Publications by authors named "V N Kakkanaiah"
Multiparametric flow cytometry is a powerful cellular analysis tool used in various stages of drug development. In adoptive cell therapies, the flow cytometry methods are used for the evaluation of advanced cellular products during manufacturing and to monitor cellular kinetics after infusion. In this report, we discussed the bioanalytical method development challenges to monitor cellular kinetics in CAR-T cell therapies.
View Article and Find Full Text PDFFlow cytometer is a powerful cellular analysis tool consists of three main components; fluidics, optics and electronics. Flow cytometry methods have been used in all stages of drug development as like ligand binding assays (LBA). Both LBA and flow cytometry methods require specific interaction between the critical reagents and the analytes.
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- The 2019 Workshop on Recent Issues in Bioanalysis (WRIB) held in New Orleans attracted over 1000 professionals from various sectors, including pharmaceuticals and regulatory agencies, focusing on current bioanalysis challenges and innovations.
- The event featured extensive discussions on topics like bioanalysis methods, biomarkers, and regulatory compliance, leading to the creation of a comprehensive White Paper to guide the bioanalytical community.
- The White Paper is divided into three parts, with Part 3 specifically addressing topics such as biomarker assay validation, reagent management strategies, and gene therapy challenges, while earlier parts discuss other key regulatory recommendations and method development.
We evaluated the sample stability for a cellular kinetics and a pharmacodynamic flow cytometry methods. First, the blood collection tubes were compared for the enumeration of chimeric antigen receptor-T cells in human whole blood. Blood samples with chimeric antigen receptor-T cells were stable up to 3 days at room temperature in both conventional EDTA and Cyto-Chex blood collection tubes (Streck Laboratories, NE, USA), but with better consistency in Cyto-Chex-BCT than conventional EDTA tubes.
View Article and Find Full Text PDFThe 12th GCC Closed Forum was held in Philadelphia, PA, USA, on 9 April 2018. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included: critical reagents; oligonucleotides; certificates of analysis; method transfer; high resolution mass spectrometry; flow cytometry; recent regulatory findings and case studies involving stability and nonclinical immunogenicity.
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