Technology Development & Transfer
Build the Cell Technology Your Program Needs
Not every organization needs to license an existing therapeutic product. Some need the capability to build their own.
Decinova develops cell and regenerative-medicine technologies around partner requirements, from early research through to defined development and technology-transfer objectives.
The objective is not simply to provide cells. It is to establish a reproducible technology platform that the partner can understand, operate and further develop.
Technology Platforms
Depending on Project Objectives and Feasibility
Stromal-Cell Platform Development
Development of stromal-cell platforms from a defined tissue source — including bone marrow, adipose or Wharton’s Jelly — covering isolation, expansion, characterization, cryopreservation and related process considerations.
Extracellular Vesicle / Exosome Development
Development of EV-related workflows including producer-cell strategy, culture and collection approaches, isolation/purification strategy, characterization and process-development considerations.
Selected Custom Advanced-Therapy Development & Transfer
Assessment, development and technology-transfer support for a limited number of additional advanced-therapy platforms where Decinova’s translational capabilities are directly relevant.
From Protocol to Platform
A Technology-Transfer Project May Include:
Assess
- Intended application
- Product concept
- Facility capabilities
- Scale requirements
- Quality requirements
- Development objective
Develop
- Cell source
- Isolation
- Culture conditions
- Expansion
- Cryopreservation
- Harvest & formulation
Optimize
- Process optimization
- Critical parameter identification
- Robustness and reproducibility
- Scale-appropriate refinement
Characterize
- Identity
- Purity
- Viability
- Phenotype
- Functional characterization
- Potency concepts
- QC strategy
Document
- Process documentation
- SOPs
- Batch documentation concepts
- Analytical procedures
- Technology-transfer package
Train
- Personnel training
- Training materials
- Hands-on process training
- Troubleshooting guidance
Transfer
- On-site or structured remote transfer
- Process implementation
- Engineering runs
- Ongoing technical support as appropriate
Technology Transfer Is More Than a Protocol
A Written Protocol Rarely Captures the Practical Knowledge Required to Reproduce a Biological Process
Successful technology transfer requires understanding which parameters are critical, where variability occurs, what can be modified and what must remain controlled.
Decinova combines documented procedures with practical process knowledge and training to help partners establish robust internal capability.
Custom Development
Your Starting Point Determines the Program
A partner may arrive with:
- An early scientific concept
- An existing laboratory protocol
- A partially developed process
- A technology requiring optimization
- Or simply a defined need for a cell platform that does not yet exist
Decinova structures the development program around that starting point.
The first step is therefore not selecting a standard package. It is defining the technology, intended application and development endpoint.
Build Capability, Not Dependence
Our objective in technology-transfer projects is to leave the partner with more than a supplied biological material. Where project scope allows, the intended outcome is a functioning technology platform supported by process knowledge, documentation and trained personnel.