I4.0 In Vitro Manufacturing Facility

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MiRXES Pte Ltd, a Singapore-headquartered biotechnology company, and A*STAR spinoff, focused on saving and improving lives with miRNA-powered cancer early detection tests, announced the opening of the first industry 4.0 (i4.0) in vitro diagnostic (IVD) manufacturing facility in Southeast Asia. This S$8 million facility at JTC MedTech Hub is the largest i4.0 IVD manufacturing site at in Southeast Asia at 15,000 square feet. Guest-of-Honour, Mr Gan Kim Yong, Minister for Trade and Industry, graced the opening ceremony.

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Mr Gan Kim Yong, Minister for Trade and Industry, fielding questions from the press.

Mr Jeremiah Decosta (Vice President, Operations at MiRXES), Dr. Zhou Lihan (Co-founder and CEO of MiRXES), Mr Peter Ong (Chairman, EnterpriseSG)

Dr. ZHOU Lihan, Co-founder and CEO of MiRXES said, “Launching this facility will empower MiRXES to further our ambitions as a global leading RNA technology innovator and cancer early detection test developer. Our first manufacturing site, built in 2016, enabled us to launch GASTROClear, the world’s first blood-based stomach cancer early detection test in 2019, and allowed MiRXES to support our nation’s pandemic response through the manufacturing of Fortitude Kit, Singapore’s first approved COVID-19 RT-PCR test in Feb 2020. This brand new I4.0 manufacturing facility, will greatly advance our IVD productization and manufacturing capabilities as MiRXES accelerates the development and commercialization of our maturing pipeline of multi cancer early detection tests, pulmonary and cardiovascular disease tests, as well as our life sciences and infectious disease portfolio. This first-of-its kind facility in Southeast Asia will equip MiRXES to address the next big challenge in healthcare – cancer, and stay prepared should we need to combat another epidemic.”

Dr. Zhou added, “MiRXES i4.0 IVD manufacturing facility is also part of the bigger MiRXES plan in pioneering industry 4.0 for IVD in Singapore, which in turn increases the capabilities in advanced manufacturing, creating more highly skilled job opportunities for the industry. This will allow MiRXES to be in the right position to contribute towards Singapore’s Manufacturing 2030 vision together with esteemed partners like A*STAR. Working together, there is great potential for Singapore to become a critical node in the global diagnostics value chain, and I am proud that MiRXES will be part of this legacy, which also has synergy with our goal to be the global leader for IVD manufacturing.”

Embracing automation: Any mix, Any volume.

Collaborating with partners

Minister Gan also witnessed the signing ceremony of the Memorandum of Understanding (MOU) between MiRXES and A*STAR’s Advanced Remanufacturing and Technology Centre (ARTC). Through the MOU, MiRXES and ARTC will scope R&D activities in automation, digitalisation, disruption analysis and prevention, and sustainability, to co-develop Industry 4.0 solutions for in-vitro diagnostics and research use only innovations.

Dr. David LOW, CEO of ARTC, said, “We are excited about our collaboration with MiRXES, to accelerate the adoption of advanced manufacturing solutions in the biotechnology industry. We look forward to co-developing I4.0 innovations with MiRXES, to facilitate manufacturing at scale.”

Combining automation and digitalisation  

Employing the best in automation and digitalisation with the principle of ‘any mix, any volume’, makes this facility unique. All necessary machinery is enabled by seamless connections that work in tandem with extraction and automated analysis in order to track the quality of all product lines, examine efficiencies and propose improvements. This means that real-time data is wirelessly captured and analysed by AI to allow integration across both manufacturing and business modules for its production line, while the MiRXES team work on building more capabilities and product lines within each function. The setup of this Industry 4.0-compliant IT infrastructure was supported by A*STAR’s ARTC.

Using data for efficiency

The facility also uses real-time data and algorithms to anticipate disruptions to supply chain and to increase the efficient translations of biotechnology research into products. This includes data for tracking capacity analysis, disruption analysis and solutions, while blockchain capability links supplier and plant data to identify areas to build resilience. These work together to create an all-encompassing self-monitoring system that ensures sustainability and minimal wastage, which MiRXES prides itself on as a responsible product manufacturer.

Enabling the future

With continuous improvement in mind, the facility’s infrastructure uses a seamless plug and play system, meaning it is ready to accommodate new technologies to support functions across the production line from prototyping, validation and manufacturing of novel IVD tests and life-sciences research reagents. The facility has the ability to increase up to five in-parallel production lines, which would create a substantial tripling of capacity and output within each product line.

Pioneering i4.0 for Singapore

This facility is a timely investment for MiRXES as the company accelerates the development and commercialisation of their pipeline of miRNA powered IVD blood tests that will be used in oncology, pulmonary and cardiovascular disease areas, which were developed in close collaboration with several local institutes of higher learning and public healthcare institutions. Its location at the JTC MedTech Hub is also close to the biomedical R&D community at Biopolis, pharmaceutical companies at Tuas Biomedical Park, and the Jurong Innovation District, allowing for more partnerships to be fostered.

Looking at the Future State

MiRXES is also part of Enterprise Singapore’s (EnterpriseSG) Scale-up SG programme, which helps high-growth local companies scale rapidly and groom them into future global champions. Since its participation in 2020, MiRXES has been working closely with EnterpriseSG and the designated consultant to explore and capture opportunities in Southeast Asia including Thailand, Malaysia, and Indonesia.

Mr. Peter ONG, Chairman, EnterpriseSG said, “The biomedical cluster is an integral part of Singapore’s manufacturing sector. We are glad to see MiRXES investing and leveraging its i4.0-enabled manufacturing capabilities to seize growth opportunities. We believe this will help to set the bar for the rest of the industry and contribute to the Manufacturing 2030 ambitions to grow a strong core of Singapore Global Manufacturers that offer innovative and distinctive solutions for the global markets, as well as create good jobs for Singaporeans. EnterpriseSG will continue to support MiRXES in its transformation journey.”

“As MiRXES expands its focus from research-related work to encompassing commercially focused activities, it is therefore important that we shape and structure our business to be relatable to our wider audience, especially the general public. We are pleased to announce that the opening of MiRXES I4.0 IVD manufacturing facility also marks the launch of MiRXES’ rebranding where we have a new logomark and exciting colours,” added Dr. Zhou. “The new logomark and colours visually represent MiRXES’ breakthrough discoveries and cutting-edge technologies, and at the same time highlights the humanity and approachability of the brand. Today’s launch of both the facility and rebranding represents MiRXES’ metamorphosis of focus and solidifies MiRXES’ commitment to achieving and meeting our customers’ needs, as well as making quality preventive healthcare accessible and affordable to the general public. This will help us achieve our ambitions of becoming an established global brand.”

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