The Korean drugmaker currently has two mammalian cell culture facilities at its site in Incheon, South Korea, boasting total capacity of 140,000L. In a decision passed through the company’s board this week an extra 170,000L will be added over the next few years.
Plant 1, consisting of four 12,500L production lines, has a capacity of 50,000L, and is set to double in size by 2018, with commercial production expected by the following year 2019. Meanwhile a third plant - which had initially been planned to add 90,000L of capacity - will now be built to house 120,000L, with commercial production expected by 2021.
The 325bn won ($275m) investment will support Celltrion’s marketed biosimilars and future mAb pipeline, spokesperson InSun Joo told Biopharma-Reporter.com.
Infliximab production
Remsima and Inflectra are both manufactured by Celltrion and have already been launched in a number of regions including Western Europe, with markets already seeing a major market impact on its reference product, Janssen’s Remicade (infliximab).
And last month the mAb was granted approval in the US.
Celltrion’s sole customer is Celltrion Healthcare – a “related party” which sells the products to global distribution partners, including Celltrion’s own sales and distribution subsidiary Celltrion Pharm and – in the US - Pfizer.
Therefore while the extra capacity will support increased demand for Inflectra/Remsima globally, “Pfizer is in charge of marketing and distribution of Inflectra in the US, and the sales schedule is in discussion,” said Joo.
However, he confirmed once constructed Celltrion’s “plants will have sufficient production capacity to cover the whole infliximab market,” and “protocols have been set up to ensure minimal risk in the stockpiling of infliximab.”
But, Joo added, the firm is also “building new facilities due to production preparation of subsequent products, Truxima & Herzuma.”
Herzuma – a version of Roche’s Herceptin (trastuzumab) - has been approved in Korea, while Truxima is a copycat of Biogen/Roche’s Mabthera (rituximab) currently awaiting approval.
The news comes six months after fellow South Korean biosimilars maker Samsung Biologics announced plans to build a third facility at its site in Songdo, effectively doubling mammalian cell culture capacity to 360,000L by 2018.
When it comes online, it will be the largest biologics site in the world, surpassing such mega-sites as Genentech’s Vacaville, California site (set to have a capacity of 240,000L) and Celltrion’s the planned 310,000L.