BIO
The evolving mRNA landscape: Exploring the development and manufacturing trends in a rapidly changing space
mRNA (messenger ribonucleic acid) drug modalities are a revolutionary breakthrough in medicine, offering the potential to treat a wide variety of rare and infectious diseases1. In fact, as of April 2023, there are over 300 mRNA therapies currently in development, with 69% in preclinical and 31% in clinical stages2.
What trends are impacting mRNA development and manufacturing?
Despite these benefits, developers and manufacturers involved in mRNA production and who strive to bring mRNA therapies to market are facing a range of trending challenges. These include:
- Funding: Recent market downturns and global economic volatility have led investors to be more cautious, particularly when it comes to investing in mid or later-stage privately held biotechs3.
While the mRNA production process is rapid, developers must harness innovative tactics to shorten timelines further and demonstrate the potential for faster ROI to these increasingly hesitant investors. - Regulatory: mRNA technologies are still relatively new, meaning their regulations are often complex, unclear, or even contradictory. As their development continues to evolve, so will the regulations surrounding them.
To ensure the safety of patients, developers and regulators must work together to bring their understanding of mRNA technologies and their judgement to put the right controls and measures in place. - Analytical and quality control bottlenecks: Performing analytical testing and ensuring the quality control of mRNAs are key stages in bringing a therapy to market, but any delays can significantly hinder the project’s progression.
To meet the surging demand for these treatments to be delivered at greater speeds, developers have had to adapt their innovative analytical technologies to allow for more rigorous product quantification and characterisation.
How can these challenges be overcome?
To navigate these obstacles, forming partnerships with CDMOs specialised in mRNA development and manufacturing is key to hitting milestones and delivering therapies at speed. But what should these CDMOs offer to help their partners ensure their therapies reach patients quickly?
In a recent piece with Innovations in Pharmaceutical Technology (IPT) Magazine, Jing Zhu, VP, of Nucleic Acid & Viral Vector Technology at ReciBioPharm explores the trends and challenges facing mRNA developers and manufacturers and shares how CDMOs can offer the solution.
References:
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American Society of Gene and Cell Therapy. Gene, Cell, and RNA Therapy Landscape. 2023 Q1 Report.
