Autoimmune and Inflammation Markers
For our European customers please contact your BBI sales representative or reach out to our customer services team. For our US and Asia customers you can also contact your BBI representative for support however sales enquiries, where relevant, will be routed through a local representative. In the US for DIARECT catalogue products, these should be ordered from our US distribution partner Surmodics.
Upon receipt, our antigens / antibodies should be stored frozen at - 70°C or below until use. We recommend thawing at room temperature, but thawed products should not remain at room temperature for extended periods of time. Mix products gently before use. If you plan on using only a portion of the product, please thaw and dispense it into aliquot volumes that are most practical for your application and store frozen at - 70°C or below. Please note that we cannot guarantee the shelf life after the antigens / antibodies have been re-dispensed and adviceagainst repeated freeze thaw cycles.
While general recommendations for antigen / antibody storage conditions and buffers are given in the antigen's / antibody's specification sheet, which can be found in the “+INFO” section associated with each antigen / antibody on DIARECT's website, the detailed buffer composition is available together with the lot-specific Certificate of Analysis (CoA).
No, we do not recommend using antigens / antibodies without a guaranteed cold chain. If you receive a thawed product please inform our customer service immediately. Regarding dry ice shipments please visit section "shipping information" on our website for detailed information on temperature
For each antigen / antibody, DIARECT created a “+INFO” section on its website, which contains the antigen's / antibody's material safety data sheet (MSDS) and specification sheet. The latter provides general recommendations regarding antigen / antibody storage and buffers. For select antigens / antibodies, the “+INFO” section also contains a brochure offering some background information and immunological test data. You can also contact your local representative or firstname.lastname@example.org for more details.
Most of our antigens have a guaranteed shelf life of five years unless otherwise noted on our Certificates of Analysis (CoA) and data sheets, and providing that they are kept frozen at -70°C or below. For the shelf life of our antibodies, please check the expiry date on the lot-specific CoA provided with the product.
We guarantee the reservation of a specified amount of antigen(s). Typically, customers reserve the amount of antigen(s) needed for a manufacturing period of up to 18 months. You simply inform us of
your antigen requirements for this period, and every 4 months you will receive an updated overview regarding the accuracy of your estimate. The reservation system also includes the allocation of early
enough samples of new lots of the respective antigen(s). This enables the customer to evaluate the new lot at an early stage for future reservations and allows a smooth transition to this new lot.
Advantages provided by DIARECT's reservation system:
- Security of supply with no additional costs
- No need for continual readjustment and fine tuning of your assay because of new antigen lots
BV and Ec represent the type of expression system that was used to produce the antigen of interest. BV stands for DIARECT's baculovirus/insect cell expression system, while Ec stands for DIARECT's E. coli expression system.
For purification, the preferred technique is the very effective, yet gentle immobilized metal-ion affinity chromatography (IMAC) in combination with His-tag technology, which yields physiologically and
immunologically active proteins. Our native proteins are purified using appropriate standard chromatography purification methods including ion exchange, size exclusion and immunoaffinity.
DIARECT's recombinant and native antigens / antibodies - always produced according to documented procedures (SOPs) and manufactured per EN ISO 13485 and 9001 standards - undergoing a rigorous series of tests in our quality control laboratory. Prior to its approval and release, each lot is subjected to various biochemical and immunological analyses to assure conformance to our strict product specifications. The goal of these extensive inspections is to ensure lot-to-lot conformance, which guarantees consistent results.
General information regarding the origin and expression constructs of antigens are provided in the respective specification sheets, however, exact sequence data are considered proprietary information. Most recombinant antigen preparations are supplied with a 6xHis-tag as part of the sequence.
DIARECT antigens are manufactured in our EN ISO 13485 and EN ISO 9001 audited facility in Freiburg, Germany. Supply is either direct from our Freiburg facility or may be managed by our local representatives in specific territories.
Why choose Autoimmune antigens from BBI Solutions?
BBI and our scientists in Freiburg are world renowned for providing a comprehensive and high-quality range of autoimmune antigens. Many of these antigens are reference materials for some rare and important disease assays.
Our autoimmune antigens are used in many primary screening methods for determination of the specific target for a serological autoimmune response. The company objective has been to derive an extensive list of targets for specific disease states where high specification and highly reproducible products are required to give the best performance across different assay platforms including ELISA, microarray and line assay.
In addition, BBI supply a comprehensive range of serum biomarker indicators of inflammation such as CRP and Procalcitonin. These materials are routinely used as critical reagents to prepare IVD assay standards and quality control materials. BBI derives its range of autoimmune antigens by molecular methods and the proteins are expressed in specific host organisms. The host cell lines are stored and propagated in our bioreactor systems. Some of our recombinant products are expressed with specific His-tag sequences to facilitate purification by nickel chelate affinity chromatography.
Some of our inflammation biomarkers are isolated as native products from human plasma or tissue sources. All human derived source material is always screened for viral safety for markers such as HIV, Hepatitis B and C prior to use. These native and untagged products are purified by a sequential series of different chromatography techniques. The purified proteins are then formulated liquid or lyophilised in the most appropriate stabilising buffer and filtered to 0.2µm to ensure low bioburden.
Quality embedded at every step of the way
Products are characterised prior to fill to determine the recovery and purity of the protein using a range of analytical techniques. Techniques such as Coomassie stained SDS-PAGE are used to test and verify the product purity. Importantly, our autoimmune markers for serological applications are tested against a defined panel of patient samples. The immunological recovery of our inflammatory biomarkers is tested by established immunoassay methods.
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. Materials are stored and shipped from our Sittingbourne or Freiburg facilities.
Materials produced at our Sittingbourne facility are shipped directly to all our customers in all territories worldwide.
Antigens prepared at our Freiburg facility are supplied directly to clients in Europe and non-China Asia territories.
For customers in America and China, our Freiburg antigens are distributed through our carefully selected and highly reputable partners.
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