Antibody Drug Conjugate (ADC) Pharmacokinetic Studies
- Part 1: Introduction: Concept and Components of ADCs
- Part 2: Pharmacokinetic Evaluation of ADCs – Trastuzumab Deluxecan as an Example
- Part 3: Bioanalysis of ADCs – How to quantify complex components? ～ ～.
- Part 4: Imaging of ADCs – Exploring the behavior of ADCs in tumor tissue
- Part 5: Analysis and ADME evaluation of ADCs in preclinical stages and modeling & simulation
Introduction to Pharmacokinetic Studies in R&D of Cell Therapy Products (Serial 2022-2023)
Cell therapy is an innovative treatment that modifies or repairs the function of cells, tissues, or organs by administering or transplanting living cells to patients. In the research and development of cell therapy products, cellular kinetics (CK) evaluation, which evaluates the concentration of cells in the blood over time, and biodistribution (BD) evaluation, which evaluates the migration of cells into tissues, are conducted. Since the properties of cell therapy products are very different from those of small molecule compounds, antibody drugs, nucleic acid drugs, etc., it is necessary to go beyond conventional wisdom in study design and data interpretation when assessing pharmacokinetics. In this article, we will introduce analytical methods for CK and BD evaluation of cell therapy products, pitfalls that experimenters often fall into when evaluating CK/BD, basic characteristics of CK and BD of cell therapy products, and usefulness of modeling and simulation for CK/BD analysis in several articles.
- Part I: What’s Next? Quantitative analysis methods for cell kinetics evaluation that you should know now.
- Part 2: Pitfalls in quantitative analysis of cell therapy products (1): Wait a minute! Why don’t you review the units and quantitation?
- Part 3: Pitfalls in quantitative analysis of cell therapy products (2): Highly sensitive quantification of human cells!
- Part 4: Examples of Cellular kinetics (CK)/Biodistribution (BD) in non-clinical and clinical settings: How can pharmacokinetic studies contribute?
- Fifth: Modeling & Simulation (M&S) of cell therapy products; how to perform M&S and human prediction of proliferating drug CAR-T cells?
Collection of Past NL Serialized Projects (Members Only)
This is a collection of projects serialized in past NLs.