Samsung Biologics Manufacturing Plant

Headquartered in Seoul, South Korea, Samsung Biologics broke ground on a new manufacturing plant in the free economic zone in Songdo, Incheon, South Korea, 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 (KRW2.1trn) in strengthening its position in the field of biopharmaceuticals. Sales of biopharmaceuticals are expected to reach approximately $167bn by 2015, according to IMARC, an international market research company.

The new facility is slated for completion by 2012 with operations scheduled to begin by early 2013.

It will be certified by the US FDA and designed to comply with the current good manufacturing practice (GMP) standards. The facility will hire approximately 300 people.

Specifications for Samsung Biologics' plant

The state-of-the-art facility will be spread over 69,000m² within a 274,000m² site, with ample space for future expansion.

Designed for multiproduct operations, the facility will accommodate 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 will be equipped with six 5,000l stainless steel bioreactors and three individual trains, capable of manufacturing 600kg of biopharmaceuticals.

Each train will be installed with two production reactors capable of batch and fed-batch operations.

It will also have three 40l, three 200l and three 1,000l seed reactors. The cell culture suites will operate in a grade C environment.

The site will also house dedicated automated glass washers and autoclaves. Two separate grade B inoculation suites will minimise the risk of cross-contamination and change-over time.

The downstream process GMP purification area will house four separate suites to improve flexibility and minimise turnover time. Each suite can be configured to suit client requirements.

It will include 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 will hold tanks with ranging capacities.

Separate areas will be dedicated for pre and post-viral equipment cleaning. Classified as grade C or higher, the suites will be installed with chromatography skids, columns, UF / DF skids and virus filtration skids.

The grade B filling area will be installed with formulation, aseptic liquid filling, pre-filled syringe lyophilisation and packaging apparatus capabilities. The area will be modular in design to support future expansion and accommodate additional pre-filled syringes, liquid fill and lyophilisation units. It will also house a wash room and a media fill suite, a 20,000ft² GMP warehouse designed with long term cold storage capacity. It will have automated clean-in-place and sterilisation-in-place systems.

Access to sensitive zones will be via an air-lock vestibule with interlocks. The layout will allow optimum flow of personnel, materials, samples, products and waste.

Production

The facility will undertake contract manufacturing of biopharmaceuticals. Due to rising demand for biopharmaceuticals, Samsung Biologics expects to generate KRW1.8trn annually by 2020.

Future of Samsung Biologics' plant

An expansion to the facility will be mechanically complete by 2016 and operational in 2017. The expansion will add six 15,000l bioreactors to the facility. Downstream capacity will also be added with streamlined purification suites with pre and post-viral segregation.