Merck announced the expansion of its high-potent active pharmaceutical ingredient (HPAPI) and antibody-drug conjugate (ADC) production capabilities and capacity at…
Headquartered in Seoul, South Korea, Samsung Biologics broke ground on its first manufacturing plant in the free economic zone in Songdo, Incheon, in May 2011.
Samsung Biologics is a joint venture established in April 2011 between Samsung Electronics (40%), Samsung Everland (40%), Samsung C&T (10%) and Quintiles Transnational (10%). Samsung Biologics invested $30m in the new venture.
Samsung identified biologics among its new strategic businesses in 2010 and partnered with Quintiles Transnational. Samsung Biologics plans to invest $1.96bn (KRW2.1tn) for strengthening its position in the field of biopharmaceuticals.
It completed construction of the new facility in July 2013 and received approval from the US Food and Drug Administration (FDA) in 2015, to begin the production. The facility is designed to comply with the current good manufacturing practice (GMP) standards. It hired approximately 300 people.
Specifications for Samsung Biologics’ plant
The state-of-the-art facility is spread over 69,000m² within a 274,000m² site, with ample space for future expansion.
Designed for multiproduct operations, the facility accommodates a cell culture hall, a research and development laboratory, an upstream suite, a downstream suite and a fill and finish suite, a warehouse and an administration building.
The cell culture hall is equipped with six 5,000l stainless-steel bioreactors and three individual trains, capable of manufacturing 600kg of biopharmaceuticals. Each train is installed with two production reactors capable of batch and fed-batch operations.
It also has three 40l, three 200l and three 1,000l seed reactors. The cell culture suites operate in a grade C environment.
The site also houses dedicated automated glass washers and autoclaves. Two separate grade B inoculation suites minimise the risk of cross-contamination and changeover time.
The downstream process GMP purification area houses four separate suites to improve flexibility and minimise turnover time. Each suite can be configured to suit client requirements.
It includes a column maintenance suite, a grade B classified bulk fill suite with grade A (laminar flow booth) bulk filling capacity and a buffer preparation suite. The temperature-controlled, high capacity buffer preparation suite holds tanks with ranging capacities.
Separate areas are dedicated for pre and post-viral equipment cleaning. Classified as grade C or higher, the suites are installed with chromatography skids, columns, UF / DF skids and virus filtration skids.
The grade B filling area is installed with formulation, aseptic liquid filling, pre-filled syringe lyophilisation and packaging apparatus capabilities. The area is modular in design to support future expansion and accommodate additional pre-filled syringes, liquid fill and lyophilisation units. It also houses a washroom and a media fill suite, a 20,000ft² GMP warehouse designed with long-term cold storage capacity. It also has automated clean-in-place and sterilisation-in-place systems.
Access to sensitive zones is via an air-lock vestibule with interlocks. The layout allows optimum flow of personnel, materials, samples, products and waste.
The facility also undertakes contract manufacturing of biopharmaceuticals. Due to rising demand for biopharmaceuticals, Samsung Biologics expects to annually generate KRW1.8tn by 2020.
Samsung Biologics’ plant expansion
The expansion programme included the construction of second plant at Songdo site by 2015. The new plant began its operations in March 2016.
The expansion added six 15,000l bioreactors to the facility. Downstream capacity was also added with streamlined purification suites with pre and post-viral segregation.
Samsung also broke ground in December 2015 for the third plant in the free economic zone in Songdo, as part of its expansion plan. The new plant is expected to commence production in 2018.
Thermo Fisher Scientific opened a new manufacturing facility in Lenexa, Kansas to meet the increasing demand for viral transport media…
Bushu Pharmaceuticals unveiled a new expansion programme for its pharmaceutical manufacturing facility in Misato, Japan, in August 2020. With the…