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Case Study

Excellence in Quantitative Pharmacology, Clinical Pharmacology, MIDD, Bioanalytics, Biomarkers, Immunogenicity, Regulatory Submissions Since 2007

Receptor Occupancy of Antibody Drug Measured by Flow Cytometry Receptor Occupancy of Antibody Drug Measured by Flow Cytometry In the present study, a method for quantifying the binding of PD-1 and its antibody was established, and the applicability in clinical ...
Immunophenotyping to Identify Peripheral Lymphocyte Subsets Immunophenotyping to Identify Peripheral Lymphocyte Subsets In this case study, we present a flowcytometric method that was developed to identify cell percentage of T/NK cells to support clinical ...
Generic LC-MS/MS Solution for ADC PK Bioanalysis Generic LC-MS/MS Solution for ADC PK Bioanalysis A generic LC-MS/MS solution was developed successfully for non-clinical PK studies of ADC drugs. The fully-validated methods are highly ...
Immunogenicity Analysis Strategy to Reduce Soluble Target Protein Interference Immunogenicity Analysis Strategy to Reduce Soluble Target Protein Interference Treatment of samples with specific blocking antibody could be an effective bioanalytical strategy to reduce the interference of soluble ...
A LC-MS/MS Method for Oligonucleotide PK Bioanalysis A LC-MS/MS Method for Oligonucleotide PK Bioanalysis In the present study, a quick, sensitive, accurate and reproducible LC.MS/MS method was developed, validated and applied successfully in an ...
Sample Pretreatment Approaches to Improve Drug Tolerance in ADA Assay Sample Pretreatment Approaches to Improve Drug Tolerance in ADA Assay To counter drug interference in ADA assays, a study added an acid dissociation-affinity capture step before standard acid treatment. This ...
Representative Pooled Matrix as Negative Control is Critical in ADA Assay Representative Pooled Matrix as Negative Control is Critical in ADA Assay The pooled matrix is vital in immunogenicity assays, serving as both negative control and sample preparation matrix, influencing the ...
Improving Nab Assay(cLBA) Sensitivity and Drug Tolerance by Optimizing MRD Improving Nab Assay(cLBA) Sensitivity and Drug Tolerance by Optimizing MRD By optimizing the MRD, the cLBA Nab assay performance can be improved in terms of sensitivity as well as the drug tolerance. In addition, ...
Receptor Occupancy of Antibody Drug Measured by Flow Cytometry Receptor Occupancy of Antibody Drug Measured by Flow Cytometry In the present study, a method for quantifying the binding of PD-1 and its antibody was established, and the applicability in clinical ...
Immunophenotyping to Identify Peripheral Lymphocyte Subsets Immunophenotyping to Identify Peripheral Lymphocyte Subsets In this case study, we present a flowcytometric method that was developed to identify cell percentage of T/NK cells to support clinical ...
Generic LC-MS/MS Solution for ADC PK Bioanalysis Generic LC-MS/MS Solution for ADC PK Bioanalysis A generic LC-MS/MS solution was developed successfully for non-clinical PK studies of ADC drugs. The fully-validated methods are highly ...
Immunogenicity Analysis Strategy to Reduce Soluble Target Protein Interference Immunogenicity Analysis Strategy to Reduce Soluble Target Protein Interference Treatment of samples with specific blocking antibody could be an effective bioanalytical strategy to reduce the interference of soluble ...
A LC-MS/MS Method for Oligonucleotide PK Bioanalysis A LC-MS/MS Method for Oligonucleotide PK Bioanalysis In the present study, a quick, sensitive, accurate and reproducible LC.MS/MS method was developed, validated and applied successfully in an ...
Sample Pretreatment Approaches to Improve Drug Tolerance in ADA Assay Sample Pretreatment Approaches to Improve Drug Tolerance in ADA Assay To counter drug interference in ADA assays, a study added an acid dissociation-affinity capture step before standard acid treatment. This ...
Representative Pooled Matrix as Negative Control is Critical in ADA Assay Representative Pooled Matrix as Negative Control is Critical in ADA Assay The pooled matrix is vital in immunogenicity assays, serving as both negative control and sample preparation matrix, influencing the ...
Improving Nab Assay(cLBA) Sensitivity and Drug Tolerance by Optimizing MRD Improving Nab Assay(cLBA) Sensitivity and Drug Tolerance by Optimizing MRD By optimizing the MRD, the cLBA Nab assay performance can be improved in terms of sensitivity as well as the drug tolerance. In addition, ...

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