
Our products meet the highest standards of quality and safety.
Exosomes are microvesicles or nanovesicles that contain bioactive material from cells (proteins, messenger RNA, growth factors), but they are not living cells, which facilitates their handling and storage.
Sealed and sterile vial packaging, transparent to facilitate visual inspection of the contents, with detailed labeling indicating concentration, volume, expiration date, and specific storage conditions.
Exosomes can be presented mainly in two forms: as a liquid suspension, where they are maintained in buffer or saline solution, or in lyophilized form, a dry material that must be reconstituted with physiological saline or water for injection before use.
The vial volume varies depending on the amount requested; available presentations include 1 mL, 2 mL, 3 mL, 5 mL, 10 mL, and 15 mL. Concentrations can range from 5 to 15 trillion exosomes, according to medical prescription.
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How is the quality and safety of mesenchymal stem cells and exosomes ensured?
The objective of these tests is to ensure that the cellular product is sterile and safe for the patient, preventing the transmission of infections.
What is?
Analysis performed on the conditioned medium to detect the presence and growth of bacteria and fungi, allowing to ensure bacteriological safety.
Importance
It ensures the maximum bacteriological safety. If the mesenchymal stem cells or exosomes were contaminated with microorganisms, they could cause sepsis (severe systemic infection) or a localized infection in the patient.
What is?
Analysis aimed at detecting the presence of lipopolysaccharides (LPS), components of the outer membrane of Gram-negative bacteria, allowing to identify the presence of LPS, pyrogenic agents (capable of generating fever) that can trigger a severe systemic inflammatory response.
Importance
It allows to prevent and identify the presence of endotoxins, even if the bacteria has died, because the LPS are still potent pyrogenic agents (capable of generating fever). When they are found in high concentrations, they can trigger a severe systemic inflammatory response, high fever or, in extreme cases, septic shock in the patient.
What is?
A type of bacteria that lacks a cell wall and can contaminate cell cultures, this test allows to confirm the presence or absence of this microorganism. Its presence can alter metabolism, proliferation and function of mesenchymal stem cell mother cells (MSCs) and exosomes, compromising both therapeutic efficacy and safety.
Importance
It allows to confirm the presence or absence of this microorganism. The contamination by Mycoplasma is difficult to detect using conventional methods, as it does not produce visible turbidity. Its presence can alter metabolism, proliferation and function of mesenchymal stem cell mother cells (CMM) and exosomes, compromising both therapeutic efficacy and safety.