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The company has made several moves in recent weeks to expand manufacturing capacity and cell line services.
Samsung Biologics has announced facility expansions and a new cell line technology in several recent moves that boost its manufacturing capacity and cell culture services. In one move, the company is preparing to break ground before the end 2020 for its fourth biologics manufacturing plant, and in another move, it is expanding an aseptic fill/finish line in its drug product manufacturing facility. Both facilities are located in Incheon, South Korea. Meanwhile, the company has also launched a new Chinese hamster ovary (CHO) cell line technology that it says improves titers.
The construction of the fourth manufacturing plant (Plant 4) in Incheon is part of Samsung Biologics’ long-term strategy to maximize operational efficiency and scale up its development and manufacturing capabilities as demand for biomanufacturing grows, the company stated in an Aug. 11, 2020 press release.
Plant 4 will add 256,000 L of capacity to the Incheon site, bringing Samsung Biologics’ total capacity up to 620,000 L upon completion, the company said in the press release. The new plant is scheduled to be operational in the second half of 2022. Construction will begin on existing ground within the Incheon site, and the new plant will comprise 23.8 million m2 in total floor area, which the company said is the equivalent to the combined floor area of its existing three plants. Using data about utility supply collected from the existing three plants, automation, and the latest biomanufacturing technologies, Plant 4 will introduce real-time production schedule simulation.
Samsung Biologics is also in negotiations with authorities at Incheon Free Economic Zone to purchase additional land for a second bio complex. When negotiations are finalized, the total size of the company’s investments into two bio complex sites (the new one under negotiation and the one housing its existing three plants) is expected to reach over KRW 2 trillion (US$1.7 billion). The land under negotiation for the second bio complex, estimated at 330,000 m2, is close to the company’s current complex. Samsung Biologics plans to create an open Innovation center that will foster biotech companies as well as build a global R&D facility. The company also plans to secure space within the new complex for future plants.
To expand its drug product manufacturing capacity, Samsung Biologics plans to build a flexible filling line and two additional lyophilizer units with 41.2-m2 chambers, the company stated in a July 20, 2020 press release. The new flexible filling line is scheduled to start up cGMP operations in the second half of 2021. The expanded lyophilization line will start operations in the first half of 2022. With this expansion, Samsung Biologics will add small-scale cartridge and syringe filling to its drug product services. The expansion will also increase its total lyophilization capacity by 246%, the company reported in its press release.
In addition to increasing its capacity with facility expansions, Samsung Biologics launched its new proprietary CHO-based cell line technology, S-CHOice. The technology builds on glutamine synthase (GS) knock-out CHO cell line technology and has demonstrated improved titers up to two-fold more than the industry standard, the company announced in an Aug. 5, 2020 press release. Cell titer has reached more than 7 g/L for standard monoclonal antibodies using the technology. The cell line has also demonstrated enhanced cell viability, achieving over 90% viability on the 21-day mark in a fed-batch study, the company said in the press release.
Another advantage of the S-CHOice cell line is a reduced development timeline from the industry average of four to five months, according to Samnsung Biologics. Approximately a month’s worth of time can be saved because of the rapid rate of cell division—18–20 hours—using S-CHOice technology in conjunction with Berkeley Lights’ Beacon technology, an optofluidic platform developed to optimize cell-line development workflow.