바이오스펙테이터

by Joungmin Cho

world-class technology competitiveness by securing about 100 patented technologies through verification of all test methods

“CAR-T, a gene and cell therapy, has important items to be checked, from the establishment of a cell line bank, to manufacturing process. CdmoGen has prepared to meet the standards of the Food and Drug Administration in the establishment process of CAR-T manufacturing protocol and technology, and the test methods have been verified by top-class experts.”

CdmoGen is a contract development and manufacturing organization (CDMO; CMO & CRO) in the field of gene therapy for the domestic market, and is challenging the manufacturing and analysis/development services of custom-made CAR-T therapeutic agents. Park Gi-rang, CEO of CdmoGen, said, “We plan to provide a one-stop total service from the GMP manufacturing of CAR-T to analysis, and we are working on preparations for a domestic clinic trial with a CAR-T development company.” In order to carry out the CMO and CRO projects for CAR-T at full swing, CdmoGen plans to establish a second manufacturing site, in addition to the existing GMP manufacturing facility.

CAR-T is a gene and cell therapy agent that artificially engineers genes to mount T-cell receptors that recognize specific cancer antigens. These engineered genes are produced by manipulating genes using viral vectors extracted from the blood of a patient.

To manufacture CAR-T, it is necessary to establish a master cell bank (MCB), which is used to produce viruses. CEO Park said, “The cell line bank is the basic raw material of the therapeutic agent, and we should accurately verify whether it can continue to be produced after commercialization.”

Before viruses made by cells from the cell line bank are applied to T cells, it is important to identify replication competent viruses. According to the guidelines for new gene therapy products newly released by the US Food and Drug Administration (FDA), a test to check the capability of viral replication is recommended for viral-based gene therapy products.

CEO Park said, “It is not difficult to carry out a test to check the replication capability of viruses. However, it is extremely difficult to verify the test method, and there are only a few places that can confirm the test. CdmoGen has world-class technology competitiveness by securing about 100 patented technologies through verification of all test methods by the top experts in the field of gene and cell therapy development.”

Novartis, which developed Kymriah and obtained its license, experienced difficulty in commercialization, due to its inability to meet product standards at the production stage. The production problem affected the sales of Kymriah, which remained at as low as 76 million dollars in 2018. Novartis has worked on several partnerships to produce Kymriah, but ended up feeling they had reached their limit, and they are now making efforts to have an integrated automation system to improve production efficiency by acquiring the French CDMO company, CellforCure. This means that producing CAR-T therapeutics of a certain quality is difficult.

CdmoGen says that the company is able to provide a one-stop total service, from the establishment of the first master cell bank, to the manufacture and analysis of CAR-T treatment. In addition to manufacturing in accordance with international standard protocol, they also provide customization services tailored to their customer’s needs, such as a consulting service in the process of specification analysis and the licensing process. Park said, “CdmoGen is able to provide customized solutions to meet the diverse needs of our customers based on our outstanding achievements and in-depth expertise. Currently, there are several companies in Korea that are developing CAR-T therapeutic products.”

Since the start of the development of virus-based gene therapy 2002, CEO Park has long been involved in the development of gene therapy products and manufacturing process development at a gene therapy technology center, a biopharmaceutical research institute, and at other research institutes. Based on these research results, CdmoGen, which opened in 2015, has become the only CDMO for gene and cell therapy to have a specialized GMP manufacturing facility in Korea. CEO Park said, “We have a high level of technology that does not pale in comparison with any global CMO.”

To keep in line with the growth of the gene therapy market, CdmoGen plans to build a second plant to increase production capacity. The company will secure the site of the second plant within Osong High-tech Medical Complex, and plans to begin construction in the second half of this year. CEO Park said, “We will provide a dedicated space according to our customers’ products to produce products that meet international standards.”

CEO Park added, “The CAR-T treatment is still at an infant stage of development with only a few products available in the market, and is showing great growth. We will make efforts to become a CDMO that will be able to assist the CAR-T development process together.”