Korean CDMO Samsung BioLogics will open labs in either the Boston or San Francisco area early 2020 on the back of demand for its development services.
In 2017, Samsung BioLogics added the ‚ÄėD‚Äô to its contract development and manufacturing organization (CDMO) credentials by announcing plans to offer customers cell line and process development (PD) services on top of its well-established clinical and commercial production services.
In the 18 months since launching these services, the South Korean firm has undertaken 33 projects and capacity at its site in Songdo, Incheon, is near to fully booked, Eun Young Yang, head of CDO Business Team, said at the BPI East event in Boston last week.
‚ÄúClient response is really exploding,‚ÄĚ she told Bioprocess Insider. Currently the firm can work on around 15 cell line development contracts per year and 20 PD projects.
‚ÄúIn terms of capability, we have the full range, however in terms of lab space, staffing and equipment we are constantly expanding. But we are having contracts coming in much faster than [we are able to expand].‚ÄĚ
Coming to America
Therefore, Samsung BioLogics is now preparing to expand further to enter ‚Äúone of the biggest markets for development services‚ÄĚ ‚Äď the US.
‚ÄúThere is a commitment from Samsung to invest in the United States in a site,‚ÄĚ John Gill, principal scientist within the CDO team, confirmed on the show floor.
‚ÄúThe site selection process has begun, so we will open in early 2020, so we have the commitment for that space, but it‚Äôs just identifying the proper location. So there are a number of incubator labs and facilities available that we have identified, and we are initiating the site visits in September/October.‚ÄĚ
While no investment has been laid down, we were told the firm is looking to rent space in either Boston, Massachusetts or San Francisco, California to open in the first half of next year.
‚ÄúThe initial footprint is to have a small facility that is expandable,‚ÄĚ said Gill. ‚ÄúIn the site selection process we want something that‚Äôs move-in ready, but also when [we‚Äôre ready to add] additional capacity in the US we can knock down a wall or go down a couple of doors and we‚Äôll have the additional labs in that space.‚ÄĚ
And whether the East or West coast avails from the initial expansion decision, Young Yang said a second US site is already in the pipeline and expected to open in 2021. There are no plans for a US manufacturing site at present.
Both Gill and Young Yang acknowledged hiring will be very competitive in both Massachusetts and California, but Young Yang said Samsung BioLogics ‚Äúalready has in place a US recruiting firm that partners with our HR team, as we have hired lots of experts [from the US] for our Songdo plant.‚ÄĚ
Proprietary cell line
The expanded capabilities will come into play as Samsung BioLogics rolls out its own proprietary cell line platform.
Currently customers have access to the CHOZN GS CHO (Chinese Hamster Ovary) mammalian cell expression system, licensed from MilliporeSigma, but beginning in 2020 the in-house system ‚Äď also CHO-based ‚Äď will be offered.
‚ÄúIt gives flexibility to the clients to choose what platform they‚Äôd like to use,‚ÄĚ said Gill. ‚ÄúIt also shows we‚Äôre capable of developing our own technology and shows the capability of the science behind the CDO. So, we‚Äôre not necessarily just a service provider but we can help the clients develop not only their cell line but their process for manufacturing.‚ÄĚ
The company claims the platform has produced titers of over 10 g/L for immunoglobulin G (IgG).
Meanwhile, plans announced last year to enter stem cell therapy services have been placed on hold, Young Yang told us, while Samsung BioLogics looks to further strengthen its R&D services.