Hematopoietic Stem Cells (HSCs)
Hematopoietic stem cells (HSCs) are characterized by the capacity for self-renewal, multipotentiality and differentiation into an entire hematopoietic system, i.e., into any and all different hematopoietic cell types including all immune cells. Established clinical applications are focused on transplantation of healthy allogeneic donor hematopoietic cells after high-dose chemotherapy for lymphoma, leukemia, and certain immune-deficiency diseases. Recent applications target the use of genetic modifications of autologous HSCs.
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 Technical Standard 20399.
CellGenix® Recombinant Human FMS-like Tyrosine Kinase 3 Ligand (Flt-3L) is a xeno-free and animal-derived component-free product. It reliably supports the proliferation of hematopoietic stem cells (HSCs). CellGenix® rh Flt-3L preclinical grade and GMP grade are both produced in a dedicated animal-free GMP facility.
Flt-3L is a cytokine that regulates proliferation and differentiation of various blood cell progenitors.
Flt-3L is used in the cell and gene therapy space for the ex vivo expansion of HSCs that are used for transplantation.
CellGenix® Recombinant Human Stem Cell Factor (SCF) is a xeno-free and 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 a xeno-free and 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.
CellGenix® Recombinant Human Interleukin-3 (IL-3) is a xeno-free and animal-derived component-free product. It reliably stimulates the proliferation of hematopoietic stem cells (HSCs/CD34+ cells). CellGenix® rh IL-3 preclinical grade and GMP grade are both produced in a dedicated animal-free GMP facility.
IL-3 is a cytokine which acts as a mediator in the body’s natural immune system. It amongst others strengthens the immune response by stimulating the proliferation of HSCs into the major blood cell types. IL-3 is produced primarily by activated T cells.
IL-3 is used in the cell and gene therapy space for the ex vivo expansion of HSCs.
CellGenix® Recombinant Human Interleukin-6 (IL-6) is a xeno-free and animal-derived component-free product. It reliably stimulates the maturation of immature to mature dendritic cells (DCs) and promotes the proliferation of cord blood derived hematopoietic stem cells (HSCs/CD133+ cells). CellGenix® rh IL-6 preclinical grade and GMP grade are both produced in a dedicated animal-free GMP facility.
IL-6 is a multifunctional cytokine that acts both pro-inflammatory and anti-inflammatory. It regulates acute phase responses, inflammatory reactions, hematopoiesis, bone metabolism, cancer progression and immune responses. It is produced primarily by T cells, monocytes and macrophages.
IL-6 is used in the cell and gene therapy space for the ex vivo maturation of immature DCs and proliferation 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.