Since our foundation we have evolved from a provider focused on antibodies for research-use only, to a global proteomics pioneer identifying, developing and manufacturing biological reagents and assays for the research and clinical communities.
We have invested in innovative platforms and technologies, high throughput automated systems, award-winning validation and quality initiatives, and a world-leading team of specialists, including immunologists and cell engineering experts, to enable antibody discovery, development and characterization at scale.
1. Recombinant protein platform
Production of high-quality antibodies starts with developing the best quality protein antigen with the desired conformation and modifications (e.g glycosylation, phosphorylation, acylation). To do this we choose between two different expression systems; mammalian cell or bacterial (E. coli). We then rapidly screen for optimum protein expression conditions and levels using automated processes. High throughput analytical tools, including mass spectrometry, confirm protein quality at the molecular level ahead of starting antibody discovery or scaling up for volume production.
2. Recombinant antibody discovery and development platform
Antibody discovery and development is the process of creating, selecting and characterizing an antibody. Antibody discovery begins in one of two ways, either in vivo by injecting the antigen of interest into a host allowing the immune system to naturally develop a wide variety of antibodies from which the most effective binding antibody is selected, or in vitro by using a phage display library approach.
Antibody discovery can be challenging depending on the nature and complexity of the target of interest and the application for which it is being developed. Our comprehensive antibody discovery platform gives us the ability to tackle and successfully develop antibodies against even the most challenging of targets.
Our in-house development efforts are focused on generating antibodies that combine the high affinity and specificity of rabbit immune system with the consistency of the recombinant format. This approach creates recombinant rabbit monoclonal antibodies (recombinant RabMAbs®) that are specific and very sensitive to the target molecule of interest. Being recombinant means that the resulting antibody can be repeatedly manufactured in vitro ensuring lot-to-lot consistency and enabling long-term security of supply. In addition this recombinant format means that they can be genetically engineered to add epitope or molecular tags and other sequences to match applications.
We have delivered custom-engineered antibodies using proprietary RabMAb technology for over 2000 collaborative projects and have over 20,000 recombinant RabMAbs in our portfolio.
To find the best binders early, antibody discovery requires an individualized assay cascade designed for the target of interest. Broadly consisting of a primary screen, secondary screen, and application-specific testing, the more extensive and well-designed the cascade, the better the chance of finding and developing the best antibody. At each step we apply more precise tests, but we always ask: is this the right test, or is there something else we should do? We are constantly innovating and finding better ways to predict performance in the final application.
3. CRISPR gene editing
Every new antibody and subsequent batch are subject to strict QC procedures to ensure that after production a high-quality, reproducible antibody is released every time. Antibody validation is part of this process and it uses specific laboratory tests to demonstrate that an antibody binds to the target protein of interest. To enable effective antibody validation, it is important that we identify the most appropriate experiments to perform, including selecting suitable positive and negative controls to demonstrate the true specificity and affinity of the antibody to the target protein.
Knockout (KO) validation is the recognized gold standard approach to identify off target binding and is a surrogate test for confirming antibody specificity. This robust technique uses CRISPR gene-editing to produce KO cell lines that do not express the target protein thereby providing a “true” negative control in which no binding of the antibody will be seen.
Abcam’s award-winning KO antibody validation initiative has received industry recognition as one of the most trusted validation processes for antibody specificity. With over 2,800 KO validated recombinant antibodies to-date, the initiative was recognized with a 2020 CiteAb award for KO validation.
Our validation strategy is constantly evolving as we adopt the latest approaches and new technologies to assess specificity, at scale.
4. Labeling, conjugation and assay development technologies
While antibodies are excellent tools for seeking and binding to protein targets, over 80% of proteomics research applications requires that a molecular label is attached to an antibody before use. This labeling process, which is known as conjugation, enables a protein target or its binding partner to be visualized, measured or purified, depending on the application.
We have deep technical expertise in both protein conjugation and label development. Our label expertise includes enzymes, metals, short DNA or RNA molecules known as oligonucleotides, and fluorescent dye molecules, which we combine with a broad range of conjugation technologies to create the best fit-for-purpose conjugated antibody for the required application.
Immunoassays are a detection tool that use antibodies to detect and measure an analyte (singleplex) or analytes (multiplex) of interest. These are regularly used in biological research and feature in a large number of the in vitro diagnostic (IVD) medical devices/platforms/instruments.
Leveraging our antibody expertise we have a best-in-class recombinant antibody pair and immunoassay kit development capability and have the largest range of fully-validated, recombinant antibody pairs and immunoassay kits commercially available.
The range and quality of our recombinant pair library allows us to partner with assay and instrument developers making this unique antibody pair content available across multiple commercially available analysis platforms.
Developing and manufacturing to global quality standards
We are committed to following strict global quality control procedures across all of our new product development and manufacturing facilities to ensure high-quality products with consistent lot-to-lot performance for our customers. Our primary new product development and manufacturing site, based in Hangzhou, China, is ISO 9001:2015 certified and all other sites work to these standards. The facility of our IVD group, located in Burlingame, California, is registered as a medical device establishment with the FDA and is subject to the FDA’s Quality System Regulation and in compliance with ISO 13485:2016.