Technology transfers
From first assessment to commercial supply
A structured transfer program, with Technical, Quality, Manufacturing and Supply Chain working to one jointly agreed plan, from feasibility and validation through launch and routine supply.
The transfer pathway
Four stages from initial assessment to routine supply.
Structured to identify requirements early, define clear responsibilities and confirm readiness before progressing to the next stage.
- 01
Technical feasibility & gap assessment
Product and process fit, equipment and batch strategy, analytical requirements, cleaning and containment, packaging requirements, and key regulatory or supply constraints.
Key deliverableA preliminary feasibility assessment: proposed manufacturing approach, key gaps, principal risks and requirements for the next phase.
- 02
Transfer planning & readiness
Transfer scope, responsibilities, documentation, analytical methods, materials, process parameters, training, engineering activities and a risk-based validation strategy.
Key deliverableA jointly agreed transfer plan with defined responsibilities, activities, timing and readiness criteria.
- 03
Qualification, validation & launch readiness
Execute the agreed qualification and validation activities, close identified gaps and confirm documented readiness for commercial manufacturing.
Key deliverableDocumented evidence that the process, equipment, analytical methods and controls are ready for commercial manufacturing and supply.
- 04
Commercial handover & routine supply
Agreed forecasting, material planning, scheduling, release responsibilities, change control, deviation management and regular performance review.
Key deliverableA stable operating model with defined responsibilities, clear demand signals and ongoing review of product and supply performance.
Project governance
One project team. Clear accountability.
Each transfer is managed through a defined project structure that brings Technical, Quality, Manufacturing and Supply Chain together, from the first feasibility review to routine supply.
Agreed with you from the outset
- 01 Functional responsibilities
- 02 Key decisions
- 03 Open risks
- 04 Escalation routes
A successful technology transfer is not simply the handover of documents. We need to understand the process, identify the critical risks and confirm that it can be reproduced reliably in routine manufacturing.
Working with Fujimino Pharma
Start with the product. Define the right transfer approach.
If you are evaluating a manufacturing transfer, we begin with an initial review and then define the scope for feasibility assessment and transfer planning.
A confidentiality agreement can be arranged before technical information is exchanged.
Typical information for an initial review
- Dosage form and current process
- Batch size and annual demand
- Packaging
- Expected supply model
- Target supply timing