White Paper

Process Development Considerations For RNA-LNP Therapeutics

Treatment with Nanoparticles Genetic therapy GettyImages-805434264

Among genomic medicine modalities, RNA-based therapeutics are a rapidly expanding class of drugs thanks to the demonstrated clinical success of the messenger RNA (mRNA) COVID-19 vaccines against SARS-CoV-2 virus. The underlying mRNA and LNP delivery technology is characterized by a great flexibility and development speed with respect to production and application, which has far-reaching potential to change the current industry approach to prophylactic vaccines and enable new treatments for cancers and beyond.

With industry investment and interest at an all-time high, scalable manufacturing processes are needed to support the growing number of investigational RNA-LNP programs ranging from novel personalized therapies to rapidly deployable large-scale pandemic responses. However, as a relatively new technology, there remain barriers to successful industrialized manufacture of LNP-encapsulated RNAs. Many of the growing pains are reminiscent of the early days of monoclonal antibodies (mAbs) when the industry struggled with low titers and poor purification yields that resulted in costly and inefficient commercial manufacturing. Process development was key to overcoming these challenges for mAbs and it will be a critical factor in driving RNA-LNP therapeutics forward as well.

Establishing robust manufacturing processes will be a critical factor in expanding RNA-LNP therapeutics beyond prophylactic vaccines and towards breakthrough treatments for cancer and rare diseases. In this paper we will help you gain an understanding of the key process considerations that are unique to this new class of drugs.

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