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. The plasma is frozen at <-20°C, then allowed to thaw at 37°C. As the plasma thaws, a precipitate forms. Most of the plasma in the bag is transferred into another sterilely connected bag. A small amount of plasma remains with the precipitate, forming the desired product, which is refrozen.

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:

• Weight and/or volume

Packaging and Shipment

Following production and in alignment with the intended use of the product and the customer’s requirements, cryoprecipitate can be packaged and shipped frozen on dry ice for overnight delivery.

Continuous temperature monitoring data tracking devices are available for use at the customer’s request.

Product Characteristics (March 2008)
Factor VIII

• Mean: 115 IU
• Range: 111-118 IU

Fibrinogen

• Mean: 380 mg/dL
• Range: 297 – 462 mg/dL