Dendritic Cells (DCs)
Dendritic cells (DCs) are professional antigen-presenting cells (APCs) that are able to sensitize T cells to antigens by ingesting structures such as components of microorganisms and presenting them via MHC class II. DCs play a central role in regulating innate and adaptive immunity through innate recognition of pathogens and activation of the adaptive immune response.
Dendritic cell therapy represents a novel and promising immunotherapeutic approach for the treatment of various cancers. A DC-based cancer vaccine is based on the DC-specific ability of presenting antigens to CD4+ and CD8+ T-cells and thus activating the cell-mediated and humoral adaptive immune system against cancer cells.
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 Granulocyte-Macrophage Colony-Stimulating factor (GM-CSF, also known as CSF2) is an animal-derived component-free product. It reliably supports the differentiation of CD14+ monocytes into mature dendritic cells (DCs). CellGenix® rh GM-CSF preclinical grade and GMP grade are both produced in a dedicated animal-free GMP facility.
GM-CSF is an important hematopoietic growth factor and immune modulator. It is produced by a variety of cell types including; T cells, macrophages, natural killer cells, endothelial cells and fibroblasts. Its’ role is to promote neutrophil proliferation and maturation.
GM-CSF is used in the cell and gene therapy space for its ability to promote DC differentiation and function as well as macrophage activity. It is considered a critical factor for the development of DC therapies.
CellGenix® Recombinant Human Interleukin-4 (IL-4) is an animal-derived component-free product. It reliably stimulates the differentiation of monocytes into dendritic cells (DCs) in combination with GM-CSF. CellGenix® rh Il-4 preclinical grade and GMP grade are both produced in a dedicated animal-free GMP facility.
CellGenix® GMP Recombinant Human IL-4 is the reference standard for USP Chapter <92> and worldwide the first cytokine that complies with this chapter (USP grade).
IL-4 is a cytokine that plays a key regulator role in humoral and adaptive immune responses. It promotes growth and differentiation of B cells, T cells and cells of the monocytic lineage.
IL-4 is used in the cell and gene therapy space in combination with GM-CSF for the ex vivo differentiation of monocytes to immature DCs.
CellGenix® Recombinant Human Tumor Necrosis Factor-alpha (TNF-α) is an animal-derived component-free product. It reliably stimulates the maturation of immature dendritic cells (DCs). CellGenix® rh TNF-α preclinical grade and GMP grade are both produced in a dedicated animal-free GMP facility.
TNF-α is a proinflammatory cytokine that plays a central role in inflammation, immune system development, apoptosis, and lipid metabolism. It is mainly produced by monocytes and macrophages as a response to infection, injury, or tumor burden. TNF-α can also be produced from a range of other cell types such as T cells, natural killer cells (NK cells) and neutrophils.
TNF-α is used in the cell and gene therapy space for the ex vivo maturation of immature DCs.
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 Interleukin-6 (IL-6) is an 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.
CellGenix® Recombinant Human Interferon-gamma (IFN-γ) is an animal-derived component-free product. It promotes the maturation of monocyte-derived dendritic cells (Mo-DCs) and the generation of cytokine induced killer cells (CIK cells). CellGenix® rh IFN-γ preclinical grade is produced in a dedicated animal-free GMP facility ensuring maximum safety for optimal use in ATMP manufacturing.
IFN-γ is a cytokine that is critical for innate and adaptive immunity against viral, some bacterial and protozoal infections. It is the only member of the type II class of interferons and is predominantly produced by natural killer cells (NK cells) and T cells.
IFN-γ is used in the cell and gene therapy space for the ex vivo maturation of Mo-DCs, ex vivo generation of CIK cells and stimulation of monocytes, macrophages and microglia.
CellGenix® Recombinant Human Interleukin-10 (IL-10) is an animal-derived component-free product. It reliably promotes the generation of anti-inflammatory dendritic cells (DCs). CellGenix® rh IL-10 preclinical grade is produced in a dedicated animal-free GMP facility ensuring maximum safety for optimal use in ATMP manufacturing.
IL-10 is an anti-inflammatory cytokine, which is classified as a class-2 cytokine. It amongst others down regulates the expression of T helper 1 cytokines, MHC Class II antigens, and co-stimulatory molecules on macrophages.
IL-10 is used in the cell and gene therapy space to support the generation of anti-inflammatory DCs.
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.