Factory & Quality

A 700 m² GMP cleanroom dedicated to PCR diagnostics.

Designed around an ISO 5 (Grade A) critical zone within an ISO 7 (Grade C) background — manufacturing under quality systems aligned with SFDA, ISO 9001, ISO 13485 and WHO GMP.

The Facility

Built for the realities of regulated PCR manufacturing

The Gene Matrix facility is purpose-built for in-vitro diagnostic manufacturing, not adapted from a general-purpose laboratory. Every flow — material, personnel, and product — is designed to maintain the integrity of the Grade A critical zone where assay assembly takes place.

Modon Oasis · Jeddah Industrial Zone

Designed and engineered to international PCR-reagent manufacturing standards through a Saudi-Chinese technical partnership — purpose-built for IVD production, not adapted from a general lab.

Take a virtual tour inside
Gene Matrix GMP facility in Jeddah.

Specifications

Facility at a glance

ParameterSpecification
Total facility footprint700 m²
Critical zone classificationISO 5 (Grade A)
Background environmentISO 7 (Grade C)
LocationModon Oasis · Jeddah · KSA
Quality systemISO 9001 · ISO 13485 aligned
Manufacturing standardWHO GMP aligned
Operators in full gowning at a laminar-flow hood inside the Gene Matrix ISO 5 cleanroom.

Equipment

Equipment & process control

Real-time PCR thermocyclers

Validated 96-well systems for assay development, QC and release testing.

Laminar-flow workstations

ISO 5 critical zones for aseptic kit assembly and reagent handling.

Automated extraction & dispensing

Automated workflows for reproducible reagent formulation and filling.

Cold-chain & stability suites

Validated cold-chain storage and an ongoing stability programme for every released lot.

Multi-channel pipette dispensing reagent into a PCR plate.

Capabilities

What we manufacture, in-house

  • Multiplex real-time PCR kit assembly
  • Reagent formulation under controlled environment
  • Lyophilised and liquid format manufacturing
  • In-process quality control and release testing
  • Stability programme and lot-traceability
  • Cold-chain validated storage and dispatch