Newsletter | July 24, 2024

07.24.24 -- Two "Hot Takes" On mRNA Delivery

SPONSOR

Explore the forefront of precision medicine at the Advancing Precision Medicine Conference and Exhibition in Philadelphia, November 1-2. Engage with cutting-edge research featuring experts who are shaping the future of healthcare. Discover new insights into personalized treatments, genomic advancements, and innovative technologies revolutionizing patient care. Expand your knowledge and network with leaders driving the field forward. View the agenda and register today!

FEATURED EDITORIAL

Two "Hot Takes" On mRNA Delivery

As I argued in a previous “Hot Take,” “the devil is in the details” when it comes to developing both our drug substances and our drug products. We need to get to the point where we have more details and knowledge about alternative methods of delivery (beyond LNPs) so we can make educated decisions on the best path forward for delivering our products. 

Synthetic Biology And Programmable mRNA

Explore genetic regulation, synthetic biology's role in genetically programming mRNA to deliver therapies, and how Strand Therapeutics is enabling precise and controlled delivery with these mRNA constructs.

Managing Change In Vaccine Production With All Stakeholders

Balancing stakeholder expectations and opinions, and sometimes mitigating disagreements, during a change can prove more daunting than the change itself.

How Is mRNA “Shaking Up” Our Regulatory Interactions & Operations Today?

The Advancing RNA Live panelists share several inconsistencies they’ve encountered working with global regulators, as well as on which aspects they’re seeing regulatory agencies applying greater scrutiny in mRNA development today.

INDUSTRY INSIGHTS

Shifting The Approach: 4 Strategies For ICH E6(R3) Implementation

In addition to codifying some best practices, R3 suggests sponsors take a proportionate approach to identifying and managing areas of risk.

mRNA Manufacturing: Overcoming CMC Development Challenges

A lack of standardization and cost-effective techniques for manufacturing and analytics for product characterization create CMC challenges for mRNA-based products.

Plasmid DNA And Advanced Therapies: Accelerating Path To Clinic

Examine the challenges CGT innovators face and how adhering to GMP requirements from an early stage helps ensure successful downstream applications from clinical development to commercial phase.

A New Centre For Continuous mRNA Manufacturing

Explore how a partnership between academia, regulatory agencies, and manufacturing organizations has the potential to reshape the way we produce and distribute mRNA-based therapies.

Effects Of mRNA Capping Technologies

This study compares two important mRNA capping technologies by evaluating the mRNA integrity, percent Cap1 content, dsRNA content, in vivo expression, and innate immune activation in mice.

How To Bring Your LNP Formulation To Clinical/Commercial Manufacturing

Gain valuable insights into key considerations when selecting lipid excipients for LNP formulations and the process development steps necessary to advance them to GMP manufacturing and clinical trials.