Newsletter | October 9, 2024

10.09.24 -- One Unspoken Issue With FDA's Platform Designation

SPONSOR

It’s impossible to attend an event on the future of RNA therapeutics without hearing about the challenges we’re facing with targeted RNA-LNP delivery. In this final Advancing RNA Live discussion of 2024, we sit down with three LNP experts to parse out the current opportunities and unknowns facing the development of next-generation LNPs. Secure your spot today! Registration is free thanks to the support of Helix Biotech.

FEATURED EDITORIAL

One Unspoken Issue With The FDA's Platform Designation

Subjectivity and hearsay will no doubt play a big role in how we approach the FDA's Platform Designation guidance moving forward, and I daresay these hard to mitigate factors will complicate our relationship with this designation in the future. 

Developing And Manufacturing Oligonucleotides: An Overview

An overview of considerations for the design and development, quality control and characterization, regulatory submissions, and future directions for oligonucleotides.

Is QbD Actually Possible In mRNA Development Today?

As the panelists of this Advancing RNA LIVE discussion argue, there are several big limitations we face in implementing QBD today for RNA development.

Report: Single-use Bioreactor Uptake Plateaued, Other SUT On The Rise

BioPlan Associates' latest manufacturing survey found signs of a maturing market and strong demand for innovation upstream and downstream.

INDUSTRY INSIGHTS

Mechanisms Of LNP-Mediated mRNA Delivery

Explore the details supporting LNP-mediated mRNA delivery, as well as the challenges facing mRNA based therapeutics in the future.

Evolving Into Biopharma 4.0: A Stepwise Journey Of Digital Transformation

Discover how incremental steps can transform your processes using digitalization and automation.

Navigating Challenges In Progressing Breakthrough RNA Therapeutics

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.

Integrated Solutions For Advanced Therapies

The right CDMO offering integrated services can ease increasingly common CGT manufacturing problems such as scale, raw material access, viral vector production, and quality requirements.

Staying On Top Of Changing FDA Regulations To Avoid Clinical Holds

As the biotech industry has grown exponentially, so has the number of FDA clinical holds. Biotech companies need strategic planning to avoid or quickly resolve costly clinical holds.