End-to-end pharmaceutical capability, under one roof
From accredited manufacturing to regulated packaging, cold-chain storage and pharmacovigilance, every capability is engineered to protect the patient and serve the customer.
Three ways to manufacture with GMPLEX™
GMPLEX™ gives pharmaceutical and biotechnology companies the flexibility to choose how they manufacture, from fully outsourced production through to their own dedicated GMP environment.
GMPLEX™
CDMO
Outsource your manufacturing to us.
For companies seeking an end-to-end manufacturing partner, GMPLEX™ provides integrated CDMO services spanning development, technology transfer, GMP manufacturing, quality assurance, quality control and batch release.
Best suited to
- Early-stage and emerging pharmaceutical companies
- Clinical and registration batches
- Companies without internal manufacturing capability
- Organisations wanting to avoid investment in their own GMP facility
You bring the product. We manage the manufacturing.
Learn more about GMPLEX™ CDMOGMPLEX™
Managed Manufacturing
Your product. Your expertise. Our GMP infrastructure.
Managed Manufacturing gives companies greater involvement and control while using GMPLEX™ facilities, infrastructure, equipment and specialist support. Your team can work alongside GMPLEX™ personnel, with services such as manufacturing support, QA, QC, equipment access and batch release available as required.
Best suited to
- Companies moving beyond traditional CDMO outsourcing
- Growing production programs
- Businesses wanting greater control over their manufacturing process
- Teams that have technical capability but don't want to build their own GMP facility
More control, without the capital cost of going it alone.
Learn more about GMPLEX™ Managed ManufacturingGMPLEX™
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.
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
Your suite. Your operations. Backed by GMPLEX™.
Learn more about GMPLEX™ Dedicated GMP ModulesCompare the three pathways
A quick guide to the scope, involvement and fit of each manufacturing option.
| Comparison | GMPLEX™ CDMO | GMPLEX™ Managed Manufacturing | GMPLEX™ Dedicated GMP Modules |
|---|---|---|---|
| Scope | End-to-end outsourced manufacturing: development, technology transfer, GMP manufacturing, QA/QC and batch release. | Shared GMPLEX™ infrastructure, equipment and specialist support, with services such as QA, QC and batch release available as required. | Standalone GMP-ready manufacturing space within the GMPLEX™ campus, with access to shared utilities and services. |
| Involvement | Low — GMPLEX™ manages the process | Medium — client team works alongside GMPLEX™ | High — tenant operates its own space |
| Suitability | Early-stage and emerging companies, clinical/registration batches, or organisations without internal manufacturing capability. | Growing production programs and businesses wanting greater control without building their own GMP facility. | Established businesses with recurring manufacturing requirements that need scheduling and operational control. |
| Typical batch stages | Clinical, registration, validation and small-scale commercial batches. | Registration, validation, commercial scale-up and pilot batches. | Commercial, recurring production and routine batch release. |
Involvement is a guide only; every program can be tailored to the partner's needs.
Start where you need. Scale when you're ready.
A company can enter GMPLEX™ as a CDMO customer, transition into Managed Manufacturing as production requirements grow, and ultimately establish its own Dedicated GMP Module.
One platform. Three manufacturing pathways. Built to grow with you.