Workflow stages
Uniogen can support individual phases or provide end-to-end development services, from early-stage design to compliant lifecycle management.
Contact us and let’s find a solution that best suits your needs.
1. Product assessment
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Product status: early-stage to manufacturing
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Availability of protocols, reagents, and materials
2. Development and feasibility
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Technology options: immunochemistry, PCR
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Solid phases: microplates, LF strips
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Detection methods: ELISA, TRF, Upcon, etc.
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Support: conjugation services and instrumentation
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Assay development and consultation services
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Assessment of manufacturing feasibility
3. Production transfer
- Scale-up
- Verification as required
- Validation as required
4. Routine production
- Bulk production
- Filling, capping, sealing
- Quality control testing as required
5. Life-cycle management
- After-sales support
- Stability studies as required
Individual phases or end-to-end development services can be provided in accordance with ISO 13485, as required.