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PharmTech.com Innovations in mRNA eBook April 2024 Pharmaceutical Technology ® 19 Regul ations FIGURE COURTESY OF THE AUTHOR Choosing a strategic partner for mRNA development To navigate the specific challenges and regulator y land- scape of mRNA therapy development, some companies opt to collaborate with a CDMO. This approach can mitigate risks by leveraging the CDMO's expertise and experience. Involving your manufacturing partner in the planning of regulatory meetings is particularly beneficial, as their prior experiences can enrich discussions with regulatory agen- cies, potentially enhancing agency discussion and feedback. Given the f luid nature of the mRNA landscape, a stra- tegic CDMO partner should demonstrate their experience with mRNA development as well as their ability to remain informed and responsive to reg ulator y advancements along the way. Conclusion mRNA technology presents an exciting prospect for inno- vative therapies addressing a variety of clinical areas and challenging disease states. In light of the lack of specific guidelines for mRNA, leading to potential regulatory am- biguit y, strategic collaborations and early and frequent one-on-one engagement with regulators are key to facil- itating the best path forward for your unique product. References 1. FDA. Liposome Drug Products: Chemistry, Manufac- turing, and Controls; Human Pharmacokinetics and Bioavailabilit y; and Labeling Documentation, Final Guidance (CDER, April 2018). 2. FDA. Drug Products, Including Biological Products, that Contain Nanomaterials–Guidance for Industr y, Final Guidance (CDER, CBER, April 2022). 3. EMA. Concept Paper on the Development of a Guide- line on the Quality Aspects of mRNA Vaccines (Bio- logics Working Party, June 22, 2023). 4. USP. Analytical Procedures for mRNA Vaccine Quality (Draft Guidelines)–2nd Edition. General Announce- ment. USPNF.com. April 28, 2023. ■ FIGURE 1: Engagement opportunities with the Center for Biologics Evaluation and Research (CBER) at FDA. Intertek 2 Thermo Fisher Scientific 7 TriLink Biotechnologies 9 Ad Index COMPANY PAGE Involving your manufacturing partner in the planning of regulatory meetings is particularly beneficial, as their prior experiences can enrich discussions with regulatory agencies.