Q. Are PRIME-XV FreezIS and PRIME-XV FreezIS DMSO-Free chemically defined media (CDM)?

A. The formulations of PRIME-XV FreezIS and PRIME-XV FreezIS DMSO-Free are chemically defined. Chemically defined media (CDM) do not contain any undefined animal-derived raw materials and are free of any animal-derived components, including human plasma or human blood-derived components. All raw materials are defined and their exact concentrations are known. This formulation provides reproducible results, traceability, and regulatory compliance.

Q. What grade are the raw materials used in PRIME-XV FreezIS DMSO-Free?

A. PRIME-XV FreezIS DMSO-Free incorporates raw materials of the highest quality available. All incoming raw materials and new vendors are qualified, and the raw material goes through a qualification process to be GMP-compliant.

Q. Is there any known toxicity from the components of PRIME-XV FreezIS DMSO-Free and at which volumes/quantities/administration routes?

A. There is no known toxicity of the cryomedium when tested on cells or in animal models (as seen in the PRIME-XV FreezIS DMSO-Free Cryopreservation Toxicological Non-Clinical Studies in Animal Models Application Note).

Q. Has PRIME-XV FreezIS DMSO-Free been used in clinical trials?

A. PRIME-XV FreezIS DMSO-Free has been used in FDA-authorized clinical trials conducted by Vitro Biopharma.

Q. What is the regulatory status of PRIME-XV FreezIS DMSO-Free?

A. Currently, PRIME-XV FreezIS DMSO-Free is labeled for RUO or further manufacturing use only.

Q. What tests are performed as part of the quality control release testing of PRIME-XV FreezIS DMSO-Free?

A. Each lot of PRIME-XV FreezIS DMSO-Free is validated as part of release testing, and the results are part of the CoA. Each lot is tested for physical appearance, product sterility, pH, osmolality, endotoxins, mycoplasma (USP <63>), and cell function assay. All of these tests must pass in order for the lot to be released for sale.

Q. What primary cell types can be cryopreserved with PRIME-XV FreezIS DMSO-Free?

A. PRIME-XV FreezIS DMSO-Free is recommended mainly for the cryopreservation of human mesenchymal stem/stromal cells (MSCs), hematopoietic stem cells (HSCs), and T cells (PBMC-derived). Other primary cell types can also be cryopreserved with this medium, pending a customer’s own validation.

Q. Can PRIME-XV FreezIS DMSO-free media be used for suspension cells, such as immune cells?

A. Data is available for T cells expanded from fresh PBMCs. Refer to the protocol published from Anemocyte using PRIME-XV FreezIS DMSO-Free and PRIME-XV FreezIS.

Q. Can PRIME-XV FreezIS DMSO-Free be used in the cryopreservation of human hematopoietic stem cells (HSCs)?

A. Yes, CD34⁺ cells isolated from umbilical cord blood have been cryopreserved using this medium as seen in the PRIME-XV FreezIS DMSO-Free product insert and in a recent publication.

Q. Can human mesenchymal stem/stromal cells (MSCs) using PRIME-XV FreezIS DMSO-Free be banked at a higher concentration than 0.5-1x10⁶ cells/mL?

A. The datasheet for PRIME-XV FreezIS DMSO-Free recommends banking MSCs at 0.5-1.0x10⁶ cells/mL. The product was validated based on 0.5-1.0x10⁶ cells/mL. Cryopreservation at higher concentrations requires a customer’s own validation.

Q. What is the starting concentration for T cells to be banked in PRIME-XV FreezIS DMSO-Free cryopreservation medium?

A. A range of T cell concentrations from 2.5x10⁶ cell/mL to 5.0x10⁶ cell/mL have been successfully banked with the cryopreservation media for T cells in the Anemocyte protocol

Q. Can PRIME-XV Cryopreservation media be used for direct freezing (without multiple steps)?

A. It is critical that cells go through a gradual drop in temperature during the cryopreservation process. The recommended protocol includes a two-step approach: (1) slow temperature decreases in a controlled rate freezer or isopropanol container, (2) followed by transfer to liquid nitrogen for long-term storage. Please refer to the PRIME-XV FreezIS product insert and PRIME-XV FreezIS DMSO-Free product insert.

Q. Can this PRIME-XV Cryopreservation media be used for long-term storage of cells at -80°C?

A. PRIME-XV cryopreservation media can be used for both short-term and long-term storage. However, -80°C is only recommended for the short-term storage of cells. For long-term storage, the cryovials should be transferred into liquid nitrogen.

Q. For cells that were preserved in PRIME-XV FreezIS DMSO-Free, is a washing step necessary (for further manufacturing)?

A. T cells (derived from PBMCs) viability and growth are not impacted when cells are thawed directly into the culture medium; therefore, a wash step is not required post-thaw for T cells. For HSCs and MSCs, a wash step post-thaw is recommended.