ANALYTICAL/QUALITY ARTICLES

ANALYTICAL/QUALITY VIDEOS

Recombinant Factor C testing offers a pharmacopeia-recognized, animal-free alternative to LAL with fewer interference risks, but regulatory hesitation slows adoption across the industry.

As both Advancing RNA Live speakers point out in this segment, the MHRA guidance focuses deeply on the critical role bioinformatics and AI/ML approaches will play in the development of personalized immunotherapies. Here, Eliquent Life Sciences’ Tiffany Lucas and CureVac’s Ulrike Jägle address the biggest challenges they anticipate companies will face in meeting the agencies’ recommendations.

Advancing RNA Live panelists Venkat Krishnamurthy, April Sena, and Max De Long share their perspectives on the most important regulatory considerations for gRNA production utilizing an enzymatic ligation approach.

We all know that plasmid quality is foundational in dictating the quality of the final mRNA drug substance. In this clip homing in on upstream process considerations, speakers Stu Sundseth (Tune Therapeutics), Marc Wolfgang (Sail Biomedicines), and Christian Dohmen (Ethris) outline some of the most important CQAs for plasmids and the impact they can have on the resulting quality of the mRNA drug substance for linear mRNA. 

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