[Antibody druggability screening process and evaluation strategy]

Area of Science:

• Biotechnology and Pharmaceutical Sciences
• Immunology and Oncology Therapeutics
• Drug Discovery and Development

Context:

• Therapeutic monoclonal antibody development has rapidly advanced since OKT3's 1986 approval.
• Diverse antibody formats including bispecific antibodies and antibody-drug conjugates (ADCs) are crucial in treating multiple diseases.
• The antibody drug discovery pipeline requires rigorous biological function and druggability assessments.

Purpose:

• To classify and define the critical process of druggability screening and evaluation in antibody discovery.
• To highlight key quality attributes and high-throughput detection technologies for druggability assessment.
• To provide a strategic framework for evaluating antibody drug candidates.

Summary:

• Druggability screening involves drug design, lead molecule optimization, and candidate validation to identify physicochemical risks.
• This evaluation ensures quality stability throughout the antibody drug development lifecycle.
• The process covers various antibody formats like monoclonal antibodies, bispecific antibodies, nanobodies, and ADCs.

Impact:

• Enhances the efficiency and success rate of antibody drug development.
• Provides a valuable reference for druggability assessment of novel therapeutic antibodies.
• Contributes to the reliable development of safe, effective, stable, and scalable antibody-based medicines.