Monoclonal antibodies (mAbs) have emerged as powerful therapeutic agents for treating a variety of conditions, including cancers, autoimmune diseases, and chronic infections. Their ability to target specific antigens makes them ideal for precision medicine, and they continue to play a significant role in both drug development and biological research. Given their therapeutic importance, maintaining the structural integrity and functionality of mAbs throughout the purification process is crucial.
Protein A Chromatography: A Key Approach for Monoclonal Antibody Purification
Protein A chromatography is particularly effective for purifying mAbs from host cell proteins (HCP), viruses and DNA, given its strong affinity for the Fc region of immunoglobulins . In downstream process platform for mAb production, protein A chromatography platform is mostly used for chromatographic capture step.
Despite its widespread use, traditional protein A chromatography poses challenges, particularly in the elution phase. Conventional methods rely on altering the pH or ionic strength of the elution buffer to release bound antibodies. This often exposes mAbs to low pH conditions, which can induce protein aggregation and loss of functionality , . Studies have shown that exposure to acidic pH during elution results in denaturation, increasing aggregation risks and reducing the yield of active antibodies by as much as 20-30% 2,3. This aggregation not only affects the stability of the therapeutic product but also requires additional processing steps to remove non-functional aggregates, driving up costs and process complexity. Additionally, the pH shift during the elution step necessitates a buffer exchange process to restore optimal conditions for the antibody, which can lead to a lower concentration of IgG1.
Our Approach: Digital Membrane Chromatography (DMC) with our PrA Membrane Adsorber
Our DMC elution method enables gentle and rapid purification of mAbs from protein A through electrical potential. For that i3 DMCPrA Membrane Adsorber are needed. The Membrane Adsorber is equipped with high capacity Protein A membrane. Electrical potential can be applied through an ultra-thin gold conductive layer and four contact elements for seamless connection to our i3 DMControl Smart Control Unit. With no additional buffer exchange required, DMC makes the purification process more efficient, maintaining a stable environment that significantly reduces aggregation risks and enhances recovery yields.