By Peter H. Calcott, Ph.D., FRSC, Calcott Consulting LLC
FDA's CDER recently issued a draft guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics. This article provides a summary and analysis. The public comment period ends January 14, 2025.
Computer-aided synthesis planning (CASP) can mitigate the impact of rising complexity. We discuss the award-winning AI and vast data that propel a leading predictive retrosynthesis technology.
A recent project applied process improvement methodology to the process validation step that ultimately provided not only an optimized, robust process but also an economic advantage.
Fast-track RNA-LNP development, streamline screening with off-the-shelf ionizable lipid mixes, and utilize validation strategies to generate reproducible and scalable LNPs for lead candidates.
Physiologically based pharmacokinetic modeling is a powerful tool for clinical trial design that can be leveraged alongside early development experiments to reduce costs and accelerate timelines.
This session highlights crucial criteria for selecting the right stem cell media and supplier, focusing on the significance of evaluating the quality systems of manufacturers.
