Plasma – Recalcified (research use only)
Plasma units are produced from whole blood collected from subjects qualified in accordance with current regulations and requirements for donors of transfusible blood components, including screening with the Uniform Donor History Questionnaire developed by the AABB and approved by the Food and Drug Administration for screening of donors of transfusible blood components.
Selection criteria may be adjusted at the request of the customer depending on the intended use of the product and the customer’s requirements, provided that subject safety requirements are met. At the customer’s request, subjects with a history of travel or medication ingestion that would preclude them from providing a blood product suitable for transfusion may provide whole blood for non-clinical and non-injectable uses.
Subjects may donate as often as once every eight weeks and up to six times in any 12-month period.
Subjects are usually prescreened prior to product collection for evidence of transmissible infectious diseases with the standard panel of tests used to screen blood products for transfusion acceptability. This panel of tests is usually repeated with each collected product.
Whole blood units are collected into a standard blood bag system used for collection of whole blood for transfusion and containing CPDA-1 anticoagulant. Plasma is separated by centrifugation into an attached bag without disrupting the closed system in which the whole blood was collected.
Calcium chloride and thrombin are added to the plasma unit. Following clot formation, the unit is centrifuged and the recalcified plasma is transferred into a separate bag for storage. In alignment with the customer’s request, the product is stored at 2°C to 6°C or frozen at <-20°C.
Specific subjects may be selected from our database based on:
- Blood type
- Gender
- Ethnicity
Optional pre-collection qualification screening is available:
- Anti-HLA Class I or Class II antibodies screen
- Recent medication usage
Optional post-collection release screening is available:
Packaging and Shipment
Following production and in alignment with the intended use of the product and the customer’s requirements, plasma units can be packaged and shipped for overnight delivery. Liquid units are packaged in a manner that ensures maintenance of a temperature between 1°C and 10°C during shipment. Frozen units are shipped on dry ice.
Continuous temperature monitoring data tracking devices are available for use at the customer’s request. |