Research Articles
Adherent Cell Detachment: Techniques, Challenges, and Future Directions for Biomedical Research
This article provides a comprehensive overview of adherent cell detachment, a critical yet challenging step in cell culture for researchers, scientists, and drug development professionals.
Setting Defensible Acceptance Criteria for Biologics Comparability: A Risk-Based Statistical Framework
This article provides a comprehensive guide for researchers, scientists, and drug development professionals on establishing scientifically sound and regulatory-defensible acceptance criteria for comparability studies.
Cross-Contamination of Cell Lines: Causes, Consequences, and Cutting-Edge Solutions for Reliable Research
This article provides a comprehensive analysis of cell line cross-contamination, a critical and persistent issue that compromises the validity of biomedical research and drug development.
Antibiotic Selection Markers: A Comprehensive Guide to Efficiency, Application, and Alternatives in Biomedical Research
This article provides a comprehensive analysis of the selection efficiency of various antibiotic markers, a critical tool in genetic engineering and biotherapeutic development.
Validating Drug Responses in Patient-Derived Organoids: From 3D Models to Clinical Predictions
Patient-derived organoids (PDOs) have emerged as a transformative preclinical model that faithfully retains the genetic, proteomic, and histological characteristics of original tumors, offering a powerful platform for predicting clinical drug...
Setting Robust Acceptance Criteria for Method Comparability: A Risk-Based Framework for Biologics and ATMPs
This article provides a comprehensive guide for researchers, scientists, and drug development professionals on establishing scientifically sound and defensible acceptance criteria for analytical method comparability and equivalency studies.
MrVI: A Deep Generative Model for Unraveling Cellular Heterogeneity in Single-Cell Genomics
This article provides a comprehensive overview of multi-resolution variational inference (MrVI), a novel deep generative model designed for the exploratory and comparative analysis of large-scale single-cell genomic data.
Overcoming Limited Batch Comparability: A Phase-Appropriate Roadmap for Biologics and Advanced Therapies
This article provides a comprehensive guide for researchers and drug development professionals facing the critical challenge of demonstrating product comparability with limited batch numbers.
Demonstrating Comparability for Biological Products: A 2025 Guide to Regulatory Strategy, Analytical Methods, and Lifecycle Management
This article provides a comprehensive guide for researchers and drug development professionals on demonstrating comparability for biological products.
FBS Supplier Comparison for Contamination Testing: A Guide to Ensuring Reproducibility and Cell Culture Safety
This article provides researchers, scientists, and drug development professionals with a comprehensive framework for evaluating and selecting Fetal Bovine Serum (FBS) suppliers based on rigorous contamination testing protocols.