CellGenix® rh PDGF-BB (GMP Grade)

Tech Support Documents
CellGenix® rh PDGF-BB (GMP Grade) CellGenix® rh PDGF-BB (GMP Grade)
 

Top Features for Recombinant Human Platelet-Derived Growth:

  • Optimal use of generation of MSC's and chondrocytes
  • ADCF Level 2
  • High purity to ensure the safety of your process
  • Available in two different grades (Preclinical and GMP grade)

Preclinical grade:

  • Intended for preclinical ex vivo use
  • GMP transferable: Seamless transition from preclinical development to commercial manufacturing

GMP grade:

  • Intended for clinical ex vivo use
  • Endotoxin Level ≤ 50 EU/mg
  • Manufactured in accordance with applicable GMP guidelines
  • Technical and regulatory support available

Application
Item No.: 
1009-1000
Availability: 

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

CellGenix® rh Cytokines - Preclinical vs GMP

Both product grades are produced under the same conditions in a GMP facility, ensuring an equal product quality and performance. We offer a more comprehensive QC testing including tighter specifications and documentation for our GMP products: CellGenix® rh Cytokines - Preclinical vs GMP

CellGenix® Recombinant Human Platelet-Derived Growth Factor-BB (PDGF-BB) is an animal-derived component-free product. It is produced in a dedicated animal-free GMP facility. PDGF-BB is used in the cell and gene therapy space for the expansion of bone marrow and adipose tissue derived mesenchymal stem cells (MSCs) and chondroctyes.

CellGenix® Recombinant Human PDGF-BB is produced following all 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

For the exact expiry date and the batch specific activity, please refer to the Certificate of Analysis on the My Sartorius Portal.

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App Note:

Reliable T Cell Expansion with CellGenix®️ rh IL-2

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App Note:

Performance of CellGenix® GMP TCM

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Tech Note:

ADCF and Serum-free Policy

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Tech Note:

Shipment at Ambient Temperatures

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Certificate of Analysis:

Download on the My Sartorius portal

My Sartorius
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Tech Note:

Stability of GMP Cytokines after Reconstitution 

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Tech Note:

Batch-to-Batch Consistency of CellGenix® GMP Cytokines

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Datasheet

CellGenix® GMP rh PDGF-BB Datasheet
en 427.4 kB

Safety Datasheet

Safety Datasheet: CellGenix® Recombinant Human PDGF-BB
en 217.1 kB

Applications

  • Application
    Clinical ex vivo use (large)
  • Application Area
    • Cell & gene therapy
    • Neuroscience
  • Cell Type
    • MSC
    • Chondrocytes
    • Neuronal Cells

Biological Information

  • Activity
    1 – 4 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

Features

  • Carrier-Protein Free
    Yes

Physicochemical Information

  • Endotoxin
    ≤ 0.05 EU/µg
  • Expression System
    E. coli

Product Information

  • Brand
    CellGenix®
  • Package Type
    Vial
  • Size
    1 mg

Sterility/Purity

  • Delivery Condition
    Sterile
  • Purity
    ≥ 97%

Weight

  • Molecular Weight (kDa)
    24.8 kDa