Amicogen Successfully Develops Next-Generation Resin for Antibody Purification

Amicogen (CEO Park Cheol), a leading company in the bio-materials and pharmaceutical fields, announced that it has successfully developed a next-generation ligand for antibody purification and completed the patent application. Through this technological development, the company plans to overcome the limitations of existing antibody purification processes and accelerate its entry into the global market.

Existing ligands for antibody purification elute in a strongly acidic environment with a pH of 2.5 to 3.5. During this process, protein denaturation occurs, causing aggregation and precipitation, which lowers production yield and degrades quality.

In particular, modified antibodies such as Fc-Fusion Proteins, Antibody-Drug Conjugates (ADCs), and Bispecific antibodies are known to experience further reduced yield and quality when eluted at low pH. To address these issues, Amicogen succeeded in developing a next-generation ligand that secures a high elution efficiency of over 98% at a mildly acidic environment of pH 4.3 or higher and reduces the elution volume by more than four times compared to existing ligands. With this patent application, the company plans to widen the technological gap with competitors, expedite the localization of resin, and actively enter the global antibody purification resin market.

An Amicogen representative stated, “There is growing demand for various antibody purification resins not only in Korea but also in the global biopharmaceutical industry. Our company has rapidly responded to these demands based on protein improvement technologies accumulated over the past 20 years.” They added, “The next-generation resin capable of elution at pH 4.3 or higher was developed in response to the on-site needs of global bio companies, and we have secured product technology that is comparable to or better than that of competitors.”

Amicogen has been developing ligands that selectively bind to antibodies such as ‘Protein A’ using its proprietary platform technology, gene evolution technology. Ligands are essential proteins in the antibody purification process and are key factors determining the performance of resins. These ligands are immobilized on carriers such as agarose beads and cellulose beads and are used by biopharmaceutical and biosimilar companies to separate and purify antibodies with high purity.

Park Cheol, CEO of Amicogen, said, “The reason our resin has achieved world-class quality is thanks to protein improvement technology using gene technology. The next-generation resin developed this time will be produced at the Yeosu plant of our subsidiary PurioGen, and based on our unique technology and stable domestic supply chain, it will greatly contribute to solving purification process issues for domestic bio companies while strengthening global competitiveness.”

The PurioGen Yeosu plant, where the next-generation resin will be produced, was completed in May last year and is currently undergoing commissioning and pilot production. Full-scale production is scheduled to begin this year, with plans to expand capacity up to 50,000 liters depending on market demand. Through this, the goal is to raise the localization rate of resin in the domestic biopharmaceutical market to 30% compared to the current level.

Amicogen’s success in developing next-generation resin is expected to address unmet needs in the global biopharmaceutical industry while further strengthening domestic antibody purification technology.