Insights from prominent industry stakeholders and experts on adopting mRNA technology.
by Josephine Cheng
Merck recently conducted a study on the future of vaccine manufacturing in the Asia- Pacific region. Nearly 40 executives from the biopharmaceutical industry, CDMOs, and research institutes across ten countries were interviewed on topics of different vaccine modalities technology adoption and the facility of the future. Here are some key findings of the study:
Each vaccine modality, including the highly popular mRNA, offers a range of benefits and challenges.
The survey found that mRNA, viral vector, virus-based, and recombinant vaccines are likely to dominate in the future. A large number of benefits were attributed to mRNA, along with several important challenges, including access to development and production technology, and talent and regulatory questions.
The survey findings reflect an active interest in mRNA vaccines, as well as the continued application of other vaccine modalities. A major reason for this is a result of extensive investment and research into the infection mechanisms used by pathogens which facilitate the identification of antigen targets, and of course, a lengthy history of these established modalities with regulatory agencies. This has created a foundation for ongoing development based on approaches such as subunit and viral vaccines.
While mRNA vaccines have proven successful against SARS-CoV-2, it will be several years before this becomes a mature modality. While the production scale is impressive, the production processes, technology, and expertise are still evolving. Once the mRNA-based regulatory landscape and manufacturing processes are more firmly established, this approach can be used to produce vaccines against new targets (novel variants or new diseases) with a minimal number of process and formulation changes since the majority of the critical quality attributes (CQAs) are the same regardless of the disease target.
Vaccine makers prefer to establish new facilities, especially for mRNA but face technical and regulatory barriers.
More than 60% of survey respondents indicated that they favour establishing new facilities or revamping existing facilities with expansion plans over the next few years. Preference for a new facility is driven by the fact that mRNA does not require an extensive setup or that there would be no excess capacity to convert. Other respondents would prefer to update and utilise existing facilities for the pilot phase of development and, in some cases, only establish new facilities after the approval of the vaccine. For mRNA vaccines, the barrier to adoption is the lack of experience with this modality, lack of access to technology and manufacturing expertise, and the evolving regulatory considerations.
The recent pandemic created a sense of urgency across the entire biopharmaceutical industry to develop new vaccines and therapeutics. Given the need to move quickly, revamping existing facilities made the most sense to enable a rapid response. With the pandemic behind us, companies now have time to consider and evaluate a range of options when it comes to vaccine production. With mRNA vaccine production requiring relatively less space than other approaches, new facilities may be more feasible and affordable.
The most important concepts for future vaccine manufacturing facilities are closed and continuous processing, plus equipment connectivity and communication.
When it comes to the vaccine factory of the future, the survey revealed that multi-products and custom-designed modular facilities are preferred to enable the production of different vaccines and biologics. Closed processing, continuous processing, equipment connectivity and communication are the most important concepts, indicating that quality, safety, productivity, and efficiency remain top priorities.
The response gathered from the survey shows that the vaccine industry is moving in the same direction as the overall industry—towards “bioprocessing 4.0”, which is defined by more intensive, more connected, and more highly automated processing. Vaccines are no longer perceived as being quite traditional and using older production technologies. Many vaccine platforms— such as recombinant protein subunits, viral vectors, and mRNA—are becoming quite advanced in their use of technology and moving towards closed and continuous processing, similar to the evolution of monoclonal antibody production.
Expertise and availability of skilled personnel are the two key challenges when planning for the adoption of new technologies.
The selection of which vaccine modality to be produced requires cost considerations and an assessment of available resources. Partnering with a technology provider with global experience in manufacturing all different types of vaccine modalities can further ensure a cost-effective, high-quality process. Take Merck as an example, we support vaccine manufacturers with raw materials, consumables and systems as well as expertise in vaccine production, process development, process optimization, scale-up implementation, testing services, and regulatory consultancy. Ultimately, a strong partner with in-depth expertise and the ability to leverage novel technologies will also help reduce risk and shorten timelines. [APBN]
This article was first published in the September & December 2023 print version of Asia-Pacific Biotech News.
About the Author
Josephine Cheng, Senior Consultant, Process Solutions APAC at the Life Science business sector of Merck, based in Singapore.