Songdo Plant #3 (cGMP ready by Q4 2018)
Plant #3 will act as the bridge between the plans and dreams of leading Biopharma scientists and engineers. We expect it to become the largest plant in the world in terms of scale, supported by competitive cost and an aggressive construction schedule. Our third plant is designed to minimize batch loss during product change over, incorporated with the most innovative maintenance scheme. Additionally the plant is combined with the latest technology of N-1 Perfusion to increase overall efficacy of the production cycle. With our third plant, Samsung BioLogics expects to become the world’s leading CMO contractor and CMO Champion by the year 2020.
Key Specifications items include Ground Breaking, Mechanical Completion, Facility Qualification, cGMP Ready, Production Capacity, Culture Type, Fill & Finish, Laboratories, Warehouse, and so on.
||12 Months (forecast)
||4Q 2018 Expected
||180,000 L (12X15KL)
||Warehouse, QC Laboratory
- Warehouse Ambient,
- 2 - 8°C and -20°C
- storage and weigh & dispensing area
"The vision for our third masterpiece was to create a ‘Dream Plant.’ Unlike Plant #1 and #2, Plant #3 minimizes cultivating and refining times so that we can produce mass quantities and many varieties of products. Furthermore, we worked to reduce losses to a minimum."
Plant #3 Project Team
QPlant #3 received a lot of national and international attention. What vision does Samsung BioLogics now have by founding a 3rd plant?
AnswerThe vision for our third masterpiece was to create a ‘Dream Plant.’ Unlike Plant #1 and #2, Plant #3 minimizes cultivating and refining times so that we can produce mass quantities and many varieties of products. Furthermore, we worked to reduce losses to a minimum. From now on, I think Samsung BioLogics can standardize its production facilities with Samsung’s own quality regulations that meet and exceed global standards.
QWhat are the schedules for construction, validation, and operation? What is being done to achieve these timetables?
AnswerIt is always a critical period until the trial test, which will be around the end of this year. After that, validation will begin. The primary goal is completing mechanical construction by September 2017, so we are extremely busy at the moment. Generally there is a set process in construction, known as the EPCV process. This is usually accepted step by step, but we do a lot of processes simultaneously. Furthermore, we have an outstanding workforce that handles all adjustments when problems are detected at each stage—of course while abiding by all domestic/international law and safety standards.
QAre there any new concepts being tried on Plant #3?
AnswerThe concepts incorporated into Plant #3 are as follows:
First is visibility. In Germany and Switzerland, plants are sometimes built as "cleanrooms" in which the outside is visible. This is to guarantee workplace quality. However, this form of building is problematic in that it is very hard to be efficient with energy usage. With Plant #3, we resolve both issues by designing cleanrooms for environmental factors and the safety of our workers, while improving energy efficiency. We are confident this was the right move.
Second is uniqueness. Unlike the first and second plants that were based on other leading plants, the third plant was developed entirely from our own hands, beginning with a new concept design. As a result, unique, productive, and efficient Samsung-only structures are now being newly constructed.
Third is centrality. We take advantage of a central core to minimize the moving line, utilizing more efficient technologies. Plant #3 is equipped with bigger cleanrooms, which requires larger investment, but we aim to keep operational cost as low as Plant #2.
QWhat do you think is the meaning of benchmarking Plant #3 to the entire industry?
AnswerWith the third plant, we expect Samsung BioLogics to have the largest bio-plant in the world. The total capabilities will reach 180,000 liters which is two-times bigger than competitors have at this time, and the production cost reduced to a half, resulting in a doubling of production efficiency. Our third plant can be operated 24/7 with a hybrid-design and facility redundancy and is the first one without an annual shutdown. The total capabilities of Samsung BioLogics including the first (30,000ℓ), the second plant (150,000ℓ), and the clinical manufacturing plant (2,000ℓ), will reach 362,000ℓ, making Samsung BioLogics the largest CMO service provider in the world.