Apheresis-Derived Platelets for Research or Further Manufacturing
Platelets collected by apheresis (plateletphereses) are available to support research and for further manufacturing into in vitro diagnostics. Collection can be performed under a protocol approved by the Institutional Review Board (IRB) or off protocol. Donors are normal healthy individuals 18 to 65 years of age who are qualified in accordance with current regulations and requirements for donors of blood components. These requirements include screening with the uniform donor history questionnaire that was developed by the AABB and accepted by the Food and Drug Administration for screening of donors for blood components.
Subjects are prescreened for evidence of transmissible infectious diseases with the standard panel of tests used to screen blood products for transfusion acceptability. This panel of tests, with the exception of screening for exposure to T. cruzi, is usually repeated with each product collection. Testing for Zika virus RNA is performed on each collection.
Specific subjects may be requested for product collection. Subjects may donate as often as every two weeks and up to 24 times during any 12-month period.
Platelets are collected using either the Trima Accel collection platform or the Amicus Separator. Both platforms produce leukocyte-reduced products. Collection with platelet additive solution (PAS) is available for products collected on the Amicus Separator platform.
A standard single product contains ~3x1010 platelets, a double product contains ~6x1010 platelets and a triple contains ~9x1010 platelets.
Products are generally collected Monday through Thursday. Multiple collections for a single customer can be performed on the same day.
Packaging and Shipment
In alignment with the intended use of the product and the customer’s requirements, plateletpheresis products are usually packaged and shipped on the date of collection for overnight delivery. Products are packaged in a manner that ensures maintenance of a temperature between 20°C and 24°C during shipment. Continuous temperature monitoring and data tracking devices are available at the customer’s request.