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For More Information, Call​ 901-252-3431
901-252-3431

Serum

Whole Blood Derived True Off-the-Clot Serum
Key Biologics provides research- and clinical-grade whole blood derived serum products, such as:
  • Single Donor Off-the-Clot
  • Single Donor Off-the-Clot (pooled and aliquoted)
Single Donor Off-the-Clot Serum
True Off-the-Clot serum is produced from a single unit of whole blood units collected into a sterile anticoagulant-free 600mL blood bag. It is not re-calcified plasma. It is collected from donors qualified in accordance with current regulations and requirements for donors of transfusible blood components. The whole blood unit is allowed to clot and the serum is separated by centrifugation. The serum is transferred into a sterilely connected transfer bag maintaining sterility of the product. A typical serum unit contains between 220 and 260mL of serum.
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 donor safety requirements are met. At the customer’s request, donors 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 donors to allow the end-user to determine suitability for targeted applications. Donors may be requested for product collection. Donors may donate as often as once every eight weeks and up to six times in any 12-month period.
Donors 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.
The serum is stored in a liquid state (2°C to 6°C) or frozen (<-80°C) depending on the customer’s specifications.
Specific donors 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
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.
Single Donor Off-the-Clot Serum (Pooled and Aliquoted)
True off-the-clot serum is produced from a single unit of whole blood units collected into a sterile, anticoagulant-free 600mL blood bag. It is not re-calcified plasma. It is collected from donors qualified in accordance with current regulations and requirements for donors of transfusible blood components, including screening with the Uniform Donor History Questionnaire that was developed by the AABB and accepted by the Food and Drug Administration for screening of donors of transfusible blood components. The whole blood unit is allowed to clot and the serum is separated by centrifugation. The serum is transferred into a sterilely connected transfer bag maintaining sterility of the product. A typical serum unit contains between 220 and 260mL of serum.
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 donor safety requirements are met. At the customer’s request, donors 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 donors to allow the end-user to determine suitability for targeted applications. Specific donors may be requested for product collection. Donors may donate as often as once every eight weeks and up to six times in any 12-month period.
Donors 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.
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 and eight units per 2L pool). Serum units are sterilely connected in series to a pooling bag using a sterile tubing welder and the serum is transferred to the pooling bag. 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 donors 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.

Key Biologics, LLC

1256 Union Ave.
Memphis, TN 38104-3411

Phone: 901-252-3434 (Donation questions)
901-252-3431 (Product questions)

Fax: 901-252-3446

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