Samsung Biologics made an announcement on July 17 that it will expand facilities for complete production (DP) such as freeze dryer and flexible filling line (FFL).
Samsung Biologics recently decided to expand its facilities as the number of new consignment production customers increased significantly and the market's demand for DP services increased.
Market research firm Roots Analysis predicted that the overall market for Vial-type products will grow 9.1% annually over the next 10 years, and that the growth rate of frozen dry products will be 11.8%, which is high compared to liquid.
Under the expansion plan, two additional 41.2 square meters of freeze dryers will be installed at the second plant. The newly introduced freeze dryer is 246 percent larger than the capacity of the existing freeze dryer (16.7 square meters), and production is expected to increase proportionally.
It will take 27 months from manufacturing equipment to validation. Samsung Biologics will shorten the construction schedule as much as possible to enable GMP production in the first half of 2022.
In addition, FFL, which can be charged to various pharmaceutical containers such as cartridges, vials, and injections, will be expanded. The move comes as bio-tech's recent development of new drugs has increased the volume of orders for small-scale clinical tests.
According to Roots Analysis, the market for clinical finished products is expected to grow by an average of 10 percent annually by 2030.
It will take 14 months from equipment manufacturing to validation and will start operation in the second half of 2021. A total of 28 billion won ($23.3 million) will be spent on the expansion of DP facilities.
Kim Tae-han, CEO of Samsung Biologics, said, "We will actively respond to the production of large-scale new orders this year by expanding our facilities. Following the world’s biggest production capacity of 364,000 liters in drug substance, we will lead the market in the finished production sector."
Meanwhile, Samsung Biologics has started providing aseptic filling and freeze drying services for Vial-type charging since 2013. In this regard, 24 or more product production approvals have been obtained from regulators in the United States, Europe and Japan.
Starting from November 2019, the company established an organization dedicated to ordering and operating DP projects to strengthen its responsible management system and expanded its business by expanding facilities.
