Bioanalysis
Hybridization LC-MS/MS Workflow to Quantify an siRNA Drug Candidate in Plasma, CSF, and Tissues
Dr. Keyhani Reflects on International Day of Women and Girls in Science
Opinion | A Day to Celebrate, and a Call to Action
Dr.
ISSUE NO. 30 — The Evolution and Advancement of Liquid Chromatography-Mass Spectrometry in Drug Development
The drug development landscape is constantly evolving, with science and technology advancing hand-in-hand to improve the essential steps of determining drug concentration profiles and the characterization of drug transformation products. The ultimate goal is to better understand drug distribution, metabolism, and pharmacokinetic characteristics, and to present regulatory bodies with a complete and comprehensive submission package driven by current guidelines.
To this end, liquid chromatography (LC) coupled with mass spectrometry (MS) via an atmospheric pressure ionization (API) interface is a well-established analytical approach to support each phase of drug development, from early discovery through to clinical studies.
In Issue 30 of The Altascientist, we explore the numerous benefits of incorporating a stable isotope labelled internal standard for quantitative LC-MS, and detail recent advances in MS technology, including:
- stable isotope labelled internal standards (SLIS) for LC-MS quantitation
- dried blood microsampling
- anti-epileptic drug panel
- COVID-19 neutralizing monoclonal antibodies
- differential mobility spectrometry
- bioequivalence
- large molecule bioanalysis
- oligonucleotides
Also included are several case studies, which exemplify novel bioanalytical workflows that are required to meet the challenges faced in both nonclinical and clinical development, across a variety of drug classes.
Ophthalmic End-to-End Drug Development Solutions
Test Your Knowledge of PCR Applications
PCR testing and analysis is a reliable way to screen many genetic markers and disease exposures including COVID-19 and other viruses. Its amplification process enables it to detect small segments or portions of genetic material in various samples to identify a specific source. PCR can also be used for a broad range of additional applications across forensics, drug development, and gene therapies.
Immunogenicity Target Interference: A Novel Blocking Approach
A Snapshot of the Webinar “Development of a Cell-Based Assay”
Cell-based assays are usually used to represent the mechanism of action (MoA) of the administered drug. Throughout various stages of drug development, they may be used for different purposes. These include detecting the presence of neutralizing antibodies (NAbs) and evaluating a drug’s potency. In Altasciences’ webinar, “Development of a Cell-Based Assay,” Dr.
Development of a Surrogate Cerebrospinal Fluid Matrix for Quantitative Analysis of Antisense Oligonucleotides by Hybridization LC-MS/MS
A Novel Method for Performing Linearity Assessments in Whole Blood Prepared Using a Lyse/No Wash Procedure
ISSUE NO. 27 — The Complexities of Early-Phase Ophthalmic Drug Development
Ophthalmic medications have a particular set of challenges that can impact their speedy and successful path to market. From prototype formulation through preclinical testing, early-phase clinical and manufacturing and development, ophthalmic drug development presents with specific and unique complexities. It is best to entrust drug development to a partner with regulatory knowledge, technical expertise, and a thorough understanding of the market in this growing therapeutic area. From current reality to future trends, being at the forefront of ophthalmic drug development delivers tangible benefits to sponsors.
In Issue 27 of The Altascientist, we dive into all areas of ophthalmic drug development, including:
- Prototype development, formulation, and manufacturing
- Preparing for first-in-human studies
- Species and strain selection parameters
- Routes of administration
- Specialized ocular assessments and equipment
- bioanalysis
- Phase I clinical research
- Phase II to commercialization
Three case studies are also included!