About Us
Mission
Philosophy
Commitment
About Supergenics
2020, The First Company Listed on BURSA Malaysia
Advanced Licensed EU GMP Stem Cell Production Plant PIC/S CGTP cGMP
• Surveillance contained in the guidance document
and guidelines for the registration of CGTP in Malaysia and PIC/s, Good
Manufacturing Practice Guidelines and Annexes for Pharmaceuticals APB
Cell Therapy Expertise
• Trade Secrets and Patented Technologies
• Human Umbilical Cord Wharton's Jelly Mesenchymal
Stem Cells (Anti-Aging Stem Cells)
• Natural Killer Cells (Immunotherapy)
ISO/IEC Certification, ILAC Standards Malaysia
• ISO/IEC
17025 Testing and Calibration Laboratories on Mesenchymal Stromal
Cell (MSCs)
i. Cell Count
ii. Cell Viability
• ISO 14644 Cleanrooms and Associated Controlled
Environment
![about supergenics, supergenics group photo](assets/img/abount-SG-Big-Group.jpg)
Research and Developments (Publications)
Solid and robust research foundation with international publications
International Standards
International Publications
Cited
Years of Experience
Accredited International Standards & Certified Auditor
![NPRA National Pharmaceutical Regulatory Agency](assets/img/certified/ca-npra.png)
NPRA National Pharmaceutical
Regulatory Agency
![NPRA National Pharmaceutical Regulatory Agency](assets/img/certified/ca-npra1.png)
NPRA National Pharmaceutical
Regulatory Agency
![PIC/S Pharmaceutical Inspection Co-operation Scheme](assets/img/certified/ca-pic_s.png)
PIC/S Pharmaceutical Inspection
Co-operation Scheme
![cGMP current Good Manufacturing Practice](assets/img/certified/ca-cgmp.png)
EU cGMP
current Good Manufacturing Practice
![CGTP Cell and Gene Therapy Products in Malaysia](assets/img/certified/ca-cgtp.png)
CGTP Cell and Gene Therapy
Products in Malaysia
![ISO 14644Cleanroom and Associated Controlled Environment](assets/img/certified/ca-iso-14644.png)
ISO 14644
Cleanroom and Associated
Controlled Environment
![ISO/IEC 17025:2017 Testing and Calibration Laboratories (Registered under ILAC)](assets/img/certified/ca-iso_iec-17025.png)
ISO/IEC 17025:2017
Testing and Calibration Laboratories
(Registered under ILAC)
![ISO/IEC 17025:2017 Mesenchymal Stem Cell Count](assets/img/certified/ca-iso_iec-17025.png)
ISO/IEC 17025:2017
Mesenchymal Stem Cell Count
![ISO/IEC 17025:2017 Mesenchymal Stem Cell Viability](assets/img/certified/ca-iso_iec-17025.png)
ISO/IEC 17025:2017
Mesenchymal Stem Cell Viability
![NEBB National Environmental Balancing Bureau](assets/img/certified/ca-nebb.png)
NEBB National Environmental
Balancing Bureau
![DSM, JSM, SM, Standards Malaysia](assets/img/certified/ca-ilac.png)
Standards Malaysia
REGISTERED
![U.S.FDA U.S. Food and Drug Administration](assets/img/certified/ca-fda-registered.png)
U.S.FDA
U.S. Food and Drug Administration
![AABB Association for the Advancement of Blood and Biotherapies](assets/img/certified/ca-aabb.png)
AABB Association for
the Advancement of
Blood and Biotherapies
SERVICES
– ISO/IEC 17025 –
WHAT IS ISO/IEC 17025 ?
ISO/IEC 17025 is an international standard that sets out the general requirements for the competence, impartiality, and consistent operation of laboratories performing testing and calibration activities. It is applicable to all types of laboratories, including those in the public and private sectors, regardless of their size or field of testing or bration. It is used as a tool to assess and demonstrate the technical competence and reliability of laboratories.
Over the years, ISO/IEC 17025, General requirements for the competence of testing and calibration
laboratories, has become the international reference for testing and calibration laboratories
wanting to demonstrate their capacity to deliver trusted results.
The International Standard, published jointly by ISO and IEC (International Electrotechnical
Commission), contains a set of requirements enabling laboratories to improve their ability to
produce consistently valid results.
![#](assets/img/service/bio-iso17025-05.png)
Over the years, ISO/IEC 17025, General requirements for the competence of testing and calibration
laboratories, has become the international reference for testing and calibration laboratories
wanting to demonstrate their capacity to deliver trusted results.
The International Standard, published jointly by ISO and IEC (International Electrotechnical
Commission), contains a set of requirements enabling laboratories to improve their ability to
produce consistently valid results.
MEASUREMENT UNCERTAINTY
• In the international ISO standards, Measurement Uncertainty (MU) holds significant importance
• Mathematical precision in addressing both statistical and systematic errors
• Crucial in ISO standards to ensure reliable and comparable measurement results
• Enhances the trustworthiness and consistency of measurement data worldwide
![MEASUREMENT UNCERTAINTY](assets/img/service/bio-iso17025-07.png)
• In the international ISO standards, Measurement Uncertainty (MU) holds significant importance
• Mathematical precision in addressing both statistical and systematic errors
• Crucial in ISO standards to ensure reliable and comparable measurement results
• Enhances the trustworthiness and consistency of measurement data worldwide
UNCERTAINTY SOURCE
![UNCERTAINTY SOURCE](assets/img/service/bio-iso17025-08.png)
TRACEABILITY
![TRACEABILITY](assets/img/service/bio-iso17025-09.png)
SUPERGENICS ACCREDITATIONS
Technical Requirements
Our Supergenics lab is equipped with qualified and competent personnel
which have undergone appropriate training to accomplish their testing and calibration tasks
Management System
Our laboratories maintain an organised management system with documented
procedures and quality policies to manage the quality of our findings effectively
Impartiality
We demonstrate impartiality and do not allow any conflicts of interest
such as commercial, financial or other pressuring factors that could compromise the quality or
integrity of our services
Reporting
We provide clear and accurate test or calibration results, including
uncertainty of measurement when relevant, to our clients
Supergenics has achieved ISO/IEC 17025:2017 accreditation for Testing and Calibration Laboratories,
including Mesenchymal Stem Cell Count and Viability. Additionally, they have received approval for four
scopes from Standard Malaysia: Cell Count and Viability, Gram Stain, and Trilineage Differentiation and
Characterization Assay. Their commitment to providing cost-effective, efficient, reliable, and high-quality
solutions and services to customers is evident.
Supergenics, as a trusted partner, ensures optimal product performance through meticulous maintenance
services, underscored by prestigious ISO/IEC 17025 certification from both ILAC and the Department of
Standards Malaysia (JSM) in testing. Within their testing services, Supergenics excels in precise
calibration of Temperature Sensors, RH Sensors, Airflow sensors, and Pressure Sensors, guaranteeing accuracy
and efficiency crucial for various applications.
The ISO/IEC 17025 accreditation from JSM signifies Supergenics' adherence to global standards, ensuring
services of the highest quality and reliability. Their comprehensive offerings include functional testing,
traceable calibration to SI units, and detailed calibration certificates. By choosing Supergenics, customers
align their equipment with internationally recognized standards, backed by SAMM accreditation with ILAC Mark
for precision and quality assurance.
Services of Beautifully Built :
ISO/IEC 17025 Accredited Calibration for Temperature Sensors ISO/IEC 17025 Accredited Calibration for Relative Humidity Sensors Calibration for Airflow Devices Calibration for Differential Pressure Sensors ISO/IEC 17025 Accredited Testing for Controlled Environment Air Temperature ISO/IEC 17025 Accredited Testing for Controlled Environment Relative Humidity Testing for Controlled Environment Airflow Testing for Controlled Environment Differential Pressure
BIOLOGY SERVICES OFFERED :
Comprehensive Stem Cell Characterization Stem Cell for Research, Preclinical and Clinical Applications
Cell Count and Viability
Trilineage Differentiation Assay
Gram Stain Assay
Service Offered of Biology Mechanical :
Comprehensive Stem Cell Characterization Stem Cell for Research, Preclinical and Clinical applications Calibration: Temperature and relative humidity meters Testing: Air temperature and relative humidity for controlled environment
OVERVIEW OF Calibration Services :
Functional testing Calibration traceable to National Metrology Institute Calibration certificate with as-found and as-left results Measurement report with 95% confident level Measurement Uncertainty Provide with correction factor for accurate measurement
Our Testing Services Include :
Measurement results traceable to National Metrology Institute Real time measurement related to the controlled environment Service report with unambiguous data and information
JSM Department of Standard Malaysia
Skim Akreditasi Makaml Malaysia (SAMM)
Skim Akreditasi Makaml Malaysia (SAMM)
![#](assets/img/service/bio-iso17025-13.png)
![#](assets/img/service/bio-iso17025-14.jpg)
![#](assets/img/service/bio-iso17025-15.jpg)
![#](assets/img/service/bio-iso17025-16.jpg)
![#](assets/img/service/bio-iso17025-17.jpg)
– STEM CELL –
Introduction to Stem Cells
Stem cells are undifferentiated cells which have the ability to differentiate into specialised cells with specialised functions. They have the remarkable property of dividing infinitely to replace worn out cells after death. With each division, the new cell has the potential to remain as a stem cell, or to specialise into a cell type, such as blood cells, skin cells and brain cells.
Classification of Stem Cells
Stem cells have different potencies, which refers to the ability of a stem cell to differentiate into more specialised cell types. Cells with greater potency can differentiate into a wider variety of cell types as compared to cells with lower potency. The classifications are as follows: totipotent stem cells, pluripotent stem cells and multipotent stem cells. Totipotent stem cells can give rise to any of the 220 different cell types in the human body, as well as form embryonic stem cells. Pluripotent stem cells can differentiate into any cell type, but don't have the ability to form embryonic stem cells. Multipotent stem cells can develop into a limited number of cell types in a particular lineage, which include ectodermal, endodermal and mesodermal cells.
about mesenchymal stem cells (MSC)
MSC is a type of multipotent stem cell that has the ability to self-renew and to differentiate into a limited number of cell types. The sources of MSC are from the bone marrow, umbilical cord, adipose tissue, dental pulp and peripheral blood.
Why Wharton's Jelly
Wharton's jelly is the main connective tissue found within the umbilical cord and is rich in MSCs, in most instances, mesenchymal stem cells are typically derived from bone marrow tissue using a painful and invasive process for extraction. Wharton’s jelly MSCs are far easier and less invasive to retrieve, and come with many other benefits compared to using MSCs derived from other sources. MSCs are also found in more abundant numbers in Wharton’s jelly compared to other sources, and the cells harvested are younger hence more viable. Aside from its powerful immunomodulatory effects and potent anti-inflammatory effects, it is also able to stimulate angiogenesis, the formation of new blood vessels, as well as having an increased proliferative capacity.
Obtaining Mesenchymal Stem Cells
A process called cell culture is used to grow mesenchymal stem cells under a controlled environment. The umbilical cord is first collected and disinfected, it needs to be incubated and given constant medium changes. Supergenics has developed a new innovative method to further increase the propagation of cells reaching abundant numbers, increasing the efficiency of our lab work. The newly grown cells are then cultured and cryogenically stored, and can be implanted into patients when needed.
Characteristics of Stem Cells
MSCs have several characteristics including low immunogenic properties,
immunosuppression and the ability to exhibit the pacarine effect. MSCs secrete
growth factors and chemokines, which can stimulate angiogenesis and to reorganise
the extracellular matrix in scar areas.
The paracrine effect is a mechanism that allows specialised donor cells to stimulate
the patient's cells to repair diseased tissue, without donor cells directly
contributing to the new tissue. Donor cells, MSCs, are attracted to the cytokines
secreted by damaged cells, and can help to reduce inflammation, promote cell
proliferation and increase vascularisation and blood flow in areas that need to be
healed.
– Mesenchymal stem cell (MSC) –
What is Mesenchymal stem cell (MSC)
MSC is a type of adult multipotent stem cell that exhibit the special characteristics of self-renewal and multilineage differentiation.
Where does Mesenchymal stem cell (MSC) come from?
MSC are found to be original from umbilical cord, bone marrow, adipose tissues,
dental pulp and peripheral blood. In our lab, the MSC will be taken from Wharton's
Jelly which pose great potential in differentiation stage of cell.
Wharton's Jelly (umbilical cord tissue), the main source of our MSC
Wharton's Jelly is rich of mesenchymal stem cell tissue that is widely applied in treating different kind of diseases or conditions as well as regenerating into most of the types of cells actively. MSC derived from Wharton's jelly are the stem cell with strong capacity and readily to differentiate into the required cell type.
The multilineage differentiations allow MSC to become
These cells can become different cell types within the mesodermal lineage, which
includes a wide range of cell types found in connective tissues, bone, cartilage,
and adipose tissue.MSC are considered multipotent, meaning they have the potential
to differentiate into several.
The main causes of aging:
Endothelial
aging
Age increased > endothelial wall stiffens > more fats deposition >
narrowing lumen of blood vessel > hight risk of sub-chronic health conditions
Mitochondria dysfunctions
Age increased > lack of mitochondria > less energy (ATP) generated > lack
of powerhouse > cellular processes disrupted > diseases developed
How does Stem Cell works?
Mechanism of actions, how does MSC helps to repair
damaged cells?
Angiogenesis
Due to endothelial aging, our blood vessels have become rather fragile and stiffen.
Consequently, our body blood circulation will be affected as well as m etabolism
rates. Under this scenario, the angiogenic property of stem cell not just only helps
to repair the blood vessel, it further regenerates new blood vessel. Therefore, the
function of our blood circulation system will be restored.
Mitochondria
Mitochondria is a double-membrane bound organelle that plays important role in
energy generation through aerobic respiration. Adenosine triphosphate (ATP) as the
form of generated energy is essential to carry out cellular biochemical
reactions.
Mitochondria Transfer
MSC acts accordingly to homing effects in which the damaged, aging cells will
release signal to be captured by MSC. Continuously, MITOCHONDRIA TRANSFER will be
carried out to replenish the powerplant of aging cells. This allows aging cells and
tissues to regain their functions.
– Natural killer cell (NK cell) –
What is NK cell ?
Natural killer (NK) cells are a group of innate white blood cell with cytolytic activity against virus-infected cells and physiologically stressed cells like tumor cells. It acts as the frontliner of our immune system to approach the abnormal cells at first. About 10 - 15% of peripheral blood mononuclear cells (PBMC) are consist of this NK cell.
What NK cells does ?
The name 'natural killer' derived from the ability of NK cells that target abnormal
cells without the need for prior activations due to the absence of specific cell
surface receptors on it.
- NK cells able to detect the cytokines released by pathogen-infected cells or
malignantly transformed cell
- This in turn will bind to the activating ligand of NK cells
- Once NK cells activated, cell-mediated cytotoxicity begin
- By producing chemokines and cytokines against the abnormal cells
- Modulating the functions of other immune cells
- Eventually, lead to the lysis of infected cells and malignant cell
This characteristic of NK cells allows it to be widely applied in various
therapies including immunotherapy to fight against cancer and certain viral
diseases.
Are we 'immortal' or 'vulnerable'?
Are these sign and symptoms sound familiar to you?
• Delayed wound healing
• Chronic fatigue: Feels tired even after sufficient hours of sleep
• Digestive issues: constipations, diarrhea, bloating
• Frequent/Recurrent infection: sinus, UTI, ear infections or usually lungs or
viral infections
• Aging
• Highly stressed
• Sedentary lifestyle
• Heavy smokers, Alcoholic
• Long-term exposed to harmful environment (pollutions/hormones)
• Family history of cancer
• Cancer patients or recurrence
A reduced in NK cell activity
• Cancers
Gastric cancer, breast cancer, prostate cancer, pancreatic cancer, colorectal
cancer, lung cancer, liver cancer, ovarian cancer, uterine cervical cancer, blood
cancer, etc.
• Aging and contagious diseases
Herpes zoster, Alzheimer's. senile diseases, human papilloma virus (HPV) infection,
AIDS (HIV) infection, chronic hepatitis, etc.
• Autoimmune Diseases
Diabetes, rheumatoid arthritis, inflammatory bowel disease (IBD), systematic lupus
erythematosus (Lupus), multiple sclerosis, etc.
• Other
Stress, chronic fatigue, anti-aging, etc.
Quick-Fix Solution: NK Immunotherapy
A promising anti-cancer strategy which flexible to be combined with other
conventional cancer therapies such as chemotherapy, radiotherapy, and surgery.
NK Immunotherapy enriches and enhances your own defend system against the enemies.
Autologous Transfer
• Autologous infusion, very low risk of rejection
• Expand the number, activate, and enrich the NK cells
• NK cells do not require genetically engineered
• Specifically targeted on malignant transform cell and virus infected cell
only, greatly minimizing side effects
• An immunity booster, prevent infections, prevent cancers
How NK cells targeted on cancerous cell
NK cells target cancerous cells by recognizing the absence of MHC class I molecules
and the presence of stress-induced ligands or antibodies bound to the cancer cell's
surface.
Sources:
https://blog.codondex.com/2019/09/hope-for-p53-autologous-natural-killer.html
![Illustration depicting how NK cells target cancerous cells by recognizing the absence of MHC class I molecules and the presence of stress-induced ligands or antibodies bound to the cancer cell's surface.](assets/img/service/nk05.png)
How NK cells targeted on virus infected cell
A series of microscopic picture on HIV-1-infected cell killing by NK cells. These
pictures were taken every 5 minutes and lead to the dying of cells.
Source:
https://research.pasteur.fr/en/team/virus-and-immunity/
Green:
HIV-1 infected
cell
Round, arrow pointed:
NK
cell
Blue dye:
Dying
cell
![Illustration representing the interaction of NK cells with virus-infected cells, aiding in the immune response against viral infections.](assets/img/service/nk06.jpg)
Green:
HIV-1 infected cell
Round, arrow pointed:
NK cell
Blue dye:
Dying cell
HIV-1 infected cell
Round, arrow pointed:
NK cell
Blue dye:
Dying cell
– Exosome –
WHAT ARE EXOSOMES ?
Exosomes are extracellular vesicles that contain nucleic acids, proteins, lipids and
metabolites.
They are secreted by cells into the extracellular space where they undergo
intercellular communication.
NUMBER OF EXOSOME PUBLICATIONS
Exosomes, once thought to be just a waste product of cells, is growing rapidly in the industry as one of the most revolutionary discoveries of our time. It has many remarkable properties that allow it to perform various new therapies that have never been previously done.
CLINICAL TRIALS OF EXOSOME
Throughout the years, exosomes derived from human, animal and plants have been
extensively studied. As of 2023, there are currently 191 clinical trials being
conducted on the study of exosomes.
BENEFITS OF USING EXOSOMES
1. Anti-inflammatory effects
• Secrete anti-inflammatory proteins, which promotes cell migration and
proliferation to accelerate wound healing
2. Stimulate collagen synthesis
• Contain growth factors and microRNAs activate fibroblasts
• Fibroblasts are a type of cell that secretes collagen proteins for tissue
repair
• Improve skin firmness and increased elasticity, reducing the appearance of
wrinkles
WHY WE USE EXOSOMES
1. EXOSOMES ARE NON IMMUNOGENIC
• Will not trigger an immune response upon entry to the body
• Lack of immunogenic surface proteins
• Small size, less prone to immune recognition
• Carry immunosuppressive cargo (microRNAs and regulatory proteins)
2. Cell-to-cell communication
• Deliver signaling molecules to and fro specific cells
3. Targeted delivery
• Travel to damaged cells to transfer necessary molecules in areas it is
neede
• Repairing damaged skin cells and treating wounds
• Used in drug delivery
4. Can be stored
• Suitable for long term storage
• Effectiveness of exosome is unaffected
5. Stability
• Very stable substance
6. Non invasive sampling
• Can be isolated from various bodily fluids such as saliva, blood, urine and
cerebrospinal fluid, culture medium
• Easy to obtain
POTENTIAL USE OF EXOSOMES
1. Diagnostic Biomarkers
• Act as early stage disease diagnostic tools
• Exosomes carry specific protein biomarkers specific to the disease
2. Immunotherapy
• Targeted antigen and drug carriers
• Can influence immune-regulation functions of target cells
• Potential cancer vaccines
3. Treatment against diseases
• Researchers are looking into potentially using exosomes to treat
cardiovascular diseases, autoimmune diseases, and neurodegenerative diseases such as
Alzheimers and Parkinsons
APPLICATIONS OF EXOSOMES – COSMETIC USES
1. Anti-Aging
• PIncreased collagen and elastin in human skin 3 days after treatment
2. Reduce Ultraviolet damage
• Cytokines, nucleic acids, proteins, and other bioactive compounds protect
skin and reduce appearance of dark spo
• CProteins and lipids plump and hydrate skin, improving skin texture
3. Minimize Scarring
• Inhibit tissue over-proliferation, which causes scarring
• Improve skin hydration and elasticity, and reduce inflammation
APPLICATIONS OF EXOSOMES – THERAPEUTIC USES
1. Reconstruction of skin flaps
• Promote angiogenesis and wound healing
• Increase survival rate of flap, decrease scarring
• Potential for skin regeneration: increased collagen and elastin
2. Early disease detection
• Exosomes carry disease-specific markers, can be used to detect diseases in
early stages
• Cancer, inflammatory diseases, infections
3. Treating Wounds
• Stimulate cell proliferation, angiogenesis and stimulate collagen
deposition
• Accelerate traumatic wound healing and chronic wound healing
– Mesenchymal Stem Cell Exosomes (Msc Exosome) –