Antibodies, also known as Immunoglobulins (Ig), are an important subgroup of therapeutic proteins. They come in several variations - IgA, IgD, IgE, IgG and IgM - among which, IgG is the most frequently used for therapy today. While classical antibody drug products comprise the entire antibody including its antigen-binding site and the Fc part, other types of antibody-related products have been developed with diverse designs, for therapeutic and diagnostic purposes. These include:

• Fab fragments, utilizing only the antigen binding fragment
• Fc-fusion proteins, where an Fc part is coupled to e.g., a receptor
• Bi- or tri-specific antibodies, which can bind to multiple antigens
• Single-chain variable fragments (scFv), employing only the variable part of the Fab fragment
• Nanobodies, also called single domain antibodies (sdAb), which only use the variable part of one antibody domain

Binding affinity and specificity

The fundamental function of an antibody and antibody-related product is to bind a designated target with high specificity and affinity. The structural and chemical integrity of the molecules are crucial for their function. During drug product development, Coriolis applies phase-appropriate and stability indicating methods to assess the physical and chemical integrity as well as binding affinity. Our expert scientists apply tailored forced-degradation studies to reveal critical degradation pathways, so your drug product remains effective and safe until application.

Aggregation and particle formation

Antibodies and antibody-related products are –like other proteins – prone to aggregation. While the presence of a small number of aggregates may be uncritical, aggregation and the formation of protein particles indicates a stability problem or issue with the formulation. The presence of aggregates and particles may also negatively impact the safety of the therapy through unwanted immunological side effects. That’s why we include a comprehensive set of analytical techniques during drug product development and trouble shooting.

Coriolis is your partner with scientific excellence

With 14+ years of experience in drug product development for full-size antibodies as well as antibody-related products, Coriolis is your expert partner of choice. We consider the individual aspects of your development program or analytical challenge and tailor our services to your need. Together, we can make future therapies available to patients and improve the quality of life for humankind.