T cells play a central role in cell-mediated immunity and immunotherapy based on these powerful cells is a rapidly growing field with promising results. Current therapies use one of four technologies to confer therapeutic benefit: chimeric antigen receptor (CAR) bearing T cells, tumor-infiltrating lymphocytes (TILs), regulatory T cells (Treg) and T cell receptor (TCR) engineered T cells. There are currently five approved chimeric antigen receptor (CAR) T cell therapies, and one T cell receptor (TCR) therapy. These treatments take advantage of the killing function of the T cells, engineering them to recognize antigens on the surface of cancer cells. While the first T cell therapies target “liquid” cancers such as lymphomas and leukemias, the first treatment for a solid tumor was recently approved and hundreds of clinical trials are underway. Trailblazing work is being done to expand the diseases that may be treated with T cell-based therapies including chronic infection and autoimmunity.
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 Interleukin-2 (IL-2) is an animal-derived component-free product. It reliably activates and expands T cells, natural killer cells (NK cells) and cytokine-induced killer cells (CIK cells). CellGenix® rh IL-2 preclinical grade and GMP grade are both produced in a dedicated animal-free GMP facility.
IL-2 is a cytokine signaling molecule that is mainly produced by T cells. It is a central regulator of immune responses and plays a role in anti-inflammatory reactions, hematopoiesis and tumor surveillance.
IL-2 is used in the cell and gene therapy space to promote proliferation and differentiation of CAR T cells, TCR T cells, Tregs, TILs, NK cells and CIK cells.
CellGenix® Recombinant Human Interleukin-7 (IL-7) is an animal-derived component-free product. It supports the survival, proliferation and differentiation of T cells and enhances survival of natural killer cells (NK cells). CellGenix® rh IL-7 preclinical grade and GMP grade are both produced in a dedicated animal-free GMP facility.
IL-7 is a cytokine that promotes the differentiation of pluripotent hematopoietic stem cells (HSCs) into lymphoid progenitor cells. Furthermore, it supports proliferation of various cells in the lymphoid lineage (B cells, T cells and NK cells). It is secreted mainly by stromal cells in the bone marrow and thymus.
IL-7 is used in the cell and gene therapy space for the ex vivo expansion of genetically modified T cells, such as CAR T cells, and differentiation of induced pluripotent stem cells (iPSCs) into T cells. It is in addition used to differentiate cord blood derived hematopoietic stem cells (HSCs/CD34+) into NK cells.
CellGenix® Recombinant Human Interleukin-15 (IL-15) is an animal-derived component-free product. It promotes the proliferation of T cells and stimulates the proliferation of natural killer cells (NK cells) as well as the generation of cytokine-induced killer cells (CIK cells). CellGenix® rh IL-15 preclinical grade and GMP grade are both produced in a dedicated animal-free GMP facility.
IL-15 is a cytokine that plays an important role in humoral and adaptive immune responses. It induces or enhances the differentiation, maintenance, or activation of NK cells and multiple T cell subsets. IL-15 is produced by a large number of cell types, including monocytes, macrophages, dendritic cells, keratinocytes, fibroblasts and nerve cells.
IL-15 is used in the cell and gene therapy space for the ex vivo expansion of various T cells (CAR T cells, TCR T cells and TILs) as well as NK cells and the generation of CIK cells.
CellGenix® Recombinant Human Interleukin-21 (IL-21) is an animal-derived component-free product. It reliably promotes the proliferation of T cells and natural killer cells (NK cells) and enhances their cytotoxic function. CellGenix® rh IL-21 preclinical grade and GMP grade are both produced in a dedicated animal-free GMP facility.
IL-21 is a cytokine that plays an important role in humoral and adaptive immune responses. It stimulates the proliferation of NK cells and multiple T cell subsets, especially cytotoxic T cells. It is produced by activated CD4+ T helper cells and NK T cells.
IL-21 is used in the cell and gene therapy space for the ex vivo expansion of T cells, including CAR T cells and TCR T cells and NK cells.
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.
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.