바이오스펙테이터

바이오스펙테이터 Jongwon Jang 기자

On December 13th, Samsung Biologics announced that the products from the second factory recently received manufacturer approval for the first time by the European Medicines Agency (EMA). Both of two factories (182,000 liters) currently in operation opened the doors to major pharmaceutical markets in the US and Europe.

This EMA manufacturer approval of second factory took two months after US FDA approval. Samsung Biologics carried out inspections on both factories concurrently in July.

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The second factory was built with a maximum of 150,000 liters, based on a single plant, using only Samsung Biologic’s design method, which applies 10 incubators to a single facility. According to the company, the complexity of the FDA and EMA inspection have been more complicated in terms of size that is bigger than a dozen times of average factory’s size, 30,000 liter plant.

An official of Samsung Biologics said, “We actively fostered quality assurance personnel, strengthened our ability to deal with inspections through constant rehearsal, and we have successfully carried out and obtained certification.”

Samsung Biologics acquired the first FDA certification n 25 months after its first factory operation in November 2015. The second factory acquired certification in 19 months, six months earlier than the first, and acquired EMA in 21 months, 11 months earlier.

Samsung Biologics shortens the time frame for approval and is able to supply their products to the customers to fulfill the market needs in a timely manner. According to ‘Report and Survey of Biopharmaceutical Manufacturing Capacity and Production' published in 2017 by the biopharmaceutical marketing research firm, BioPlan Associate, the most important condition for customers in a contract manufacturing organization (CMO) is ‘stick to schedule’.

Samsung Biologics has won 11 manufacturer approvals from regulatory agencies in the US, Europe, and Japan, which are the top three global markets in the first six years of its opening, and won 15 orders from 10 pharmaceutical companies including BMS and Roche by proving its quality competitiveness in the market. Meanwhile, the third factory that were completed construction last month will have a capacity of 180,000 liters, and Samsung Biologics will have a total production capacity of 362,000 liters.

CEO Kim Tae-han said, “Samsung Biologics once again proved our world-class capabilities in quality control as well as production scale”, and “We will continue to do our best so that customers and patients can receive medicine in a timely manner by continuously producing top-quality biopharmaceuticals through continuous innovation.”