Quality Assessment Test (QAT)

Prodia StemCell Indonesia (ProSTEM) is a company specializing in the processing and storage of stem cells, which has actively contributed to advancing regenerative treatment efforts in Indonesia. ProSTEM is experienced in processing cells for degenerative disease therapy, following the standards outlined in the Ministry of Health Regulation of the Republic of Indonesia No. 48 and 50 of 2012. This ensures that the quality of processed and stored stem cells meets the required standards.

In order to ensure the quality of stem cells, progenitor cells, and their derivatives, ProSTEM also provides quality inspection services for these cells and their derivative (Quality Assessment Test). This examination service is conducted by competent laboratory personnel using validated methods to ensure the best results in guaranteeing the quality of cells, stem cells, and their derivatives for regenerative therapy.

Identity, potency, purity, sterility, and stability assessments are critical parameters that must be met as criteria to ensure the quality of cell-based products and their derivatives. Therefore, ProSTEM provides quality assessment testing services for cells and their derivatives as follows :

1. Identification

One way to test identity is by observing specific surface markers of cells. Some of these tests can be conducted at ProSTEM, such as :

• • • hMSC (CD73, CD90, CD105, Lin-)
    • EPC (CD34, CD45, CD133)
    • HSC (CD34, CD45)

The examination is conducted using a flow cytometer device to detect antibody dyes that have adhered to the cell surface.

2. Potential

Potency testing is utilized to ensure that the product possesses inherent biological functions or is capable of inducing therapeutic effects for the intended clinical indications.

• • • Differentiation

One example of potential tests that can be conducted at ProSTEM is the differentiation test of MSC cells into osteocytes, chondrocytes, and adipocytes. Stem cells are cultured with specific differentiation media for 14 days to produce the desired cells. Subsequently, the differentiated cells will undergo specific staining and analysis under a microscope.

• • • Viability

Furthermore, the number of viable cells can indicate the potential of living cells that can be utilized for therapy using an automated cell counter.

3. Purity

Purity testing is utilized to ensure that the product does not contain any unwanted components, such as contaminated cell types or residual process reagents.

• • •   Endotoxin

Uji endotoksin digunakan untuk memastikan produk murni tanpa adanya kontaminan endotoksin yang bersumber dari bakteri Gram-negatif. Pengujian ini dilakukan dengan metode gel-clotting, dimana ketika sampel yang mengandung endotoksin dicampurkan pada tabung reaksi akan menjadi gel.

4. Security

The endotoxin test is utilized to ensure the purity of the product without any endotoxin contaminants originating from Gram-negative bacteria. This testing is conducted using the gel-clotting method, wherein when a sample containing endotoxin is mixed into a reaction tube, it forms a gel.

• • • Mycoplasma

One of the standard bacteria used in cell product testing for quality assessment is mycoplasma, which can cause diseases when injected into humans. At ProSTEM, mycoplasma testing is conducted using an enzymatic reaction from the mycoplasma bacteria, which converts ADP into ATP, subsequently transformed into a ratio and adjusted according to acceptance criteria.

• • • Sterility and Identification of Microorganisms

Sterility testing is necessary to ensure that there are no contaminating microorganisms in a product. This testing is conducted by inoculating samples onto the surface of media such as Tryptic Soy Agar (TSA), which are then incubated for 14 days at appropriate temperatures. If growth is detected on the media, microbial identification is then carried out to the species level.

Potential

• 1. Differentiation test
     • Adipocytes
     • Chondrocytes
     • Osteocytes
  2. Viability
     • Trypan blue method
     • 7AAD Flowcytometry Method
  3. Purity & Security
     • Mycoplasma
     • Endotoxin
     • Sterility test
     • Identify bacteria

The advantages related to the ProSTEM product include:

1. Facilities that have obtained GMP certification and are licensed as stem cell processing laboratories under Minister of Health Regulation No. 50 of 2012.
2. Examination methods that have been nationally validated and adhere to international standards.
3. Qualified personnel.
4. Have collaborated with national and international clinical laboratories.
5. Examination devices that are registered for In Vitro Diagnostic use, such as CD34 examination.
6. Processing and testing of varied sample sources such as bone marrowperipheral blood, umbilical cord blood, umbilical cord, fat, and dental pulp.
7. Proper and prompt sample handling in accordance with Good Laboratory Practices (GLP).