Flow cytometry is an advanced cell analysis technique widely used in regenerative medicine, cell biology, and stem cell therapies for phenotypic characterization, identification, and quality control of cell populations. This methodology allows for the rapid, precise, and multiparametric analysis of thousands of cells per second by detecting specific markers present on the cell surface or within the cell.

The principle of flow cytometry is based on the individual passage of cells suspended in a fluid through a laser beam. During this process, monoclonal antibodies labeled with fluorochromes bind to specific proteins expressed on the cell membrane, allowing the identification of molecular expression patterns characteristic of each cell type. Subsequently, the cytometer detectors record the light scattering and fluorescent emission generated by each cell, producing highly precise quantitative and qualitative information.

In the context of regenerative medicine, flow cytometry is an essential tool to confirm the identity and purity of mesenchymal stem cells (MSCs). According to the criteria established by the International Society for Cellular Therapy (ISCT), mesenchymal stem cells must express markers such as CD73, CD90, and CD105, and show negative expression of hematopoietic markers such as CD34, CD45, CD14, CD19, and HLA-DR. This immunophenotypic characterization ensures that the cells used meet international quality and safety standards for clinical and therapeutic applications.

In addition to cell identification, flow cytometry allows for the evaluation of additional parameters such as cell viability, proliferation, apoptosis, differentiation, and immune response. Thanks to this multiparametric capability, it is considered one of the most important technologies for monitoring and validating processes in cell therapy and advanced regenerative medicine laboratories.

The implementation of flow cytometry in quality control protocols provides greater reliability, reproducibility, and traceability in stem cell handling, ensuring that cell therapies are developed under appropriate scientific and regulatory standards. Therefore, it is currently an essential tool in biomedical research and the development of personalized regenerative treatments.

Nanoparticle Tracking Analysis (NTA), also known as nanotracking, is an advanced technology used for the quantification, characterization, and analysis of nanoscale particles, especially extracellular vesicles such as exosomes, microvesicles, and biological nanoparticles. This technique has become a fundamental tool in regenerative medicine and biotechnology due to its ability to provide precise information on the size, concentration, and distribution of particles present in a biological sample.

The principle of NTA is based on the visualization and individual tracking of nanoparticles suspended in a fluid using a laser scattering system and highly sensitive microscopic video capture. Through the analysis of the Brownian motion of each particle, specialized software calculates its hydrodynamic diameter using the Stokes-Einstein equation, allowing for highly accurate determination of the size and concentration profile of the analyzed particles.

In the context of regenerative medicine, NTA plays an essential role in the characterization of exosomes and other extracellular vesicles derived from stem cells. This technology allows verification of critical quality parameters such as the nanometer size range, sample homogeneity, particle concentration and biological stability of extracellular vesicles. Because exosomes act as vehicles of intercellular communication and contain proteins, RNA and bioactive factors related to regenerative processes, their adequate characterization is essential to guarantee safety, reproducibility and therapeutic efficacy.

Furthermore, nanotracking is widely used in biomedical research and cell therapy laboratories to standardize production processes, validate isolation protocols, and monitor the quality of biological products intended for clinical applications. Its ability to analyze individual particles in real time makes it a highly sensitive and accurate tool for studying nanovesicles and advanced biomaterials.

Implementing technologies like NTA within quality control processes strengthens scientific and regulatory standards in regenerative medicine, ensuring better characterization of biological products and contributing to the development of safer, more personalized, and evidence-based therapies.

GMP (Good Manufacturing Practices)

At America Cell Bank we implement GMP (Good Manufacturing Practices) standards to ensure that all processes related to the handling of biological samples are carried out under controlled, safe and standardized conditions.

GMP is an international quality system that ensures the correct receipt, processing, storage and distribution of biological samples, maintaining their integrity, viability, traceability and reliability at each stage of the process.

Our GMP approach includes standardized operating procedures (SOPs), continuous monitoring of storage conditions, document control, equipment maintenance and calibration, ongoing staff training, and strict biosafety and quality control measures.

Implementing these standards allows us to offer high-quality biological samples that are reliable for scientific research, biotechnological development, and clinical applications.

Our mesenchymal stem cells are expanded exclusively to pass 3 (P3), a stage considered optimal for preserving the balance between expansion capacity, viability, and biological function. Working at P3 allows us to obtain an adequate cell count while maintaining essential characteristics such as paracrine activity, immunomodulatory capacity, and phenotypic stability, avoiding the changes associated with prolonged in vitro expansions. Unlike lower passes, where the cell count may be limited, pass 3 offers efficient expansion without compromising biological quality. Furthermore, compared to higher passes, it helps minimize phenomena related to cellular aging, senescence, and decreased regenerative potential. This approach reflects our commitment to cell therapy based on criteria of quality, safety, and preservation of biological potency.

International Society for Cell & Gene Therapy

At America Cell Bank we follow the scientific and technical guidelines established by the ISCT (International Society for Cell & Gene Therapy), a leading international organization in the development of standards for cell therapy, regenerative medicine and biotechnology research.

The ISCT establishes reference criteria for the characterization, processing, expansion, storage and quality control of cell products, promoting the standardization and reproducibility of processes associated with the handling of cells and biological samples.

The society's guidelines include parameters related to cell identity, viability, purity, traceability, biosafety, and quality control, ensuring the integrity and reliability of samples used in research and clinical applications.

Implementing ISCT-based standards strengthens our quality system and ensures that our processes are developed under internationally recognized scientific practices in the field of cell and gene therapy.