This article is from The Circle of Biological Products

The outbreak of novel coronavirus pandemic in 2020 caused huge disasters in the world, including more than billions of infected cases and millions of deaths. At present, it is urgent to take epidemic prevention and control measures against a new round of strain variation. Vaccines are deemed as the most effective weapons for transmission interruption and disease control. Among all types of vaccines, SARS CoV-2 mRNA vaccines are safe and effective with a short development cycle and simple manufacturing process, which have aroused wide public concern. Therefore, they have become “dark horse” vaccines in the vaccine industry.

The mRNA vaccines deliver the artificially edited mRNA to human cells, translate the mRNA fragments to code some proteins (e.g. spike protein (S protein)) or receptors on novel coronavirus in human cells, activate the specific immune response of B- and T-cells to this antigen protein, and establish the immune memory. Therefore, they have stronger immunogenicity and longer protective effect.

At present, the mRNA vaccines are mainly used by western countries. According to the data of WHO, as of July 20, 2021, clinical studies have been carried out for 18 kinds of mRNA vaccines in the world, including 2 kinds of marketed vaccines: BNT162b2 (developed by Pfizer/BioNTech) and mRNA-1273 (developed by Moderna). According to the 2021 semiannual reports from global pharmaceutical companies, Pfizer ranks first in terms of the gross revenue in pharmaceutical sector due to its development and sales growth of SARS CoV-2 vaccines, while Moderna plays a leading role in the industry. The domestic SARS CoV-2 vaccines are mainly inactivated, but mRNA technology is being actively deployed. At present, a few domestic manufacturers of SARS CoV-2 mRNA vaccines have obtained the clinical approvals, including Walvax Biotechnology which has been approved for phase 3b clinical study on booster injections of SARS CoV-2 mRNA vaccines.

The first national SARS CoV-2 mRNA vaccine industrial production plant delivered by Yuxi Walvax Biotechnology Co., Ltd. (Yuxi Walvax) in September 2021 (“the project”) has a building area of more than 5,000 m2, providing the plasmid production, bulk preparation, drug product production and filling processes. The project has been completed within 7.5 months, first achieving the industrial production of SARS CoV-2 mRNA vaccines in China.

So how Yuxi Walvax first realized the industrial production of SARS CoV-2 mRNA vaccines in China quickly? What was the driving force, in addition to its own strength? Pharmadule Morimatsu helped Yuxi Walvax to carry out the clinical studies and industrial production as soon as possible by providing deep understanding of process and production, development support, process product matching and integration, so that Yuxi Walvax could seize market opportunities quickly. Moreover, why Yuxi Walvax selected Pharmadule Morimatsu among numerous suppliers?

First, delivery of one-stop modular project. As a world-leading supplier of integrated project solution, Pharmadule Morimatsu has cutting-edge project design concept and rich experience in modular manufacturing. During the modular manufacturing, which was like erection of Lego building blocks, the core parts of the whole project were transferred to workshops for production and assembly, so that all critical process equipment and components could be processed and assembled in a safe and clean environment. During the implementation of the project, the modular solutions were adopted to ensure faster delivery, lower risks, predictable implementation and great flexibility of the project, so that the customer could feel the power of certainty. For the project, more than 80% of work were completed offsite before shipment, which improved the production quality of products and the delivery certainty of the project, and minimized the onsite work quantities compared to traditional construction. The total lead time was finally reduced by more than half compared to traditional projects. In addition, the one-stop services from design, construction, FAT, transport, field installation to debugging provided for the project also effectively reduced the communication interfaces, improving the project controllability and communication efficiency.

Second, rapid response. Pharmadule Morimatsu, by full use of its highly localized resources and supply chain advantages and through real-time communication with the customer, completed the conceptual design, basic design and detailed design within 2.5 months, and the plant construction within 6 months by optimizing the project implementation process. It met the high expectation of the customer with a high satisfaction degree by use of modern project management mode.

Third, application of digital technology in the project. Pharmadule Morimatsu adopted the most advanced digital technology for the project. The plant equipment provided digital technology-based information throughout the life cycle of the project including design, production, installation and debugging, in order to ensure the implementation efficiency and data traceability of the project. In addition, after delivery of the project, the equipment maintenance plan and spare parts supply scheme were prepared through big data analysis in order to optimize the manufacturing process. The digital technology was helpful in the fast delivery of the project. It will also help Yuxi Walvax to achieve lean plant management, operation and maintenance in future.

In the project, the mRNA vaccines using national innovative technical route can be stored above 0 ℃, which has aroused extensive attention in the industry.

At present, SARS CoV-2 vaccines are in short supply in developing countries. The mRNA vaccines have huge market demands due to the application of booster injections and the trend of pandemic. The consistently preferred mRNA technology ranks first on the 2021 list of global top ten breakthrough technologies due to its technology platform with significant advantages, broad application prospects and high-profile industrial chain. A new generation of mRNA technology-based nucleic acid drug platform can be used to manufacture various kinds of vaccines, bringing revolutionary innovation in the oncotherapy and having infinite development potential as recognized in the industry.

In the project for the first industrial production of SARS CoV-2 mRNA vaccines in China, Pharmadule Morimatsu helped Yuxi Walvax to carry out the clinical study and industrial production as soon as possible, thus making substantial contributions to the fight of the epidemic. The implementation mode of the project has been noticed by global biopharmaceutical industry, and the project, probably as a typical project in this industry will be cited by numerous companies, with high referential significance.

About Shanghai Morimatsu Pharmaceutical Equipment Engineering Co., Ltd.

Founded in Japan and basing in China, Morimatsu has developed into a diversified multinational company which has rich experience and core technology in core equipment, process system and project solutions. Replying on the advanced manufacturing base in China, Morimatsu opened affiliated companies in Sweden, USA, India and Italy. It has delivered different products and services for more than 40 countries to date. Shanghai Morimatsu Pharmaceutical Equipment Engineering Co., Ltd. is a wholly-owned subsidiary of Morimatsu International Holdings Company Limited. Morimatsu International Holdings Company Limited (stock abbreviation: Morimatsu International, stock code: 2155.HK) was successfully listed in June 2021.