Whole Blood-derived Leukocytes

Key Biologics offers two unique leukocyte-rich products derived from whole blood. For more information, click the relevant link below.

• Source Leukocytes (Buffy Coats)
• Leukocyte Reduction Filter Product

Source Leukocytes (Buffy Coats)

Source Leukocytes are produced from whole blood units 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 whole blood for non-clinical and non-injectable uses.

We also offer qualification samples on potential subjects to allow the end-user to determine suitability for targeted materials. Specific subjects may be requested for product collection. 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, with the exception of screening for exposure to T. cruzi, is usually repeated with each product collection.

Whole blood units are collected into a standard blood bag system used for collection of whole blood for transfusion and containing CPDA-1 anticoagulant. Source Leukocytes are produced by centrifugation without disrupting the closed system in which the whole blood was collected.

Specific subjects may be selected from our database based on:

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

Optional pre-collection qualification screening is available:

• Cell counts
• Anti-HLA Class I or Class II antibodies screen
• Recent medication usage

Optional post-collection release screening is available:

• Total nucleated cell count and/or other white cell fraction yield
• Residual platelet count in product
• Weight and/or volume
  

Packaging and Shipment

In alignment with the intended use of the product and the customer’s requirements, Source Leukocytes 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, unless the customer specifies an alternative method.

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

Leukocytes (Back-flushed Leukocyte-reduction Filters)

Key Biologics recovers leukocytes from in-line filters that were used to leukocyte-reduce whole blood-derived red blood cells collected from volunteer blood donors who were qualified in accordance with all current regulations and requirements, 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.

All products have been screened with the standard panel of infectious disease tests used to screen blood products for transfusion acceptability.

Whole blood units are usually collected into a standard blood bag system used for collection of whole blood for transfusion and containing CPDA-1 or CP2D anticoagulant. Red blood cell units are produced using centrifugation without disrupting the closed system in which the whole blood was collected. Following refrigerated storage for at least 24 hours, a leukocyte-reduction filter is attached to the red blood cell tubing using a sterile tubing welder. The filtration produces a red blood cell with less than 5x10⁶ residual leukocytes in the final product. Following filtration, the filter is aseptically removed and back-flushed with 100mL phosphate-buffered saline and the leukocytes are collected into an attached transfer bag. Alternatively, the filter can be provided directly to the customer for removal of the cells. A unique tracking number is adhered to transfer bag or to the filter, if provided, to allow linkage to the collection procedure, as needed.

Specific subjects may be selected from our database based on:

• Blood type
• Gender
• Ethnicity

Optional post-collection release screening is available:

• Total nucleated cell count and/or other white cell fraction yield
• Residual platelet count in product
• Weight and/or volume

Packaging and Shipment

In alignment with the intended use of the product and the customer’s requirements, the filter or the recovered cells may be packaged and shipped on the date of production for overnight delivery.

Products are packaged in a manner that ensures maintenance of a temperature between 20°C and 24°C during shipment, unless the customer specifies an alternative method.

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