Quality Control
Our highly trained staff with over 10 years of experience in stem cells and research protocols ensure that all treatments and MSC extraction processes are conducted in sterile conditions, using the highest quality culture media and supplements. We have the necessary equipment and protocols to:
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Preserve a large quantity of cells, managing ultra-freezers that surpass -120°C.
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Perform bacteriological assessments throughout all stages of the process.
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Maintain the phenotypic and functional characteristics of the cells during expansion.
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Ensure genomic stability during the in vitro culture period.
Quality control includes:
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Detection of HIV, HBV, HCV, CMV, and Syphilis.
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Mycoplasma determination.
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Microbiological cultures.
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Immunophenotyping by flow cytometry.
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Endotoxin quantification.
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Cytotoxicity studies.
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Oncogenicity assays.
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Class 1000 (ISO 6) laboratory based on the NOM-059-SSA1-2015 biosafety standard.
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Permanent sanitization system.
Donors
We utilize these essential tests and evaluations to identify optimal mesenchymal stem cell (MSC) donors.
These analyses help ensure donor suitability and the quality of the cells obtained for therapeutic use.
SF-36 Questionnaire:
This is used to assess the quality of life and general health status of potential donors, providing valuable information about their physical and emotional well-being.
Laboratory Tests:
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Infectious serology: Determines if the donor has viral or bacterial infections that could compromise the quality of the cells obtained.
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Tumor markers: Help rule out the presence of abnormal cells that could interfere with the therapeutic use of MSCs.
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Routine analysis: Provides a general overview of the donor's health, identifying potential conditions that could affect the suitability of the cells.
Genetic Tests:
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Karyotype and genetic analysis: Detect potential genetic anomalies that could impact the efficacy or safety of the cells obtained.
PCR (Polymerase Chain Reaction):
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Infectious serology, respiratory, mycoplasma, among others: Detect the presence of viral, bacterial, or other pathogenic infections that could compromise the utility of MSCs.
These tests aim to ensure the safety, quality, and efficacy of the mesenchymal stem cells obtained from donors, ensuring they are suitable for therapeutic use in medical and research treatments.
