Our laboratory is governed by different health standards and protocols which comply with all the legal requirements that regulate the obtention and use of cell therapies in the Mexican Republic.
They innovate in quality policies and strict control of their donors, procurement practices, cell expansion, as well as technology within the laboratory, exclusive methods that improve medical care and the satisfaction of all patients.
Due to their sanitary and quality protocols, only authorized and specialized personnel are allowed to enter the laboratory, under mandatory clothing conditions and following good manufacturing practices issued by the WHO.
Inside the laboratory we can find a gray and a white area, these have a curved corner design which prevents dust and particles from being deposited or accumulated, in addition to this, the floor, walls and ceilings have an epoxy coating which provides an antistatic capacity, in addition to a high chemical resistance to humidity, alkalis, acids and contamination by microorganisms.
Both areas are immersed in the positive pressure effect generated through a system that drives the entry of sterile air from outside into the laboratory, which is constantly recirculated through a HEPA filter system.
The laboratory also counts with an incubation area, a space where the stem cell cultures destined for cell therapy, cultures that are in quarantine and cultures in expansion are located, which are protected in model incubators (Labotect C201) that have state-of-the-art technology generation in the field of regenerative medicine.
The Labotect C201 incubators are enabled to maintain the proper control and setting so that our mesenchymal stem cells grow in optimal conditions, coupled with the quality controls to which the cultures are periodically subjected.
In this area there is also an inverted epifluorescence microscope (MOTIC AE31E SERIES), which is essential for monitoring parameters such as morphology, growth and confluence of mesenchymal stem cells in culture.
It is important to mention that the laboratory has a special processing area with highly specialized equipment so that the cells have the corresponding harmlessness. In this area there are class A2 biosafety cabinets (ESCO A2 Air Stream; ESCO A2 Lab-; LABCONOCO A2) which are essential to work our cell cultures since they are designed for the protection of the sample. perform processes such as cell isolation, expansion, preparation of reagents and culture media, training and packaging of cells for cellular therapy.
As well as an automatic cell counter model LUNA II TM Automated Cell Counter, with which the evaluation of cell density is carried out (millions of cells / milliliter), also processes with our subcultures or cell passages such as expansion and evaluation of the viability (% of live and dead cells) of our cells in real time, finally the counting of the number of cells when packaging the vials.
Mesenchymal stem cells are obtained from donors who are selected following very specific and strict acceptance criteria. For a patient to be considered as a candidate, it is required that they be between 19 and 35 years old, do not suffer from any chronic-degenerative disease nor family history of it, are not alcoholic, do not smoke and do not have any infection by HIV 1 and 2, hepatitis B and C, syphilis, chlamydia and SARS CoV2.
After confirming that the donor is suitable, we proceed to collect the tissue for the isolation of the cells, once the process of isolation and primary expansion of the cells has been completed, we submit each batch to an evaluation by means of microbiological analysis and PCR techniques by external laboratories to endorse and guarantee that the cells are mesenchymal and that they are suitable for the application of cellular therapy.