“ST Pharm, LNP technology, mass production… Aim for mRNA CDMO”

ST Pharm is accelerating the expansion of its mRNA CDMO (consignment development) business through its solid LNP (lipid nanoparticle) technology.

Yang Ju-seong, managing director of ST Pharm, announced the ‘integrated mRNA CDMO service learned from COVID-19 mRNA vaccine development’ at the National Cancer Center Cancer Science Forum on the 27th and talked about the company’s LNP platform technology and future business plans.

Yang Joo-seong, managing director, said, “ST Pharm’s identity was to be in the business of CMO and CDMO of raw materials, but after Corona 19, according to the government’s request, it has been immersed in developing its own new drug to develop a domestic vaccine.”

Since 2008, ST Pharm has established an oligo GMP manufacturing facility to produce and supply oligonucleotides to companies. ST Pharm, which has been engaged in mRNA R&D since 2018, is said to be capable of producing a variety of xRNAs such as Conventional mRNA, CircRNA, and Self Amplifying mRNA with polynucleotides.

Yang said, “If you look at the platform technology in the development of mRNA vaccines, you have abundant experience in optimization in the IVT (In vitro transcription) synthesis process. We named ourselves as SMARTCAP,” he said.

Smartcap has completed the domestic patent registration and is currently in the process of applying for a PCT (international patent). In addition, SmartCap is building a Capping library screening system.

Regarding the company’s LNP technology, Managing Director Yang said, “We have our own from the LNP technology transferred from Genevant Science to the 3rd generation LNP system.” We have built an integrated purification system (one-pot purification system) by directly applying our know-how and methods to the mRNA LNP production process.”

He said, “ST Pharm has a platform strategy for three LNPs. First, there is a technology transfer LNP. In April last year, Genevant introduced LNP through a license agreement.” It has been approved for phase 2 clinical trials. Safety has been confirmed in a large number of patients.” ST Pharm submitted an IND (clinical trial plan) for the mRNA vaccine under development to the Ministry of Food and Drug Safety.

The company’s second LNP is the STLNP. STLNP is ST Pharm’s first-generation LNP developed for use in the mRNA CDMO business. STLNP can be applied to cancer and autoimmune diseases. The third LNP is SMARTLNP, which is ST Pharm’s second-generation LNP. It is being developed with a focus on improving safety and immune response. SMARTLNP has filed a material patent application.

In May of last year, ST Pharm built the first mRNA GMP (Good Manufacturing Practices and Quality Control Standards) facility in Korea. Approved as a phase 1 clinical sample manufacturing site. It has established a non-GMP stage R&D and small-scale production system. In addition, a medium-scale production facility at the GMP stage has been established, and multi-gram production is possible every month.

ST Pharm is expanding commercial-scale production facilities on the 3rd and 6th floors of the mRNA plant. Regarding this, Yang said, “Through the microfluidics-based system, we will expand to a system that can produce up to 200 million doses.”

Regarding the direction of the company’s development, he said, “ST Pharm has three LNP technologies and LNP mass production capabilities.” “There is also a post-COVID-19 strategy. We will expand the xRNA project through Levatio and Vernagen. plan,” he said.