One of Southeast Asia’s Largest NPRA-Certified Cell Culture Facilities
One of our greatest strengths is owning and operating our own stem cell culture and manufacturing facility. Located in Malaysia, the 23 Century International Life Science Centre (23C) is a leading research institution equipped with one of the largest cell culture and manufacturing facilities in Southeast Asia.
With state-of-the-art equipment, we carry out every stage—from culture and processing to quality control—in-house, supporting the advancement of regenerative medicine.
Our facility spans over 15,000 square feet of manufacturing laboratories, allowing us to comprehensively manage the entire process from stem cell culture to clinical application.
It is an NPRA (National Pharmaceutical Regulatory Agency)–certified facility under the Malaysian Ministry of Health, operating as a cGMP- and cGTPs-compliant laboratory in line with the standards of PIC/S, the global pharmaceutical inspection network.
Our spacious lab allows multiple projects to be conducted simultaneously, enabling agile development from research to clinical application.
This capability ensures we can rapidly bring innovations in regenerative medicine—such as the development of new cell products for intractable diseases and process improvements for enhanced quality—into clinical practice.
NPRA is the government agency that oversees the manufacturing and quality control of cell therapy products in Malaysia. It certifies facilities based on the Cell and Gene Therapy Products Guidelines.
We have obtained this certification and established pharmaceutical-grade quality control systems, including sterile environments and patented automated culture systems. Every step from culture to final product is managed in-house to deliver the highest quality cells to patients.
We also regularly pass stringent third-party external audits, ensuring clinical-grade safety and quality.
Over 20,000 Clinical Cases
Our strength lies in our extensive clinical experience. We have been involved in more than 20,000 cell therapy cases worldwide, collaborating with medical institutions in over 70 countries.
This figure is not merely a number of cases—it represents the accumulation of scientific evidence through diverse cases.
In regenerative medicine, building knowledge on “which conditions respond to treatment,” and “whether safety issues exist” is of utmost importance.
Based on years of research data, 23C has established safe and effective treatment protocols.
Global Clinical Network
- Provided technology to medical institutions in over 70 countries
- Collaborate globally to apply the latest research findings
Cell Therapy for a Wide Range of Conditions
- Applicable to neurological, cardiovascular, autoimmune, and many other diseases
- Personalized cell products tailored to each patient
- Patented technologies driving research and development for conditions such as diabetes, Parkinson’s disease, and liver failure
Evidence-Based Achievements
- Pursue safety and efficacy based on long-term clinical data
- Ongoing research toward standardizing stem cell therapy
- Utilizing patented cancer treatment technology to develop new cell therapies
For example, in patients with osteoarthritis and chronic knee pain, intra-articular administration of Wharton’s Jelly stem cells promoted cartilage regeneration and reduced pain. In spinal cord injury patients with paralysis, intravenous stem cell infusions led to partial recovery of motor function. (All outcomes based on our own follow-up data)
We have also undertaken allogeneic stem cell transplants for neurodegenerative diseases, with multiple administrations showing cases of slowed disease progression.
At 23C, we combine rich case data with the latest research to deliver personalized treatments.
Treatment plans are developed to address both intractable and rare conditions, utilizing both past clinical data and the latest innovations.
World-Class Quality Assurance
The quality of stem cell products directly impacts the safety and efficacy of treatment.
Even minimal contamination or environmental variation can influence the outcome, making consistent quality control essential.
23C has established a comprehensive quality assurance system that meets international standards, ensuring the highest safety and efficacy at all times.
Internationally Compliant Manufacturing Processes
- Cell manufacturing in compliance with cGMP (Current Good Manufacturing Practice)
- Strict control under cGTPs (Current Good Tissue Practices)
- Patents in cell culture and cryopreservation technology to ensure consistent quality supply
Top-Level Cleanroom Facilities
- Grade A and B cleanrooms for critical culture operations
- Prevention of external contamination to ensure highest quality cells
- Patented automated cell culture system for consistent product quality
Audited by NPRA
- Third-party certifications for clinical-grade cell products
- Over 45 clinical-grade raw materials used to maintain consistent quality
Only the highest quality cells that pass multiple quality checks are delivered to patients. For cell viability, we consistently exceed the Malaysian guideline requirement of 70%, maintaining over 95% viability.
For example, the most recent batch recorded an exceptionally high viability rate of 98%, delivering fresh cells capable of maximum therapeutic effect.
Rigorous Risk Management and Safety Measures
Ensuring patient safety is paramount in stem cell therapy.
This requires strict management to confirm that cultured cells maintain appropriate quality and are free from contamination or genetic abnormalities.
Cell characteristics and suitability must also be carefully evaluated to minimize risks of side effects or rejection during treatment.
From manufacturing to administration, 23C applies stringent risk management at every stage to maximize safety.
Full Traceability of All Cells
- 24-hour monitoring system with continuous cell condition logging
- Accurate tracking of which cells were administered to which patient
- Patented technology for tracking information in the cell culture process
Strict Quality Testing
- Only final products passing multiple pre-release tests are provided
- Comprehensive impurity testing, virus screening, and viability checks
- Patented cancer treatment technologies to enhance safety
Risk Assessment to International Standards
- Compliance with PIC/S quality standards
- Adherence to global regulatory benchmarks to ensure safety
Donor health and infection status are strictly checked, with confirmation that all donors are negative for major infections such as hepatitis viruses and HIV at the time of donation.
PIC/S is an organization that sets international standards for ensuring the quality and safety of pharmaceuticals. Over 50 countries and regions, including the EU, USA, and Japan, are members, promoting the harmonization of GMP (Good Manufacturing Practice) worldwide.
Our culture facility operates in compliance with PIC/S standards, implementing quality control on par with global pharmaceutical companies. This ensures high-quality stem cell products manufactured through internationally compliant processes.
About cGMP and cGTPs
cGMP (Current Good Manufacturing Practice) and cGTPs (Current Good Tissue Practices) are international standards that ensure the safety and quality of stem cell products.
cGMP focuses on overall quality control in manufacturing, while cGTPs emphasize quality and safety management of stem cell and tissue products—both are essential for ensuring trust in stem cell therapy.
Why cGMP and cGTPs Matter
- Safety: Minimizes risks of bacterial or viral contamination and maintains consistent quality
- International Compliance: Meets regulatory requirements of the FDA (USA), EMA (Europe), NPRA (Malaysia), and others
- Consistency: Ensures the same quality and effect in every manufacturing lot through strict testing and control
Difference from GMP/GTPs
The “c” stands for “current,” indicating compliance with the latest regulatory standards.
| Standard | Target | Features |
|---|---|---|
| GMP | Pharmaceuticals | Older standard; may not reflect the latest regulations |
| cGMP | Pharmaceuticals & Cell Products | Meets the latest quality control standards |
| GTPs | Tissue & Cell Products | Older standard; insufficient for cell products |
| cGTPs | Stem Cell & Tissue Products | Latest standards ensuring cell product quality and safety |
At 23C, we manufacture in full compliance with cGMP and cGTPs to maintain world-class quality.
cGMP incorporates the latest regulations and technologies for strict quality management, essential for ensuring the safety and efficacy of cells.
Facilities providing stem cell therapy must comply with cGMP standards.
Stem cell therapy will continue to evolve as a field that opens new possibilities in medicine.
We are committed to advancing research and technology to provide safe and effective treatments.
By maximizing the potential of stem cells, we aim for a future where more people can live healthier, more fulfilling lives.
We will continue to move forward without pause.