Human Serum & Control Materials
Ethically sourced human serum from BBI
We manufacture every depleted serum – and release externally sourced disease-state plasma – under our ISO 13485 quality system in Crumlin, UK.
Whether you need a clean base for calibrators or a disease-state pool for positive controls, our ethically sourced human serum and plasma come from one of our ISO 13485-certified facilities, licensed to store human tissue by the UK Human Tissue Authority. Off-the-shelf formats include normal pools, vitamin-D-depleted serum and other analyte-adjusted matrices, alongside selected high-titre disease-state units – each qualified for IVD use and produced under controls designed to deliver consistent performance.
Analyte Depleted Serum
Proprietary ligand-affinity processing drives hormones, vitamins or CRP below assay detection, delivering ISO 13485, 0.2 µm-filtered serum for linearity studies and negative controls.
Disease State Plasma
Titre-verified autoimmune and infectious-disease plasma pooled from screened donors, frozen on dry ice, provides authentic positive controls and interference material in lots up to 100 L.
Human Chimeric Antibodies
Transgenic-mouse–derived human IgG calibrators give reproducible, ethically sourced alternatives to scarce patient plasma for Jo-1, PL-7, LKM-1 and other rare autoantibodies.
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Inside this catalog you’ll find one of the industry’s broadest collections of enzymes, antibodies, antigens, and more – meticulously developed to power world-class diagnostics and keep your pipeline moving.
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Frequently asked questions
Human Serum & Control Materials
What range of Serum and plasma products are available from BBI, what are they generally used for?
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
What is the difference between serum and plasma?
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.
What volumes of serum and plasma products are available?
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.
Are the Disease state plasma serum and plasma products sourced by BBI from plasmapheresis or are they “remnant” materials collected from blood transfusion and other procedures?
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.
How are the analyte levels determined in BBI serum and plasma products?
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).
Are samples available from all serum and plasma prior to purchase?
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.
How do I store and transport the material?
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.
Where do BBI collect the serum and plasma?
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.
How are the units screened for infectious disease markers?
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.
How can I get further information about the product?
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.
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IN FOCUS
ISO Certifications
All our human serum & control materials are manufactured at facilities certified to internationally recognised ISO13485 quality management standards – so your diagnostics start with a proven quality backbone. Our ISO27001 certification ensures your data is safeguarded, and we’re now charting a path to ISO 14001 and ISO 45001 to fold sustainability and safety into every batch.
ADDING VALUE
Performance
Backed by 70 years of reagent expertise, BBI products are engineered for consistent, assay-grade performance – batch after batch.
Scalability
From pilot-scale to full scale industrial runs, our bioprocesses and global logistics flex with your forecasts, ensuring on-spec supply worldwide.
Compliance
ISO 13485 certification plus FDA registration and full documentation make every lot audit-ready – speeding global approvals and market entry.
Security
Global primary manufacturing and secure supply chains ensure security of supply, so your production timeline stays protected.
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And if the issue is technical, they’ll bring in our world-leading expert scientists to troubleshoot side-by-side with you and keep your project moving.
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