Approximately 50 global PDA officials and experts visited to verify the manufacturing competitiveness of Korean biopharmaceuticals.
Tour of the new Nabota plant and Daewoong Bio Center showcased cutting-edge sterile manufacturing processes and quality control systems.
The site visit, requested by the PDA, aimed to facilitate technical exchange among global pharmaceutical manufacturing and quality experts.
Daewoong Pharmaceutical has introduced its new Nabota plant and the Daewoong Bio Center to global pharmaceutical manufacturing and quality experts, highlighting its sterile production processes and quality control systems to strengthen technical cooperation for global regulatory compliance.
[Photo: PDA officials touring the production facilities at the new Daewoong Pharmaceutical Nabota plant.]
Daewoong Pharmaceutical announced that approximately 50 officials from the Parenteral Drug Association (PDA) and domestic pharmaceutical experts visited its two production facilities in Hwaseong, Gyeonggi Province, on the 2nd. Participants toured the new Nabota plant and the Bio Center, examining sterile manufacturing processes and automated equipment while discussing operational systems with company officials.
The visit was a pre-conference program for the '2026 PDA Biopharmaceutical Sterile Processing International Conference' held in Incheon on the 3rd and 4th. According to the company, the visit was arranged at the request of the PDA Korea Chapter, which highly evaluated Nabota's global market performance and manufacturing infrastructure.
The PDA, founded in 1946 and based in the U.S., is a global non-profit association that supports technical advancement and academic exchange in pharmaceutical manufacturing, quality, and regulation.
Nabota New Plant Targets Regulatory Approval by First Half of Next Year
The new Nabota plant is a dedicated botulinum toxin production facility built to meet rising global demand. It passed the Ministry of Food and Drug Safety's preliminary GMP inspection in October and aims for full regulatory approval by the first half of 2027. The company has secured an initial annual production capacity of 6 million vials and plans to expand to 12 million vials through the addition of a second production line.
The new facility features automated sterile filling volume measurement and packaging systems to minimize human intervention. It also includes automated warehouses with capacities for 1,200 low-temperature cells and 800 room-temperature cells, integrated with Warehouse Management Systems (WMS), Enterprise Resource Planning (ERP), and Laboratory Information Management Systems (LIMS) to ensure data integrity and operational efficiency.
Nabota has established partnerships in approximately 80 countries and obtained marketing authorizations in 69, supported by production and quality systems certified by U.S. cGMP and EU GMP. Daewoong Pharmaceutical plans to further enhance its global regulatory response capabilities by applying digital quality management systems, such as electronic Quality Management Systems (eQMS), to the new plant.
Yoon Jun-soo, Head of the Nabota Business Division at Daewoong Pharmaceutical, stated, "This visit allowed global experts to verify the competitiveness of our sterile manufacturing and quality control systems. We will continue to strengthen our quality management to meet global standards and expand technical exchanges with international experts."
Bio Center Expands CMO Business Based on PFS Sterile Filling
[Photo: Advanced automated facilities at the Daewoong Bio Center.]
During the tour, Daewoong Bio showcased its integrated production facilities and contamination control strategies. The Bio Center, completed in August 2024 after 18 months of construction and validation, is a facility capable of producing microbial-based biopharmaceuticals from raw materials to finished products.
The company explained that the Bio Center was designed to meet U.S. FDA cGMP and EU GMP standards. It is equipped to handle everything from fermentation and purification of recombinant protein raw materials to sterile finished product production, including pre-filled syringes (PFS), cartridges, and liquid or lyophilized vials.
The facility employs a Contamination Control Strategy (CCS) reflecting the EU GMP Annex 1 guidelines updated in 2022. It manages contamination risks through Restricted Access Barrier Systems (RABS), Pre-Use Post-Sterilization Integrity Testing (PUPSIT), and single-use bag systems. On July 6, the facility received GMP certification from the Ministry of Food and Drug Safety for its PFS sterile filling line.
Lee Ho-jin, Head of the Daewoong Bio Center, remarked, "We have strengthened our manufacturing competitiveness through the GMP certification of our PFS sterile filling line. By sharing our operational experience based on EU GMP Annex 1, we intend to further expand our microbial-based biopharmaceutical CMO business."
