Bioanalysis
ISSUE NO. 20 — Validation of Immunogenicity Assays
Regulatory guidelines focusing on immunogenicity assays for clinical studies are not all applicable to nonclinical requirements and their unique challenges. While we have a full understanding of regulatory requirements for clinical studies, the lack of regulatory documents addressing the particular needs of nonclinical immunogenicity studies has contributed to less consensus on appropriate immunogenicity testing strategies and validation parameters. This, by extension, has led to different approaches being adopted by the drug development industry.
In Issue 20 of The Altascientist, we review and share some of Altasciences’ approaches to validating immunogenicity assays for nonclinical and clinical studies, including insight on:
- how to plan for immunogenicity assessments
- drug tolerance
- positive control
- managing variability
- critical reagent validation and changes
- neutralizing anti-drug antibodies (NAbs)
Using Anti-Drug-Antibody Screening Assay to Resolve Selectivity Issues in Toxicokinetic Ligand-Binding Assay
Mitigation of On-Column Conversion of Ivabradine to Desmethylivabradine Metal Chelation With Citric Acid Modifier
Dual Purpose of a Cell-Based Assay for an Agonist of the GLP-2 Receptor
Development of an Oligonucleotide Drug Immunogenicity Assay: A Case for the Characterization of the Immune Response
Five Ways Altasciences Simplifies the Drug Development Process for You
Bringing new drugs to market, from lead candidate selection through preclinical testing, to clinical proof of concept, is a complex, time-consuming, and costly process.
Making Early-Phase Drug Development Faster, Better, and More Efficient
Early-phase drug discovery and drug development are complex processes, where many moving parts can, and do, influence the success of a program.
Leveraging the Benefits of Microsampling for Safety and Convenience
In a previous blog, we provided an overview of microsampling technology for preclinica
Q&A Session with Dr. Danielle Salha
Renowned for our full-service offering, we often get asked — how does Altasciences manage the development process for biologics and biosimilars so seamlessly from the require
ISSUE NO. 16 — Microsampling in Drug Development
Microsampling significantly lessens the volume of blood and plasma/serum that is collected and analyzed to determine circulating concentrations of therapeutic drugs, metabolites, and biomarkers in preclinical and clinical research.
In preclinical research, microsampling technology supports the 3Rs of animal research, and allows for less intrusive blood collection procedures.
By definition, clinical microsampling reduces sample volume to less than or equal to 50 microlitres (μL) compared to conventional venipuncture wherein millilitres (mL) of blood volume is collected. In Altasciences’ experience, microsample volumes being analyzed are less than or equal to 20 μL, with some microsampling techniques as low as 5 μL.
In Issue 16 of The Altascientist, we explore the benefits, applications, and considerations of microsampling in preclinical, clinical, and bioanalytical research, including:
- regulatory considerations
- case study: Anti-Epileptic Drug Monitoring – Sample Preparation Using Impact-Assisted Extraction
- case study: Large Molecule – Determination of Rituximab Using a Surrogate Peptide Approach