This white paper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.
Developability assessment or preformulation studies of small molecule is an important part the of drug discovery process leading to selection of New Chemical Entities (NCEs) for clinical studies. This white paper dives deeper into why we need developability assessment as well as its processes.
We describe a Droplet Digital PCR-based method, Drop-Phase, which allows users to quickly and accurately phase genomic variants. We successfully phased pairs of CFTR variants and show the methodology can measure linked species that are up to 210 kb apart. This method can be used to phase variants discovered through sequencing or to screen unsequenced individuals for a particular haplotype of interest for clinical trials.
Thermo Fisher Scientific's Kaspar van den Dries and Helena Teles discuss potential mechanisms of increased absorption with lipid formulations and appropriate screening tools that are used during the development approach of these formulations, as well as scale up and industrialization considerations.