Publication
Immunogenicity assessment strategy for a chemically modified therapeutic protein in clinical development
The clinical immunogenicity assessment for complex multidomain biological drugs is challenging due to multiple factors that must be taken into consideration. Here, we describe a…
Identification and Biosynthesis of an N-Glucuronide Metabolite of Camonsertib
This is the first report of a glucuronide metabolite of camonsertib formed by human hepatocyte incubations. This study reveals the structure and stability of an…
Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development
The emerging use of qPCR and dPCR in regulated bioanalysis and absence of regulatory guidance on assay validations for these platforms has resulted in discussions…
Validation of Anti‑Adeno Associated Virus Serotype rh10 (AAVrh.10) Total and Neutralizing Antibody Immunogenicity Assays
Immunogenicity assessment of Adeno-Associated Virus (AAV) vectors is a critical part of gene therapy drug development. Whether the assays are used for inclusion/exclusion criteria or…
Evaluation of Cellular Immune Response to Adeno‑Associated Virus‑Based Gene Therapy
The number of approved or investigational late phase viral vector gene therapies (GTx) has been rapidly growing. The adeno-associated virus vector (AAV) technology continues to…
Bioanalytical Assay Strategies And Considerations For Measuring Cellular Kinetics
Drug development has been evolving dramatically over the past several decades to counter the unmet challenge of previously untreatable diseases. Novel and refined technologies have…
Anti‑drug Antibody Sample Testing and Reporting Harmonization
A clear scientific and operational need exists for harmonized bioanalytical immunogenicity study reporting to facilitate communication of immunogenicity findings and expedient review by industry and…
Comparison of Titer and Signal to Noise (S/N) for Determination of Anti‑drug Antibody Magnitude Using Clinical Data from an Industry Consortium
During biotherapeutic drug development, immunogenicity is evaluated by measuring anti-drug antibodies (ADAs). The presence and magnitude of ADA responses is assessed using a multi-tier workflow…
Best Practices in qPCR and dPCR Validation in Regulated Bioanalytical Laboratories
The use of molecular techniques in the bioanalytical laboratory is becoming more common as the number of gene and cell therapy products continues to increase.…
Points to Consider Document: Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the Qualification of Biomarkers in Biological Matrices, June 2019
Developed by the Biomarker Assay Collaborative Evidentiary Considerations Writing Group, Critical Path Institute (C-Path) This Points to Consider document was originally designed to establish consensus…