The structural diversity and complex assembly pathways of bispecific antibodies (bsAbs) present significant downstream purification challenges that differ markedly from those of traditional monoclonal antibodies. These challenges include elevated levels of product-related variants such as mispaired species and aggregates, which complicate the purification process. Additionally, certain bsAb formats show reduced compatibility with conventional Protein A-based affinity chromatography, raising concerns about their stability under low-pH processing conditions. As these issues become increasingly critical in clinical manufacturing, adherence to stringent regulatory expectations is paramount.
In an upcoming GEN webinar, Joshua Orchard, a purification applications scientist with extensive experience in downstream process development, will share data-driven strategies for effectively purifying bsAbs. His insights will focus on overcoming unique challenges such as mispairing and aggregation, while also exploring advanced affinity capture techniques that enhance selectivity and process robustness beyond traditional methods.
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