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

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.