Amicogen: "The Essence of Cell Culture Media Supply Instability Is High Overseas Dependence"

Presenting Solutions for Stabilizing the Domestic Supply Chain

Amicogen announced on June 2 that, amid the rapid growth of the biopharmaceutical market, the stable supply of cell culture media has emerged as a core issue across the industry.

In particular, most domestic bio companies active in various fields such as cell therapy products, antibody drugs, and biosimilars?as well as suppliers of liquid media required for basic research?are heavily dependent on overseas manufacturers for their media supply.

This structure goes beyond simple dependence and leads to a range of complex risks, including supply chain instability, leakage of composition information, and quality variability due to long-distance transportation. In fact, cases of supply delays caused by deteriorating global conditions or logistics bottlenecks are increasing, and these are cited as factors threatening the sustainable growth of the domestic bio industry.

The global cell culture media market was estimated at approximately $6.13 billion in 2023, with an expected average annual growth rate of 11.65% through 2033. The domestic market is also growing rapidly, driven by the expansion of biopharmaceutical development and the implementation of the Advanced Regenerative Bio Act. As a result, localization and quality advancement of media have become essential tasks for the bio industry.

In this market environment, Amicogen (CEO Park Cheol) is attracting attention as a next-generation media supplier that combines a domestic production base with global quality standards. By localizing cell culture media, Amicogen is not only contributing to the stability of the domestic supply chain but also providing a groundbreaking alternative to significantly reduce risks at biopharmaceutical manufacturing sites.

Amicogen has established the nation's first manufacturing process capable of large-scale contract production of media for cell therapy products, antibody production, and biosimilars. Based on production and quality systems that meet GMP (Good Manufacturing Practice) standards, the company has obtained ISO9001 and ISO13485 certifications, and, with the advice of experts who previously led research at global media manufacturers, has completed international-level production facilities and process systems.

In particular, Amicogen's media production technology demonstrates outstanding performance in key quality indicators such as impurity management (including Trace Metals and Endotoxins), GMP-level process validation systems, supply chain stability and production transparency, and protection of media composition information.

Currently, Amicogen has secured an annual production capacity of over 300 tons of dry powder media (DPM) and is able to respond stably to diverse customer demands through flexible lead time management. In addition, the company has already established systems for batch-to-batch quality consistency, long-term storage stability, and documentation support for DMF (Drug Master File) submission, laying the foundation for entry into global markets.

Recently, Amicogen has begun full-scale contract manufacturing of media dedicated to cell therapy products, for which demand is surging, and is also supplying basic media such as DMEM, RPMI, and MEM-a, as well as serum-free media and feed supplement product lines, on an OEM basis.

Amicogen goes beyond simple OEM supply by also offering customized media development services optimized for customers' cell line characteristics and process conditions. By comprehensively analyzing cellular metabolic characteristics, target protein productivity, and culture conditions, the company designs optimal media compositions and provides one-stop support through pilot production, thereby effectively helping customers achieve productivity improvement and process consistency.

Currently, Amicogen's customized media have demonstrated their performance at major government-funded research institutes and university laboratories in Korea, and are being widely applied in actual research and production processes, thereby validating the company's technological capabilities and quality.

Based on its domestic production base, Amicogen is also accelerating its entry into the global media market. The company is currently in export cooperation discussions with numerous overseas distributors and bio companies, and plans to actively expand the global presence of its domestic media brand through these efforts.

A company representative stated, "Supply risks and quality uncertainties arising from overseas contract manufacturing can pose significant obstacles to the development and production of biopharmaceuticals," and emphasized, "Amicogen's systematic system, which enables stable production and supply of media domestically, will dramatically reduce risks for our customers."

The representative added, "We will continue to lead the stabilization of the global cell culture media supply chain and enhance the competitiveness of the domestic bio industry through ongoing improvements in manufacturing technology, quality advancement, and expanded overseas expansion."