Apheresis-derived Granulocytes (Neutrophils)

Granulocytapheresis products are 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 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 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 granulocytes for non-clinical and non-injectable uses.

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

Subjects receive prednisone orally to induce leukocytosis prior to collection. G-CSF is not administered to donors at this time.

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 collection system.

Specific subjects may be selected from our database based on:

• Blood type
• Gender
• Ethnicity
• Human Neutrophil Antigen genotype
• Human Leukocyte Antigen phenotype

Optional pre-collection qualification screening is available:

• Total white cell count, neutrophil count, and/or other cell counts
• Recent medication usage

Optional post-collection release screening is available:

• Total nucleated cell yield
• Neutrophil yield

Packaging and Shipment

In alignment with the intended use of the product and the customer’s requirements, granulocytaphereses 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, unless an alternative method is specified by the customer.

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