Whole Blood-derived True Off-the-Clot Serum

Key Biologics provides research- and clinical-grade whole blood-derived serum products. For more information, click the product name below.

• Single Donor Off-the-Clot

• Single Donor Off-the-Clot (pooled and aliquoted)

• Pooled Off-the-Clot

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Single Donor Off-the-Clot Serum

True off-the-clot serum is produced from whole blood 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 collected product.

Whole blood units are collected into an anticoagulant-free blood bag system. The whole blood unit is allowed to clot and the serum is separated by centrifugation and transferred into an attached bag without disrupting the closed system in which the whole blood was collected. A typical serum unit contains between 220 and 260mL of serum.

The serum is stored in a liquid state (2°C to 6°C) or frozen (<-80°C) depending on customer’s specifications.

Specific subjects may be selected from our database based on:

• Blood type
• Gender
• Ethnicity
• Transfusion history
• Pregnancy history

Optional pre-collection qualification screening is available:

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

Optional post-collection release screening is available:

• Weight and/or volume
• Appearance
• Bacterial culture (BacT/ALERT)

Packaging and Shipment

Following production and in alignment with the intended use of the product and the customer’s requirements, serum units can be packaged and shipped for overnight delivery. Liquid units are packaged in a manner that ensures maintenance of a temperature between 1°C and 10°C during shipment. Frozen units are shipped on dry ice.

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

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Single Donor Off-the-Clot Serum (pooled and aliquoted)

True off-the-clot serum is produced from whole blood 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 collected product.

Whole blood units are collected into an anticoagulant-free blood bag system. The whole blood unit is allowed to clot and the serum is separated by centrifugation and transferred into an attached bag without disrupting the closed system in which the whole blood was collected.

The serum is stored in a liquid state at 2°C to 6°C prior to pooling. As defined by the customer’s request, an adequate number of serum units are removed from storage for pooling (approximately four units per liter pool). Serum units are sterilely connected in series to a pooling bag using a sterile tubing welder. Following creation of the pool, each specified volume of serum is sterilely aliquoted into a container of a size and construction that meets the customer’s requirements. All production steps are performed in a manner that maintains the integrity of a closed system, e.g. use of sterile tubing welder, and/or performed in a biosafety cabinet.

The aliquots may be stored at 2°C to 6°C or frozen (<-80°C) pending shipment to the customer.

Specific subjects may be selected from our database including:

• Blood type
• Gender
• Ethnicity
• Transfusion history
• Pregnancy history

Optional selection qualification screening can be performed:

• Anti-HLA Class I or Class II antibodies screen

Optional post-collection release screening is available:

• Weight and/or volume
• Appearance
• Bacterial culture (BacT/ALERT)
• Endotoxin
• Mycoplasma

Packaging and Shipment

Following production and in alignment with the intended use of the product and the customer’s requirements, serum aliquots can be packaged and shipped for overnight delivery. Liquid units are packaged in a manner that ensures maintenance of a temperature between 1°C and 10°C during shipment. Frozen units are shipped on dry ice.

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

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Pooled Off-the-Clot Serum

Serum is produced from whole blood in anticoagulant-free sample tubes collected from individuals providing a blood product determined to be suitable for transfusion. The individuals are 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. Prior to serum pooling, the blood product associated with each sample tube is screened with the standard panel of tests used to screen blood products for transfusion acceptability and found to be non-reactive (negative) on all tests.

The serum sample tubes are stored in a liquid state at 2°C to 6°C prior to pooling. Serum is removed from the sample tubes and placed into a one-liter pooling bottle. Each sample tube yields approximately 2mL of serum (approximately 500 donor samples per liter). Following creation of the pool, it is frozen pending shipment to the customer.

Serum from donors with specific characteristics may be requested:

• Blood type
• Gender
• Ethnicity
• Transfusion history
• Pregnancy history

Optional pre-collection qualification screening is available:

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

Optional post-collection release screening is available:

• Weight and/or volume
• Appearance

Packaging and Shipment

Following production and in alignment with the intended use of the product and the customer’s requirements, the pooled serum is packaged and shipped to the customer on dry ice.

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