Stem cell and primary cell cultures are specialized systems, and as such developing and manufacturing media for these systems come with inherent complexities. We strive for excellence in the management of these complexities with the end goal being to provide a comprehensive workflow solution.
In addition to our catalogue media products, we can also precisely cater to customers' specifications with our flexible and scalable manufacturing facilities. We have the unique ability to deliver media in a variety of customized packaging configurations (e.g. bags vs. bottles of different fill volumes) or optimize our media formula to suit our customers' specific application.
Mesenchymal stem cells and mesenchymal stromal cells (MSCs) are the leading adult stem cells in clinical trials due to their immune modulatory properties and multipotent differentiation potential to form cartilage, bone and other cell types. However, because mesenchymal stem cells and mesenchymal stromal cells exist in small populations, the ability to expand these progenitor cells in vitro is a limiting step in utilizing MSCs for cell therapy applications. Using our PRIME-XV brand of validated MSC media and reagents, users are able to maximally expand mesenchymal stem cells and mesenchymal stromal cells derived from human bone marrow, adipose tissue, umbilical cord, and other cell sources in a serum-free cell culture system. As with many of our other PRIME-XV products, Irvine Scientific’s PRIME-XV MSC Expansion Serum-Free Medium and differentiation media are manufactured under cGMP and are designed for research use or further manufacturing applications.
In addition to offering our “off-the-shelf” stem cell media and related products, we can also precisely cater to your specifications with our flexible, scalable manufacturing and custom media services.
PRIME-XV solutions for T cell cultures offer serum-free, xeno-free, chemically defined and animal component-free media solutions to fulfill the potential of T cell applications from research to the clinic. Manufactured to provide an optimal environment during ex-vivo manipulations, PRIME-XV T cell media products have been formulated to deliver improved performance over serum-containing media while maintaining functionality and potency.
The PRIME-XV family of products is designed to simplify the transition to clinical production while adhering to global and regional regulatory standards. Irvine Scientific understands that adherence to a stringent Quality Management System including a robust Raw Material Program are critical to ensure traceability, consistency and reliable performance in supporting immunotherapy applications.
To facilitate clinical applications and scale-up, both PRIME-XV T Cell Expansion XSFM and PRIME-XV T Cell CDM are available for custom formulation and packaging.
Dendritic cells (DCs) are the most potent antigen-presenting cells capable of priming naïve T cells and are therefore essential tools in the activation of immune responses to tumors. They can be generated in vitro from CD14+ peripheral blood or cord blood derived monocytes through a maturation process. It is essential monocyte-derived DCs (Mo-DCs) maintain their functional capacity – the launching of Ag-specific immunity – leading to T cell proliferation and polarization into effector T cells. Serum and undefined components found in animal- or human-derived raw materials can impact this functional capacity. PRIME-XV Dendritic Cell Maturation CDM provides a robust process to generate Mo-DCs in chemically-defined culture conditions thereby maintaining their capacity to induce T cell response.
The PRIME-XV family of products is designed to simplify the transition to clinical production while adhering to global and regional regulatory standards. Irvine Scientific understands that adherence to a stringent Quality Management System including a robust Raw Material Program are critical to ensure traceability, consistency, and reliable performance in supporting immunotherapy applications.
To facilitate clinical applications and scale-up, both PRIME-XV Dendritic Cell Maturation CDM is available for custom formulation and packaging.
Solutions for natural killer (NK) cell culture feature PRIME-XV, a chemically-defined, animal component-free medium to fulfill the potential of NK cell applications from basic and translational research to further manufacturing use. Designed to deliver an optimal environment for ex vivo expansion, PRIME-XV NK Cell CDM has been formulated to provide robust cell growth while maintaining NK cell functionality and potency—without the need for serum supplementation.
The PRIME-XV portfolio of products is specially designed to simplify the transition to further manufacturing use while adhering to global and regional regulatory standards. FUJIFILM Irvine Scientific understands that adherence to a stringent Quality Management System, including a robust Raw Material Program, is critical to ensuring traceability, consistency, and reliable performance in supporting immunotherapy applications.
To facilitate further manufacturing use and scale-up, PRIME-XV NK Cell CDM is available for custom formulation and packaging.
Stem cells obtained from the amniotic fluid have recently become an interesting alternate source of pluripotent stem cells for therapeutic applications. Similar to embryonic stem cells, amniotic fluid stem cells are clonogenic and have the capacity to differentiate into cells of the endoderm, mesoderm and ectoderm lineages. These cells are characterized by their positive expression of Oct4-A, SOX2 and NANOG. PRIME-XV AFSC Expansion Medium is the first commercially available medium specifically designed to expand this small subset of cells in the amniotic fluid.
The ability to expand neural stem / progenitor cells (NPCs) in vitro offers significant potential for their utilization as a cell source for cell therapy applications, as well as a model system for understanding neural development and pathology. Irvine Scientific provides comprehensive solutions for supporting NPC culture, including cell attachment substrates, media, biopreservation solutions, and growth factors.
Cancer initiating / stem cells (CSCs) represent a minority of the tumor cell population and are difficult to eradicate through conventional cancer therapeutic treatments. The ability to destroy CSCs by priming immune intervention represents a novel approach in personalized medicine. Similar to other stem cells, these cells possess self-renewing and differentiation potential. They are characterized by their ability to form tumorspheres in suspension cultures. As part of the PRIME-XV brand of validated cell therapy media, Irvine Scientific provides a serum-free medium designed for maximal enrichment of CSCs from solid tumors.
PRIME-XV Osteogenic Differentiation Serum-Free Medium is manufactured in a GMP environment and made to induce optimal osteogenesis of human mesenchymal stem cells. Osteogenesis in PRIME-XV Osteogenic Differentiation SFM was validated by calcium deposition and expression of RUNX2 and OSTEOCALCIN.
Mesenchymal stem/stromal cells (MSCs) are an important source of cells for maintaining bone homeostasis and bone tissue engineering, partly by their ability to differentiate into osteocytes. While original research on osteocytes suggests that these cells play a passive role, numerous recent studies have found osteocytes to be responsible for modulating osteoclast and osteoblast activities. Efficient osteogenic differentiation is marked by positive alkaline phosphatase activity, an increase in calcium deposition into the extracellular matrix, and expression of RUNX2 and OSTEOCALCIN by osteocytes.
PRIME-XV Adipogenic Differentiation Serum-Free Medium is manufactured under GMP and made to induce optimal adipogenesis of human mesenchymal stem cells. Adipogenesis in PRIME-XV Adipogenic Differentiation SFM was validated by testing for the presence of lipid vacuoles with Oil Red O staining.
PRIME-XV Chondrogenic Differentiation Xeno-Free Serum-Free Medium is manufactured under GMP and made to induce optimal chondrogenesis of human mesenchymal stem cells. Chondrogenesis in PRIME-XV Chondrogenic Differentiation XSFM has been validated by Alcian Blue staining of compact spheroids with expression of cartilage extraceullar matrix.