GMPLEX™
OPERATE
You manufacture using our platform.
GMPLEX™ OPERATE puts your team in the driver's seat. You run your manufacturing environment with dedicated equipment and workflows, while GMPLEX™ maintains the shared GMP infrastructure, utilities, quality systems and specialist services around you.
Operational ownership, without owning the plant.
What's included
A platform model — you own the operation, GMPLEX™ owns the infrastructure and keeps it inspection-ready.
You operate the process
Your trained personnel run production, changeover and in-process activities within qualified GMPLEX™ areas.
Dedicated equipment & workflows
Equipment and process flows assigned to your program, so campaigns run to your schedule without contention.
Shared GMP infrastructure
Utilities, clean utilities, environmental monitoring, waste and engineering support maintained by GMPLEX™.
Quality systems on tap
Operate under GMPLEX™ Process quality systems or bridge to your own, with documentation, deviations and change control supported.
QC testing & release
In-process, release and stability testing available, with batch release by GMPLEX™ or under your own authorisation.
Warehousing & cold chain
Ambient and temperature-controlled storage, quarantine, sampling and dispatch with full traceability.
Best suited to
- Established companies scaling recurring commercial campaigns
- Teams with their own trained manufacturing personnel
- Programs needing dedicated equipment and predictable capacity
- Companies preparing for a fully dedicated GMP module
How engagement works
- 01
Scope & capacity fit
Product, volumes, equipment train and the capacity you need reserved.
- 02
Responsibility matrix
Confirm which activities your team owns and which GMPLEX™ retains.
- 03
Training & qualification
Site induction, SOP alignment and qualification of your operators.
- 04
Technology transfer
Process transfer, engineering and validation batches under GMP.
- 05
You operate at scale
Your team runs routine campaigns with GMPLEX™ infrastructure behind them.
Ready to operate your own line?
Step up from GMPLEX™ COLLABORATE into OPERATE, and move to GMPLEX™ CONTROL when you're ready for full independence.