MANUFACTURING ARTICLES

MANUFACTURING VIDEOS

Though the mRNA industry is excited about the possibilities of the FDA’s yet-to-be-clarified “Platform Provision,” a recent discussion between regulators suggests differences in opinion are emerging.

Akhilesh Bhambhani, Sr. Director, Biologics Drug Product Development at Ultragenyx Pharmaceuticals and Roberta Duncan, VP and mRNA Program Lead at Seqirus offer insight into CMC considerations and entertain audience questions on the topic.

In this Advancing RNA Live clip, CMC Consultant Sujit Jain explains the numerous ways that adding targeting ligands “stress tests” the standard LNP manufacturing platform, as well as outlines which capabilities are most important for companies to consider when selecting an outsourcing partner for their active delivery strategies.

Struggling with mRNA integrity? Discover essential strategies to boost stability in mRNA manufacturing with innovative endonuclease-free DTT and Spermidine chemicals.

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