Growth factors and cytokines iPSC and ESC (2023)

Induced Pluripotent Stem Cells (iPSCs) and Embryonic Stem Cells (ESCs)

In 2012, the Nobel Prize in Physiology or Medicine was awarded for the discovery that adult somatic cells can be reverted to a pluripotent stem cell state by reprogramming factors. Since then, induced pluripotent stem cells (iPSCs) have emerged as one of the most promising avenues for therapeutic applications.

Pluripotent stem cells, including iPSCs and embryonic stem cells (ESCs), have the innate ability to permanently self-renew and differentiate into any cell type. This confers a unique advantage compared to other cell therapies in that the initial cells can be differentiated into any specific cell type required for the final therapy. Pluripotent stem cells can also serve as a screen for genetic modification before they differentiate. This increases the specific therapeutic benefit by producing not only the desired phenotypic traits, but also the genetic traits to maximize efficacy. Furthermore, the effects of graft-versus-host-disease (GvHD) can be mitigated with certain genetic modifications. Lastly, ESCs and iPSCs can be used as novel cell sources for DC generation, T cells, NK cells, and pancreatic islet therapies.

To ensure a seamless transition from preclinical development to commercial manufacturing, we offer CellGenix®cytokines and growth factors in both GMP and preclinical grade.

Our GMP cytokines come with documented evidence of purity, potency, consistency, and stability. Combined with our expert technical and regulatory support, this will help streamline your raw material qualification and validation efforts.

CellGenixGenericName®Recombinant GMP cytokines are produced following all applicable GMP guidelines and allow for safe use in accordance with USP chapter <1043>, Ph. I r. General Chapter 5.2.12 and Technical Standard ISO 20399.

Growth factors and cytokines iPSC and ESC (2)

iPSC and ESC growth factors and cytokines

FGF-2More informationVisit to the electronic store

TGF-β1

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active A

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FIGMore informationVisit to the electronic store

IL-1β

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OSM

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SCF

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TPO

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Growth factors and cytokines iPSC and ESC (4)

FGF-2

CellGenixGenericName®Recombinant Human Fibroblast Growth Factor-2 (FGF-2, also known as bFGF) is a product with no animal-derived components. Reliably enhances mesenchymal stem cell (MSC) proliferation. Furthermore, it supports the proliferation and differentiation of chondrocytes and supports the propagation of undifferentiated pluripotent stem cells (PSCs). CellGenixGenericName®rh FGF-2 Preclinical Grade and GMP Grade are produced in a dedicated GMP facility.

General information

Fibroblast growth factor-2 (FGF-2) is a basic fibroblast growth factor. Among others, it plays an important role in wound healing and tumor development by mediating the formation of new blood vessels.

FGF-2 is used in the cell and gene therapy space for the expansion of MSCs derived from bone marrow and adipose tissue.

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Growth factors and cytokines iPSC and ESC (6)

TGF-β1

CellGenixGenericName®Recombinant transforming human growth factor beta 1 (TGF-β1) is a component-free product derived from animals. It reliably promotes the expansion of induced pluripotent stem cells (iPSCs), embryonic stem cells (ESCs), mesenchymal stem cells (MSCs), and regulatory T cells (Tregs). It also stimulates T cell differentiation into Tregs. CellGenixGenericName®The preclinical grade of rh TGF-β1 and the GMP grade are produced in a dedicated GMP facility.

General information

TGF-β1 is a member of the growth factor beta superfamily and plays a role in several cellular functions, such as cell differentiation, proliferation, and apoptosis. It is secreted by most immune cells and interacts especially with T cells, B cells, macrophages, and monocytes.

TGF-β1 is used in the cell and gene therapy space to promote the expansion of iPSCs, ESCs, MSCs, and Tregs.

CellGenixGenericName®Recombinant human TGF-β1 is produced using a human amniocyte cell line (CAP®). use of cap®technology, we are able to produce this difficult-to-express glycoprotein with authentic human post-translational modifications. These human post-translational modifications are not accessible by bacterial expression.

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Growth factors and cytokines iPSC and ESC (8)

active A

CellGenixGenericName®Recombinant Human Activin A is a product free of components of animal origin. It reliably promotes definitive endodermal differentiation of embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs). In addition, it maintains the undifferentiated state of ESC and iPSC. CellGenixGenericName®rh Activin A Preclinical Grade and GMP Grade are produced in a dedicated animal-free GMP facility.

General information

Activin A belongs to the transforming growth factor-beta (TGF-β) superfamily. It regulates a variety of biological functions including cell proliferation, differentiation, apoptosis, and wound repair.

Activin A is used in the cell and gene therapy space to promote the differentiation of ESCs and iPSCs into definitive endoderm and for the maintenance and self-renewal of pluripotent stem cells (PSCs).

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Growth factors and cytokines iPSC and ESC (10)

FIG

CellGenixGenericName®Recombinant Human Epidermal Growth Factor (EGF) is a product free of animal-derived components. It reliably promotes the expansion of mesenchymal stem cells (MSCs). In addition, it promotes the differentiation of embryonic stem cells (ESCs) and hepatoblasts derived from induced pluripotent stem cells (iPSCs). CellGenixGenericName®rh EGF Preclinical Grade and GMP Grade are produced in a dedicated, animal-free GMP facility.

General information

EGF is a growth factor that promotes cell growth, proliferation, and differentiation. It is found in a variety of human bodily fluids.

EGF is used in the cell and gene therapy space for the expansion of bone marrow and adipose tissue-derived MSCs and the generation of stem cell-derived hepatocytes.

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Growth factors and cytokines iPSC and ESC (12)

IL-1β

CellGenixGenericName®Recombinant human interleukin-1 beta (IL-1β) is a product with no components of animal origin. It reliably stimulates the maturation of immature dendritic cells (DC). In addition, it promotes the generation of megakaryocytes derived from pluripotent stem cells (PSCs). CellGenixGenericName®Both the preclinical grade of rh IL-1β and the GMP grade are produced in a dedicated animal free GMP facility.

General information

IL-1β is a proinflammatory cytokine that is produced primarily by activated monocytes and macrophages as a proprotein. Inflammatory responses are mediated by IL-1β in T cells, natural killer cells (NK cells), and B cells. It induces the production of proinflammatory cytokines (IL-2, IL-3, IL-6) as well as interferons. In addition, IL-1β modulates cytokine secretion by various subsets of human DC.

CellGenixGenericName®IL-1β is used in the cell and gene therapy space for ex vivo maturation of immature DCs.

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Growth factors and cytokines iPSC and ESC (14)

OSM

CellGenixGenericName®Recombinant Human Oncostatin M (OSM) is a product free of components of animal origin. Promotes the differentiation of embryonic stem cell (ESC)-derived hepatoblasts and induced pluripotent stem cells (iPSC) into hepatocytes. CellGenixGenericName®rh OSM is produced in an animal-free GMP facility, ensuring maximum safety for optimal use in ATMP manufacturing.

General information

Oncostatin M (OSM) is a cytokine belonging to the interleukin-6 (IL-6) subfamily and most closely resembles leukemia inhibitory factor (LIF) in both structure and function. It is mainly produced by T cells and monocytes. OSM plays an important role in liver development, hematopoiesis, and inflammation, and has also been shown to be associated with bone formation and resorption.

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Growth factors and cytokines iPSC and ESC (16)

SCF

CellGenixGenericName®Recombinant Human Stem Cell Factor (SCF) is a product free of animal-derived components. It reliably supports the survival and differentiation of hematopoietic stem cells (HSCs) and progenitor cells, as well as the differentiation of umbilical cord blood-derived CD34+ cells into natural killer cells (NK cells). It is also used to differentiate embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs) into megakaryocytes and T cells. CellGenixGenericName®rh SCF Preclinical Grade and GMP Grade are produced in a dedicated, animal-free GMP facility.

General information

SCF is a cytokine produced by fibroblasts and endothelial cells. It plays an important role in hematopoiesis, spermatogenesis and melanogenesis.

SCF is used in the cell and gene therapy space to expand HSCs that are used for transplantation.

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Growth factors and cytokines iPSC and ESC (18)

TPO

CellGenixGenericName®Recombinant Human Thrombopoietin (TPO) is a product free of components of animal origin. It reliably supports the self-renewal and maintenance of hematopoietic stem cells (HSCs), as well as the differentiation of HSCs into natural killer cells (NK cells). It is also used to differentiate embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs) into megakaryocytes. CellGenixGenericName®rh TPO preclinical grade and GMP grade are produced in a dedicated, animal-free GMP facility.

General information

TPO is a glycoprotein hormone produced by the liver and kidney. It regulates the production of platelets and stimulates the production and differentiation of megakaryocytes.

TPO is used in the cell and gene therapy space for the ex vivo expansion and differentiation of HSCs.

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technical notes

Quality

Designed to meet the demands of translational research, our "preclinical grade" cytokines are ideal for enabling a seamless transition from preclinical to clinical development.CellGenix®Preclinical and GMP cytokines are produced under the same conditions in a GMP facility, using identical production steps and expression systems. This ensures equality of product quality and performance.

The difference between the two quality levels is that we offer more comprehensive quality control testing, including more stringent specifications and documentation for our GMP products. Our preclinical grade products therefore offer a cost-effective alternative for the early development phase, when the safety and quality of ancillary materials are of lower priority.

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quality attributes

preclinical grade

GMP grade

sterility test

Sim

EUR PhD.

Pureza

≥ 95%

≥ 97%

Endotoxin test (all cytokines except IL-2, IL-7, IL-15, IL-21, and TGF-β1)

< 1000 UE/mg

≤ 50 UE/mg

Pruebas de endotoxinas (IL-2, IL-7, IL-15 and IL-21)

< 25 UE/mg

≤ 25 UE/mg

Endotoxin test (TGF-β1)

< 25 UE/mg

≤10 UE/mg

batch-to-batch consistency

SartoriusCellGenix®is the only supplier with a preclinical grade that can be directly substituted for the corresponding GMP grade product in clinical and commercial manufacturing use.

The quality and consistency of critical ancillary materials are directly related to the clinical and commercial success of the therapy. Several years of proven batch-to-batch consistency across the full range of GMP and preclinical cytokines demonstrate the high quality, safety, and reliability of CellGenix.®cytokines.

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Growth factors and cytokines iPSC and ESC (20)
ADCF

Biologically derived auxiliary materials may present risks to the MTA process and final product, including transmission of viruses.

Use of cytokines free of animal-derived components:

  • Guarantees maximum safety ATMP, none of our cytokine products are part of animal or human derived components.
  • Reduces variables associated with animal-derived components.
  • It makes costly and time-consuming viral safety studies obsolete, resulting in significant economic benefit.

The vast majority of our cytokines are produced in a unique animal-free facility (ADCF level 2). These cytokines have never been exposed to animal components or by-products.

Very few cytokines produced in the secreted animal-derived component (ADC) production area require the use of ADC in the production process or a human expression system to allow proper functional expression (ADCF level 1). To ensure maximum safety, we provide documented evidence of viral and prion safety.

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shipment

CellGenixGenericName®Cytokines are lyophilized, making them stable over a wide range of temperatures. Products are delivered in our standard packaging at room temperature.

To ensure product quality is not compromised during room temperature shipping, we have implemented a validated shipping procedure. As part of this procedure, we implement special temperature control measures and conduct shipment stability studies.

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