Daewoong Pharmaceutical is ramping up efforts to commercialize its obesity and diabetes treatment patches, constructing a production facility for ‘microneedle’ medications that adhere to the skin instead of being injected.
The company announced on Wednesday that it will establish a dedicated sterile clinical drug manufacturing facility for microneedles at its Daewoong Bio Plant 3 in Hyangnam-eup, Hwaseong City, Gyeonggi Province. Daewoong aims to complete the Good Manufacturing Practice (GMP) approval process by the first half of next year.
Microneedles are ultra-fine needles, thinner than a human hair, that deliver medication through the skin. This technology offers a significant advantage over traditional injections, as patients can apply the patch themselves, reducing the burden of administration and improving convenience.
Daewoong Pharmaceutical is optimizing its facility for the production of patch-type medications, including DWRX5003, an obesity and diabetes treatment candidate containing semaglutide. This development is based on the company’s proprietary microneedle technology, CLOPAM.
The new manufacturing facility will feature cutting-edge technology, including precision dispensing automation to evenly distribute medication onto the microneedles and pressurized drying to concentrate the drug at the needle tips. These innovations aim to ensure uniform drug content and minimize quality variations during production.
Notably, applying microneedle technology to peptide medications like semaglutide, used in obesity and diabetes treatments, has the potential to expand treatment options through this novel administration method.
By integrating its unique drug delivery technology with sterile automated production infrastructure, Daewoong Pharmaceutical aims to strengthen its competitive edge in developing and producing next-generation patch-type medications.
To minimize the risk of cross-contamination and human error, the company plans to implement a robotic transfer system throughout the entire process, from precision dispensing to pressurized drying and product packaging.
Furthermore, Daewoong will introduce a state-of-the-art sterile barrier system to prevent external contamination, along with precision air filtration equipment. The company will also establish real-time monitoring and electronic record tracking systems to enhance quality control across the manufacturing process.
Daewoong’s goal is to utilize this facility for producing clinical trial medications and lay the groundwork for future commercial production.
Lee Seung-ha, head of Daewoong Pharmaceutical’s production division, emphasized that for innovative formulations like microneedles, the top priority is to demonstrate the highest levels of sterility and quality under stringent GMP standards, beyond mere technological development. It’s committed to building the sterile automated manufacturing infrastructure promptly to establish a foundation for the global commercialization of the next-generation pipeline.
