Celltrion Pharm, Cheongju Plant Subcutaneous Injection Formulation Production Line Completed... Annual Production of 18 Million Units

[Asia Economy Reporter Seo So-jung] Celltrion Pharm announced on the 27th that it has completed the construction of a prefilled syringe (PFS) production line for subcutaneous injection (SC) formulation biopharmaceuticals at its Cheongju plant and has begun preparations for global Good Manufacturing Practice (GMP) certification.

With the expansion of the PFS production line, Celltrion Pharm has secured an annual production capacity of approximately 18 million SC formulation finished pharmaceutical products.

The PFS production line was finally completed at the end of December last year after about 1 year and 7 months from the start of construction in May 2019, including the production equipment commissioning period, with a budget of 60 billion KRW invested.

The production line is a three-story building with a total floor area of 2,315㎡ (approximately 700 pyeong), capable of handling all processes from formulation to filling, foreign matter inspection, assembly, and packaging by receiving active pharmaceutical ingredients (DS). Based on the core process of filling, it can produce up to 29 million syringes annually.

In particular, it can produce a total of three types of SC formulation products, including one type of pen (auto-injector) and two types of prefilled syringes.

Celltrion Pharm plans to fully launch SC formulation drug production through this expansion. First, the world’s first infliximab subcutaneous injection formulation autoimmune disease treatment product, ‘RemsimaSC,’ is scheduled to be produced. If GMP approval from global regulatory agencies such as the European Medicines Agency (EMA) proceeds as planned, commercial production is expected to begin within the year.

In addition to GMP certification for RemsimaSC manufacturing, Celltrion Pharm intends to actively pursue orders and production preparations for subsequent products.

A Celltrion Pharm official said, "With the establishment of the PFS production line, Celltrion Pharm’s Cheongju plant has laid the foundation to leap forward as a global pharmaceutical production base equipped with the capability to produce biopharmaceuticals following chemical pharmaceuticals."