Daewoong eyes 2027 GMP approval for microneedle facility

Daewoong Pharmaceutical is expanding its manufacturing capabilities for microneedle drug patches, aiming to secure Good Manufacturing Practice approval for a dedicated sterile production facility by the first half of 2027.

The facility, located at Daewoong Bio's Plant 3, will support clinical trials and lay the groundwork for commercial production of next-generation medicines, including DWRX5003, a semaglutide-based treatment candidate for obesity and diabetes.

Using the Clopam microneedle platform developed by Daewoong Therapeutics, the company aims to develop drug patches that offer a more convenient alternative to conventional injections.

The new facility will combine sterile manufacturing with automated production systems to ensure consistent drug dosing and minimize contamination risks.

Key technologies include precision dispensing to distribute drugs evenly into microscopic molds and pressure-assisted drying to concentrate active ingredients at the needle tips. Robotic systems will handle materials throughout production, reducing human intervention and the risk of errors or cross-contamination.

Daewoong is also introducing clean rooms, sterile barriers, advanced air filtration and closed-loop piping to prevent contamination. Real-time monitoring and electronic tracking systems will strengthen quality control and data integrity.

"Developing innovative formulations such as microneedles is not enough; we must also demonstrate sterility and quality under strict GMP standards," said Lee Seung-ha, head of production at Daewoong Pharmaceutical. "We will establish the sterile automated manufacturing infrastructure as planned to support the global commercialization of our next-generation drug pipeline."