Custom antibody development FAQs
            
                        
            
                        
        
                        
        
                        
            
            
                                        
                
                                    
                    
                        
                        
                        Answers to some of the most common questions about our custom antibody generation services.
                        
                    
                                           
                            
                        
                                
                        
        
                        
                            
                        
                
                                
                
                        
                    
                        
                        
                        Overview

                        What services do you provide?
                        We provide comprehensive solutions for custom antibody development, with the ability to go from initial target evaluation through to delivery of purified fit-for-purpose antibody for research, diagnostic or therapeutic application.
                        We have highly experienced teams dedicated to antibody discovery for custom projects. We design and execute tailor-made discovery and selection strategies to generate and select binders that meet your desired antibody specifications.
                        What platforms do you use for custom antibody discovery?
                        We will utilize the most appropriate technology dependent upon the target of interest, antibody requirements, and customer timelines.
                        We have comprehensive antibody discovery platforms that we deploy as required to achieve the goal of each custom antibody discovery program.
                        Why rabbit?
                        The unique features of the rabbit immune system make it ideal for antibody generation, particularly to challenging targets.  Rabbits generate an expansive B-cell repertoire due to reliance on a gene-conversion mechanism in concert with somatic hypermutation during B-cell development. 
                        The rabbit’s immune system supports the generation of a diverse selection of antibodies that can differentiate between even the most subtle structural variants, such as post-translational modifications, point mutations, and epigenetic targets. The diverse epitope recognition found in the rabbit also helps in identifying high-sensitivity antibody pairs. Additionally, rabbits possess a single subclass of IgG, removing the need for isotyping and allowing direct comparison of candidates at an early stage in screening cascades.
                        Can you give more information on your different platforms?
                        RabMAb antibody discovery
                        Hybridoma-based
                        • Our RabMAb antibody discovery platform is built on rabbit hybridoma technology to generate highly specific, recombinant antibodies.
                        • Use of our proprietary rabbit fusion cell line increases the stability of the resulting hybridoma lines compared to standard heterogenous myeloma production.
                        • The number of target-specific clones that meet challenging selection criteria is maximized in our selection process, via both B-cell enrichment and the broad epitope diversity delivered by the rabbit immune response.
                        • Sequencing positive hybridoma clones at an early stage in the selection process allows us to accelerate the selection process and allows you to test a range of sequence-unique clones to generate a final fit-for-purpose recombinant antibody.

                        B-cell cloning
                        • The second arm of our RabMAb discovery platform interrogates circulating or splenic, high-secreting B cells, likely plasma cells to identify high affinity antibodies, faster. 
                        • Peripheral blood cells (or lymphoid residing cells) are isolated and the recombinant antibody product is selected from antigen-binding candidates. 
                        • Initially, oligoclonal recombinant Ab pools are screened, followed by molecular subcloning to ensure monoclonality of the final recombinant antibody.

                        Next-Generation Sequencing
                        • Our proprietary NGS platform, with full bioinformatic analytic support, builds upon the diversity of the rabbit immune system, enabling mining of the breadth and depth of the immune response, to give a bioinformatic blueprint of target-reactive recombinant antibodies.
                        • Maximum antibody diversity and rare antibody clones with specific binding characteristics can be identified through analysis of the full immune repertoire.
                        • Optimal antibody selection can be performed, with native light and heavy chain pairing, using our single-cell sequencing and proprietary bioinformatic platform.
                        • NGS is well-suited for combination with recombinant RabMAb approaches to allow lineage mining for discovery and optimization on especially challenging targets or needs.

                        Phage display
                        If an in vivo approach to antibody generation can’t be used, e.g., the target is toxic or non-immunogenic, we can combine our phage display technology with our other antibody discovery platforms to generate highly sensitive and specific antibodies for your needs.
                        • Phage display utilizes high-diversity libraries based on human-derived sequences in a single-chain variable fragment (scFvs) format.
                        • Diversity and target specificity of the selected clone can be maximized using our proprietary affinity maturation technology. 
                        • Pre-existing Ab can also be engineered using this technology to give enhanced performance.
                        • The scFv are converted to IgG for provision.
                        How do you select antibodies that meet my specific requirements?
                        In addition to selecting the optimum antibody discovery platform (or combination of platforms), tailor-made assay cascades are designed for each custom antibody discovery project.
                        Our assay cascades detail the screens and any application-specific tests that will be executed to ensure identification of the best antibody for your specific requirements in terms of selectivity, sensitivity and application performance.
                        Can you give examples of the types of assays/ testing that can be performed during a custom project?
                        Assay capabilities
                        (including but not limited to)
                        • Homogeneous high throughput biochemical binding assays (TR-FRET)
                        • High throughput pair finding
                        • LOQ/LOD determination
                        • Matrix Tolerance Assay
                        • Ligand/receptor neutralization
                        • Functional assays
                        • Cell-based binding assays
                        • Reporter assays and competition assays
                        • Internalization assays
                        • ADCC reporter assay

                        Application-specific screening
                        • ELISA
                        • Western Blot
                        • IHC
                        • ICC
                        • Flow cytometry
                        How are your antibodies produced?
                        All our custom antibodies are sequenced, cloned, and produced in a recombinant system. This ensures high antibody yields, batch-to-batch consistency, and sustainable long-term supply.
                        What can your antibodies be used for?
                        We can produce antibodies for use in research, diagnostics* and as therapeutics*.
                        In the IVD space, we have agreements in place with several leading IVD manufacturers, that enable us to act as a single point of contact to transition reagents from research onto multiple IVD platforms.
                        More details on our partnership strategy can be found here.

                        What quality systems do you have in place?
                        Our RabMAb antibody manufacturing site is ISO 9001:2015 certified and all other sites work to these standards.
                        Our In Vitro Diagnostics (IVD) group is registered with the USFDA and operates under USFDA Quality System Regulation (21 CFR Part 820) and in compliance with ISO 13485:2016. This facility and its quality system have a Medical Device Manufacturing License granted by the California Department of Public Health (CDPH).
                        What is the timeframe for developing a custom antibody?
                        The timelines for custom antibody development are dependent upon the complexity of each project and the technological and engineering requirements needed to identify an antibody that meets the specific end-user needs.
                        The approximate timeframes for antibody development and delivery of a purified antibody are in the range of 5-9 months, including NGS services, with indications of success from as early as 2 months.
                        What kinds of antigens/immunogens can you use?
                        We routinely work with a wide variety of immunogens including
                        • Recombinant protein
                        • Peptide (+/- post-translational modification)
                        • Over-expressing cell lines
                        • Small molecules (such as nucleotides, organic chemicals, eg PEG)
                        • Toxins
                        • Polysaccharides
                        How much does it cost to develop a custom antibody?
                        The costs for custom-antibody generation are dependent upon project requirements. 
                        A costed proposal is developed on a case-by-case basis and will be discussed with you before the project starts.
                        Will the antibody be sold on Abcam’s catalog?
                        For some customers, it can be beneficial to have their specific reagent validated by our global customer base and it is possible to agree commercial terms that will allow the reagent to be included in our portfolio for Research Use Only.
                        Do you support GMP production?
                        We can support antibody and assay development to a GMP-ready position and then work with you to transfer your antibody to a partner for GMP manufacture.  We can also support GMP manufacture for use in immunohistochemistry.
                        Can you support the engineering of the antibody?
                        Following discovery, if appropriate, we can support a variety of antibody engineering options, including:
                        • Fc switches
                        • Removal of manufacturing sequence liabilities
                        • Enhancements to Tm
                        • Full engineering of properties via generation of phage display variant libraries, with tailor-made selection and assays to select for required improvements.

                        Can antibodies be humanized for therapeutic purposes?
                        Several RabMAb antibodies have been successfully humanized for therapeutic use. We work with a partner organization to carry out humanization on a case by case basis. 
                        We also support CDR grafting to selected frameworks, using phage display as an intermediate to confirm engineered Ab performance.

                        *Subject to commercial terms and conditions. Please contact partnerships@abcam.com for more information.
                        
                    
                                           
                    
                        
                        

                        
                    
                        
                    
                        
                        

                        
                    
                        
                        
                        
                            
                        
                        
                                            
                    
                        
                        

                        
                    
                                              
                            
                        
                                
                        
        
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