The Asia-Pacific has emerged as the second largest region for ATMP trials, surpassing Europe and governments across Singapore, South Korea, Australia actively backing up the mRNA innovation. Asia Pacific is well positioned to lead the global mRNA clinical trials in cancer treatment. Cytiva discusses how the industry in the Asia-Pacific region can sustain this growth, navigating the challenges, and unlocking the region’s full potential through collaborations among different stakeholders.

by Peiqing Zhang and Krishna Karnati

With a population exceeding 4 billion and accounting for nearly half of global cancer cases, Asia faces a growing cancer incidence. Effective cancer treatments are critical for improving the quality of life in Asia. In the realm of therapeutic innovations, mRNA, validated by the success of COVID-19 vaccines and distinguished by its efficient design-to-manufacturing process, has risen as a highly promising avenue for cancer management, especially for virus-related cancers, which account for approximately one-fifth of cancers.

Recent advancements in mRNA development further reignited excitement for mRNA as a modality for cancer treatment. From MSD and Moderna’s recent launch of personalised mRNA cancer vaccine phase 3 trial to Memorial Sloan Kettering Cancer Center (MSK)’s latest development of the mRNA pancreatic cancer vaccine, it is a race to the top. While the majority of these advancements are happening in the West, the Asia-Pacific region is rapidly emerging as a hotbed for innovation in mRNA development.

According to data from the Q4 2022 data from the Alliance for Regenerative Medicine, the Asia-Pacific region has established itself as the second largest region for Advanced Therapy Medicinal Product (ATMP) trials. A recent development in this landscape involves a strategic partnership between South Korea-based firms Samyang Holdings and LG Chem, focused on advancing novel mRNA-based cancer therapeutics. Gennova Biopharma in India is now considering use of the technology in making vaccines against cancer and infectious diseases. Meanwhile, in China, Likang Life Sciences recently received clinical trial approval for China’s first personalised neoantigen-targeted cancer vaccine.

The Rise of Asia Pacific in mRNA Development Is Backed by Governments

The upward trajectory of mRNA technology in APAC is underpinned by a governmental commitment to fostering local innovation.

Singapore is a prime example, where the government has exemplified strong support for mRNA research and development. Earlier this year, the Ministry of Health in Singapore announced its financial backing for the development of mRNA-based cancer vaccine development in the country. In South Korea, the government has set an ambitious target to produce at least one domestically developed mRNA vaccine by 2023 as a pivotal part of their strategy to establish themselves as a global hub for vaccine production. A substantial budget of approximately US$1.92 billion has been allocated over a five-year span to realise this ambitious goal.

Australia, too, has emerged as a proactive player in strengthening its vaccine production capabilities. In the past year, they initiated two partnerships with BioNTech and Moderna to bolster mRNA vaccine manufacturing capacity in Melbourne, along with the establishment of a global mRNA vaccine hub in Brisbane. Recent announcements of plans for an mRNA training centre further underscore Australia’s commitment to developing sovereign vaccine manufacturing capabilities.

Over the past three decades, India has made efforts to strengthen the research and development ecosystem for local vaccines including mRNA, through the adoption of pioneering strategies like fostering active partnerships with relevant global leaders and the implementation of innovative funding mechanisms, e.g., the Ind-CEPI Mission.

As the demand for mRNA continues to surge with increasing clinical trials and faster drug approvals, contract development and manufacturing organisations (CDMOs) are finding themselves compelled to rapidly enhance their capabilities. This surge in demand highlights the necessity for a robust ecosystem to effectively meet these heightened requirements.

More Can Be Done to Sustain the Current Growth

The momentum behind mRNA development in the APAC region can be accelerated by several key factors:

1. Expanding talent pool

A global competition for highly qualified biologics manufacturing talent is evident. The biopharma industry has long grappled with this challenge, and in comparison to the COVID time when lockdown restrictions were limiting how far the industry could cast their net to find skilled workers, governments across the region are now proactively implementing strategies to attract and retain talent, particularly in the biotech sector. It is also encouraging to see that the evolution of mRNA medicines following the advent of COVID-19 vaccines has contributed to the rapid growth of the APAC biotech industry, making it an increasingly appealing destination for skilled professionals.

For instance, Singapore has introduced the Deep Tech Talent Central (DTTC) initiative to address talent shortages in emerging technology sectors. Similarly, Australia has established the Global Business and Talent Attraction Taskforce, along with the Researcher Exchange and Development within Industry (REDI) Fellowship Program since 2020. These efforts are geared towards bridging skill gaps in vital growth sectors such as advanced manufacturing, digital technology, healthcare, and life sciences. The 2023 Global Biopharma Resilience Index, which surveyed 1250 biopharma and healthcare executives, highlighted that in the longer term, flexible policies enable biopharma firms to access talent from overseas, and consistent regulatory frameworks are needed in place to support collaboration between government, academia, and business that nurture the local R&D ecosystem.

2. Domain knowledge of therapeutic application

Pioneering advancements in the mRNA field demand substantial resources, often undertaken by prominent biopharmaceutical companies, especially within the APAC region. Nevertheless, an increasing number of biotech firms are embracing mRNA technology, and many APAC countries score highly in the 2023 Global Biopharma Resilience Index when it comes to manufacturing agility.

It is encouraging that the industry and the government are removing hurdles for local companies in the development of mRNA technology, providing support beyond monetary needs. For instance, Singapore’s Agency for Science, Technology and Research (A*STAR) has shown a concerted effort to advance the implementation of RNA-based medicine in Singapore with the launch of the official NAT Programme focused on the biomanufacturing aspects of mRNA. The diverse expertise of A*STAR’s scientists, which spans RNA design, protein engineering, process manufacturing, and more, contributes to an ecosystem ripe for progress with the inclusion of local SMEs, industry partnerships, and academic collaborations.

3. Funding Support

The clinical development of mRNA-based treatments requires significant capital investment to foster ongoing innovation. Despite the economic challenges experienced across various sectors in the past year, there’s a bright spot in the form of increased innovation and investment in Advanced Therapy Medicinal Products (ATMPs) within the APAC region (as indicated by the Alliance of Regenerative Medicine report).

Governments and the industry have been actively providing funding support to establish mRNA capabilities, with infectious diseases as an immediate target. For instance, Ricoh started a Biomedical Startup Fund in Japan to support mRNA drug discovery and invest in local startups in the drug research field, enhancing their support for mRNA drug development. Just recently, ARCALIS, a partnership between Axcelead and Arcturus, received $115 million in grants from the Japanese government. This funding will be used to build a factory and buy equipment for mRNA drug production meeting Good Manufacturing Practice (cGMP) standards. This global trend is reinforced by the Coalition for Epidemic Preparedness Innovations (CEPI), which recently pledged funding of up to US$3.6 million to propel Gennova Biopharmaceutical’s self-amplifying thermostable mRNA vaccine platform. This funding is specifically directed towards expediting the development of vaccine candidates targeting “Disease X.”

The cumulative efforts and financial support of various countries and organisations in supporting mRNA research and development are crucial not only for immediate applications targeting infectious diseases but also for creating a robust knowledge and platform base that can be leveraged to expand mRNA applications into other critical areas, including cancer therapeutics.

Navigating the Challenges

The establishment of a manufacturing toolkit, complete with dedicated equipment and consumables, is crucial for maintaining consistency in the process development of mRNA. This toolkit is poised to play a pivotal role in propelling mRNA technology forward.

1. Scalability

As a multifaceted aspect, scalability encompasses the adaptability of biomanufacturing technologies to different scales, from process development through clinical and commercial manufacturing, as well as ranging from largescale production for pandemic vaccines, where current technologies can be readily adjusted, to smaller personalised applications that often face gaps in biomanufacturing capabilities. Australia’s University of Adelaide, in partnership with BioCina, has inaugurated the nation’s first Good Manufacturing Practice (GMP) facility. This facility equips Australia with the capacity to manufacture plasmid DNA (pDNA), encapsulations, and formulations.

Realising the potential of mRNA demands meticulous process development solutions. Progress within the industry hinges on collaborative efforts, effective communication, and a collective drive to materialise the full potential of mRNA. Initiatives such as Cytiva’s BioChallenge support biotech startup innovation, while Fast Trak™ Services optimise resource utilisation. Fast Trak™ Bioprocess Training and Education not only grooms the next generation of bioprocessing talent but also enhances specialist knowledge. Collaborations, such as that with Innoforce, bolster talent retention and upskilling within the sector. Cytiva’s involvement encompasses technical and leadership training for executives, as well as the promotion of cell and gene production technology.

2. Supply chain complexities

Supply chain intricacies pose another challenge. Fulfilling the storage and delivery needs of custom-made DNA templates is complicated by physical manufacturing limitations and the complexities of coordinating the transportation of materials that require constant freezing. According to the 2023 Global Biopharma Resilience Index, manufacturing for cell and gene therapies still grapples with a lack of streamlining and limited standardization. Many new therapies come from start-ups or academic labs that are innovative but lack the ability to scale up.

Noteworthy solutions have emerged. Arranta Bio harnessed Cytiva’s FlexFactory™ single-use manufacturing platform to consolidate the mRNA GMP manufacturing supply chain, enhancing standardisation and efficiency. In response to escalating market demand, Chinese manufacturers are enhancing their facilities. For instance, Catug Bio collaborated with Cytiva to unite pDNA and mRNA development capabilities within a single facility, fostering future-proof manufacturing. It is an example of end-to-end or segmented technical services covering the entire life cycle that are expected to usher in a comprehensive capability so as to better meet the needs of various users, such as scientific research institutions, medical institutions, and pharmaceutical companies, for gene and nucleic acid drug modalities at all stages.

The development of COVID-19 vaccines presented mRNA’s potential; it is also an example of what can be done when key stakeholders work together. However, looking ahead, while the APAC region’s ascent as a hub for mRNA development in cancer treatment holds immense promise, it’s imperative to strategize for the sustained growth of mRNA manufacturing to meet future demands. Collective effort is needed among governments, academia, and the life science industry; no single organisation can do it alone. By nurturing this potential through collaboration, investment, and innovation, the region is poised to make significant contributions to the future of healthcare and cancer treatment on a global scale. Together, we can accelerate the development of novel therapeutics from discovery to delivery, ultimately easing the suffering of patients worldwide. [APBN]

Fast Trak™ and FlexFactory™ are trademarks of Global Life Sciences Solutions USA LLC or an affiliate doing business as Cytiva.

This article was first published in the September & December 2023 print version of Asia-Pacific Biotech News.

About the Authors

Peiqing Zhang is the Strategic Technology Partnership Leader at Cytiva, responsible for technical engagement with customers and the gene therapy community across the Asia Pacific.

Peiqing has more than 15 years of experience in biotech research, development, and commercial manufacturing. Prior to joining Cytiva, he held various roles with increasing responsibilities in technical transfer, analytical sciences, manufacturing science and technology, and CMC management.

Krishna Karnati is the General Manager Commercial and leads the Genomic Medicine business for APAC. He leads an expert team of technical, product and business development to support the customers’ needs in APAC including India. He is based in Singapore.

He has more than 19 years of experience in the Pharmaceutical and Biopharmaceutical industry. Prior to Cytiva, he worked for companies such as GSK, and Takeda in different capacities heading Manufacturing, Validation and technology transfer.

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