NutriFreez® D5 Cryopreservation Solution

The product is designed for cryogenic storage, including short-term storage (e.g. < 1 week) at -80°C and long-term storage in liquid nitrogen at approximately -196 °C.

Yes, a Certificate of Analysis (CoA) is available for each batch. CoAs can be accessed via the Sartorius customer portal on the My Sartorius website (my.sartorius.com) or provided upon request.

No, the formulation is serum-free, protein-free, and free of animal- and human-derived components.

Yes, the product is supplied as a ready-to-use formulation and requires no additional preparation. Cells can be resuspended directly prior to cryopreservation.

Store at 2–8 °C and protect from direct sunlight. Brief exposure to room temperature and light during use is acceptable. The product has a validated 24‑month shelf life when stored as recommended. Typically, it is delivered with at least 12 months remaining. Always check the expiry date on the label before use.

Yes, DMSO is included as a cryoprotective agent. It isavailable in different DMSO concentrations depending on application requirements. NutriFreez® D5 contains an optimized DMSO content of 5% (v/v).

Yes, a Certificate of Origin (CoO) is available for this product. The document can be provided upon request. Please contact your Sartorius representative for further assistance.

Our biopreservation solutions are manufactured under an ISO 13485–certified quality management system with processes aligned to GMP principles. They are chemically defined and free of animal components, with available preclinical safety data supporting evaluation for clinical manufacturing. Final suitability for specific clinical applications remains the user’s responsibility.

The product is suitable for cryopreservation of a broad range of cell types. Suitability should be evaluated for each specific cell type and application. These include, but are not limited to:Stem cells (e.g. MSCs, hESCs, hiPSCs)Primary and immune cells (e.g. PBMCs, T cells, NK cells)Adherent and suspension cell lines (e.g. CHO, HEK293, Vero)Organoids, 3D cultures, tissue samples

Yes. Preclinical animal safety studies have been conducted to support safe use. These included intracutaneous reactivity, dermal sensitization, and single as well as repeated intravenous (IV) administration for up to 14 days. These studies were performed in compliance with GLP and showed no adverse effects under the conditions tested. A summary report is available upon request.

Batch release testing includes, but is not limited to: Sterility, Appearance (visible particulate matter), pH, Osmolality, Endotoxins, and Cell viability (functional performance testing).

Yes, a Drug Master File (DMF) is available. A Letter of Authorization (LoA) can be provided. Request via Sartorius customer portal (my.sartorius.com) or connect your Sartorius representative.

Mycoplasma testing is not part of the standard batch release. In line with USP <1043> and ISO 20399:2022, the product is qualified using a risk-based approach. Its chemically defined, animal component-free composition, combined with controlled manufacturing and sterility testing, minimizes the risk of mycoplasma contamination.

NutriFreez® D5 is a ready‑to‑use, chemically defined cryopreservation solution for long‑term storage of cells and organoids. It is serum free, protein free, and animal/human‑component‑free, enables direct resuspension before freezing, and ensures reliable preservation at −80 °C (≤1 week) or in liquid nitrogen (~−196 °C) for long-term use.