Antibody- and oligonucleotide-based therapeutics are reshaping modern medicine, providing a means to target previously 'undruggable' conditions with fewer side effects and deliver personalized treatment for patients facing conditions that currently lack effective therapies.

However, the development of these novel modalities presents significant analytical challenges in ensuring their safety and efficacy. Addressing issues such as impurities, structural variability, and instability requires the use of sensitive, high-throughput analytical techniques to maintain effective quality control throughout the bioproduction process.

In this interactive resource, created in partnership with Shimadzu, we provide an application-based guide to analyzing antibody- and oligonucleotide-based therapeutics across the biopharmaceutical development pipeline.

Read on to explore how cutting-edge chromatography and mass spectrometry tools, cell culture media analysis platforms, and informatics software can support each production stage – from cell culture optimization to final product characterization.

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Shimadzu shares the journey of one of its customers CatSci Ltd, a UK-based company that provides process chemistry, analytical, pre-formulation and oligonucleotide solutions for drug development. Hear how CatSci's new laboratory is equipped with the latest technology from Shimadzu including HPLC/UHPLC, LCMS, GC and GCMS instrumentation, all controlled via LabSolutions CS software, giving 21 CFR Part 11 compliance.

Most biologics, such as monoclonal antibodies, are produced using living mammalian cells, requiring careful optimization of cell culture processes. To achieve optimal cell growth, harvesting, and purification, it is essential to monitor key medium conditions. These can include sugars and sugar nucleotides, glutamine, and other vital compounds such as vitamins, nucleic acids, and primary metabolites.

One effective approach for optimizing the cell culture process is monitoring the cell culture supernatant, which offers a comprehensive view of cell culture health. Shimadzu’s newly developed C2MAP system provides an all-in-one cell culture media analysis solution, combining automated pretreatment with LC/MS/MS technology. With several method packages available, the C2MAP system enables users to monitor various cell types, including pluripotent stem cells (iPS and ES), mesenchymal stem cells, and antibody-producing cells, supporting a more efficient and robust bioproduction process.

In the resources below, learn more about Shimadzu’s C2MAP system and see how LC-MS/MS and ICP-MS can be used to simultaneously measure organic and inorganic components in culture medium, helping to identify metabolic pathways linked to antibody production.

The production of antibody-based therapies, such as antibody-drug conjugates (ADCs), bispecific antibodies, and other antibody analogs, involves the use of animal cells, which presents unique challenges in achieving structural homogeneity compared to chemically synthesized small molecule drugs. Consequently, these biopharmaceuticals demand rigorous quality control measures at every stage of production.

In this section, explore various analytical methods for quality control of antibody drugs and ADCs, along with optimization tips tailored for different samples and analytical conditions. Additionally, discover how the Nexera XS inert UHPLC and Nexera Lite inert HPLC systems, designed to handle high salt concentrations, deliver stable data for antibody drug analysis and other applications utilizing mobile phases with corrosive salts.

How can you accelerate the development of therapeutic drug candidates while also reducing their cost?

The global AI-driven precision medicine company Exscientia, headquartered in Oxford, UK, thinks it has the answer. Hear how they have recently collaborated with Shimadzu to further automate the discovery process with an aim to synthesize and purify new drug candidates in super-fast time.

The Nexera XS inert from Shimadzu Corporation can be paired with any of the companion systems and software below to create a unique platform for the analysis of antibody and oligonucleotide therapeutics: