume: 500mL