Newsletter | November 20, 2024

11.20.24 -- Regulatory Considerations For mRNA Platforms

SPONSOR

Webinar: Early Preclinical Development of mRNA/LNP projects - Setting Up Your Project for a Successful Transition to cGMP Manufacturing

Join us on December 2nd to explore mRNA construct development at Lonza, focusing on cGMP manufacturing, analytical advancements, and testing methods. Gain insights into the transition from research to manufacturing and the technologies shaping mRNA development for future projects. Click here to learn more.

FEATURED EDITORIAL

Lessons From The Past: How mRNA Can Thrive In The Evolving ATMP Market

By AR Welch, Editorial & Community Director, Advancing RNA

Not only do these case studies from the industries preceding our own provide a few tactical pointers for those of us in the mRNA/RNA therapeutics space, I also think they can be particularly instructive in helping us craft/finetune mRNA’s value proposition.

EMA Issues Draft Guideline On The Development & Manufacture Of Oligonucleotides

By Peter H. Calcott, Calcott Consulting LLC

The EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides. It includes requirements and considerations related to conjugation, active substance in solution, and more. The consultation period ends Jan. 31, 2025.

Regulatory Considerations For The mRNA Platform

Joseph Barberio of Strand Therapeutics and Christian Moreno of Nutcracker Therapeutics share how their companies ensure data integrity and privacy compliance throughout R&D and manufacturing.

INDUSTRY INSIGHTS

Establishing Analytical Methods For mRNA-Based Therapies

White Paper | MilliporeSigma

Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.

How To Make The Best LNPs

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

There are various factors that require careful consideration throughout the process of formulating LNPs and utilizing them for successful mRNA delivery and translation.

Alternatives To CRISPR-Cas9: Nucleases For Next-Gen Therapy

Application Note | By Rebecca Roberts, Ph.D., Synthego Corporation

Alternatives to CRISPR-Cas9 address limitations like delivery challenges and off-target effects. Emerging nucleases offer improved specificity, smaller sizes, and therapeutic applications.

Defining A Process For Your Unique mRNA

Infographic | Sartorius

Define a process for your unique mRNA with this interactive guide to pDNA, mRNA, and LNP. Overcome challenges with solutions that can help you develop a next-generation production strategy.

Levers To Optimize The IVT Reaction For Increased mRNA Yield

Application Note | Roche CustomBiotech

Learn about tools to optimize the IVT reaction for enhanced mRNA yield, along with how factors such as magnesium ion and nucleotide concentrations significantly impact that IVT reaction performance.

Navigating Challenges In Progressing Breakthrough RNA Therapeutics

Infographic | ReciBioPharm

RNA therapeutics hold immense promise for precision treatment, but their development faces challenges. A CDMO with adaptable platforms and flexible timelines can help reduce time and costs.

Oligonucleotide Manufacturing: Take Control Of Your Process

Article | By Lucy Cook, Ph.D., Cytiva

What do you need to know before you take your process in-house? A team of experts on nucleic acids therapeutics outlined five key things for you to consider as you make the change.