Research Articles
A Strategic Framework for Risk Assessment in Pharmaceutical Manufacturing Process Changes
This article provides a comprehensive guide to risk assessment for manufacturing process changes, specifically tailored for researchers, scientists, and drug development professionals in the pharmaceutical and biotech industries.
Navigating Biotechnological Product Comparability: A Strategic Framework for Process Changes and Biosimilar Development
This article provides a comprehensive guide to demonstrating comparability for biotechnological/biological products following manufacturing process changes, as outlined in ICH Q5E and related regulatory guidances.
2025 Regulatory Expectations for Product Comparability: A New Era of Analytical Confidence
This article provides drug development researchers and scientists with a comprehensive analysis of the paradigm shift in regulatory expectations for product comparability.
Post-Translational Modifications and Product Comparability: A Strategic Guide for Biopharmaceutical Development
This article provides a comprehensive overview of the critical role post-translational modifications (PTMs) play in demonstrating product comparability during biopharmaceutical development.
Critical Quality Attributes in Comparability Studies: A Comprehensive Guide for Biologics Development
This article provides drug development researchers and scientists with a comprehensive framework for understanding and implementing Critical Quality Attribute (CQA) assessments in comparability studies.
Cell Detachment Techniques: A Comprehensive Viability Comparison for Biomedical Research
This article provides a critical analysis of common cell detachment methods, including enzymatic, non-enzymatic, and novel electrochemical techniques, for researchers and drug development professionals.
Cell Detachment Methods and Metabolomic Profiles: A Critical Consideration for Reproducible Research and Drug Development
This article synthesizes current evidence on the profound impact cell detachment techniques have on subsequent metabolomic analysis.
Cell Health Assessment After Detachment: A Critical Guide for Maintaining Viability and Phenotype
This article provides a comprehensive guide for researchers and drug development professionals on assessing cell health following various detachment methods.
Accutase Compromises Fas Receptor Expression: A Critical Guide for Cell-Based Assays and Therapeutic Development
This article synthesizes current evidence demonstrating that Accutase, a commonly used enzymatic cell detachment solution, significantly cleaves and reduces the cell surface expression of the Fas receptor (CD95) and its...
Scraping vs. Enzymatic Detachment in Cell Metabolomics: A Comprehensive Guide for Optimal Sample Preparation
Accurate sample preparation is the cornerstone of reliable cell metabolomics, and the choice between mechanical scraping and enzymatic detachment is a critical, yet often overlooked, step.