Monoclonal Antibodies

Monoclonal antibodies, pivotal in the realm of therapeutic interventions, are delineated into four distinct categories. This classification hinges upon the relative composition of mouse and human antibodies within each type. The intricacies of these categories are as follows:

Murine Monoclonal Antibodies

These antibodies are entirely constituted of mouse antibodies, marking them as wholly murine in origin. Their application, while significant, is often limited by the human immune system’s response to murine proteins.

Chimeric Monoclonal Antibodies

A fusion of mouse and human antibodies, these contain upwards of 65% human antibodies. The process involves the amalgamation of mouse antibodies with human counterparts, resulting in a chimeric entity that is less likely to be rejected by the human immune system.

Humanized Monoclonal Antibodies

Predominantly composed of human antibodies (over 90%), these are crafted by grafting minimal mouse antibody regions onto human antibodies. This method significantly reduces the immunogenicity compared to murine and chimeric antibodies.

Human Monoclonal Antibodies

These are entirely derived from human antibodies. The creation process entails the integration of mouse antibody genetic material into human antibodies, facilitating the production of antibodies without invoking a murine framework.

Furthermore, the advent of recombinant DNA technology has revolutionized the production of monoclonal antibodies. This technique involves the transfer of specific antibody genes into host cells, such as yeast, bacteria, or mammalian tissues, which are then capable of producing the antibody on a large scale. This method, distinct from traditional animal-based production techniques, enables the synthesis of antibodies in a controlled laboratory environment, thereby eliminating the need for animal involvement and potentially increasing the production efficiency and purity of the antibodies.

To advance these products through clinical trials and ultimately introduce them to the market, it is imperative to conduct thorough characterization. This process not only ensures the safety and efficacy of these therapeutic agents but also aligns with regulatory standards, paving the way for their successful commercialization.

What we do:

In vitro Assays: for detailed functional analysis: neutralization capacity, ADCC, CDC, ADCP, Ig isotype and subclass characterization, affinity, and Fc Glycosylation profile
Cell Line Development: for efficacy and safety assessment.
Animal Models: Predominantly composed of human antibodies (over 90%), these are crafted by grafting minimal mouse antibody regions onto human antibodies. This method significantly reduces the immunogenicity compared to murine and chimeric antibodies.
Pharmacokinetic and Toxicology Studies: to define optimal dosing and safety profiles.

We analyze mAbs for antiviral and anti-bacterial activity, tumor activity, bocking activity (e.g., cytokines).