With the advent of genetic engineering, it has been possible to develop new methods to obtain monoclonal antibodies, both for improvement with regard to these humanized antibodies and for production models. Advances in molecular and cell biology for the development of more efficient antibodies have allowed advances in diagnostic and therapeutic areas. Such advances have triggered improvements in production processes, allowing for the reduction of production costs and thus leading to an increase in the popularization of treatments with mAbs. All process improvements provide a consistent and reproducible production of large quantities of mAbs at a moderate cost. Large-scale production has revolutionized the market for monoclonal antibodies by boosting its production, making this a more practical method of production. Production techniques have only had a sizable breakthrough due to molecular techniques.

In general, a process of commercial production of mAb begins with the generation of an mAb by immunizing an animal or by molecular biology methods involving the identification and optimization of the coding DNA sequence and the construction and identification of a stable high-producing clone. Improvements in cultivation are similar to those applied in other bioproducts that rely on culturing microorganisms or cells, requiring the development of a well-designed culturing process comprising the full range of control and associated operations that will support technical evaluations.

mAbs production processes in wave or single-use bioreactor (SUBs) are characterized by flexibility and low operating costs when compared to the production processes in fixed stainless steel vats. The development of bioprocesses involving these production platforms can reap greater acceptance by the industry. For example, Leading Biology’s scientists have invented an advanced technology in its platform for Monoclonal Antibody Production & Purification, which has realized high pure antibody fractions with low endotoxin in preparation of the monoclonal antibody by using the cell line. It provides a method for purifying the antibody and a horseradish peroxidase labeling method for the antibody, setting up a stable and effective way for isolation and purification.

Leading Biology with over 5 years of experience in custom antibodies service, we offers numerous benefits for developing your custom antibody service.