Daewoong Pharmaceutical is set to establish a production base for microneedle drug delivery technology.
The company announced on October 14 that it will create a sterile clinical drug manufacturing facility dedicated to microneedles at its Daewoong Bio Plant 3 in Hwaseong, Gyeonggi Province, with plans to complete Good Manufacturing Practice (GMP) approval by the first half of 2027.
This facility aims to ensure a stable supply of clinical trial drugs and to secure production infrastructure for future commercial production.
The primary production target is DWRX5003, a candidate obesity and diabetes treatment that utilizes Daewoong Therapeutics' microneedle technology, CLOPAM, which contains semaglutide.
Daewoong Pharmaceutical is developing a sterile manufacturing process and an automated production system tailored to the characteristics of microneedle patches. The company plans to enhance the uniformity and quality reproducibility of peptide drugs by applying precision dispensing automation technology that evenly distributes the drug into micro molds and pressure drying technology that concentrates the drug at the tips of the microneedles.
Additionally, a robotic transfer system will be introduced throughout the entire process, from precision dispensing to pressure drying and product packaging, minimizing direct human intervention. This approach aims to reduce the risk of cross-contamination and human error while ensuring consistency in the sterile manufacturing environment.
The company has also focused on contamination control, implementing a sterile barrier system to block external contamination, along with precision air filtration equipment and a closed piping circulation system to structurally prevent the influx of microorganisms and particles.
Lee Seung-ha, head of Daewoong Pharmaceutical's production division, stated, "Innovative formulations like microneedles require not only technological development but also the demonstration of the highest level of sterility and quality under strict GMP standards. We will build a sterile automated manufacturing infrastructure without any setbacks to establish a foundation for the global commercialization of our next-generation pipeline."
Meanwhile, DWRX5003 is a patch-based obesity treatment being developed by Daewoong Therapeutics, a subsidiary of Daewoong Pharmaceutical, utilizing microneedle technology. When applied to the skin, the microneedle drug delivery system dissolves, delivering the semaglutide component into the dermal layer of the skin. Unlike injections, patients can apply the patch once a week, enhancing convenience.
The ongoing Phase 1 clinical trial is evaluating the safety, pharmacokinetic properties, and relative bioavailability of DWRX5003 in healthy adults aged 18 to 65.
The company announced on October 14 that it will create a sterile clinical drug manufacturing facility dedicated to microneedles at its Daewoong Bio Plant 3 in Hwaseong, Gyeonggi Province, with plans to complete Good Manufacturing Practice (GMP) approval by the first half of 2027.
This facility aims to ensure a stable supply of clinical trial drugs and to secure production infrastructure for future commercial production.
The primary production target is DWRX5003, a candidate obesity and diabetes treatment that utilizes Daewoong Therapeutics' microneedle technology, CLOPAM, which contains semaglutide.
Daewoong Pharmaceutical is developing a sterile manufacturing process and an automated production system tailored to the characteristics of microneedle patches. The company plans to enhance the uniformity and quality reproducibility of peptide drugs by applying precision dispensing automation technology that evenly distributes the drug into micro molds and pressure drying technology that concentrates the drug at the tips of the microneedles.
Additionally, a robotic transfer system will be introduced throughout the entire process, from precision dispensing to pressure drying and product packaging, minimizing direct human intervention. This approach aims to reduce the risk of cross-contamination and human error while ensuring consistency in the sterile manufacturing environment.
The company has also focused on contamination control, implementing a sterile barrier system to block external contamination, along with precision air filtration equipment and a closed piping circulation system to structurally prevent the influx of microorganisms and particles.
Lee Seung-ha, head of Daewoong Pharmaceutical's production division, stated, "Innovative formulations like microneedles require not only technological development but also the demonstration of the highest level of sterility and quality under strict GMP standards. We will build a sterile automated manufacturing infrastructure without any setbacks to establish a foundation for the global commercialization of our next-generation pipeline."
Meanwhile, DWRX5003 is a patch-based obesity treatment being developed by Daewoong Therapeutics, a subsidiary of Daewoong Pharmaceutical, utilizing microneedle technology. When applied to the skin, the microneedle drug delivery system dissolves, delivering the semaglutide component into the dermal layer of the skin. Unlike injections, patients can apply the patch once a week, enhancing convenience.
The ongoing Phase 1 clinical trial is evaluating the safety, pharmacokinetic properties, and relative bioavailability of DWRX5003 in healthy adults aged 18 to 65.
* This article has been translated by AI.
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