PH: What is the origin of the company?

James Park

Park: Samsung BioLogics was founded in 2011 after our CEO, Dr Kim, and multiple colleagues spent three years looking for the next engine of growth for Samsung in general. He chose healthcare, especially in the biotechnology arena, because of the attractive growth prospects and focused particularly on the contract manufacturing side. We first established a joint venture with Biogen in biosimilars in early 2012, and in 2017 we expanded our CMO business to include cell line and process development services.

PH: Samsung is a giant conglomerate, of course…

Park: Samsung, historically, has a strong manufacturing capability We have built 24 semiconductor plants and over 50 petrochemical plants, so we have the knowledge from those industries to bring into biologics. For example, the clean air we use in semiconductor plants is even more stringent than in biologics, so we drew on that experience. We also have a construction and engineering company to build our plants. Manufacturing excellence is the key to our success.

PH: Is all your manufacturing in Korea?

Park: Yes, all at Incheon. Plant No. 1 has 6 x 5,000 litres capacity, Plant No. 2 has 10 x 15,000 litres and Plant No. 3, which we built quite recently has 12 x 15,000. We also have small-scale 2 x 1,000 litre reactors for clinical supply. Over the course of the last seven years, we have surpassed our two main competitors.

PH: I understand that Plant No. 3 has just had its first manufacturing contract signed.

Park: Yes, with a US-based company. It was mechanically completed last year and we are currently in validation mode; it will be GMP-ready in October 2018 and this first client will start tech transfer activities. We are currently in talks with about six other companies for additional orders for the plant this year. Plant No. 2 had its first approval for a monoclonal antibody drug substance late last year. This year, we had an FDA inspection at the site for one of our clients’ drug substances, so we anticipate additional work. We expect to have at least 12 regulatory approvals this year, as well as many more customer audits.

PH: If there is that much pent-up demand in the market, why has no-one jumped in before?

Park: Part of it is down to return on investment. We can do it because we build plants much faster – two and a half years against the usual six or seven – because of our experience in building them.

PH: You are presumably here to sell the idea of biologics manufacturing in Korea?

Park: Yes, but in time, who knows, we may also build in the US or anywhere else. Our focus is where the value is in terms of the scale we bring in Korea with our massive capacity, bringing significant savings to clients. Our smallest plant requires 500 people to run; Plant No. 3 is six times bigger and only needs 50% more people

PH: It must have been a massive investment.

Park: Not as much as you might think. For comparison, one major US pharma company built a 90,000 litre biologics facility in Ireland for $1.1 billion. Plant No. 3 is twice as big as that, but cost $750 million. Some of that is down to our expertise in welding from building semiconductor plants – there is a lot of stainless steel piping in these plants.