Every protocol is produced in a current Good Manufacturing Practice cleanroom, tested against release specifications, and traceable from donor screening through patient administration.
Our 15,000 sq ft facility in Mines Wellness City is Southeast Asia's largest licensed cell manufacturing lab, operating under NPRA, PIC/S, and cGMP authority.
No single standard guarantees safety alone. Patients are protected by the overlap.
The same standard applied to pharmaceutical production. Covers facility design, equipment, validation, and quality systems end to end.
Malaysia's Ministry of Health regulator. 23C operates under the same authority that governs the country's medicine supply.
A network of 56 regulators worldwide, including Japan's MHLW and the European Medicines Agency.
Harmonised regulatory format across ASEAN. Documentation aligns with regional submission requirements.
ISO 9001 governs organisational quality processes. ISO 17025 governs testing laboratories — essential for credible release-testing.
International conformity-assessment standard. Affiliated network includes the first CNAS-accredited adult stem cell lab (2011).
Not all cell therapy providers operate at the same quality level.
Regulatory overlap is defence in depth. Each checkpoint exists because an earlier era of medicine learned a costly lesson.
Visit the facility or discuss your specific protocol with our medical team.
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