A Quality by Design Approach to Chromatographic Method Development
An overview of a QbD process for chromatographic method development.
Quality by Design (QbD) has recently been advocated by the FDA and applied to the development and manufacture of drugs within the pharmaceutical sector. In efforts to ensure consistent quality and performance of drugs, ICH guidelines1 and recommendations encourage pharmaceutical companies to improve process control by adopting a QbD approach early in drug development.
Understanding how QbD applies to the development of chromatographic methods, as a process, requires a closer look into the architecture of method design, the influence of input variables on critical output measurements, and use of modern software tools to support QbD objectives. Practical implications of QbD include modelling the influence of variables on quality, design of experiments and refinement of processes as information is collected.
The Complexity of Oligonucleotide Separations
January 9th 2025Peter Pellegrinelli, Applications Specialist at Advanced Materials Technology (AMT) explains the complexity of oligonucleotide separations due to the unique chemical properties of these molecules. Issues such as varying length, sequence complexity, and hydrophilic-hydrophobic characteristics make efficient separations difficult. Separation scientists are addressing these challenges by modifying mobile phase compositions, using varying ion-pairing reagents, and exploring alternative separation modes like HILIC and ion-exchange chromatography. Due to these complexities, AMT has introduced the HALO® OLIGO column, which offers high-resolution, fast separations through its innovative Fused-Core® technology and high pH stability. Alongside explaining the new column, Peter looks to the future of these separations and what is next to come.
Metabolomics Analysis of Low Birth-Weight Infants Using UHPLC-MS/MS Following Lipid Emulsion
January 10th 2025A recent study aimed to directly compare the changes in serum metabolites among very low birth-rate (VLBW) infants following the administration of the soybean oil-based lipid emulsion and soybean oil, medium-chain triglycerides, olive oil, and fish oil (SMOF) lipid emulsion using untargeted metabolomics techniques.
Analyzing New Drug Modalities: An ISC 2024 Interview with Kelly Zhang
January 10th 2025At ISC 2024 in Liverpool, United Kingdom, LCGC International interviewed Kelly Zhang of Genentech about her work analyzing new drug modalities, such as mRNA, oligonucleotides, peptides, and cell and gene therapies.
