Selected Mononuclear Cell Fractions

Key Biologics provides purified mononuclear cell (MNC) fractions derived directly from whole blood, human umbilical cord blood, bone marrow, or from a number of leukocyte-rich products.

Cell selection methods include Ficoll-Paque™ separation, positive and negative immunomagnetic bead selection (CliniMACS^® or autoMACS^®) and counter-flow elutriation (Elutra^®). Key Biologics’ wide range of leukocyte-rich base products, listed below, and selection methods provide the customer with the flexibility to select the product that best fits its need.

• Back-flushed leukocyte-reduction filter
• Whole blood-derived source leukocyte
• Back-flushed LRS chamber
• Apheresis-derived source leukocyte
• Non-mobilized MNC product
• G-CSF mobilized MNC product
• Human umbilical cord
• Bone marrow aspirate

The purified cell fractions listed below can be produced on demand and provided fresh or from a frozen inventory. The list is not exhaustive and other cell fractions can be produced on demand.

• Pan T cells
• TH cells (CD4⁺)
• Naïve CD4⁺ cells (CD4⁺/CD45RA⁺)
• Memory CD4⁺ cells (CD4⁺/CD45RO⁺)
• Treg cells (CD4⁺/CD25+)
• TC cells (CD8⁺)
• Naïve CD8⁺ cells (CD8⁺/CD45RA⁺)
• Memory CD8⁺ cells (CD8⁺/CD45RO⁺)
• B cells (CD19⁺)
• NK cells (CD56⁺)
• Monocytes (CD14⁺)
• BDCA-4⁺ Primary Lymphoid Dendritic cells
• CD34⁺ cells
• CD34^- cell fraction
• CD133⁺ cells

Cell yield and purity vary based on the leukocyte-rich base material and selection method used. Larger quantities of rare cell fractions are generally only produced from apheresis-derived MNC products. For some very rare cell fractions, use of an enriched MNC product collected from a G-CSF stimulated subject is required to allow production of an acceptable cell yield.

All leukocyte-rich base products (except umbilical cord blood 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.

For apheresis-derived base products, 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 applicable to the product collection 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 a product for non-clinical and non-injectable uses, if protocol requirements allow.

We also offer qualification samples collected from potential subjects to allow the end-user to determine suitability for targeted materials.

Depending on the source material, subjects are prescreened for evidence of transmissible infectious diseases with the standard panel of tests used to screen blood products for transfusion acceptability. As warranted, this panel of tests may be repeated at the time of product collection.

Specific subjects may be selected from our database based on:

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

Optional post-collection release screening is available:

• Targeted cell fraction yield

Packaging and Shipment

In alignment with the intended use of the product and the customer’s requirements, fresh products can be packaged and shipped on the date of production for overnight delivery. Non-frozen products are packaged in a manner that ensures maintenance of a temperature between 20°C and 24°C during shipment, unless the customer specifies a alternative method.

Products that are to be stored frozen are placed into the vapor phase of liquid nitrogen after transitioning to a frozen state at -1°C/minute in “Mr. Frosty” freezing containers. These products are shipped to the customer on dry ice or in a dry shipper charged with liquid nitrogen.

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