The manufacturing process for antibody drugs can be roughly divided into the following steps.
1. Antibody Selection and Design
2. Generation of cell lines
3. culture
4. Isolation and purification
5. Formulation and quality control

First, antibodies that target specific antigens of the target disease or pathogen are selected and then typically modified through genetic engineering approaches to create antibodies that are sufficiently effective and have few side effects. For example, humanization of antibodies is a commonly used modification. Antibodies derived from animals such as mice can potentially trigger an immune response in the human body, so they are humanized using human genes . In this process, the parts of mouse-derived antibodies that specifically bind to antigens (variable regions) are maintained, while the other parts (constant regions) are replaced with human antibodies. be made to improve productivity in cell culture and to facilitate the purification process .

A cell line capable of mass-producing the selected antibody is created. Typically, CHO (Chinese Hamster Ovary) cells are used. Cells transfected with the desired antibody gene are grown, and those capable of stable mass production of the antibody are selected. engineered antibody gene is introduced into cells using a viral vector or transposon. At this stage, the efficiency of antibody production is confirmed and the optimal cell line is selected.

The selected cell line is then cultured on a large scale to produce large amounts of the antibody. This process is carried out in large vessels called bioreactors, where conditions are strictly controlled to ensure that the cells have an optimal environment to grow and secrete the antibody. The amount of antibody produced per unit of culture medium is called the titer. In recent years, the amount of antibody produced per liter has reached a high titer of 1 to 10 g/L. Since improving titer is extremely effective in reducing production costs, designing antibody genes and establishing cell lines to achieve high titers have become important research themes.

After cultivation, the antibodies are collected from the culture medium and the desired antibodies are isolated and purified, which requires advanced techniques using chromatography and filters. Cellufine, manufactured and sold by JNC, is used in the chromatography process. Chromatography is a separation and purification process to separate the produced monoclonal antibodies from cell line-derived proteins and impurities. Methods such as affinity chromatography and multiple types of ion exchange chromatography are used. JNC sells Cellufine SPA-HC for protein A chromatography, and multiple types of ion exchange chromatography, such as Cellufine MAX GS and Cellufine MAX Qh. Antibody drugs require the purification of high-concentration monoclonal antibodies. For this reason, chromatography packing materials must be highly adsorbent and highly pressure-resistant.

Purified antibodies are then formulated into a form suitable for administration to patients. At this stage, additives are added to maintain stability and efficacy, and the product is adjusted to the appropriate concentration. Strict quality control is also performed to ensure the product maintains consistent quality. In particular, recent improvements in cell culture have made it possible to produce high-titer monoclonal antibodies. However, the higher the titer, the more likely it is that antibody aggregates will become a problem. Antibody aggregates can reduce the efficacy of the drug and cause side effects. JNC has discovered that Cellufine MAX GS and Cellufine Phenyl EX can efficiently remove antibody aggregates. These unique chromatography packing materials are used in manufacturing processes where antibody aggregates are a problem.

The manufacturing of antibody drugs is a process that requires advanced technology and management. However, due to their high specificity and therapeutic effect, they have become a new hope for the treatment of many intractable diseases, including anti-cancer drugs. It is expected that as scientists involved in drug development continue to innovate every day, they will become available to more patients. As such, the manufacture of antibody drugs requires many steps, complex production processes, and strict quality control. However, the therapeutic effects that can be obtained are great, making it an important field that will support the medical treatment of the future.