Research Theme

• Establishment of GMP-compliant manufacturing technologies for investigational products of novel biopharmaceutical modalities
• Development of cell-free manufacturing technologies for mRNA therapeutics

Keyword

• Antibody therapeutics
• mRNA therapeutics
• Startups
• Drug discovery research

Overview of Research

• This study aims to overcome the “valley of death” in drug development that hinders the transition of innovative biopharmaceutical modalities to the clinical stage by establishing manufacturing platform technologies and systematizing development processes. In the wake of the COVID-19 pandemic, the effectiveness of emerging modalities such as mRNA–lipid nanoparticle (LNP) technologies and antibody therapeutics has been clearly demonstrated, marking a major turning point in drug discovery research. Next-generation biopharmaceuticals based on mRNA therapeutics and genome editing technologies are rapidly advancing, especially in the field of rare diseases. However, the lack of established GMP-compliant manufacturing technologies and the complexity of development strategies remain significant barriers to clinical translation. This study focuses on establishing GMP manufacturing technologies and quality control methods for investigational biopharmaceutical products, thereby building a technological foundation that bridges basic research and practical application. This framework will enable robust quality control, manufacturing scale-up, and progression to non-clinical evaluation, ultimately accelerating the clinical development of novel biopharmaceutical modalities. Furthermore, by introducing a funding circulation model through startup creation and industry–academia collaboration, the study aims to foster a sustainable drug discovery ecosystem and promote the social implementation of domestically developed innovative biopharmaceuticals.