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Addressing the challenges of using RNA as a therapeutic or a gene-editing tool

RNA technologies, including mRNA therapeutics, have emerged as a promising drug modality due to their essential biological role in protein expression and their potential versatility in manufacturing. As a result, RNA is in the global spotlight and is being prioritized due to the Covid-19 pandemic. To maintain the current momentum as industry returns to a ‘normal’ cycle of drug and therapy development, BioPhorum experts have come together to...

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The challenges of using RNA as a therapeutic or a gene editing tool

While previously only found in academic, pre-clinical and early clinical stages, RNA technologies, including mRNA therapeutics, have emerged as a promising drug modality due to their essential biological role in protein expression and their potential versatility in manufacturing. RNA is in the global spotlight and is being
prioritized due to the COVID-19 pandemic. However, to maintain the current momentum as industry and agencies return to a ‘normal’ cycle of development for a wider range of drugs and therapies, experts in this field need to come together to identify and address challenges unique to the RNA modality. BioPhorum has started this by bringing together industry leaders to identify RNA-focused manufacturing challenges, and is working toward solutions to common challenges and improving current processes. The purpose of this article is to introduce this critical area and to show the unique RNA challenges, not only limited to mRNA therapeutics already identified by the cross-industry team, but also to include how these challenges could potentially negatively impact companies and the RNA industry. It sets out what the team is hoping to achieve via this collaboration, both in terms of outputs and benefits to the industry.

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RNA: new CGT workstream to focus on this industry priority

When planning the 2021 BioPhorum Cell & Gene Therapy program, senior member representatives indicated that they wanted a new workstream focusing on what they considered to be the most critical topic: RNA.  By early February 2021, companies were recruited to a pathfinder activity to determine what should be covered in the workstream: RNA - mRNA therapeutics and RNA tool. Discussions led to the creation of a charter, which has been...

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