E-Book | July 1, 2025

Face The Unknown: Efficiently Select Your Antibody Or Antibody Variant Purification Strategy For Elevated Safety And Efficacy

Source: Cytiva
GettyImages-1076055404 chromatography, purification

Antibody therapeutics have undergone decades of development and now represent the largest and most established class of biotherapeutics in the pharmaceutical industry. A pivotal moment in this field occurred in 1986 with the FDA’s approval of muromonab-CD3, the first monoclonal antibody (mAb) therapy to reach the market. Since then, the field has expanded dramatically, moving beyond traditional monoclonal antibodies to include a diverse array of engineered antibody variants. Today, approximately one-quarter of antibody-based molecules in the development pipeline fall into this category. These include multi-specific and bispecific antibodies (BsAbs), antibody fragments, and antibody-drug conjugates—each offering unique mechanisms of action and therapeutic advantages. Several of these next-generation antibody formats have already received regulatory approval for a range of indications, which demonstrates their clinical value and commercial viability.

This ebook explores the evolving landscape of antibody therapeutics, with a particular focus on strategies for developing and optimizing purification protocols. As antibody formats become more complex, so too do the challenges associated with their production and purification.

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