[Asia Economy Reporter Park Hyungsoo] Aprogen announced on the 2nd that it is preparing to obtain the current Good Manufacturing Practice (cGMP) certification from the U.S. Food and Drug Administration (FDA) for its Osong factory. Aprogen has deployed about 40 professional consultants to the Osong factory and allocated a budget of approximately 25 billion KRW for consulting.
The consultants working at Aprogen belong to Validant, a U.S.-based cGMP consulting company recognized as one of the world's top firms. They have accumulated over 20 years of experience at U.S. cGMP facilities producing antibody drugs, such as the Genentech factory. Validant has provided cGMP-related consulting to more than 20 companies among the world's top 30 pharmaceutical firms. They also participated in the preparation process for Samsung Biologics' factory to obtain U.S. FDA certification.
Aprogen obtained the Japanese product approval for the Remicade biosimilar through KBCC (Korea Bioindustry Center for Commercialization) facilities of Bionex located in Songdo. The strategy for entering the U.S. market with subsequent products is to obtain U.S. product approval through the Osong factory.
A company official stated, "If the Osong factory is certified as a cGMP facility by the U.S. FDA through the Remicade biosimilar, Aprogen will be able to pursue product approvals for other biosimilars such as Herceptin, Rituxan, and Humira that it is developing."
He added, "The acquisition of product approval from the U.S. FDA for our next-generation revenue source, the bispecific antibody new drug, is also expected to proceed smoothly."
He explained, "Due to the strict standards required by the U.S. FDA for cGMP, certification of production facilities is a stage as challenging as the success of clinical trials."
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