Human Chimeric Antibodies

Serums and plasmas should be stored below -15°C and the use of dry ice is recommended for shipping. Repeated freeze-thaw cycles should be avoided as this can cause the material to become “cloudy” due to residual Fibrinolysis.

BBI’s Serum and plasma is collected at hospitals and blood banks worldwide, specific sources can be used if requested however bespoke collections can take additional time to facilitate. Most pooled normal human serum and plasma and depleted serum are from US sourced paid blood donations.

Most of our products are screened for the current World Health Organisation (WHO) list of recognised infectious agents (https://www.who.int/bloodsafety/ScreeningDonatedBloodforTransfusion.pdf) and the results are listed on the product C of A, however as they are derived from human materials they should be treated as potentially hazardous and only handled in laboratories with appropriate biological containment facilities. Some Disease State Plasma products may be positive for specific infectious agents which will be reported on the product Certificate of Analysis. These materials should be handled in laboratories with appropriate biological containment facilities.

Technical information and product specifications can be found in the product-specific Certificate of Analysis and the Product Information Sheet. If any further technical information is required, this can be requested by emailing technicalsupport@bbisolutions.com or contacting customer services.

BBI supplies the following human serum and plasma products:

• Pooled normal human serum and plasma for use as calibrator/control bases and product testing
• Pooled specific disease state plasma used for calibrators/controls for immunology products
• Analyte depleted serum and plasma used as negative base for calibrators/controls

Plasma and serum are both the liquid portion of blood that remains once the cells are removed.

Plasma is the liquid that is formed when the cellular components are removed, and clotting is prevented with the addition of an anticoagulant. There may be residual anticoagulant remaining in the plasma.

Serum is the liquid that remains after the blood has been allowed to clot, then the cellular components are removed. It does not contain fibrinogens as these are removed as part of the blood clot. The resulting serum will not contain any anticoagulant.

Typical volumes depend on the specific product however in general individual unit volumes for Disease state plasma range between 1ml samples and up to 1L however generally these are available as 200- 240ml remnants and 850-950ml units with samples of 1-5ml. Depleted serums and pooled normal human serums are available in lots of up to 50L.

Disease state serums and plasmas are collected as remnants and as plasmapheresis units, the availability is specific to the analyte. Please contact your account manager or customer service for details.

Specific immunoassays are normally used to determine the levels of the analytes. These are specified on the Certificate of Analysis. In some cases it is possible to offer an alternative method to those stated, please contact your account manager for details. In certain cases, the materials are tested by LC-MS (Liquid chromatography mass spectroscopy).

Plasma and serum samples can normally be provided; however to ensure that the product is likely to meet the requirement it is essential to agree the titre requirement and testing methodology, as well as any other specifications, prior to sampling. Units of the bulk can be held for a maximum of 3 months pending sample approval.