In-House Stem Cell & Cellular Biotechnology Laboratory
From Cell Preparation to Clinical Use, Quality Controlled Under One Integrated System
At Immunotherapy Regenerative Medicine, our cellular therapies begin within our own laboratory. By integrating mesenchymal stem cell (MSC) research, preparation, quality control, release, and clinical coordination within the same organization, we maintain direct oversight throughout the process.
Every MSC preparation must meet predefined quality criteria before being released for physician-led administration. This includes confirmation of ≥98% live-cell viability at release, together with separate controls for identity, purity, sterility, and dose verification.
- ≥98% Viability at Release: Every MSC preparation must meet our predefined live-cell viability threshold before clinical release.
- In-House Quality Control: Cell preparation, quality assessment, documentation, and clinical coordination operate within one integrated system.
- End-to-End Traceability: Each preparation receives a unique lot code connecting laboratory processing and quality-control records with the patient's clinical documentation.
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- Patients from 12 + countries
Why Mesenchymal Stem Cell Viability at Release Matters
With cellular therapy, what matters is not simply how many cells were cultured; it is the quality of the preparation when it is ready for clinical use.
Viability represents the proportion of living cells present in a preparation. Because handling conditions, time, and temperature can influence cellular integrity, our laboratory evaluates MSC viability at the release stage using validated assays, including flow-cytometry viability gating when appropriate.
We clear a preparation only when it meets our predefined release specifications, including a ≥98% live-cell viability threshold. Preparations outside established specifications are not released for administration.
Viability, however, represents only one component of cellular quality. Identity, purity, sterility, safety, and dose verification are evaluated independently within our quality-control framework.
Measured at Release
Viability is assessed close to clinical release rather than relying solely on measurements obtained earlier during cell preparation.
Non-Release Policy
Preparations that do not meet predefined quality specifications are not cleared for physician-led administration.
Live-Cell Dose Verification
The intended treatment dose is checked against the quantified live-cell content before release.
Stem Cell Laboratory Quality & Release Standards
Four Controls Before Clinical Release
Quality control is integrated into every MSC preparation. Before physician-led administration, each preparation undergoes defined release controls designed to confirm that the cellular product meets our established specifications.
Identity & Purity
We evaluate cellular identity and purity according to established internal acceptance criteria, including relevant MSC-associated markers. These controls help confirm that the preparation corresponds to the intended stromal cell population, with results documented within the applicable clinical and laboratory records.
Sterility, Endotoxin & Mycoplasma
Each batch undergoes sterility testing, endotoxin review against established limits, and mycoplasma screening. Preparations that fall outside defined specifications are not released for clinical use.
Dose Verification
Before release, the intended clinical dose is verified against the quantified live-cell content, connecting laboratory measurement with the physician-directed treatment protocol.
Documentation & Patient Traceability
Every preparation receives a unique lot code linked to its processing and quality-control documentation. Records are maintained under established SOPs and connected with the patient’s clinical documentation. Patients may also request a Viability Certificate reporting the live-cell value measured at release.
Mesenchymal Stem Cell Sources & Preparation
Multiple Validated Tissue Sources. One Controlled Preparation Framework.
Our in-house laboratory cultures and prepares mesenchymal stem cells (MSCs) from validated tissue sources according to the requirements of our cellular preparation framework. Current sources include apical papilla, placenta, dental pulp, Wharton’s jelly, endometrial tissue, adipose tissue, and periodontal ligament.
Rather than presenting one cell source as universally appropriate, cellular preparations are integrated according to the physician-directed protocol and applicable laboratory specifications.
Regardless of source, each MSC preparation must complete the corresponding identity, purity, viability, and safety controls before being cleared for clinical use.
COFEPRIS-Licensed Stem Cell Laboratory in Mexico
Regulatory Oversight Meets In-House Quality Control
Our cellular laboratory operates under COFEPRIS authorization and maintains documented quality-assurance systems governing the preparation and release of MSC-based cellular products. The website currently identifies Immunotherapy’s regenerative medicine authorization as License No. 25 TR 14 067 0001, Ref. 253300CT040763.
Every preparation is evaluated according to predefined quality criteria before clinical release, including viability, cellular identity, and sterility controls. By integrating laboratory operations with physician-led care, we maintain a direct connection between the cell preparation, quality documentation, treatment protocol, and the patient receiving the therapy.
Advantages of Our In-House Stem Cell Laboratory
The principal differentiator here should be control of the complete process, rather than simply saying that Immunotherapy has a laboratory.
