Bispecific Antibody PK And ADA Bioanalysis: An Experienced Approach

By Dr. Tom Zhang, Chief Scientific Officer, Large Molecule Bioanalysis

The recent surge in approvals for bispecific antibodies (BsAbs) underscores their potential to revolutionize therapeutic development. These complex biologics, with their multiple functional domains targeting various disease-related targets, offer a broader range of therapeutic applications compared to traditional monoclonal antibodies (mAbs).

Despite the potential of BsAbs, their complex mechanisms of action pose significant challenges for bioanalytical development. One critical area is determining which drug status (free, partially bound, or fully bound) to measure in pharmacokinetic (PK) studies. Additionally, immunogenicity evaluations require extra effort to identify the specific domain(s) triggering an immune response. This article outlines a strategic approach to address these bioanalytical challenges for BsAbs, ensuring accurate and reliable assessment of safety and efficacy.