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ABOUT OUR LABORATORY

Our Laboratory

Our laboratory is a research partner of the National University of Malaysia (UKM), a public research university. As such, we comply with and are under strict regulation by the Ministry of Health Malaysia and hold ourselves to high operational standards.

We also hold a Letter of Acceptance from Malaysia’s National Pharmaceutical Regulatory Agency (NPRA), confirming that our laboratory complies with Good Manufacturing Practices (GMP) in accordance to the current Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP Guides.

We are also internationally certified with:

ISO9001 Quality Management System accredited
Cleanroom Compliant certified
Good Manufacturing Practices Resources certified

As such, post-therapy, every patient is given a Certificate of Analysis (CoA) authenticating the Wharton’s jelly mesenchymal stem cells (wjMSCs) and secretomes that the patient has received. The certificate states the:

  • Source,
  • Passage number,
  • Quantity,
  • Barcode I.D.,
  • Thaw time and date, and
  • Certifies that the wjMSCs and secretomes have been screened for syphilis, HIV 1, HIV 2, HIV p24, hepatitis B, hepatitis C, herpes, and leukaemia-causing retroviruses in accordance with the requirements of the International Society for Cellular Therapy.

Our Wharton’s Jelly Mesenchymal Stem Cells (wjMSCs)

We use MSCs that have been extracted from human baby umbilical cords. More specifically from the Wharton’s jelly layer, which is a gelatinous tissue found within the umbilical cord. All our umbilical cords are harvested once a baby is born and with no harm or discomfort to both mother and child.

The harvested umbilical cords are then sent to our laboratory, where they are tested for a host of diseases in accordance with the requirements of the International Society for Cellular Therapy. These tests include:
  • Syphilis (RPR-VDRL),
  • HIV 1 & 2 antibody,
  • Hepatitis B surface antigen (HbsAg),
  • Hepatitis C antibody (Anti-HCV),
  • Herpes (Cytomegalovirus IgM antibody),
  • Leukaemia-causing retroviruses (HTVL 1 & 2 antibody), and
  • HIV p24 antigen.

Only umbilical cords that pass this disease screening stage are approved for future processing. The wjMSCs and its secretomes are then extracted and allowed to expand in culture medium, before they are tested a second time for:

01Bacteria culture,
02Fungal culture, and
03Mycoplasma.

Only wjMSCs and secretomes that pass all the above tests will be cleared to move on to the next stage, which is sub-culturing. Each time the wjMSCs in a culture dish divide and multiply enough to crowd the dish, they are gently removed and plated on several new culture dishes. This process is called sub-culturing. Each cycle of sub-culturing is referred to as a passage.

At Cyrona, we only produce and use Passage 2 wjMSCs and secretomes in all our therapies to ensure that our patients receive the highest quality wjMSCs as well as have the best chance of successful treatment with minimum to no side effects.

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