Induced Pluripotent Stem Cells (iPSCs) and Embryonic Stem Cells (ESCs)
In 2012, the Nobel prize for physiology or medicine was awarded for the discovery that adult somatic cells can be reverted to a pluripotent stem cell state using reprogramming factors. Since then, induced pluripotent stem cells (iPSCs) have become one of the most promising pathways for therapeutic applications.
Pluripotent stem cells, including iPSCs and embryonic stem cells (ESCs), have the innate ability to self-renew indefinitely and differentiate into any cell type. This confers a unique advantage when compared to other cell therapies since the starting cells can be differentiated into any specific cell type required for the final therapy. Pluripotent stem cells can also serve as a canvas for gene modification before they are differentiated. This enhances the targeted therapeutic benefit by yielding not only the desired phenotypic characteristics but also the genetic characteristics to maximize efficacy. Additionally, the effects of graft versus host disease (GvHD) can be mitigated, with certain genetic modifications. Finally, ESCs and iPSCs can be used as new cell sources for the generation of DC, T cell therapies, NK cells and pancreatic islets.
To ensure a seamless transition from preclinical development to commercial manufacturing, we offer CellGenix® cytokines and growth factors both in GMP and preclinical grade.
Our 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.
CellGenix® GMP recombinant cytokines are produced following all applicable GMP guidelines and allow for the safe use in accordance with USP Chapter <1043>, Ph. Eur. General Chapter 5.2.12 and ISO 20399:2022.
CellGenix® Recombinant Human Fibroblast Growth Factor-2 (FGF-2, also known as bFGF)is an animal-derived component-free product. It reliable improves proliferation of mesenchymal stem cells (MSCs). It in addition supports proliferation and differentiation of chondrocytes and supports propagation of undifferentiated pluripotent stem cells (PSCs). CellGenix® rh FGF-2 preclinical grade and GMP grade are both produced in a dedicated GMP facility.
Fibroblast Growth Factor-2 (FGF-2) is a basic fibroblast growth factor. It amongst others 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 bone marrow and adipose tissue derived MSCs.
CellGenix® Recombinant Human Transforming Growth Factor-beta 1 (TGF-β1) is an animal-derived component-free product. It reliably promotes the expansion of induced pluripotent stem cells (iPSC), embryonic stem cells (ESC), mesenchymal stem cells (MSC) as well as regulatory T cells (Tregs). It also stimulates the differentiation of T cells into Tregs. CellGenix® rh TGF-β1 preclinical grade and GMP grade are both produced in a dedicated GMP facility.
TGF-β1 is a member of the growth factor beta superfamily and plays a role in various cellular functions like cell differentiation, proliferation and apoptosis. It is secreted by most immune cells and especially interacts with T cells, B cells, macrophages and monocytes.
TGF-β1 is used in the cell and gene therapy space to promote expansion of iPSC, ESC, MSC and Tregs.
CellGenix® Recombinant Human TGF-β1 is produced using a human amniocyte cell line (CAP®). By using the CAP® technology we are able to produce this difficult to express glyco-protein with authentic human post-translational modifications. These human post-translational modifications are not accessible by bacterial expression.
CellGenix® Recombinant Human Activin A is an animal-derived component-free product. It reliably promotes definitive endoderm differentiation of embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs). It in addition maintains the undifferentiated state of ESCs and iPSCs. CellGenix® rh Activin A preclinical grade and GMP grade are both produced in a dedicated animal-free GMP facility.
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 differentiation of ESCs and iPSCs into definitive endoderm, and for the maintenance and self-renewal of pluripotent stem cells (PSCs).
CellGenix® Recombinant Human Epidermal Growth Factor (EGF) is an animal-derived component-free product. It reliably promotes the expansion of mesenchymal stem cells (MSCs). It in addition promotes the differentiation of embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs)-derived hepatoblasts. CellGenix® rh EGF preclinical grade and GMP grade are both produced in a dedicated animal-free GMP facility.
EGF is a growth factor that promotes cell growth, proliferation and differentiation. It is found in a variety of human body 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.
CellGenix® Recombinant Human Interleukin-1 beta (IL-1β) is an animal-derived component-free product. It reliably stimulates the maturation of immature dendritic cells (DCs). It in addition promotes the generation of megakaryocytes derived from pluripotent stem cells (PSCs). CellGenix® rh IL-1β preclinical grade and GMP grade are both produced in a dedicated animal-free GMP facility.
IL-1β is a proinflammatory cytokine that is mainly produced by monocytes and activated 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 pro-inflammatory cytokines (IL-2, IL-3, IL-6) as well as interferons. Furthermore, IL-1β modulates the secretion of cytokines by various subsets of human DCs.
CellGenix® IL-1β is used in the cell and gene therapy space for the ex vivo maturation of immature DCs.
CellGenix® Recombinant Human Oncostatin M (OSM) is an animal-derived component-free product. It promotes the differentiation of embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs) derived hepatoblasts into hepatocytes. CellGenix® rh OSM is produced in a dedicated animal-free GMP facility ensuring maximum safety for optimal use in ATMP manufacturing.
Oncostatin M (OSM) is a cytokine belonging to the interleukin-6 (IL-6) subfamily and it most closely resembles leukemia inhibitory factor (LIF) in both structure and function. It is primarily produced by T cells and monocytes. OSM plays an important role in liver development, hematopoiesis, and inflammation, and also has been shown to be associated with bone formation and resorption.
CellGenix® Recombinant Human Stem Cell Factor (SCF) is an animal-derived component-free product. It reliably supports survival and differentiation of hematopoietic stem cells (HSCs) and progenitor cells as well as the differentiation of 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. CellGenix® rh SCF preclinical grade and GMP grade are both produced in a dedicated animal-free GMP facility.
SCF is a cytokine that is 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 for the expansion of HSCs that are used for transplantation.
CellGenix® Recombinant Human Thrombopoietin (TPO) is an animal-derived component-free product. 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. CellGenix® rh TPO preclinical grade and GMP grade are both produced in a dedicated animal-free GMP facility.
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.
Designed to meet the demands of translational research, our ‘preclinical grade’ cytokines are ideal to allow for a seamless transition from preclinical development to the clinical stage. CellGenix® preclinical and GMP cytokines are produced under the same conditions in a GMP facility, using identical production steps and expression systems. This ensures an equal product quality and performance.
The difference between both quality levels is that we offer a more comprehensive QC testing including tighter specifications and documentation for our GMP products. Our preclinical grade products therefore offer a cost-efficient alternative for the early development phase when safety and quality of ancillary materials have a lower priority.
Endotoxin testing (all cytokines except IL-2, IL-7, IL-15, IL-21 and TGF-β1)
< 1000 EU/mg
≤ 50 EU/mg
Endotoxin testing (IL-2, IL-7, IL-15 and IL-21)
< 25 EU/mg
≤ 25 EU/mg
Endotoxin testing (TGF-β1)
< 25 EU/mg
≤ 10 EU/mg
Sartorius CellGenix® is the only supplier with a preclinical grade that can be replaced directly with the corresponding product at GMP grade in clinical and commercial manufacturing use.
Quality and consistency of critical ancillary materials are directly linked to the clinical and commercial success of a therapy. Several years of proven batch-to-batch consistency across the preclinical and GMP cytokines range demonstrate the high quality, safety and reliability of CellGenix® cytokines.
Ancillary materials derived from biological origin can introduce risks to the process and final ATMP product, including transmission of viruses.
Using animal-derived component-free cytokines:
- Ensures maximum safety of the ATMP, no animal or human-derived components are part of any of our cytokine products.
- Reduces variables associated with animal-derived components.
- Makes time-consuming and expensive viral safety studies obsolete, thereby bringing a significant economic benefit.
The large majority of our cytokines is produced in a dedicated animal-free facility (ADCF Level 2). These cytokines have never been exposed to animal components or byproducts.
Very few cytokines produced in the segregated animal-derived components (ADC) production area require either 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.
CellGenix® cytokines are lyophilized, making them stable at a wide range of temperatures. The products are delivered in our standard packaging at ambient temperatures.
To ensure that the product quality is not compromised during shipment at ambient temperatures we have put a validated shipment procedure in place. As part of this procedure, we implemented special temperature control measures and performed shipment stability studies.