The largest cell culture facility in Southeast Asia, approved by NPRA Malaysia.
23Century.id has its own cell culture and production facilities, which is our main strength. The 23 Century International Life Science Centre (23C) in Malaysia is a research institution with one of the largest cell culture and production facilities in Southeast Asia.
With state-of-the-art equipment, we perform integrated cell culture, processing, and quality control to support the development of regenerative medicine.
Our cell manufacturing laboratory facility, spanning over 15,000 square feet, enables us to manage the entire process, from culture to clinical application.
This facility is approved by the NPRA (National Pharmaceutical Regulatory Agency) of the Ministry of Health Malaysia, operates in accordance with PIC/S standards, and complies with cGMP and cGTPs guidelines.
In addition, because the extensive laboratory facilities allow for the simultaneous execution of multiple projects, we were able to rapidly develop research and clinical applications.
The development of new cell products for difficult-to-treat diseases, as well as process improvements to enhance quality, are examples of how we will soon apply continuously evolving innovations in regenerative medicine in the clinical world.
NPRA is a Malaysian government agency that oversees the manufacturing and quality control of cell therapy products. NPRA provides facility certification based on the "Cell and Gene Therapy Products" guidelines; seeGuidance documentFor details.
23C has obtained this certification and implements a pharmaceutical-grade quality control system, including an aseptic environment and a patented automated cell culture system. We manage the entire process from cell culture to final product and regularly undergo third-party external audits to ensure clinical-grade safety and quality.
Over 20,000 clinical experiences
23Century's strength lies in its extensive clinical experience; to date, we have been involved in over 20,000 cell therapy procedures and collaborated with medical institutions in over 70 countries.
These figures represent more than just the volume of cases. Through a diverse range of cases, we gather valuable scientific evidence (data). In the field of regenerative medicine, accumulating insights into 'efficacy in specific diseases' and 'safety profiles' is paramount.
Drawing upon years of research data, 23Century has established safe and effective treatment protocols.
Global Clinical Network
- Has provided technology to over 70 countries.
- Collaborating with medical institutions worldwide and leveraging the latest research findings
Cell Therapy for Various Diseases
- Used in various conditions such as neurological, cardiovascular, and autoimmune diseases.
- Providing customized stem cell products for each patient based on personalized treatment.
- Leveraging patented technology to develop therapies for diabetes, Parkinson's, liver failure, and other diseases.
Evidence Collection Based on Footprint
- Pursuing evidence of safety and effectiveness based on years of clinical data.
- Continuing research for the standardization of Stem Cell Therapy
- Leveraging patented technology in cancer treatment to drive research and development of novel cell therapies.
For example, for osteoarthritis patients experiencing chronic knee pain, intra-articular administration of Wharton's jelly MSCs can stimulate cartilage tissue regeneration and reduce pain. There are also cases where cellular infusion for spinal cord injuries has demonstrated partial recovery of motor function. (These findings are based on our internal post-treatment monitoring data.)
We also perform allogeneic cell transplantation for neurodegenerative diseases, and reports indicate suppression of symptom progression following multiple administrations.
At 23Century, we provide personalized care for each individual, drawing upon an extensive repository of case data. We integrate historical clinical data with cutting-edge research to devise treatment plans capable of addressing intractable diseases and rare conditions.
International standard quality assurance
The quality of stem cell products directly impacts therapeutic effectiveness and safety. Contamination or subtle alterations to the culture environment can affect outcomes, consequently, cell production requires consistent quality control.
At 23Century, we have implemented a robust quality assurance system, compliant with international standards, to ensure utmost safety and effectiveness.
Production process complies with international standards.
- cGMP-compliant cell production (Current Good Manufacturing Practice)
- A rigorous management system in accordance with cGTPs (Current Good Tissue Practices).
- Leveraging certified/patented technology for culture and cryopreservation to ensure a high-quality supply.
Top-tier cleanroom facility
- The culture environment utilizes Grade A and B cleanrooms.
- Prevent external contamination and produce cells of the highest quality.
- Leveraging patented automated cell culture system technology to ensure consistent quality.
Successfully audited by Malaysia's NPRA (National Pharmaceutical Regulatory Agency)
- Achieving third-party certification and providing clinical-grade cells
- Utilizing over 45 types of clinical-grade raw materials to ensure consistent quality.
We exclusively supply cells of the highest quality, which have undergone rigorous multidimensional quality control assessments. Regarding viability, our processes are managed to consistently exceed the official Malaysian standard (NPRA) of 70%, with an operational target set above 80%.
We observed exceptionally high viability rates and provide fresh cells, ensuring optimal therapeutic efficacy.
Risk management and stringent security measures
In stem cell therapy, patient safety is the paramount concern. Stringent controls are required to ensure that cultured cells meet specified quality standards and remain free from contaminants or genetic alterations.
Additionally, to minimize the risk of adverse effects or immune rejection during treatment, cellular characteristics and the specific indications must be carefully evaluated.
At 23Century, we employ rigorous risk management across all processes—from cell production to patient delivery—to enhance safety.
Ensuring the traceability of all cells
- A 24/7 monitoring system that continuously records cell conditions.
- Accurately tracking which cells are used for each patient.
- Utilizing patented technology for a cell culture process information tracking system.
Implement rigorous quality testing.
- Only final products that pass various pre-shipment inspections are supplied.
- Performing comprehensive impurity, viral, and viability testing.
- Harnessing patented technology for cancer therapy to enhance the safety profile.
Risk assessment based on international standards
- Adhering to PIC/S (Pharmaceutical Inspection Co-operation Scheme) quality standards
- Ensuring adherence to the standards of pharmaceutical regulatory authorities in various countries to guarantee safety.
PIC/S is an organization that establishes international standards to ensure the quality and safety of pharmaceutical products. Currently, over 50 countries and regions, including the EU, US, and Japan, are members, promoting the international standardization of GMP.
The 23Century Culture Facility adheres to PIC/S standards and implements a quality control system comparable to those of global pharmaceutical companies. Our manufacturing process meets international standards, enabling us to provide high-quality stem cell products.
Regarding cGMP and cGTPs
cGMP (Current Good Manufacturing Practice) and cGTPs (Current Good Tissue Practices) are international standards designed to ensure the safety and quality of stem cell products.
cGMP menekankan Quality control throughout the entire production process, whereas cGTPs aims atManagement of quality and safety of cell and tissue products, both of which are important to ensure the reliability of Stem Cell Therapy.
Why are cGMP and cGTPs important?
- Ensuring the security of stem cellsMinimizing the risk of bacterial/viral contamination and maintaining consistent quality.
- Conformity with international standards: Memenuhi persyaratan regulator seperti FDA (AS), EMA (UE), dan NPRA (Malaysia)
- Konsistensi mutu:Rigorous inspection and management to ensure every production lot provides consistent results.
Differences from GMP/GTPs
Penambahan huruf c (current) menunjukkan bahwa standar tersebut memenuhi regulasi terbaru dan praktik terbaik saat ini.
| Nama Standar | Sasaran | Ciri |
|---|---|---|
| GMP | Obat | Old standards that do not always keep up with the latest regulatory changes |
| cGMP | Obat & Produk Sel | Memenuhi standar pengendalian kualitas terbaru |
| GTPs | Tissue & cell products | Outdated standards that are inadequate for cell products |
| cGTPs | Cell & tissue products | The latest standards to ensure the quality and safety of cell products |
In the 23rd century, our production fully adheres to cGMP and cGTPs standards, ensuring international quality.
GMP is a common standard for pharmaceutical production; however, it is not always sufficient for live cell products such as stem cells.
cGMP (Current Good Manufacturing Practice) emphasizes the most current quality controls required to ensure the safety and effectiveness of cellular products.
Therefore, facilities providing Stem Cell Therapy must comply with cGMP.
Stem Cell Therapy is a rapidly evolving field, pioneering new possibilities in medicine. We are committed to pursuing cutting-edge research and development to deliver safe and effective treatments.
We are dedicated to maximizing the potential of stem cells, enabling more individuals to enjoy a healthy and high-quality life. 23Century will continue to advance relentlessly for a better future.