Diabetes and Renal
Antigens are a range of mostly human purified proteins that are commonly used in In-Vitro diagnostic tests as critical reagents to add to a base to create calibrators and Quality Control material for specific
biomarkers (a measurable indicator of some biological state or condition). Certain products will have additional biological functionality that can be used for other applications.
Recombinant (prokaryotic/eukaryotic) or native from human tissue (sourced with informed consent), human cancer cell line grown in culture or human body fluids such as blood, plasma,serum and urine. All samples are given with informed consent from the donor.
The material is purified in our laboratories in Sittingbourne UK. The site is registered to design, develop, manufacture and supply in-vitro diagnostic reagents, blood and plasma products and operates a quality management system which complies with the requirements of ISO: 13485. the raw material is sourced from various territories, where this is specific this is detailed on the Certificate of Analysis (C of A). In general, material prepared from blood plasma is sourced from US based blood donations. Our Sittingbourne site also holds a Human Tissue Authority license for the
storage of human tissues for the purpose of Research.
Most of the products we supply are made on site however there are a few specific products that are contracted out to carefully selected partner laboratories.
The specific methodologies are proprietary to BBI however a general purification methodology can be provided after execution of a non-disclosure agreement
Extract grade – Less than 40%, immunoassay recovery as a percentage of total protein.
Part-pure – Greater than 40%, immunoassay recovery as a percentage of total protein. A band on SDS-PAGE or Native PAGE corresponding to the pure protein molecular weight to be visible.
Pure grade – Greater than 90%, band corresponding to protein visible clearly on Coomassie stained SDS-PAGE or Native PAGE with no more than 2 other bands which are not multimers of the protein
occurring as minor bands. These bands should represent an intensity judged to be faint in comparison to the main band. One band only or no contaminating bands on cellulose acetate electrophoresis.
This information needs to be backed up with at least one other technique such as HPLC or Immunoassay as percentage of total protein which shows a purity of > 90%.
High Pure grade – Greater than96% band corresponding to protein visible clearly on Coomassie stained SDS-PAGE or Native PAGE with no other bands which are not multimers of the protein occurring as minor bands. One band only or no contaminating bands on cellulose acetate electrophoresis. This information needs to be backed up with at least one other technique such as HPLC or Immunoassay as percentage of total protein which shows a purity of >96%.
Very High Pure grade – Greater thank98% band corresponding to protein visible clearly on Coomassie stained SDS-PAGE or Native PAGE with no other bands which are not multimers of the protein occurring as minor bands. One band only or no contaminating bands on cellulose acetate electrophoresis. This information needs to be backed up with at least two other techniques such as
HPLC or Immunoassay as percentage of total protein which shows a purity of >98%.
Ultra-pure grade – Greater than99% band corresponding to protein visible clearly on Coomassie stained SDS-PAGE or Native PAGE with no other bands which are not multimers of the protein occurring as minor bands. One band only or no contaminating bands on cellulose acetate electrophoresis. This information needs to be backed up with at least two other techniques such as HPLC or Immunoassay as percentage of total protein which shows a purity of >99%. Product should also be tested for likely contaminating proteins and show a level of less than 0.1%. Also, Western blot
or immunoelectrophoresis should show no bands other than the specific protein or its multimers.
The appearance will vary between products depending on the formulation and protein characteristics, please consult the example Certificate of Analysis. Where possible the product is presented in a liquid format, where this is not possible it is formulated for ease of use and maximum shelf-life. BBI will consider custom re-formulation to meet specific requirements, contact an account
manager for further information.
This varies between products, please consult the example Certificate of Analysis. If any further technical information is required, this can be requested by emailing firstname.lastname@example.org.
We do not have stability data on our lyophilised products once they have been reconstituted or liquid products after dilution. There are too many variables, such as diluent used and environmental controls to be able to give specific advice. Once reconstituted, the product falls outside of our recommended storage parameters as stated on the product C of A and the stability should be determined by the user in the specific application.
Although all our products are screened to test for the infectious agents listed on the product’s C of A, they are derived from human materials and should be treated as potentially hazardous. Our purification processes will partition infectious agents and so the likelihood of these products containing infectious agents is extremely low however the all material should be handled using appropriate precautions. Safety data sheets are available on request.
Each specific product is presented in a range of aliquot sizes, usually based around the 1mg size as a base unit and normally in ”factors of 10” from this base however there are some exceptions. The
material cannot be re-dispensed, should a specific dispensation be required this can be accommodated if enough notice is given.
All of our human antigen products will be sent from our Sittingbourne facility directly, our terms are “FCA (free carrier)” meaning it is the customers responsibility to ensure the package is delivered safely. We use an air courier service and we will make a charge for this service or pass the shipping charges forward.
In general material is supplied packed on cool-pack or frozen on dry ice. This varies between products, please consult the example Certificate of Analysis (found in the ‘Technical Documents’ section of the
product page) for this information.
The primary packaging is product specific and appropriate to the product. The secondary packaging is a cardboard outer box with a Styrofoam outer containing appraise materials to maintain product
integrity (e.g. Dry ice/cool pack).
The product is shipped with a Certificate of analysis (the product specifications, the formulation, the expiry date, handling/storage information, infectious disease testing) and a delivery note/commercial invoice. Safety data sheets are available on request (by emailing email@example.com).
This varies between products, please consult the example Certificate of Analysis for this information.
The material is dispensed by the method specified in “determination method” section of the C of A. A small dispensing overage is included, so the vial may contain more material than is specified on the
label. The recovery by immunoassay will be dependent on the matrix and antibody used in the assay.
Finished Goods shelf life from date of manufacture have been determined by specific stability trials or by reference to similar formulations/scientific literature and are generally defined as follows.
• Liquid stock (2-8°C) 2 years
• All other stock (liquid frozen stock, lyophilized) 5 years
Exceptions to this will be detailed on the C of A template where shelf lives will be supported by stability data. BBI tests the product stability by immunoassay and lists the shelf-life and storage conditions on the Certificate of Analysis. The stability of freeze-dried products after re-constitution is not determined as there are too many potential variables to make this practical. Additionally, stability trials are carried out in order to confirm or extend current stated shelf life periods.
In some cases, BBI has data to show products have a longer shelf-life. When a product comes close to the end of a shelf-life BBI has a programme of re-certification however most products are
consumed before the end of shelf-life. BBI recommends that products are not used past the shelf-life stated.
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 firstname.lastname@example.org.
These should be sent to email@example.com for completion. Due to the high number of requests received, BBI has compiled a document of frequently requested information of this
nature, which is available upon request.
For larger volumes BBI does not publish list prices as often product pricing is dependent on volumes and recovery testing. Please contact your local account manager for a product price quotation. If you
are new to purchasing from BBI please contact Customer Services firstname.lastname@example.org.
BBI carries stock of most of the listed products however some specific products are made to order please contact your account manager for specific up to date stock information. If a product is not
available from stock, then the preparation will need to be scheduled. It is essential to ensure forecasts are communicated to BBI in good time (at least 6 months’ notice) to ensure material is available.
Stock can be reserved for a maximum of 3 months pending testing of samples.
These requests can be sent directly to your designated account manager who will be happy to advise of current stock availability and advise on appropriate samples. For products ordered from stock or
against an approved sample orders can be sent directly to email@example.com who will direct your request appropriately.
Our products are fully tested for quality and prepared in ISO 13485:2016 controlled laboratories however in the unlikely event of having an issue with the product performance we will endeavour
to find a satisfactory resolution. In the first instance contact your account manager who will advise on the course of action to resolve any issue.
How are our Diabetes and Renal biomarkers produced?
BBI derives its Diabetes and Renal biomarker products from either native human tissues or they are produced by molecular methods expressed in specific host organisms. Where the source material is human biomaterial, we procure this from regulated sources with our approval to store the tissue under our government issued human tissue authority licence. All human derived source material is always screened for viral safety for markers such as HIV, Hepatitis B and C prior to use.
Antigens are either expressed from stored cell lines in our cell proliferation systems or derived from human biomaterials. They are isolated using a range of techniques, usually a specific set of optimised chromatography steps to purify the specific protein. A wide range of techniques are used for initial isolation including salt precipitation, dialysis, hollow-fibre and tangential flow filtration.
Some of our recombinant products are expressed with specific His-tag sequences to facilitate purification by Nickel chelate affinity chromatography. Other materials are purified by a series of different chromatography techniques including Ion exchange, ligand affinity, hydrophobic interaction, size exclusion and immunoaffinity. The purified proteins are then formulated liquid or lyophilised in the most appropriate stabilising buffer and filtered to 0.2µm to ensure low bioburden. Products are characterised prior to fill to determine the recovery and purity of the protein using a range of analytical techniques.
Immunological recovery is tested using specific immunoassays standardised against reference preparations. Where practical, BBI will offer to define the recovery on a specific IVD platform immunoassay system such as the Siemens Immulite or, specifically for our HbA1c, the DCA Vantage system. Techniques such as Coomassie stained SDS-PAGE and HPLC chromatography are used to test and verify the product purity. After the products have been filled and formulated, they are retested by our independent Quality Control laboratory to verify the analytical results and define the biological integrity.
BBI has a range of specific Renal biomarker and Diabetes critical raw materials which are supplied as standard products from stock, plus there are several products that we make to order. As we are the manufacturer, we can provide the most cost-effective solution for our clients. Most products are supplied as highly purified or part-purified preparations. Some of our clients require specific high purity proteins and, in some cases, we offer our ultra-pure grade for use as immunogens. For these materials trace impurities are removed by immunoaffinity absorption using an affinity resin coupled to Antiserum to normal human serum. Testing of the ultra-pure grades includes assessment using immunoelectrophoretic techniques.
HbA1c for Diabetes
Our HbA1c products are prepared from normal human red blood cells and are formulated to be blended in specific ratios to create HbA1c solutions spanning the testing range for all immunological HbA1c testing applications.
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