Localization of Biopharmaceutical Materials, Components and Equipment, Started 

As COVID-19 vaccine makers have become a "black hole" for biopharmaceutical raw materials, emergency lights have been turned on for small and medium-sized Korean biotechs. As global vaccine makers, with their deep pockets, preemptively purchase pharmaceutical raw materials, the laggard domestic companies are facing the double whammy of lack of raw materials as well as self-sufficiency for drug development.

"We ordered the raw materials needed for drug manufacturing months ago, but we still haven't received the goods," said an official from a bio company, adding, "Multinational companies have preempted most of the 'medium' (cell feed), which is a key raw material for biopharmaceuticals, and it is difficult to get enough."

According to the Ministry of Trade, Industry and Energy and related industries, the self-sufficiency rate of producing finished drugs from domestically produced raw materials is about 20 percent, and the localization rate of biopharmaceutical production equipment is about 16.5 percent.

As most of the equipment needed for the production of raw materials and finished drugs is procured from overseas, both raw materials and equipment are not free from supply and demand insecurity in the event of a situation such as COVID-19 in the future.

The government and large contract manufacturing organizations (CMOs) such as Celltrion and Samsung Biologics have recognized this problem and have been working with SMEs to localize raw materials for the bio industry since last year.

In September last year, the Ministry of Trade, Industry and Energy launched the 'Solidarity Cooperation Council for Biomaterials, Parts and Equipment' and provided 85.7 billion won in support over five years. The council includes 13 companies that demand biomaterial parts and equipment, such as Celltrion and Samsung Biologics, and 42 suppliers, such as Amicogen, Dongshinkwan Glass Industry, EcoNiti, and J-OTECH. The council is supported by the Korea Biotechnology Association and the Korea Institute of Industrial Technology Evaluation and Management.

Although the program is still in its infancy, some companies are gradually showing results. In addition to developing customized media or media additives for production biopharmaceuticals, the 'Biomaterials, Parts, and Equipment Solidarity Cooperation Council' is working on a total of eight projects to develop production equipment, consumable parts equipment, and purification and analysis material technologies necessary for drug production.

Vioxx, an SME, is the first to localize potassium hydroxide cleaning agent and supply it to Samsung Biologics and Hanmi Pharmaceutical.

To produce biopharmaceuticals made from living cells or tissues, a cell culture machine is used. Oil, chemical solutions, and proteins are stuck inside the incubator, so special cleaning agents are used. Until now, domestic bio companies have mostly imported cleaning materials from Japan, the United States, and Europe. The cleaning agents were treated as toxic and were not easy to transport overseas, but by successfully localizing them, they not only reduced the cost by 20% compared to imports, but also simplified the ordering process.

Amicogen was selected as a national project company to localize customized cell culture media used in biopharmaceutical production and has been building a media factory in Songdo, Incheon, since March. The company expects to be able to produce prototypes as early as September this year.

An official from Amicogen said, "The need for localization of medium development and manufacturing technology is becoming increasingly necessary to ensure stable supply of raw materials." "We will help domestic bio companies secure price competitiveness and contribute to the national bio industry by successfully localizing medium," he said. 

Source : https://n.news.naver.com/article/008/0004585992