• Non-mobilized
• Normal Subjects
• Research Subjects (IRB-approved protocols)
• G-CSF Mobilized
• Normal Subjects (IRB-approved protocol)

Non-mobilized Normal Subjects

Lifeblood Biological Services collects mononuclear cell (MNC) products 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 approved 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 mononuclear cells 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 a month and up to six 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 is usually repeated with each collected product.

Products are collected on the COBE^® Spectra collection system using either the MNC or AutoPBSC^® collection protocol and disposable software, as directed by the customer. The total volume of blood processed during the collection procedure is as directed by the customer, provided that subject safety requirements are met. The standard processed volume is 10 liters. Additional plasma may also be collected from the subject during the collection procedure if requested by the customer.

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:

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

Optional post-collection release screening is available:

• Total nucleated white cell, mononuclear cell count, and/or other cell fraction yield

Packaging and Shipment

In alignment with the intended use of the product and the customer’s requirements, mononuclear cell 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, unless the customer specifies an alternative method. Lifeblood Biological Services uses the Golden Hour® Platelet Shipper for shipment of these products, unless an alternative method is specified by the customer.

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

Current Product Characteristics (10 liter processed volume) (last 50 products as of first day of current quarter):

MNC Protocol and Disposable
Total Nucleated Cell Yield:

• Mean: TBD
• Median: TBD
• Range: TBD

Mononuclear Cell Yield:

• Mean: TBD
• Median: TBD
• Range: TBD

Hematocrit:

• Mean: TBD
• Median: TBD
• Range: TBD

AutoPBSC Protocol and Disposable
Total Nucleated Cell Yield:

• Mean: TBD
• Median: TBD
• Range: TBD

Mononuclear Cell Yield:

• Mean: TBD
• Median: TBD
• Range: TBD

Hematocrit:

• Mean: TBD
• Median: TBD
• Range: TBD

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Non-mobilized Research Subjects

Lifeblood Biological Services supports many companies’ research needs by recruiting, screening, consenting, and enrolling subjects in IRB-approved research studies that require collection of mononuclear cell products for specific process development and process validation uses, and/or for further manufacturing for clinical research. In addition, LBS provides other support services  that allow a study sponsor to initiate and complete studies in a time-efficient and cost-effective manner. For more information, see Protocol Development & IRB Submission Services.

These products are collected from subjects qualified for participation in accordance with the specified IRB-approved inclusion and exclusion criteria. In addition, most subjects are also 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 approved by the Food and Drug Administration for screening of donors of transfusible blood components. Depending on the intended use of the collected products and protocol specifications, subjects with a history of travel or medication ingestion that would preclude them from providing a blood product suitable for transfusion may participate and provide MNCs for a study.

In accordance with the study protocol, subjects can be 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 is usually repeated with each collected product as per protocol requirements.

Products are collected on the COBE^® Spectra collection system using either the MNC or AutoPBSC^® collection protocol and disposable software, as directed by the protocol and/or the study sponsor. The total volume of blood processed during the collection procedure is as defined by the protocol and/or the study sponsor. The standard processed volume is 10 liters.

Packaging and Shipment

In alignment with the intended use of the product as directed by the protocol and/or the study sponsor, mononuclear cell 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, unless the customer and/or the protocol specify an alternative method. Lifeblood Biological Services uses the Golden Hour® Platelet Shipper for shipment of these products, unless an alternative method is specified by the customer and/or the protocol.

Continuous temperature monitoring data tracking devices are available for use at the customer’s request or as defined by the protocol.

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G-CSF Mobilized Normal Subjects (IRB-approved study)

Lifeblood Biological Services supports many companies’ research needs by recruiting, screening, consenting, and enrolling subjects in IRB-approved research studies that require collection of G-CSF mobilized mononuclear cell products for specific process development and process validation uses, and/or for further manufacturing for clinical research. In addition, LBS provides other support services that allow a study sponsor to initiate and complete studies in a time-efficient and cost-effective manner. For more information, see Protocol Development and IRB Submission Services.

These products are collected from subjects qualified for participation in accordance with the specified IRB-approved inclusion and exclusion criteria. In addition, most subjects are also 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 approved by the Food and Drug Administration for screening of donors of transfusible blood components. Depending on the intended use of the collected products and protocol specifications, subjects with a history of travel or medication ingestion that would preclude them from providing a blood product suitable for transfusion may participate and provide MNCs for a study.

In accordance with the study protocol, subjects can be 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 is usually repeated with each collected product as per protocol requirements.

Products are collected on the COBE^® Spectra collection system using either the MNC or AutoPBSC^® collection protocol and disposable software, as directed by the protocol and/or the study sponsor. The total volume of blood processed during the collection procedure is as defined by the protocol and/or the study sponsor. The standard processed volume is 10 liters.

Products Available from Lifeblood Biological Services - Sponsored Study

LBS is performing a research study to evaluate the impact of mobilization schedules, product collections, and repeated product collections on normal subjects. Products collected as part of this study can be provided for use in pre-clinical research, process development, process validation, and device validation. Products from this protocol cannot be provided for clinical use.

As part of this study, two mobilization options are available:

• Short-course: 10µg/kilogram body weight X 3 days, single collection on day 4
• Long course: 5µg/kilogram body weight X 5 days, 2 collections, one on day 5 and one on day 6

Packaging and Shipment

In alignment with the intended use of the product as directed by the protocol and/or the study sponsor, mononuclear cell 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, unless the customer and/or the protocol specify an alternative method. Lifeblood Biological Services uses the Golden Hour® Platelet Shipper for shipment of these products, unless an alternative method is specified by the customer and/or the protocol.

Continuous temperature monitoring data tracking devices are available for use at the customer’s request or as defined by the protocol.

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