Custom Reagent Manufacture
Haematologic Technologies offers manufacturing services to those customers who need a custom solution for their project or assay product. These fall into two categories: complex reagents for use in IVD or Point-of-Care devices or purified, plasma protein those not offered on our menu.
Custom IVD and Point-of-Care reagents – HTI manufactures custom reagents for In-vitro diagnostic (IVD) kits and Point-of-care diagnostic (POC) devices for many recognizable companies. These range from ELISA kit reagents such as capture antibodies and antigen standards to enzymes for the cleavage of fusion proteins to controls on hand-held INR devices for patient monitoring. We can manufacture bulk amounts of plasma proteins and associated antibodies, as well as create custom cocktails of reagents to be used in device-specific chemistries. As an ISO 9000 company we can offer dedicated, quality resources to your project as well as our over 30 years of blood coagulation experience to help you get your product on the market. We can:
- 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
- Perform stability testing on your reagent in our cGMP QC-testing division, Haemtech Biopharma Services.
Some of the more common products that fall into this catagory are human or bovine thrombin, factor Xa, and fibrinogen as well as custom chemistries for POC device strips and chips.
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.