Pamisel Expands GMP Plant 2 for Stem Cell Therapy Production

Pharmicell announced on the 13th that it will expand its GMP (Good Manufacturing Practice) Plant 2 for stem cell therapy production capacity in response to increased demand and the government's efforts to improve the advanced regenerative medical environment.

The GMP Plant 2 is located in the same apartment-style factory as the existing GMP Plant 1. The space secured over 10 years ago will be expanded into a state-of-the-art pharmaceutical manufacturing and quality control facility with an investment of 5 billion KRW.

GMP Plant 2 is designed as a smart factory compliant with the latest regulations. It can be efficiently controlled from a single location through a central control system. The aseptic workroom is equipped with an individual air conditioning system to efficiently manufacture various types of cell therapies without concerns of cross-contamination.

From 2025 onwards, GMP Plant 1 will also be renovated to triple the current production capacity of stem cell therapies. The company plans to prepare for the launch of products currently in clinical trials, such as Cellgram-LC for alcoholic liver cirrhosis and Cellgram-ED for erectile dysfunction.

A Pharmicell representative stated, "We will establish an integrated one-stop service from early development to market launch, including cell therapy manufacturing process development, GMP production services for non-clinical trials, and clinical trial approval support," adding, "We will further strengthen our CDMO business, including pharmaceutical contract manufacturing and quality testing services."

Recently, a revision to the Advanced Regenerative Medicine and Advanced Biopharmaceuticals Act, which expands the scope of advanced regenerative treatments, is being discussed in the National Assembly.

This content was produced with the assistance of AI translation services.