Diagnostic Coagulation Reagent Manufacture
Haematologic Technologies offers research, development and manufacturing of custom reagents for coagulation-based, In-Vitro Diagnostics (IVD) and Point-of-Care (POC) devices. These reagents can be a single, purified clotting factor or antibody, or a complex cocktail of purified proteins for use in device-specific applications.
Custom IVD and Point-of-Care reagents – For decades, HTI has been helping well-known companies in the coagulation field launch IVD/POC solutions into the marketplace. As an ISO 9001 company, we offer dedicated, quality resources to your project as well as our over 30 years of blood coagulation experience. Examples of instruments/diagnostics we create chemistries for:
- Hand-held INR meters/coagulation analyzers (test strip or cartridge chemistries)
- PT/aPTT instruments (bulk or vialed reagents)
- Lab-on-a-chip devices (chip chemistries)
- ELISA kits (capture/detection antibodies, purified protein standards)
We are not just a vendor - we are your partner, and can help you through the entire design of your device.
- Consult with you on the appropriate design of your kit, assay or device
- Discuss reagent and control options
- Manufacture pilot batches
- Optimize and validate your custom reagent
- Offer continual manufacturing support throughout the life of your product
- Efficacy testing on your device or kit
- Perform stability testing on your reagent in our cGMP QC-testing division, Haemtech Biopharma Services.
Custom-purified proteins – HTI has been purifying plasma proteins in the coagulation cascade for 3 decades, and we can use that experience to purify your target protein. Whether it be a coagulation factor from a different species or a new protein from human we will work with you to meet your needs. Some examples include cynomolgus vWF, Porcine factor Xa and Rat prothrombin.
Please contact us about your project today.