… on recent issues in bioanalysis: Vaccine assay validation, qPCR assay validation, QC for CAR-T flow cytometry, NAb assay harmonization and ELISpot validation  …

B Corsaro, T Yang, R Murphy, I Sonderegger, A Exley… - Bioanalysis, 2021 - Taylor & Francis
… qPCR and infectivity assays in challenging matrices such as … protein in a cell-based assay.
Different companies are using … These cell-based assays are routinely used to measure the …

Recommendations for the development of cell-based anti-viral vector neutralizing antibody assays

B Gorovits, M Fiscella, M Havert, E Koren, B Long… - The AAPS journal, 2020 - Springer
… This article focuses on cell-based assays designed to detect anti-AAV antibodies that may
… , although collection of such samples may be challenging. Whereas it is feasible to collect …

Assessing toxicity with human cell-based in vitro methods

D Zink, JKC Chuah, JY Ying - Trends in molecular medicine, 2020 - cell.com
… current applications of human cell-based in vitro methods. Unsolved problems and emerging
… Replacement of animal experiments is motivated by ethical and scientific concerns and …

High-throughput screening: today's biochemical and cell-based approaches

V Blay, B Tolani, SP Ho, MR Arkin - Drug Discovery Today, 2020 - Elsevier
Cell-based assays are used throughout all the stages of drug discovery: target identification
and validation, … Pending challenges in this area include cell growth inside droplets and the …

A novel human pluripotent stem cell-based assay to predict developmental toxicity

K Lauschke, AK Rosenmai, I Meiser, JC Neubauer… - Archives of …, 2020 - Springer
… We were able to detect the human-specific teratogenicity of … than thalidomide in our assay.
We conclude that the PluriBeat … PluriBeat assay, since they possess no ethical concerns and …

Recommended guidelines for developing, qualifying, and implementing complex in vitro models (CIVMs) for drug discovery

JE Ekert, J Deakyne, P Pribul-Allen… - … the Science of Drug …, 2020 - journals.sagepub.com
… One of the biggest challenges in the development and … information relative to conventional
HTS cell-based assays. … to safety issues represents a huge liability for the drug development

An overview of cell-based assay platforms for the solute carrier family of transporters

V Dvorak, T Wiedmer, A Ingles-Prieto… - Frontiers in …, 2021 - frontiersin.org
… As cell-based assays are the focus of this review we concentrated on these assays for the …
not only to address practical issues such as throughput and cost concerns but also to consider …

Best practices in the development and validation of physiologically based biopharmaceutics modeling. A workshop summary report

N Parrott, S Suarez-Sharp, F Kesisoglou… - Journal of …, 2021 - Elsevier
… to (1) challenges and opportunities for using PBBM to assess the … Cell-based permeability
assays should be scaled to a … When optimizing parameters, identifiability issues arise if the …

Discovery and validation of biomarkers to aid the development of safe and effective pain therapeutics: challenges and opportunities

KD Davis, N Aghaeepour, AH Ahn, MS Angst… - Nature Reviews …, 2020 - nature.com
… In 2018, the NIH-led Discovery and Validation of Biomarkers to Develop Non-Addictive … to
discuss progress, challenges, gaps and ideas to facilitate the development of biomarkers and …

Engineered tissues and strategies to overcome challenges in drug development

AS Khalil, R Jaenisch, DJ Mooney - Advanced drug delivery reviews, 2020 - Elsevier
… based on human tissues. In vitro, cell-based assays are critical tools in drug development, …
with clear and precise outputs and easy incorporation of human cells and tissues [14,15]. Also…