The ‘super’ plant is expected to be partially operational by the end of 2022 and fully GMP-ready in 2023 in an effort to meet increased production demand, reported the South Korean contract development and manufacturing organization (CDMO) as it released ‘record-high’ financial results for Q3 of fiscal 2021 earlier this week.
Samsung Bio’s work spans development, manufacturing and laboratory testing services for biopharma products. Its other facilities are nearing full capacity so the focus is getting this ‘super’ plant operational as soon as possible.
The initial plan was for the facility to be up and running by the end of 2023, but now “we think the entire plant will be fully ready by the middle of 2023,” James Choi, senior VP and chief information and marketing officer, Samsung Bio, told Bloomberg earlier this month.
The company broke ground on the site in November 2020.
Located in Incheon, the multi-story 238,000-square-meter construction will boast 256,000 liters total manufacturing capacity. Upon completion, the plant is set to become accountable for a third of the total global bio-CMO manufacturing capacity.
Plant 4 will also have a focus on flexibility: with a line-up of bioreactors ranging from 2,000-liters to 15,000-liters. It will provide a full range of CDO, CMO, and CRO processes for a ‘one-stop’ service, including early-stage development capabilities and large-scale commercial manufacturing with integrated aseptic fill/finish capabilities and a full QC Lab for testing services.
Speeding up mAb development
The earnings statement documents a strong cumulative backlog of US$7.1bn in signed contracts with pharma giants such as Roche and MSD this year.
The financial report also highlighted Samsung Bio’s launch of a new drug development service platform. The CDMO said S-Cellerate offers an expedited process for the development and commercialization of monoclonal antibodies (mAbs) to IND and BLA.
It is ramping up its sustainability focus as well; September saw the CDMO sign up to the Frontier 1.5D initiative, a collaborative effort to limit temperature rise to 1.5°C above pre-industrial levels.
The company said it will be closely monitoring, identifying, and providing data for each of its biopharma manufacturing plants through its Carbon Disclosure Project (CDP) initiative with Science Based Targets (SBT) to determine risks and opportunities on climate change as well as the financial impact to translate this data into actions.