Building a Modern, International-Standard Mescells Institute of Applied Cell Technology Research

The MESCELLS Institute of Applied Cell Technology Research is one of the first private organizations in Vietnam licensed by the Ministry of Science and Technology to conduct research on cell technology applied in regenerative medicine. Alongside its scientific research mission, the MESCELLS Institute is a pioneer in international cooperation, receiving transfers of advanced cell technology from leading countries in the field such as Japan and the United States. With a modern laboratory system built to GMP – WHO standards, the MESCELLS Institute aims to research, develop and bring the world’s most advanced cell technology achievements to the people of Vietnam.

GMP (Good Manufacturing Practices) is a system of regulations or guidelines ensuring that a manufacturer consistently produces products that meet their registered quality and are safe for users. According to the Ministry of Health, GMP is mandatory for all fields that manufacture or process products requiring high standards of hygiene and safety, such as pharmaceuticals, food, cosmetics and medical devices… including cell products used in treating disease. GMP helps ensure that products are manufactured consistently and controlled to standards appropriate to their intended use and to the requirements of the marketing authorization, while minimizing risks that cannot be controlled by testing alone, such as cross-contamination and mix-ups.

The laboratory at the MESCELLS Institute operates in strict compliance with the GMP guidelines issued by the World Health Organization (WHO good manufacturing practices for biological products, Annex 2, TRS No 999 – 2016), covering requirements for facilities, control of the working environment, personnel, and control of the collection, processing, culture, storage-preservation and distribution of cell products.

1. Facilities and working environment

The MESCELLS Institute’s laboratory system is divided into areas of different cleanliness grades, including the cell culture and production room, the quality control room, the product storage room and other ancillary areas (technical area, biological sample reception area, product dispatch area). Air in all rooms is controlled by an AHU (Air Handling Unit) system using several filtration stages – pre-filtration, secondary filtration and HEPA filtration – able to remove extremely small contaminants (dust, bacteria…) of 0.3 micron. The rooms are designed with positive pressure at different pressure levels to prevent air flowing from dirtier areas into clean areas. The AHU system also controls temperature and humidity, keeping conditions stable over time. The MESCELLS Institute’s laboratory has received ISO 14644-1:2015 certification, meeting the standards for cleanroom design, construction and operation.

2. Equipment

With the goal of building an international-standard scientific research institute, the MESCELLS Institute has invested in modern equipment made by reputable manufacturers worldwide and certified to quality management standards. Notable items include:

2.1. CelCulture® CO2 Incubator by Esco

This incubator is widely used in cell-related laboratories. It has a ULPA filter system and a heat sterilization function validated by the UK Health Protection Agency, and can regulate temperature and gas flow precisely.

2.2. Airstream® Class II Biological Safety Cabinet by Esco

The cabinet is where technicians handle cells. It is a standard-size unit with three protective functions – protecting the biological sample, the user and the environment – and meets the European standard EN12469.

2.3. ECLIPSE Ts2 inverted microscope by Nikon

The instrument uses the CFI60 optical system, the most advanced in the world, providing clear images at every magnification. In addition, phase-contrast observation makes cell images sharper and more vivid.

2.4. FACSCanto™ II flow cytometry system by BD Biosciences

BD Biosciences has more than 35 years of experience and is a leader in developing cell analysis systems. Its FACSCanto™ II is an outstanding system that is easy to operate while delivering accurate, high-quality analytical results.

2.5. QuantStudio 5 real-time PCR system by ABI

The instrument is used to detect and quantify target nucleic acid sequences based on PCR (polymerase chain reaction) and fluorescence signals. At the MESCELLS Institute, it is used to detect the presence of mycoplasma in cell products, to study the expression of functional genes in cell activity, and for a number of other applications.

2.6. Lexicon® Ultra-low Temperature Freezer by Esco

The freezer is built from proven high-quality components with an energy-efficient cooling design, and can protect cell samples for long periods while preserving their integrity. The product complies with the ANSI/ASHRAE 72-2005 and ARI 1200-2006/2008 standards and has been verified by three different laboratories of Underwriters Laboratories (UL).

2.7. MVE XC 47/11-10 liquid nitrogen storage tank by Chart

The tank is used to keep cell samples in liquid nitrogen for long periods under static conditions, with capacity for a large number of biological samples (1,050 cell vials). Made from durable, lightweight materials and using vacuum technology, it holds liquid nitrogen for a long time with little evaporation.

3. Quality system

In routine operations, quality control (QC) and quality assurance (QA) procedures are established to build a quality system that assures the collection, processing, storage and distribution of cell products for therapy. For cell products and their derivatives to be used in clinical research and treatment protocols, they must undergo rigorous quality control, including endotoxin testing, mycoplasma testing, sterility testing, and checks of chromosomal integrity and cell characteristics. This process ensures the maximum efficacy and safety of biological products for human use. In addition, the work of researchers and technicians is closely supervised to prevent contamination and cross-contamination between different biological samples.

4. Personnel

Members of the MESCELLS Institute have a solid grounding in cell technology, having trained in this specialty at reputable universities; most hold postgraduate degrees and therefore have professional research and laboratory skills. Before taking part in production, all personnel are comprehensively tested and assessed against criteria of qualifications, health (free of infectious diseases) and discipline. Furthermore, once they become permanent staff, the Institute’s researchers and technicians receive additional skills training and regular health checks, and take part in academic exchange sessions to deepen their knowledge.

With facilities and operating policies built to GMP – WHO standards, the MESCELLS Institute is confident in its capacity for scientific research and for applying the achievements of cell technology research in practical medicine.