Newsletter | April 24, 2024

04.24.24 -- What mRNA Can Learn From Art History

SPONSOR

Join GeneVentiv Therapeutics CEO, Damon R. Race hosted by ReciBioPharm for our upcoming Passport to Biologics event on May 3rd, 9am-3pm EST at the Boston Marriott Cambridge, and discover how you can achieve success on your ATMP journey. Take part in discussions on advances in mRNA manufacturing, viral vs. non-viral delivery platforms, and how AI in continuous manufacturing will lead to improved production. Click here to RSVP for the free event!

FEATURED EDITORIAL

Future-Proofing mRNA Drug Manufacturing: IVT And Supply Chain

Regulatory and technical uncertainty surrounding mRNA necessitates predictive and proactive innovation enabling better manufacturability assessments, more robust in vitro transcription techniques, and improved downstream processing.

Defining Phase-Appropriate GMP Principles: Where Do We Start?

In this excerpt from Advancing RNA Live's Got Raw Materials? The State Of The mRNA Supply Chain, our featured guests share how they and their teams align around the definition of “phase-appropriate.”

Fine-Tuning Analytical Development Strategies For Every Phase

Analytical challenges morph phase-by-phase during drug development. Three Novartis scientists describe a platform approach based on guidance from the ICH and USP.

SPONSOR

Advancing RNA discusses the broad learnings therapeutics developers can (or can’t) adapt from previously approved mRNA vaccine products, and what an “ideal” RNA therapeutics regulatory paradigm could look like in the long term. Reserve your spot today for this May 2nd digital event. Registration is free thanks to the support of Roche CustomBiotech.

INDUSTRY INSIGHTS

High-Velocity Development: Gene Therapy Vs. Small Molecule

Combined with the inherent difficulty of the chemistry behind gene therapy development, its pace, structure, and funding dynamics are unique among treatment modalities.

Developing A Comprehensive Regulatory Approach For LNP Drugs

The path to regulatory approval for LNPs demands carefully considered strategies and, by adopting proactive and strategic approaches, developers can overcome many hurdles to achieve approval.

Nanoparticle Engineering: Address The Challenge Of Poor Aqueous Solubility

As pharma companies aim to overcome development obstacles, it is important to incorporate GMP expertise alongside novel technologies that can enhance the properties of APIs and dosage forms.

Lipid Nanoparticle Compositional Analysis By UHPLC-CAD

Explore results generated from an internal study using a proprietary mRNA-LNP formulation and UHPLC-CAD, a powerful technique for the analysis of compounds that do not contain chromophores.