Cell Therapy Laboratory with Verified High-Viability Standards
Our in-house facility prepares every therapy under controlled conditions and releases each batch only after confirming ≥ 97% cell viability.
Why Cell Viability Is the Core of Effective Therapy
In cellular therapy, what truly determines clinical value is not only the number of cells administered but how many remain alive and functional at the time of infusion. A therapy with lower viability delivers fewer active cells and more cellular debris, reducing consistency and potential effectiveness.
Cell viability represents the proportion of living, metabolically active cells ready to perform their biological functions. Factors such as handling, storage, and transport can compromise viability. For this reason, our laboratory prepares therapies fresh and applies a strict release threshold.
- Minimum release threshold: ≥ 97% viability.
- Testing method: validated viability assays (e.g., trypan blue exclusion and/or flow cytometry).
- Policy: batches not meeting the threshold are not released for administration.
- Dose accuracy: alignment between infused dose and actual active cells.
- Safety: fewer non-viable cells means less cellular debris and inflammatory risk.
High viability is essential, but it is only one of several pillars of quality. Identity, sterility, purity, and potency are equally evaluated under our standards, as detailed in the next section.
Our Laboratory Standards
Quality in cell therapy depends on rigorous control at every stage, not only on viability. Our laboratory operates under strict health authority oversight and applies international best practices in handling and release criteria.
- Regulatory License: authorized by COFEPRIS, Mexico’s national health authority.
- GMP alignment: our infrastructure and procedures follow Good Manufacturing Practice (GMP) standards in design and operation, although we do not hold formal GMP certification.
- Sterility & Safety: every batch is tested for sterility, endotoxins, and mycoplasma before release.
- Identity & Purity: flow cytometry and molecular assays confirm correct cell population and exclude undesired cell types.
- Safety: fewer non-viable cells means less cellular debris and inflammatory risk.
Leaders in the Development of Treatments with Stromal Precursors (Mesenchymal Cells)
At Immunotherapy Regenerative Medicine, we take pride in offering world-class services in Cellular Therapy Protocols and Biomedical Research, standing out in the field of regenerative medicine.
Our laboratory specializes in the personalization of cellular therapy treatments, tailored to the specific needs of each patient. We utilize various sources of mesenchymal stem cells, including Apical Papilla, Placenta, Dental Pulp, Wharton’s Jelly, and Endometrial, to address different medical conditions with precision.
Our team, composed of experienced doctors, biologists, biochemists, and biophysicists, works together using advanced technology and data-driven analysis to optimize treatment outcomes. This personalized approach enhances diagnostic accuracy and treatment effectiveness, reducing complications and improving the quality of life for our patients.
Regulatory Compliance and Certifications
In our commitment to maintaining the highest standards of safety and efficacy, the Regenerative Medicine and Immunotherapy Laboratory is fully licensed and regulated by the Federal Commission for Protection against Health Risks (COFEPRIS). COFEPRIS is the official regulatory body in Mexico, equivalent to the United States Food and Drug Administration (FDA).
Achieving this credential is no small feat. It involves rigorous inspections, exhaustive documentation, and ongoing adherence to the strict quality and safety standards set by the institution. The COFEPRIS certification is a testament to our commitment to providing reliable, safe, and high-quality stem cell therapies for our patients.
Our patients can be assured that they are receiving treatments that comply with and often exceed the strict guidelines established by regulatory authorities. We are committed to maintaining this standard of excellence and continuously improving our practices for the wellbeing of our patients. Your health and safety are our utmost priority, and this guiding principle is reflected in our compliance with COFEPRIS regulations.
Advantages of Our Laboratory
No Cell Freezing
At the Regenerative Medicine and Immunotherapy Laboratory, we ensure maximum cell viability by avoiding freezing during transport, a common practice at other facilities. Our process guarantees a higher ratio of active and quality cells available, significantly enhancing the efficacy of our treatments.
Multidisciplinary Team
Our team consists of experienced physicians, biologists, biochemists, and biophysicists, all specialized in the development of biotechnological products and protocols for biomedical research. Their collective expertise ensures a comprehensive understanding of your needs and the development of the most effective treatment plans.
Personalized Cell Therapy
We recognize that regenerative therapy cannot be encapsulated in a "one-size-fits-all" methodology. Hence, we provide highly specialized cellular solutions, crafted meticulously and personalized to align with your specific health requirements. This bespoke approach amplifies the efficiency of our treatments, ensuring that you benefit from the most suitable, sophisticated, and customized cell regeneration therapy available.
Advantages of Our Laboratory
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