Newsletter | September 11, 2024

09.11.24 -- Is This The Hardest Question Facing mRNA Therapeutics Makers?

FEATURED EDITORIAL

Is This The Hardest Question Facing mRNA Therapeutics Makers?

By AR Welch, Editorial & Community Director, Advancing RNA

As I’ve been reminded on a few different occasions, there is a difficult truth we may need to wrap our brains around in certain situations: Just because we can make an mRNA therapy for an indication, doesn’t necessary mean we should — or that the patient population will necessarily want it or be able to access it. 

INDUSTRY INSIGHTS

A New Centre For Continuous mRNA Manufacturing

Article | ReciBioPharm

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.

PEG In LNP Formulations: Addressing Challenges And Seeking Solutions

White Paper | By Michael Nguyen, Ph.D., Helix Biotech

Polyethylene glycol and similar variants have driven innovative research for therapies. However, the continued use of PEG poses significant drawbacks.

Potent Immune Response With Vernal's LNP-mRNAs

Article | By Julia Sakamoto, Vernal Biosciences

As mRNA medicine continues to evolve, understand how trusted manufacturing partners will continue to play a pivotal role in translating innovative concepts into clinical reality.

Regulatory Considerations For Excipients Used In Lipid Nanoparticles

White Paper | MilliporeSigma

Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

End-To-End Cold Chain Management: A Next-Generation Approach

Webinar | Sartorius

Three experts in cold chain management walk through the advantages of end-to-end platforms for bulk drug substance management.

Developing A Comprehensive Regulatory Approach For LNP Drugs

Article | Precision NanoSystems

The path to regulatory approval for LNPs demands carefully considered strategies. By adopting proactive and strategic approaches, developers can overcome regulatory hurdles on the path to approval.

Streamline Process Characterization For Successful Validation Campaigns

Webinar | Catalent

Explore how a stepwise approach for process characterization can help target the right experimental design and be tailored for different programs based on prior knowledge and experience.

ADDITIONAL FEATURED EDITORIAL

Rising Allure And Critical Considerations Of Point-Of-Care Processing

By Maik Jornitz, principal consultant, BioProcess Resources LLC

Mobile and standard cleanroom infrastructures are becoming more popular to meet the logistical demands of personalized medicine and public health emergencies.

How Analytical Development Is Informing mRNA Process Development Today

In this clip, Advancing RNA LIVE, panelists share their perspectives on how advancements in RNA analytical development are complementing and informing process development efforts for linear mRNA.