Apheresis-derived Platelets

Plateletpheresis products are collected under an IRB-approved protocol 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 accepted 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 and protocol requirements are met.

We also offer qualification samples on potential subjects to allow the end-user to determine suitability for research use or for further manufacturing. Specific subjects may be requested for product collection. Subjects may donate as often as once a week and up to 24 times in any 12-month period.

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.

Products are collected on the COBE® Spectra, Trima Accel^® or Haemonetics MCS+^® collection systems. Specific instrument will be used at customer’s request. Either single (%7E3.0X10¹¹ in 280mL plasma) or double (%7E6.5X10¹¹ in 300mL plasma) plateletpheresis products are available. Products may be collected using an in-line leukocyte-reduction filter that produces a product with <5X10⁶ residual leukocytes. Collections are generally performed Monday through Thursday.

Specific subjects may be selected from our database based on:

• Blood type
• Gender
• Ethnicity
• BMI
• Historic platelet count
• Human Platelet Antigen genotype
• Human Leukocyte Antigen phenotype
  

Optional pre-collection qualification screening is available:

• Platelet count and/or other cell counts
• Anti-HLA Class I or Class II antibodies screen
• Platelet Function Assay (PFA-100^®)
• Recent medication usage
  

Optional post-collection release screening is available:

• Platelet yield
• Residual white blood cell count
• Bacterial culture (BacT/ALERT)
• pH
  

Packaging and Shipment

In alignment with the intended use of the product and the customer’s requirements, plateletphereses can be 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 data tracking devices are available for use at the customer’s request.