Pathway three

GMPLEX™ Dedicated GMP Modules

Your own manufacturing environment within GMPLEX™.

Dedicated GMP Modules provide companies with a standalone GMP-ready manufacturing space inside the GMPLEX™ campus. Tenants operate within their own dedicated environment while accessing shared infrastructure, utilities and specialist services across the wider GMPLEX™ platform.

Your module. Your operations. Backed by GMPLEX™.

Dedicated GMP manufacturing module at GMPLEX

What's included

A dedicated module for your operations, supported by the shared backbone of the GMPLEX™ platform.

Dedicated GMP module

A standalone, qualified manufacturing environment reserved for your operations, with controlled access and your own scheduling.

Shared infrastructure

HVAC, purified water, compressed air, power and waste systems maintained and monitored across the GMPLEX™ platform.

Warehousing & cold chain

Ambient and temperature-controlled storage, cold rooms, quarantine and release areas with full traceability.

On-site office suite

Optional administrative suite space so your technical, quality and operations teams can sit alongside the module.

Quality & regulatory support

Access to GMPLEX™ QA/QC systems, validation lifecycle support, documentation control and batch release as required.

Backup capacity

Use of the wider GMPLEX™ platform as a backup house for continuity during maintenance, peaks or qualification work.

Module refers to a GMP manufacturing unit. Suite refers to on-site office space.

Best suited to

  • Companies with recurring manufacturing requirements
  • Established pharmaceutical and biotechnology businesses
  • Businesses requiring greater scheduling and operational control
  • Companies looking to establish Australian manufacturing capability without developing an entire standalone facility

How occupancy works

  1. 01

    Requirements review

    Dosage forms, volumes, containment needs, equipment and headcount.

  2. 02

    Module selection & fit-out

    Match to an available module and agree layout, equipment and utilities.

  3. 03

    Qualification

    Commissioning, qualification and validation aligned to TGA and PIC/S expectations.

  4. 04

    Occupancy & transition

    Team onboarding, SOP alignment, technology transfer and engineering batches.

  5. 05

    Routine operations

    Commercial production, release and ongoing shared-service support.

Ready to establish your own GMP module?

Talk to us about module availability, fit-out requirements and the transition timeline from CDMO or Managed Manufacturing.