Mesenchymal Stem Cells (MSCs)
Mesenchymal stem cells (MSCs) are multipotent, with the ability to differentiate into a variety of cell types, including osteoblasts, chondrocytes, myocytes and adipocytes. In addition, MSCs can also be recruited to excrete cytokines that help in cell repair, metabolism, and reducing inflammation in response to inflammatory signals. Given this remarkable versatility, MSCs offer great therapeutic potential in the fields of cell–based tissue engineering and regenerative medicine. Because they can generate immune-evasive secretions and immunomodulatory factors these cells have an intrinsic advantage for cell therapy application. Currently, these stem cells are being used for the prevention or treatment of graft versus host disease (GvHD) following allogeneic blood stem cell transplantation. The immunomodulatory properties of MSCs can also be employed in autoimmune diseases like diabetes and Crohn’s disease.
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 Platelet-Derived Growth Factor-BB (PDGF-BB) is a xeno-free and animal-derived component-free product. It reliably supports proliferation of mesenchymal stem cells (MSCs) and chondrocytes. CellGenix® rh PDGF-BB preclinical grade and GMP grade are both produced in a dedicated animal-free GMP facility.
Platelet-derived growth factor-BB (PDGF-BB) is a member of the platelet-derived growth factor family. It is produced by platelets and plays an important role in angiogenesis.
PDGF-BB is used in the cell and gene therapy space for the expansion of bone marrow and adipose tissue derived MSCs and chondrocytes.
CellGenix® Recombinant Human Fibroblast Growth Factor-2 (FGF-2, also known as bFGF) is a xeno-free and 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 a xeno-free and 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 Epidermal Growth Factor (EGF) is a xeno-free and 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.
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.