Reagent & Kit Manufacturing
In Vitro Diagnostics (IVD) and Reagent Contract Manufacturing
Reagent components (diluents, standards, controls, calibrators, buffers, and other solutions) manufactured at Affinity or provided by our customers can be filled, sealed, labeled, and packaged per customer requirements. These components may then be used individually or packaged as in vitro diagnostic kits or custom specific kits.
Affinity Life Sciences can also develop and formulate these reagent components in-house according to customer specifications. All processes are fully documented within our Quality System documentation. Our cGMP and ISO compliant facility will meet the strict quality demands of our customers and allows for the production of products in a controlled and documented environment.
cGMP facility located in Amherst, NH offering reagent contract manufacturing and lyophilization services since 2005.
Other Related Services
- Performance Testing of individual components and manufactured kits
- Stability Testing of all assay components
- Process and Product Validation including all necessary documentation for the production of your assay/product
- Assistance in:
- Packaging and labeling
- Package insert preparation
- Distribution
- CE marketing for European Union distribution
How Can We Help?
Please fill out the form below and an Affinity representative will promptly respond to your request.