Our Expert Network
-
In Vivo Genetic Medicines Need a Guide: The Answer Lies in Harnessing the Transcriptome
7/15/2024
This article by Radar Therapeutics explains why the DNA/RNA revolution is underway and why solving specific targeting is next.
-
End-To-End mRNA DS And DP Manufacturing Processes
7/10/2024
This article demystifies the manufacture of mRNA encapsulated in lipid nanoparticles across unit operations for plasmid linearization, drug substance (DS) manufacture, and drug product (DP) manufacture.
-
Innovation Advances In mRNA Medicine
7/9/2024
The post-pandemic mRNA pipeline surge has led to a substantial investment in innovation. Let’s look at nonamplifying mRNA, saRNA, and circRNA.
-
Making Cancer Vaccines Is Complex; New Platform Guidance Could Help
7/3/2024
FDA's draft guidance on platforms is mostly for established, well-characterized modalities, but it also has implications for the emerging area of personalized medicine.
-
CRISPR-Cas Genome Editing For Rejuvenation Of Aging Stem Cells
7/1/2024
As stem cells age, their regenerative capacity declines due to accumulated genetic and epigenetic changes. Using CRISPR-Cas, scientists can directly edit these changes or modulate aging-related pathways.
-
What Does FDA's Draft Platform Guidance Mean For CGT Companies?
6/17/2024
Details of the FDA's highly-anticipated platform technology program were released in the form of a draft guidance. Let's explore with a former FDA/CBER regulator.
-
Do You Know Your QMM? Moderna Might Some Day
6/17/2024
Don’t panic if you aren’t familiar with the above acronym, which stands for Quality Management Maturity. Chief Editor Louis Garguilo wasn't – until schooled by Jason Kerr, Regulatory Intelligence Senior Manager, Moderna and Adjunct Professor of Quality Systems, Keck Graduate Institute. QMM, it appears, may very well be in your future.
-
Have We Got Novel Drug Production And Compliance Timelines All Wrong?
6/13/2024
Drug developers might want to consider longer-term approaches to meeting manufacturing and regulatory requirements.
-
Managing Change In Vaccine Production With All Stakeholders
6/12/2024
Balancing stakeholder expectations and opinions, and sometimes mitigating disagreements, during a change can prove more daunting than the change itself.
-
The Ins And Outs Of Modern Barrier Systems For Sterile Manufacturing
6/10/2024
This article looks at key features of restricted access barrier systems and isolators and discusses some of their applications.