Our cell-based, clinical-grade products for clinical trials were manufactured in a world-class, state-of-the-art cGMP facility/laboratory. This is the first cGMP laboratory in a Malaysian government institute, specifically designed to cater to human living cells and tissue engineering. The lab was built at a cost of RM10 million and was fully completed in 2012. This cGMP facility is another hallmark achievement in advancing medical technology in the country.

The facility conforms to the requirements of Good Manufacturing Practice (GMP) in accordance with the current Pharmaceutical Inspection Co-operation Scheme (PIC/S) guidelines. It is accredited for processing, constructing, and storing human cells and approved by the National Pharmaceutical Regulatory Agency (NPRA) of the Ministry of Health (MoH).

The facility is divided into three areas based on air cleanliness classification, functionality, and access status: namely the General Area, Unclassified Area, and Classified Area. In terms of grades, they are classified as Grade A, Grade B, Grade C, and Grade D, according to ISO 14644-1:1999 Classification of Air Cleanliness and PIC/S guidelines. In equivalence with ISO, during operation, Grade A corresponds to ISO 5, Grade B to ISO 7, and Grade C to ISO 8, whereas Grade D is not defined.

Air pressure and particle counts are strictly controlled and monitored to ensure the safety of our products. Cleaning and environmental monitoring are carried out during operation and even at rest (when no operations are ongoing), on a quarterly basis.

Personnel and material flow is unidirectional and strictly controlled with keylocks, digilocks, and/or access cards. Communication between operators in different parts of the facility is facilitated through 16 intercoms. The facility is also equipped with 15 CCTV cameras to monitor different areas of the cleanrooms.

A Building Monitoring System (BMS) is in place to control air pressure, relative humidity, and temperature. In addition, an Equipment Monitoring System (EMS), which is a wireless, expandable, primary monitoring system, is in place to monitor all critical equipment in the facility. Environmental parameters are recorded constantly, and any deviation triggers alarm notifications.

CTT is also equipped with a general R&D laboratory for research and development and for producing research-grade products. The facility is also used for one-to-one, hands-on training in basic cell culture techniques.