AMM brings the best minds together to overcome the most critical obstacles inhibiting the advancement of mRNA research, development and manufacturing. Furthermore, AMM forges inclusive and collaborative partnerships with other networking forums to co-publish, augment or improve upon technical and scientific content generated by these groups.
AMM’s members are deeply involved in mRNA research, as academic institutions and private sector R&D organizations. The organization supports policies and funding opportunities that advance such research, like the recently announced Advanced Research Projects Agency for Health (APRA-H) CUREIT project that aims to train the immune system to better fight cancer and other diseases with the goal of developing generalizable mRNA platforms to treat diverse diseases and save lives and the FDA-funded center for research on continuous mRNA manufacturing.
To fully realize the benefits of mRNA technology across its many potential applications, the field needs further alignment on manufacturing standards. Support for, and recognition of, standards will provide significant benefits, including fostering collaboration and knowledge sharing, enabling innovation and development of new products, advancing regulators’ comprehensive review of new products, and decreasing unnecessary and wasteful costs to patients.
AMM will play an industry-wide role in ensuring mRNA products can overcome current barriers to commercialization. Our members span the full range of the R&D lifecycle and collectively are poised to address these issues.
AMM is hosting a year-long webinar series exploring the scientific issues related to mRNA product manufacturing from beginning to end. Register to join us live, or view the recordings of previous webinars below.
The webinar focuses on quality attributes of mRNA drug products and quality control release assays. It provides background on quality attributes of mRNA drug products and discusses establishing a framework: consensus, standards, and analytical tools.
The webinar covers the comprehensive characterization of mRNA medications, emphasizing the importance of analyzing components like the cap structure, UTRs, and poly(A) tails, which influence translation efficiency and immune response. Researchers present analytical techniques such as LC-MS for evaluating capping efficiency and sequence integrity, along with specialized methods for studying circular RNA (circRNA) structure and degradation.
The webinar provides expert insights on self-amplifying RNA, circular mRNA, and continuous manufacturing. It covers various technical challenges in mRNA manufacturing, including production methods, purification techniques, and continuous manufacturing approaches, while also addressing regulatory considerations and potential cost reductions.
The webinar covers key considerations in mRNA engineering and therapeutics. Topics include the roles of untranslated regions, cap and tail structures, and codon optimization in enhancing protein expression.
Note: In the ‘Strategies for designing mRNA: Importance of the cap and tail’ presentation, for the M6-3’OMe data, the second panel shows different capping efficiencies when using optimized transcription conditions versus traditional transcription conditions, not AG versus M6 cap as described.
In addition, the final two panels show that M6-3’OMe capped mRNAs are resistant to decapping by Dcp2 enzyme.
The webinar explores the critical role of raw materials in vitro transcription (IVT) reactions and their impact on mRNA product quality. Panelists discuss challenges in raw material production, the need for harmonized testing standards, and the potential for industry guidance through organizations like USP. The session also covers the use of IVT kits in development, the adoption of new technologies, and the need to improve polymerases to reduce impurities and costs.
