Aprogen "Obtains MFDS GMP Certification for Osong Plant"

[Asia Economy Reporter Hyunseok Yoo] Aprogen announced on the 1st that Osong Plant, owned by its affiliate Aprogen Biologics, recently received the final certification of Good Manufacturing Practice (GMP) compliance from the Ministry of Food and Drug Safety.

The certification items include ▲Bulk GMP for active pharmaceutical ingredients (non-sterile) involving genetic recombination (culture, purification, virus inactivation, bulk manufacturing process) ▲Finished pharmaceutical products (sterile) involving genetic recombination (injectables, lyophilized injectables, filling process), each receiving a GMP compliance certificate.

Constructed with an investment of approximately 380 billion KRW, the Osong Plant is situated on a site of about 42,300㎡ (12,800 pyeong) with a total floor area of approximately 45,900㎡ (14,000 pyeong), consisting of 5 floors including 4 above ground and 1 basement level. It currently has an annual raw material production capacity of 2,500 kg, ranking 5th among global biosimilar manufacturing companies in terms of CAPA (capacity).

A company official stated, “Aprogen plans to leverage the GMP compliance certification as a stepping stone to produce active pharmaceutical ingredients and finished pharmaceutical products and to actively enter the global market. Starting with the Remicade biosimilar, whose Phase 3 clinical trial in the U.S. has been completed, we are simultaneously developing six biosimilars and plan to obtain FDA approval for all substances.”