CENTRE FOR TISSUE ENGINEERING & REGENERATIVE MEDICINE, FACULTY OF MEDICINE
OUR SERVICES
CTERM’s cGMP Facility is certified as an ISO 14644 compliant cleanroom and is re-certified on an annual basis. It has also been audited by the National Pharmaceutical Regulatory Agency (NPRA) and conforms to the requirements of Good Manufacturing Practices (GMP) in accordance to the current Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP Guides and its relevant Annexes.
Clinical Trial & Contract Manufacturing Services
CTERM’s cGMP Facility is capable for the manufacture of human cell and tissue based treatments or products for a variety of clinical trials and projects. The trials involve the in-vitro culture and /or expansions of a variety of cellular therapeutics manufactured to cGMP standards and involve the collection and manipulation within cleanroom suites.
*Disclaimer: CTERM has not been and is currently not producing any cells/stem cells/exosomes for clinical use except for those produced in the
Good Manufacturing Practice (GMP) laobratory. GMP grade cells are distributed to sponsors under the provision of a registered clinical trial with
NMMR or ethics approval from Institutional Review Board / National Review Board or Contract Manufacturing Service Agreement.
Under the Contract Manufacturing Services Programme, CTERM will not be responsible for any misuse or treatment outcome of these products.
For any inquiries about services, email us at: ctermfper@ukm.edu.my
CENTRE FOR TISSUE ENGINEERING AND REGENERATIVE MEDICINE (CTERM)
Admin Office:
15th Floor, Pre-Clinical Building,
Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Kuala Lumpur, MALAYSIA.
Operational Office:
12th Floor, Blok Klinikal HCTM,
Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Kuala Lumpur, MALAYSIA.
Phone: +6 03 9145 6239
Email: ctermfper@ukm.edu.my
VISIT US AT:
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