Description
Donor horse serum (DHS) is defined as the liquid fraction of clotted blood derived from horses from a closed, controlled standing herd that is under veterinary supervision and routinely monitored for various equine diseases. DHS can be used for various cell culture and immunochemical assays and is used to product antitoxins to a variety of diseases.
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Sera Processing
Using industry leading techniques, blood is aseptically collected from a closed, controlled standing herd, serum is then isolated from the red blood cells and immediately frozen for testing and further processing. The raw sera is then true pooled and is 0.2 micron sterile filtered with a Sterility Assurance Level (SAL) of 10-3. Every lot then must pass USP <,71>, sterility testing and test negative for mycoplasma and number of industry-monitored viruses. Additional testing includes endotoxin, hemoglobin, pH, osmolality, total protein and a biochemical profile that contains various metals, proteins, hormones and other metabolites.
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Compliance
Sera is aseptically collected and processed in a facility that is compliant with FDA guidelines for Class I Medical Devices.
Технические характеристики
| Certifications/Compliance | cGMP |
| Species | Horse |
| Quantity | 500 mL |
| Endotoxin Concentration | ≤5EU/ mL |
| Hemoglobin Concentration | <,20 mg/dL |
| Osmolality | 315 ± 35mOsm/kg |
| Protein Content | 6 ± 2 g/dL |
