Thanks to years of prior research, substantial government funding, and global collaboration, the biopharmaceutical industry was able to accelerate the approval process for mRNA COVID-19 vaccines. These vaccines, which first received emergency approval in 2021, have demonstrated both the effectiveness of mRNA-based vaccines and the scalability of mRNA vaccine production. As research progresses on novel applications for mRNA vaccines and therapeutics, governments, developers, and manufacturers are considering how the regulatory environment for mRNA vaccine production will evolve post-pandemic.
One such manufacturer is Samsung Biologics, one of the world’s largest contract development and manufacturing organizations (CDMOs). The company was involved in the production of early COVID-19 mRNA vaccines as a provider of fill/finish services for Moderna’s vaccine. It has since expanded its mRNA vaccine production capabilities, adding drug substance services as part of a suite of end-to-end mRNA capabilities at its Songdo, South Korea, facilities.
Recently, leaders from Samsung Biologics answered several pressing questions on the future of mRNA vaccine production in a wide-ranging Q&A. Pierre Catignol, executive vice president and head of manufacturing, and Huisub Lim, lead scientist of mRNA manufacturing, discussed the outlook for regulations as they explained Samsung Biologics’ expansion of mRNA vaccine production capabilities.
“The Emergency Use Applications accepted during the pandemic are no longer expected to be applicable to mRNA-based treatments or vaccines. Moreover, the establishment of a regulatory framework has lagged behind the rapid rise of mRNA therapeutics,” said Catignol and Lim. “Due to the novelty of mRNA vaccines and their manufacturing process, regulators have taken a comprehensive approach to understanding every relevant detail, ensuring that all elements of concern can be considered by manufacturers when developing this type of product — and by regulators when evaluating such products.”
The History of mRNA Vaccine Production Regulation
Prior to the COVID-19 pandemic, there were no mRNA vaccines approved for human use. However, research had been progressing for decades and significant progress was being made leading up to the onset of the pandemic, particularly due to advancements in lipid nanoparticle (LNP) encapsulation technology used to ensure the stability of mRNA molecules. The first clinical trials for LNP-based mRNA vaccines began in 2015.
In 2020, COVID-19 was designated as a priority disease through the World Health Organization R&D Blueprint, a strategy and preparedness plan that allows for the rapid activation of R&D activities. MRNA vaccines were some of the first to enter clinical trials following this designation. These vaccines don’t require growing viruses in living cells, making them ideally suited to address infectious diseases such as COVID-19 due to editability and the scalability potential of mRNA vaccine production.
COVID-19 mRNA vaccines were approved for human use in 2021, and they continue to be used to vaccinate individuals around the world. Since the initial approval of these vaccines, mRNA-based booster vaccines have also been approved.
The WHO Expert Committee on Biological Standardization continues to consider long-term strategies for regulating mRNA vaccines and therapeutics as researchers pursue a wide variety of applications, ranging from targeted cancer treatments and heart disease therapeutics to vaccinations for infectious diseases such as HIV and Zika virus.
In discussing the WHO’s actions on this front, Catignol and Lim noted that the committee “expressed its support for the development of a WHO guidance document on regulatory considerations in the evaluation of mRNA vaccines, which could be updated as more scientific and clinical data on this novel product type become available.”
Samsung Biologics’ Approach
Catignol and Lim explained that the CDMO’s broader focus on regulatory compliance has extended into its more recent mRNA vaccine production projects.
“Samsung Biologics’ proven track record of success includes numerous regulatory approvals for GMP production of [drug substance] products, including mRNA-based products. As a result, Samsung Biologics has formed a strong, positive relationship with both the FDA and the [European Medicines Agency].”
This track record includes a recent collaboration with GreenLight Biosciences on an mRNA vaccine production project, which completed its first commercial-scale manufacturing run earlier this year. The first run, including technology transfer and scale-up to commercialization, was completed just seven months after the strategic partnership was announced in late 2021, demonstrating the potential pace at which mRNA vaccine production projects can reach commercialization.
“This demonstrates a major achievement in our continuing goal to offer one-stop end-to-end mRNA production from drug substance to aseptic fill/finish to commercial release, all from a single site, as we strive across our biomanufacturing network to fight the pandemic,” said John Rim, CEO and president at Samsung Biologics, in a statement announcing the completion of the manufacturing run.
While mRNA vaccine production projects continue to focus on COVID-19 applications, Samsung Biologics is developing end-to-end capabilities that could position it as a CDMO partner for other mRNA projects as the technology develops. When it comes to building the capabilities of an ideal CDMO partner in this area, Catignol and Lim emphasize a commitment to expertise and compliance: “A validated analytical method to evaluate mRNA for characteristics such as size, encapsulation efficiency, and purity is crucial. Hand in hand with expertise is the experience from which it is drawn. A CDMO should be able to exhibit stellar records relevant to audits and supplier management, as well as regulatory compliance associated with quality systems and facilities.”
The Future of mRNA Vaccine Production
Despite some degree of uncertainty on exactly how mRNA vaccine regulation will progress in the near future, Catignol and Lim are confident in the broader development of the market for mRNA vaccines and therapeutics.
“The global mRNA vaccines and therapeutics market is forecasted to grow steadily in the next few years. This is largely because mRNA can create therapeutics based on a novel mechanism of action for applications that cannot be targeted by existing antibody platforms (e.g., gene editing, targeting of intracellular protein or pathogens, etc.),” they said. “MRNA technology also is conducive to highly specific molecular designs and functionalities, giving it the potential to achieve greater efficacy than traditional drugs by addressing the underlying causes of disease.”
Given this upside for mRNA vaccines, as well as the demonstrated ability of mRNA vaccine production to respond in a pandemic situation, the technology is likely to continue to receive support from developers, manufacturers, and regulators.
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