High-quality biological products for clinical application.

At America Cell Bank we have a biobank developed under international standards, designed to guarantee the quality, safety and traceability of biological products intended for clinical practice.

We integrate specialized infrastructure, standardized processes, and a highly qualified team to offer reliable, safe, and applicable solutions in demanding medical environments.

Features of our biobank

Infrastructure and controlled processing

Cellular products are processed in cleanrooms designed under international environmental control standards, which guarantee an environment with defined levels of viable and non-viable particles, minimizing the risk of contamination.

These areas include:

HEPA filtration systems and differential pressure control, which ensure a clean and unidirectional airflow.
Continuous monitoring of critical parameters such as particles, temperature, humidity and microbiological load.
Certification and periodic auditing of air quality, including external controls, that validate the efficiency of the environmental cleaning system.

Within these areas, processing takes place in biosafety cabinets, designed to provide a sterile working environment through

a unidirectional airflow filtered through HEPA systems.

These booths guarantee the simultaneous protection of the product, the operator and the environment, by containing aerosols and preventing cross-contamination during the handling of biological material.

Its use is fundamental in cell isolation, expansion and preparation processes, ensuring aseptic conditions and compliance with biosafety standards in controlled environments (GMP and FDA).

Environmental control and biosecurity

Strict cleaning and disinfection protocols are implemented for surfaces, equipment, and critical areas, using validated agents and standardized procedures (GMP and FDA). Environmental control includes: microbiological monitoring programs, validation of cleaning processes, and controlled access for personnel and materials through airlocks and separate flows.

Air quality is a critical factor in a biobank, as it directly impacts the safety, viability, and stability of biological products. A controlled environment reduces the risk of contamination and ensures the reproducibility of cellular processes. ACB Biobank has a monthly air quality certificate audited by an external company.

Personal especializado

America Cell Bank has been working in laboratory settings since 2012. Continuous training and ongoing team updates allow for the incorporation of technological advancements and recent scientific evidence, ensuring optimized, reproducible processes that align with current trends in the biotechnology and regenerative medicine sectors.

Their cross-cutting participation in each stage of the process (from obtaining and handling biological samples to characterizing and releasing the product) guarantees compliance with rigorous scientific, technical and clinical standards, aligned with good laboratory practices (GLP) and, where applicable, good manufacturing practices (GMP).

Control and traceability

We implemented a comprehensive control and traceability system that allows for complete, documented, and verifiable tracking of each biological product throughout its entire life cycle.

Processing under controlled conditions, in regulated environments and validated critical parameters.
Cold chain storage with continuous monitoring, recording systems and control of critical variables (temperature, time and storage conditions).
Distribution under specialized logistics, with comprehensive tracking and transport control to guarantee product stability.

Each phase of the process is monitored and documented using quality management systems, allowing for bidirectional traceability, reproducibility of procedures, and compliance with regulatory standards, thus ensuring the safety, consistency, and reliability of the final product.

Analytical control and characterization

Cellular products are evaluated using advanced technologies that guarantee their identity, purity, and functionality:

Flow cytometry: This is the technique used for cellular phenotypic characterization by detecting specific markers (such as CD73, CD90, CD105), ensuring the identity of mesenchymal stem cells.
Nanoparticle Tracking Analysis (NTA) Nanotracking: Technology used for the quantification and characterization of extracellular vesicles (such as exosomes), allowing the measurement of size, concentration and distribution of particles at the nanometric scale.

Products from our biobank

Mesenchymal stem cells

Neonatal MSCs with high proliferation and advanced regenerative action, which promote modulation of the tissue microenvironment and cellular repair

Exosomes

MSC-derived exosomes, obtained under controlled conditions, with high purity and capacity to modulate inflammatory and regenerative processes

Peptides