Plasma & Serum Diluents & Derivatives
Human Blood Fractions
SeraCare offers a number of key components for use in assay production, including purified blood-based proteins derived from human and bovine sources. These purified proteins are suitable for use in controls, calibrators, diluents, and buffer formulations. The human blood fractions, including human serum albumin and human gamma globulin, are available in powder and liquid formats. These materials are readily available to drive your assay development and production.
Human Serum Albumin (HSA)
Suitable for use in IVD diagnostic reagents or cell culture applications, SeraCare’s HSA is manufactured in a cGMP, FDA?registered, and ISO 13485-certified facility. HSA powders are diagnostic?grade, soluble, off?white, and of ultra?high purity. They are processed according to Cohn fractionation techniques from plasma collected in US?licensed or EU?accredited facilities.
- Manufactured from plasma that has been tested and found negative by FDA-approved methods for required viral markers
- Available in a variety of concentrations (5%, 20%, 25%, and 30%) with a purity of ≥ 96% and bioburden of ≤ 10 cfu/mL
- Materials can be custom-manufactured to meet your specifications
Human Gamma Globulin (HGG)
SeraCare’s HGG products are isolated from pooled plasma collected at FDA?licensed facilities and tested using FDA?approved methods. They’re well?suited for use as diluents in the design of IVD test kit controls and calibrators, or for use in research products.
- Manufactured from human plasma that has been tested and found negative by FDA-approved methods for required viral markers
- Features purity of ≥ 96% and bioburden of < 10 cfu/mL
For research use only, not for use in diagnostic procedures.