Korean Biopharma Companies Pioneering Next-Gen Drug Manufacturing: A Leap Towards Continuous Production

 

In a bold move that's turning heads in the pharmaceutical industry, leading Korean biopharmaceutical giants like LG Chem, Hanmi Pharmaceutical, and Daewoong Bio are contemplating a groundbreaking shift towards continuous manufacturing (CM). This innovative approach is poised to revolutionize drug production by seamlessly processing raw materials without interruptions, replacing the traditional batch-type production method. The allure? Reduced production costs and enhanced efficiency.

Continuous manufacturing is a relatively new concept in the global pharmaceutical arena. It gained prominence in 2015 when the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved Vertex Pharmaceuticals' cystic fibrosis drug Orkambi as the pioneer continuous manufacturing drug. Since then, eight more drugs have secured global regulatory approval for this transformative approach.

The allure of continuous manufacturing lies in its ability to significantly slash production expenses. According to a report by KoreaBIO, the global pharmaceutical continuous manufacturing market is estimated to reach a staggering $1.59 billion in 2022, with a compound annual growth rate (CAGR) of 17.2% projected through 2028.

Professor Won Kwon-yeon, President of the Korean Society of Pharmaceutical Science and Technology, compares continuous manufacturing to established practices in the food industry, such as making ramen or bread, where ingredients are continuously added, mixed, kneaded, and dried. However, pharmaceutical production has traditionally followed a more conservative path, setting up a manufacturing unit in advance and meticulously scrutinizing each batch for quality control.

The appeal of continuous pharmaceutical manufacturing is clear—streamlined mass production. Once the raw materials are injected, the drug production process flows seamlessly. However, the challenge lies in ensuring the quality of each step in this continuous process.

The FDA has so far approved only oral solid drugs for continuous manufacturing due to their lower risk to human safety in the event of quality issues. This cautious approach underscores the agency's commitment to safety.

Professor Na Dong-hee of Chung-Ang University College of Pharmacy emphasizes the potential for reduced labor costs, especially for products with slim profit margins. Continuous manufacturing offers a way to lower production costs for such pharmaceuticals.

One major obstacle cited by many academics is institutional uncertainty. To address this, the Ministry of Food and Drug Safety (MFDS) is poised to release guidelines for continuous manufacturing processes, making it the first regulatory agency globally to do so since the International Conference on Harmonization of Medicinal Products (ICH) issued its guidelines in March.

Around ten companies, with a strong presence from pharmaceutical giants like LG Chem and Hanmi Pharmaceutical, are actively participating in this initiative. Daewoong Bio, a subsidiary of Daewoong Group, has also embraced continuous manufacturing as part of its "World Class Plus" program, focusing on producing enavogliflozin, a key ingredient in their domestic diabetes treatment drug.

The road ahead is marked with both excitement and apprehension as Korean companies embark on the journey to adopt continuous manufacturing processes, while regulators refine the necessary systems. The implementation of Process Analytical Technology (PAT) for real-time quality monitoring is a significant investment in terms of time and resources. Yet, as Professor Won suggests, if Korea proactively lays the groundwork, this venture could become another success story akin to the biosimilar revolution.