Regulatory Frameworks For mRNA Therapeutics: Implications For Development And Manufacturing

The market for RNA therapeutics and vaccines has seen remarkable growth in recent years and shows no signs of slowing down. This expansion began in earnest in 2018 with the approval of the first siRNA-based therapeutic. The momentum continued with the introduction of mRNA-based and self-amplifying mRNA vaccines, which played a crucial role in combating the SARS-CoV-2 pandemic. Today, emerging mRNA technologies are being harnessed for a diverse array of applications. These include the development of cancer vaccines, which aim to stimulate the immune system to target and destroy cancer cells. Additionally, mRNA technologies are being used to create vaccines that offer protection against a broad spectrum of pathogens, enhancing our ability to respond to infectious diseases.

Beyond vaccines, mRNA is also being explored for its potential in therapeutics. This includes targeted antibody expression, where mRNA is used to instruct cells to produce specific antibodies that can neutralize diseases. Enzyme replacement therapies are another promising application, where mRNA can be used to produce enzymes that patients with certain genetic disorders lack.

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