Product Datasheet

CellGenix®
Preclinical &GMP Cytokines
PortfolioHigh Quality Raw Materials
for Cell and Gene Therapy
Manufacturing
Product Information
Growth factors and cytokines are small signaling proteins
crucial in regulating cell growth, differentiation, and function.
CellGenix® growth factors and cytokines are designed as
raw | ancillary materials for cell and gene therapies andregenerative medicine. They are added to cell cultures topromote the proliferation and differentiation of various
human cells towards the desired target cell type, like immune
cells (e.g., T cells) or stem cells (e.g., human mesenchymal
stem cells). To ensure a seamless transition from preclinicaldevelopment to commercial manufacturing, we offer
CellGenix® cytokines in GMP and preclinical grade.

--Features and Benefits
Seamless transition from early development to clinicalstages with consistent product quality & performance
Exceptional batch-to-batch consistency to ensure
optimal cell expansion and differentiation
Manufactured in compliance with applicable GMP
guidelines. Regulatory support available for GMP products.

Introduction

Relevant Applications

CellGenix® growth factors and cytokines combine optimalquality and safety with excellent performance due to stateof-the-art production, stringent quality control, and expert
regulatory support. The growth factors and cytokines are
manufactured in a dedicated animal-free facility to ensure
the highest safety level.
CellGenix® growth factors and cytokines are available inpreclinical and GMP grades, produced under the same
conditions in a ISO-certified facility, using identical production
steps and expression systems. This ensures consistent productquality and performance during scale-up.

CellGenix® growth factors and cytokines are ideal for
activating, expanding, and differentiating human cells forex vivo (outside the human body) cell culture. To ensure aseamless transition from preclinical development tocommercial manufacturing, we offer CellGenix® cytokinesand growth factors in GMP and preclinical grade.
Customized solutions, including bulk requests, can beprovided to meet special manufacturing needs.
For further information, visit	
Cytokines and Growth Factors

GMP cytokines come with documented evidence of purity,
potency, sterility, and stability (including methods andresults). Expert regulatory support includes auditing of ourproduction site and providing reference to our Drug master
Files (DMFs) filed at FDA.

Technical Specifications
Attributes

Preclinical Grade

GMP Grade

Intended use

Intended for preclinical ex vivo use

Intended for ex vivo use in clinical trials and commercial Cell andGene Therapy products manufacturing

Volume50 µg

50 µg and 1 mg for selected cytokines

Access to batch documentation

NoYes

Identity of product confirmed

One method≥ two methods

Activity value on CoA

Minimum

Specific

Regulatory support, DMF, on-siteaudits, change notifications, etc.

NoYes

Regulatory compliance

USP <1043>, Ph. EUR 5.2.12

USP <1043>, Ph. EUR 5.2.12, ISO 20399:2022

2

Figure 1: Workflow Examples for T Cell Therapies

Expansion | differentiation

Apheresis derived
leukocyte fraction

4Cell®
Nutri-T GMP
orCellGenix®
GMP TCM
CellGenix® TGF-β1
andCellGenix® Il-2

T cells

Treg cells
4Cell®
Nutri-T GMP
orCellGenix®
GMP TCM
Expansion | differentiation

Resected tumor

Isolation

Expansion

TILs

CellGenix® IL-2
CellGenix® IL-15
CellGenix® IL-7
CellGenix® IL-21
CAR-T cells
TCR-T cells

4Cell®
Nutri-T GMPorCellGenix®
GMP TCM
CellGenix® IL-2
CellGenix® IL-15
TILs

Note. T cells play a central role in cell-mediated immunity. Immunotherapy based on these powerful cells is a rapidly growing field with promising results.
Current therapies use one of the four following technologies: chimeric antigen receptor (CAR) bearing T cells, tumor-infiltrating lymphocytes (TILs),
regulatory T cells (Treg) and T cell receptor (TCR) engineered T cells.

3Ordering Information
Growth Factors & Cytokines

FormatAmountQuantity

Order Number

CellGenix® Preclinical rh GM-CSF

Lyophilized, glass vial

50 µg

11412-050

CellGenix® GMP rh GM-CSF

Lyophilized, glass vial

50 µg

11012-050

CellGenix® GMP rh GM-CSF

Lyophilized, glass vial

1 mg

11012-1000

CellGenix® Preclinical rh IL-4

Lyophilized, glass vial

50 µg11403-050

CellGenix® GMP rh IL-4

Lyophilized, glass vial

50 µg

11003-050

CellGenix® GMP rh IL-4

Lyophilized, glass vial

1 mg

11003-1000

CellGenix® Preclinical rh TNF-α

Lyophilized, glass vial

50 µg11406-050

CellGenix® GMP rh TNF-α

Lyophilized, glass vial

50 µg

11006-050

CellGenix® Preclinical rh IL-1β

Lyophilized, glass vial

50 µg

11411-050

CellGenix® GMP rh IL-1β

Lyophilized, glass vial

50 µg

11011-050

CellGenix® Preclinical rh IL-10

Lyophilized, glass vial

50 µg

11414-050

CellGenix® GMP rh IL-10

Lyophilized, glass vial

50 µg

11014-050

CellGenix® Preclinical rh IFN-γ

Lyophilized, glass vial

50 µg11425-050

CellGenix® Preclinical rh SCF

Lyophilized, glass vial

50 µg11418-050

CellGenix® GMP rh SCFLyophilized, glass vial

50 µg11018-050

CellGenix® GMP rh SCF

Lyophilized, glass vial

1 mg

11018-1000

CellGenix® Preclinical rh TPO

Lyophilized, glass vial

50 µg11417-050

CellGenix® GMP rh TPO

Lyophilized, glass vial

50 µg11017-050

CellGenix® GMP rh TPO

Lyophilized, glass vial

1 mg

11017-1000

CellGenix® Preclinical rh FLt-3L

Lyophilized, glass vial

50 µg11415-050

CellGenix® GMP rh FLt-3L

Lyophilized, glass vial

50 µg

11015-050

CellGenix® GMP rh FLt-3L

Lyophilized, glass vial

1 mg

11015-1000

CellGenix® Preclinical rh IL-2

Lyophilized, glass vial

50 µg

11420-050

CellGenix® GMP rh IL-2

Lyophilized, glass vial

50 µg

11020-050

CellGenix® GMP rh IL-2

Lyophilized, glass vial

1 mg

11020-1000

CellGenix® GMP rh IL-2

Liquid, syringe

1 mg in 1 mL

11520-1000 available soon

CellGenix® Preclinical rh IL-6

Lyophilized, glass vial

50 µg11404-050

CellGenix® GMP rh IL-6

Lyophilized, glass vial

50 µg

11004-050

CellGenix® GMP rh IL-6

Lyophilized, glass vial

1 mg

11004-1000

CellGenix® Preclinical rh IL-7

Lyophilized, glass vial

50 µg

11410-050

CellGenix® GMP rh IL-7

Lyophilized, glass vial

50 µg11010-050

CellGenix® Preclinical rh IL-15

Lyophilized, glass vial

50 µg

11413-050

CellGenix® GMP rh IL-15

Lyophilized, glass vial

50 µg

11013-050

CellGenix® Preclinical rh IL-21

Lyophilized, glass vial

50 µg11419-050

CellGenix® GMP rh IL-21

Lyophilized, glass vial

50 µg11019-050

CellGenix® Preclinical rh IL-3

Lyophilized, glass vial50 µg

11402-050

CellGenix® GMP rh IL-3

Lyophilized, glass vial

50 µg

11002-050

CellGenix® Preclinical rh OSM

Lyophilized, glass vial

50 µg11423-050

CellGenix® Preclinical rh TGF-β1

Lyophilized, glass vial

50 µg11426-050

CellGenix® GMP rh TGF-β1

Lyophilized, glass vial

50 µg11026-050

4

Growth Factors & Cytokines

FormatAmountQuantity

Order Number

CellGenix® Preclinical rh PDGF-BB

Lyophilized, glass vial

50 µg11409-050

CellGenix® GMP rh PDGF-BB

Lyophilized, glass vial

50 µg

11009-050

CellGenix® GMP rh PDGF-BB

Lyophilized, glass vial

1 mg

11009-1000 (please enquire)

CellGenix® Preclinical rh FGF-2

Lyophilized, glass vial

50 µg

11421-050

CellGenix® GMP rh FGF-2

Lyophilized, glass vial

50 µg

11021-050

CellGenix® GMP rh FGF-2

Lyophilized, glass vial

1 mg

11021-1000

CellGenix® Preclinical rh EGF

Lyophilized, glass vial

50 µg11416-050

CellGenix® GMP rh EGF

Lyophilized, glass vial

50 µg

11016-050

CellGenix® GMP rh EGF

Lyophilized, glass vial

1 mg11016-1000

CellGenix® Preclinical rh Activin A

Lyophilized, glass vial

50 µg11422-050

CellGenix® GMP rh Activin A

Lyophilized, glass vial

50 µg11022-050

5

Germany
Sartorius Stedim Biotech GmbH
August-Spindler-Strasse 1137079 Goettingen
Phone +49 551 308 0

For further information, visit	www.sartorius.com

Specifications subject to change without notice.
Copyright Sartorius Stedim Biotech GmbH.
Status: 10 | 2023

Sartorius CellGenix GmbHAm Flughafen 16
79108 Freiburg
Phone +49 761 88889 0Fax + 49 761 88889 830
info@cellgenix.com

USASartorius Stedim North America Inc.
565 Johnson Avenue
Bohemia, NY 11716
Toll-Free +1 800 368 7178