Disease State Plasma

BBI’s Disease State Plasma

BBI supplies a streamlined range of disease state plasma products and can support enquiries for certain autoimmune disease and infectious disease assays where the titre requirement is defined.

BBI has a strong supply chain after working in the IVD reagent supply industry for over 40 years. We can only procure a limited range of disease state plasma from our global network of suppliers. The material we procure and supply is of the highest quality; it is material that has a defined titre and provenance. Although BBI no longer runs a biobanking/plasma repository service where units of disease state plasma are kept and can be sampled, BBI can often supply bespoke collections where the requirements are well defined and can supply in significant volumes up to 100l lots.

Products

Product Name	Code	Type	Applications
Synthetic Rubella IgM Serum	SH252-9	Infectious Disease		Buy now
Third Trimester Pregnancy serum	SH284-2	Hormones		Buy now

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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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Supply of Disease State Plasma

Our disease state plasma offering is contained to a few autoimmune and infectious disease parameters and we offer a pooling and testing service for certain materials. Materials are supplied from our Sittingbourne site and are shipped frozen on dry ice following all the recognised conventions for supplying potentially biohazardous materials.

We also offer a highly characterised synthetic disease state plasma for Rubella IgM positive material and can potentially offer to extend this on a customised basis subject to minimum order restriction to other chimeric antibodies.

Specialists in Disease State Plasma

BBI specialises in sourcing very specific Disease State Plasma products to support applications in autoimmunity, infectious disease testing and interference testing. Materials are sourced from highly reputable partners in Europe and in the USA that collect the plasma on behalf of BBI to a defined specification. Our partners have been assessed by BBI for the quality of the material they can provide but also for the information provided with the disease state plasma.

BBI rarely relies on approval of pre-shipment samples, relying instead on the provision of material to a defined titre specification using standardised testing methodologies. Materials are collected to order, and these bespoke collections may take longer but the quality and titre of the material is guaranteed. We specialize in the supply of Anti-TPO and Anti-Tg positive plasmas along with Pregnancy serum and some specific infectious disease such as Hepatitis B surface antigen. BBI also has a unique, popular “synthetic” disease state plasma for Rubella IgM that has been characterised for dose response linearity on several commercial immunoassay platforms.

Core Competencies

Large product range

Quality

Stability

Custom manufacture

Our product range includes enzymes for biosensor, immunoassay, clinical chemistry, molecular and pharmaceutical applications with a range of different grades to suit all applications.

We aim to develop, manufacture and supply high quality enzymes which meet both customer and regulatory requirements.

We use quality raw materials, innovative production methods and product formulations to achieve maximum stability for our products. We test our products regularly to ensure this remains consistent.

If one of our off-the-shelf products does not meet your requirements, we can offer custom development and manufacturing services to deliver an enzyme to your specification, perfect for your application.