Bioanalysis
Strategy to Increase Throughput and Method Sensitivity for Clinical Immunogenicity Studies
Development of a Hybridization LC-MS Methodology for Quantitation of siRNA in Cynomolgus Monkey
Quantitative Bioanalysis of HT-KIT Vivo-Morpholino Using Hybridization LC-MS/MS
Strategies to Improve Assay Sensitivity for Bioanalysis of Therapeutic Oligonucleotides Through Ligand Binding Assays
ISSUE NO. 41 — Immunomodulation Assessments for Clinical Trials: Sophisticated Bioanalytical Approaches to Support Complex Modalities
Immunomodulatory drugs are at the forefront for the treatment of various types of cancer, infectious diseases, and numerous autoimmune diseases, including rheumatoid arthritis, type I diabetes, lupus, and multiple sclerosis. As the complexity of these therapeutics increases, so must the sophistication of the bioanalytical assays designed to either quantify them or measure their impact on the patient.
In Issue 41 of The Altascientist, we explore common classes of immunomodulators, bioanalytical methods used to quantify them, and their associated biomarkers. Featuring two scenarios that explore the complexities of bioanalysis for immunomodulators, The Altascientist offers practical considerations for ensuring accurate bioanalysis, as well as pharmacokinetic, pharmacodynamic, and safety data in clinical trials.
This issue also covers:
• classes of immunomodulators, including monoclonal antibodies, CAR-T cells, and vaccines;
• immunotherapy trials, focusing on complex study designs and diverse patient populations; and
• bioanalytical methods and assays, including pharmacokinetics and anti-drug antibodies (ADA).
Key Considerations for Nonclinical AAV Gene Therapy Development
Top 10 Life Science Resources for Summer 2024
There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for your convenience. Catch up on what you might have missed below!
My Attendance at the 2024 Boston Society Cell and Gene Therapy Conference
My fellow Altascientists and I recently attended the 2024 annual Boston Society G
Development of an Assay for Atropine in Rabbit Plasma by LC/MS/MS and the Impact of Atropine Esterase
Optimizing for Success: How Sponsors Can Overcome the Challenges in Early-Phase Drug Development
The Challenges With Outsourcing Drug Development
In a Biopharma Dive survey, 45% of the over 143 biopharmaceutical executives surveyed cited the inability to adhere to tight deadlines as a common challenge in nonclinical and Phase I clinical development.