Research Articles
GMP-Compliant Validation of MSC Surface Markers by Flow Cytometry: A Guide from Foundational Principles to Clinical Release
This article provides a comprehensive guide for researchers and drug development professionals on validating mesenchymal stromal cell (MSC) surface marker expression using flow cytometry within a Good Manufacturing Practice (GMP)...
Ensuring Genetic Stability in Extended-Passage MSCs: Strategies for Robust GMP Production
This article addresses the critical challenge of maintaining genetic stability in Mesenchymal Stem Cells (MSCs) during extended in vitro passaging, a key requirement for scalable and compliant Good Manufacturing Practice...
Animal-Free Media for MSC Proliferation: A GMP-Compliant Guide for Clinical Translation
This article provides a comprehensive analysis of animal-free culture media for Mesenchymal Stem Cell (MSC) expansion under Good Manufacturing Practice (GMP) standards.
A Practical Guide to Validating Cell Counting Methods for GMP Compliance Under ICH Q2(R1)
This article provides a comprehensive roadmap for researchers, scientists, and drug development professionals tasked with validating cell counting methods in a Good Manufacturing Practice (GMP) environment.
Optimizing Population Doublings for GMP Fibroblast Feeder Cells: A Guide to Scalable and Compliant Cell Therapy Manufacturing
This article provides a comprehensive guide for researchers and drug development professionals on optimizing the population doublings of Good Manufacturing Practice (GMP)-grade fibroblast feeder cells.
Scalable Manufacturing of Mesenchymal Stromal Cells: A Complete Guide from Laboratory to Pilot Scale
This article provides a comprehensive guide for researchers and drug development professionals on scaling up Mesenchymal Stromal Cell (MSC) manufacturing from laboratory to pilot scale.
Closed System Automation in Cell Selection: Advancing GMP Manufacturing for Scalable Therapies
This article provides a comprehensive overview of closed system automation for cell selection within GMP manufacturing frameworks.
Automating GMP Cell Therapy Manufacturing: A Comprehensive Guide to the Lovo Cell Processing System
This article provides researchers, scientists, and drug development professionals with a complete overview of the Lovo Automated Cell Processing System for GMP-compliant workflows.
Strategies for Minimizing Toxicity of Transduction Enhancers in GMP-Compliant Gene Therapy Manufacturing
This article provides a comprehensive guide for researchers and drug development professionals on integrating transduction enhancers into Good Manufacturing Practice (GMP) compliant gene therapy workflows while prioritizing safety and minimizing...
Optimizing Post-Thaw Viability in GMP Stem Cell Products: A Guide to Robust Protocols and Quality Assurance
This article provides a comprehensive guide for researchers and drug development professionals on improving the post-thaw viability of GMP-grade stem cell products.