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.
Four 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™ OUTSOURCE
We manufacture for you.
- GMPLEX operates manufacturing
- High use of shared people and services
- Integrated into shared GMP infrastructure
- Ideal for early stage and clinical manufacturing
GMPLEX™ COLLABORATE
We manufacture with you.
- Shared operations and people
- Dedicated access and gowning
- Collaborative use of equipment and services
- For companies building internal capability
GMPLEX™ OPERATE
You manufacture using our platform.
- You operate your manufacturing environment
- Access to shared infrastructure and services
- Dedicated equipment and workflows
- For established companies scaling operations
GMPLEX™ CONTROL
Your manufacturing environment. Your control. Our infrastructure.
- You control your GMP environment
- Maximum operational independence
- Choose the services you need
- For commercial manufacturers and market leaders
Compare the pathways
A quick guide to the scope, involvement and fit of each manufacturing option.
| Comparison | GMPLEX™ OUTSOURCE | GMPLEX™ COLLABORATE | GMPLEX™ OPERATE | GMPLEX™ CONTROL |
|---|---|---|---|---|
| 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. | Dedicated manufacturing environment operated by the client, with GMPLEX™ Process, Platform infrastructure, utilities and specialist services on demand. | Standalone GMP-ready manufacturing space within the GMPLEX™ Precinct, with access to shared utilities and services. |
| Involvement | LowGMPLEX™ manages the process | MedClient works alongside GMPLEX™ | Med-HighClient operates equipment under GMPLEX™ Process guidelines | HighTenant operates its own space |
| Suitability | Early-stage companies, clinical programs and organisations that need GMP manufacturing without investing in their own facility or team. | Growing programs that need more control over production and quality, while continuing to leverage GMPLEX™ shared systems and support. | Companies with in-house manufacturing expertise that want a dedicated GMPLEX™ module operated by their own team, backed by shared services. | Established businesses with recurring, high-volume manufacturing needs that require a standalone module and full operational autonomy. |
| Typical batch stages | Clinical, registration, validation and small-scale commercial batches. | Registration, validation, commercial scale-up and pilot batches. | Commercial, recurring production and scale-up 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 an OUTSOURCE customer, transition into COLLABORATE as production requirements grow, and ultimately establish its own OPERATE or CONTROL environment.
One platform. Four manufacturing pathways. Built to grow with you.