Cone Bioproducts
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Custom Control Manufacturing
FromCone Bioproducts
We meet the needs of In Vitro Diagnostic manufacturers as well as end users with our custom manufactured controls. We utilize our reliable base matrices and are able to achieve flexibility for a wide range of analytes.
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Advantages of a manufacturing partnership with us include:
Strategic flexibility
Iterate and prototype more of your own products with time saved manufacturing
Agile response times
Begin your pilot production quickly with short lead times on custom material
Free up internal resources
Devote more of your manufacturing resources to critical tasks
Design
- Safety and effectiveness of product
- Basematrix selection
- Analyte and Target Levels, # of Levels, Stabilizers, Packaging
- Form: Liquid or Lyophilized
Pilot Production
- 1st Pilot – Confirm specifications achievable
- 2nd Pilot – Use approved manufacturing instructions, Duplicate 1st Pilot
- 3rd Pilot – Bulk Lot
Regulatory Submission
- 510K/CE Mark Approval sought as needed
- Compile data from 3 Pilots and submit for approval
Bulk Production
- Continued performance testing including real-time stability
Change RequestDetermine if change is:
- Feasible
- Requires design changes
- Validated in pilot production
- Requires new regulatory submission
- Approval by customer