SERVICES

Good Manufacturing Practice Laboratory (GMP)

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Introduction

Our Good Manufacuring Practice Laboratory is officially Malaysia’s first government-owned GMP facility for Cell and Gene Therapy Products (CGTPs) to achieve a valid GMP compliance status from the National Pharmaceutical Regulatory Agency (NPRA) under the Ministry of Health. This landmark accreditation ensures that our locally produced clinical-grade cell and gene therapy applications meet the highest international safety, quality, and ethical standards set by the NPRA and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guideline.

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Manufacturing Clinical-Grade Therapies

We are dedicated to the production of clinical-grade, high-quality Mesenchymal Stem Cells (MSCs) derived from umbilical cord and bone marrow, which are essential for clinical trials and potential future treatments. Furthermore, we are actively advancing the development and preparation for clinical trials of CAR T-cell therapies.

Quality Commitment

Our commitment to upholding the highest quality standards in manufacturing is non-negotiable, ensuring the safety and efficacy of every product. This involves rigorous adherence to GMP guidelines, encompassing:

  • Meticulous facility design and maintenance.

  • Strict equipment qualification and calibration.

  • Comprehensive personnel training and qualification.

  • Detailed, precise documentation practices.

The GMP Lab is a cornerstone of Malaysia’s effort to establish a safe, regulated pathway for cutting-edge regenerative medicine.

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