大熊制药将建微针制剂专用无菌自动化工厂，2027上半年完成GMP认证以支撑司美格鲁肽微针药商业化

Daewoong Pharmaceutical (069620.KS) is building a sterile, automated manufacturing facility to produce microneedle-based drugs. The company plans to complete Good Manufacturing Practice (GMP) certification for a microneedle-only clinical drug manufacturing site inside Daewoong Bio's No. 3 plant by the first half of 2027, laying the groundwork for commercial production.
Daewoong Pharmaceutical said on Oct. 14 that it is building a sterile manufacturing process and an automated production system tailored to microneedle patch drugs. Based on CLOPAM, the microneedle technology developed by Daewoong Therapeutics, the site will be used to produce candidates including DWRX5003, a semaglutide-based treatment for obesity and diabetes.
Microneedle technology delivers drugs through tiny needles attached to the skin, easing the burden of administration compared with injections. Daewoong Pharmaceutical plans to expand its output from the current pilot production stage to the manufacture of investigational drugs for clinical trials, and eventually to commercial production.
The facility will use precision automated dispensing, which distributes the drug evenly into micro-molds, and pressurized drying technology, which concentrates the drug at the needle tips. The company expects the combination to improve content uniformity and quality reproducibility for peptide drugs such as semaglutide.
A robotic transfer system will be installed across the entire process, from precision dispensing through pressurized drying to packaging. The step is intended to reduce direct handling by workers and lower the risk of cross-contamination and human error.
The company is also installing equipment to secure a sterile manufacturing environment. A sterile barrier system that blocks outside contaminants, air filtration equipment and a sealed piping circulation system will be used to minimize the entry of microbes and particles. Real-time monitoring and electronic record tracking systems will strengthen data management across the manufacturing process.
"For new formulations such as microneedles, what matters is not only technology development but also securing sterile manufacturing and quality control systems that meet GMP standards," said Lee Seung-ha, head of production at Daewoong Pharmaceutical. "By building sterile automated manufacturing infrastructure, we will lay the foundation for global commercialization of our next-generation pipeline."