Day One (13th May 2025)Tuesday, 13 May 2025 - CET/CEST (Cent Europe Summer, GMT+2)

For decades, affinity purification platforms like Protein A and Protein L have been essential in the manufacturing of therapeutic monoclonal antibodies. However, the emergence of engineered modalities such as bispecific antibodies, fragments, and Fc-fusion proteins presents new challenges in downstream processing. To overcome these obstacles, affinity chromatography resins targeting specific antibody subdomains offer a promising solution for purifying these novel formats. This advancement is critical for enhancing the commercial manufacturing of next-generation antibody therapeutics.

This presentation will demonstrate how the Thermo Fisher CaptureSelect portfolio can be utilized as a versatile toolbox for the affinity purification of highly engineered antibody molecules, supported by real industry case studies.

Current cell therapy manufacturing sciences are evolving rapidly to enable more reliable and faster scale-up and scale-out of lab-based processes to GMP manufacturing. The key challenge is striking a balance between significantly reducing time-to-market and integrating as many commercialization solutions as possible into the process. In this review, we share key lessons learned from recent engineering and GMP runs, highlighting the impact of automation and process modeling in enhancing readiness for final product supply.

Characterizing products and bioprocesses is critical for R&D and manufacturing of biologics, e.g., mAbs or viral vectors. Evolving product complexity and regulatory demands are dictating the use of advanced bioanalytics. This study outlines an MS-based Multiple Attribute Method (MAM) strategy for post-translational modifications (PTMs) assessment of mAbs and adeno-associated viruses (AAVs) and host cell protein (HCP) profiling. Bioprocess parameters impact on product attributes and process-related impurities was assessed.

MAM enabled the profiling of key PTMs like glycosylation, oxidation, and deamidation. Using DIA-SWATH we quantified targeted high-risk HCPs and other relevant ones. These results defined the best design space, maximizing product quality and purification performance of our polishing platform.
We applied a MAM workflow to several AAV serotypes achieving a MS/MS coverage >95% of capsid viral proteins. PTMs identified (oxidation, deamidation, phosphorylation) were aligned with literature reports. Ongoing HCP profiling aims to improve further bioprocess understanding.

High-sensitivity and high-resolution MS-based approaches, namely MAM, are emerging as leading tools for biologics R&D and QC. These analytical solutions are being applied to characterize established biotherapeutics, e.g., mAbs, but also hold promise for more complex biologics, like AAVs, currently a major focus in gene therapy clinical trials.