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Overcome the Difficulties of Bioanalysis in the Application of Gene Therapy Drugs with AAV as a Vector
Overcome the difficulties of bioanalysis in the application of gene therapy drugs with AAV as a vector Preface The concept of gene therapy was proposed in the early 1970s. The original concept was to introduce a normal copy of a gene to replace a mutated counterpart....
The Method of Improving Drug Tolerance in The ADA Testing Process
Almost all biopharmaceutical products will cause a certain anti-drug antibody (ADA) response after entering the body, which refers to immune response. ADA may affect or change the pharmacodynamic effect between the therapeutic protein and its target. Its...
The Application of Minimum Required Dilution (MRD) in ADA Methods
Minimum Required Dilution (MRD) is used in almost all PK and ADA (including Biomarker and Nab) methods. Usually, all samples in an analysis plate, including standard curve points, quality control samples, and unknown samples, will be diluted multiple folds in the...
Development of Stable Cell Lines For Cell-Based Functional Assay
Based on protein interaction, Bioassays mainly include two types: ligand-binding assay (LBA)-based method and MOA (Mode of Action)-based method with cell experiment. LBA-based methods are used for drug affinity test, blood drug concentration test, biomarker...