Discover Custom Antibody and Immunoassay Development Solutions

Contract Antibody Development, Manufacturing, Purification, and Cell Banking for Immunoassays How partnering with an antibody production expert can improve your assay, accelerate launch, and maintain your manufacturing. Antibody development for diagnostic immunoassays Antibody-based disease biomarker detection powers many of the diagnostic tests in use today. Despite its venerable 40+ year history in diagnostics, antibody development, scale-up and mass manufacturing for assays remains a complex process with many pitfalls and restarts. Part of the challenge is that the skill sets needed for each of the three main steps: Antibody Development, scale up, and manufacturing are considerable and different, requiring the assay commercialization team to master diverse technologies and techniques. Further, the commercialization team is faced with decisions on outsourcing parts of the process or investing in in-house expertise and capital expenditures. Often, when the immunoassay project has narrow performance specifications or tight launch deadlines, seeking out experienced development support is prudent. Fortunately, advanced technologies in the hands of antibody and assay development experts are improving the immunodiagnostic process. In this paper, we take you through key steps in the modern antibody development process for diagnostic assays using advanced technology. By simplifying cell line development, scale up and antibody manufacturing with a partner who understands diagnostic immunoassay development we can supplement your IVD capabilities and shorten your time to commercialization. Antibody & Immunoassay Development The sensitivity, consistency, and reliability of immunoassays, as well as their manufacturing cost, is heavily dependent on the quality of the antibodies used. Despite the use of antibodies to identify disease antigens since the 1890’s, the production of antibodies, from immunogen design to immunoglobulin purification remains a formidable process requiring significant expertise from the beginning. For many antigen targets, care must be taken to design linear or 3D immunogens for optimal antibody avidity against natural epitope structures. Polyclonal & monoclonal antibody development Until the recent development of recombinant technologies, the classical methods to produce polyclonal and monoclonal antibodies relied on an animal's immune response when exposed to a selected antigen. For polyclonal antibodies, a given antigen is introduced into an animal to elicit it's immune response. The collected plasma will contain a blend of antibodies produced from several clones. All antibodies are directed toward the same antigen but will recognize different epitopes. Monoclonal antibodies take this process further by isolating a single B cell that is then merged with a human myeloma cell line, to create a hybridoma cell line, which will consistently produce the exact same antibody using in vitro or in vivo production vector. The Life Science business of Merck operates as MilliporeSigma in the U.S. and Canada. SLS_DX_WW_51628_Custom Antibody White Paper_MRK.indd 1 SLS_DX_WW_51628_Custom Antibody White Paper_MRK.indd 1 10/11/23 1:42 PM 10/11/23 1:42 PM2 Both techniques have challenges: • Scalability: Milligram quantities are accessible, but gram or kilogram amounts become difficult because too many animals could be needed. • Responsiveness: Both methods rely on immune system response, which needs time. When a quick turnaround is needed (i.e., for rapid development of assays) this is not the best option for robust antibody production. • Biological variability: Lot-to-lot inconsistency for polyclonals is common due to considerable variability in each animals' immune response. • Even monoclonals are not always 100% monoclonal: The clone selection process is imperfect science and can sometimes lead to multiple clone selection, resulting in manufacturing of antibodies able to recognize several epitopes. This can be a problem when a high level of specificity is required from the antibody. • AG drift: Shift in antigen recognition after too many clone cell culture productions could result in changes to the antibody's specificity. • Production efficiency: There are limitations in scale but also in animal species. • Animal welfare constraints: Polyclonal and monoclonal production requires considerable animal usage through animal immunization and subsequent sera collection or the use of fetal bovine serum (FBS) in cell culture media, respectively. Recombinant antibody development The emergence of recombinant protein technologies has provided an efficient and sustainable approach to antibody development. Although the approach requires considerable expertise, from a technical standpoint, recombinant antibodies production present many advantages: • Scalability: By scaling the size of a bioreactor, antibody quantity requirements can be met more easily. • Efficiency: Optimizing the recombinant protein expression system increases the cell line production efficiency. • Reproducibility: By controlling the genetic code it is easier to ensure the antibody's consistency. • Species flexibility: Antibodies can be created in species that are not able to be used as a host in traditional methods. • 100% monoclonality: By engineering the DNA, there is much tighter control of the antibody's specificity. • Sustainability: Recombinant antibody production utilizes an animal free media to produce large quantities of antibodies for commercial applications. Support from Us Partnering with a comprehensive expert in antibody design, development, and manufacturing is an increasingly viable business decision in creating a firm foundation for your immunoassay commercialization. Merck has been providing the research and diagnostics community with precision antibodies since the 1980’s. With a 90K+ Product Portfolio and 400 new products developed per year, their experienced and dedicated R&D team has developed an extensive range of custom antibody. In recent years, we have been using Recombinant Antibody technology to create the next generation of research antibodies and engineered custom antibody development for commercial partners. With dedicated ISO certified, GMP-guided IVD Antibody Innovation Centers in Rocklin, CA, USA and Livingston, Scotland we have the expertise to support your antibody development at any stage.