Bioanalysis has published a supplement presenting the Global CRO Council for Bioanalysis’ (GCC) feedback to the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline from the 13th GCC Closed Forum (LA, USA, 5 April 2019).
This infographic reflects changes in the oligonucleotide field over the last 2 years including: what types of oligonucleotides are studied, assay formats and opinions on methodology for oligonucleotide analysis.
Although qPCR is a golden standard for sensitive quantitation of DNA and mRNA molecules, the assays usually have insufficient sensitivity for short or heavily modified oligonucleotide therapeutics. In this editorial, the authors discuss the development of oligonucleotide-based therapeutics and the methods used to study them.
In this editorial, Neil Henderson (AstraZeneca) discusses the explosion in types of drug molecules – the so-called ‘new modality’ drugs – which includes antisense oligonucleotides (ASOs) and modified mRNA.
Therapeutic oligonucleotides are already established as a successful technology, with many additional siRNA and antisense drugs in development. New applications for targeting non-coding RNA and gene editing are on the horizon.
In this editorial Helen Shen (QPS; PA, USA) discusses the projected growth in the global small molecule discovery market and what impact this may have on the management of chronic diseases as well as what to look for when partnering with a CRO for small molecule studies.
In this installment of Robert MacNeill’s (Covance) column, Robert discusses where to best place specific QC samples within a calibration range for a methodology, and the challenges associated with establishing suitable nominal levels for the internal standard concentration.
In this editorial, Reiner Schulte (Cambridge Institute for Medical Research, UK) discusses the market of flow cytometry analyzers and cell sorters, highlighting some interesting developments in the field of flow cytometry.
With the reality of Brexit already impacting the UK’s clinical trials environment, Zamas Lam (QPS; DE, USA) discusses the effect this will have on bioanalytical research, and suggests 10 questions to ask when relocating UK-based preclinical and bioanalysis research projects.
In this installment of Robert MacNeill’s (Envigo) column, Robert discusses methodologies for small lipids, and why these can be a particularly challenging area of biologics.