CellGenix® GMP TCM (1000 mL Bag)

  • Optimized, xeno-free, serum-free medium
  • Exceptional performance with no need to add serum
  • Highly efficient for the expansion and cultivation T cells, CAR-T cells and Tregs
  • Manufactured in accordance with applicable GMP guidelines
  • For the exact expiry date and the batch specific activity, please refer to 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.

Package Type
Volume
Item No.: 
20914-1000
Availability: 

*Custom/bulk order quotes are provided within 72 hours of request.

Letter of Authorization (LOA)

Place a request for a Letter of Authorization (LOA) for our Drug Master File (FDA)

CellGenix® TCM is optimized for serum-free expansion and cultivation of T cells. It supports the expansion of CD4+ and CD8+ T cells and promotes a central memory and early differentiated memory T cell phenotype. It is highly efficient for the expansion and cultivation T cells, CAR-T cells and Tregs.

Please refer to Certificate of Analysis link for the exact expiry date and the batch specific activity.

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.

Applications

  • Application
    Clinical ex vivo use
  • Application Area
    • Cell & gene therapy
    • Immunology
    • Immune cell culture
  • Cell Type
    T Cells

Biological Information

  • Functional Assay
    Ex vivo-culture of primary human CD3+T-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
    Without Phenol Red

Features

  • Serum Free
    Yes

General Specifications

  • pH Range
    pH 7.2 – 7.5

Physicochemical Information

  • Adherence/Suspension
    Adherent/Suspension
  • Endotoxin
    ≤ 0.5 EU/ml
  • Osmolality
    280-320 mOsm/kg H2O

Product Information

  • Brand
    CellGenix®
  • Package Type
    Bag

Sterility/Purity

  • Delivery Condition
    Sterile
  • Mycoplasma
    Not detectable

Volume

  • Volume
    1000 mL