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Manufacturing mRNA products at a glance
The mRNA technology is based on two in-vitro reactions, followed by adequate purification steps and final formulation into liposomes. Even if the process is relatively simple, a platform based approach is still missing; moreover, equipment (and related batch) size can be very different, thus posing potential constraints in scalability, technology transfer and yields. In addition, the cost to purchase some specific materials and critical components have a big impact on final product cost and lead time.
With respect to traditional vaccines and current biotechnological products in general, animal-derived raw materials and cell impurities are completely absent, posing huge advantages in terms of regulatory and process compliance: mRNA manufacturing process is also extremely fast compared to traditional biotechnological products.
More than 20 years of biotechnological products’ experience can leverage mRNA based products
MRNA-based products have further highlighted the fact that biotechnological products can be extremely different from each other. For example, the following cases, already considered the current state of the art, each have their own complexity, peculiarities, issues and challenges:
- Different products manufactured on the same process platform, like different monoclonal antibodies in the same characterized cell line
- Same product manufactured on different platforms (e.g., different hosts), for example biosimilars
- Same product family (e.g., vaccines), different product types (e.g. Attenuated, VLP, mRNA-based, DNA-based, etc.)
- Biological origin products manufactured with extractive processes, such as plasma products, IgG, albumin, etc.
- Cell and Gene Therapy products (ATMPs), for which a dedicated GMP chapter has already been released
Pharmaceutical companies and technology suppliers have been constantly involved in optimizing biotechnological processes and products, at least since the 1990s, in order to increase products’ quality and improve patients’ access to such therapies. The current challenges of mRNA products should be addressed, taking into consideration such products’ peculiarities but also leveraging more than 20 years of biotechnological product development experience.
For example, the use of the following fields of expertise should improve mRNA products’ flexibility, scalability and transfer:
- Continuous manufacturing approaches
- P based processes
- PAT (Process Analytical Technologies)
- Quality compliance materials and components
Huge initiatives are already ongoing, such as the mRNA technology transfer program, a global initiative that aims to improve health and health security by establishing sustainable, locally owned mRNA manufacturing facilities, especially in low- and middle-income countries. The program is being started with mRNA vaccines, but plans exist to include further mRNA based products for a variety of diseases.
Investments in such facilities/technologies are constantly increasing all over the world: certainly, mRNA based products have successfully entered the biotechnological products’ family and are here to stay!
