
Global Guide to Stability Testing for Cell Therapy Products & Regulatory Compliance
Discover how cell therapy stability requires multi-parametric assays beyond viability to preserve function, phenotype, and safety during storage and thaw.
Discover how cell therapy stability requires multi-parametric assays beyond viability to preserve function, phenotype, and safety during storage and thaw.
Cryopreservation is a technique designed to preserve the viability and functionality of biological specimens, such as cells, tissues, and organs, by cooling them to subzero
The concept of Critical Quality Attributes (CQAs) plays a pivotal role in a drug development process. According to the ICH Guideline Q8(R2) on Pharmaceutical Development,
Adoptive cell therapy (ACT), including TILs, CAR T, NK, and CAR NK cell therapies, is revolutionizing immunotherapy. With over 2,000 clinical trials underway (ClinicalTrials.gov, 2025),
Cell and gene therapies (CGTs), particularly autologous therapies like CAR-T/TCR-T cells, represent a breakthrough in personalized medicine. These treatments offer life-changing outcomes for patients with
Extracellular vesicles (EVs) have emerged as critical players in diagnostics, vaccine development, and therapeutic applications, driving the need for precise characterization tools. Exoid, powered by
The rapid advancement of cell and gene therapies (CGTs) offers transformative potential for treating a myriad of diseases, including various cancers and genetic disorders. However,
Adeno-associated viruses (AAVs) have become a cornerstone of gene therapy, offering a powerful platform for delivering therapeutic genes to both dividing and non-dividing cells. However,
Clinical trials are the bedrock of medical progress, enabling the development of new treatments and therapies that improve patient outcomes. However, they are notoriously complex,
Nanomedicines such as extracellular vesicles (EVs), liposomes, and lipid nanoparticles (LNPs) hold great potential for advancing medicine. In recent years, EVs have gained significant attention
The rapid growth of translational applications for mesenchymal stem cells (MSCs) has heightened the need for efficient, scalable production systems. Central to this effort is
Liquid biopsy analysis has emerged as a groundbreaking tool in precision medicine, offering a minimally invasive way to detect and monitor diseases through biomarkers found
China has rapidly emerged as a vital hub for clinical research, driven by its large population and an evolving regulatory environment. However, foreign companies conducting
China’s Dual-Track Regulatory System: Shaping the Future of Cell Therapy Research and Commercialization Cell therapy has rapidly advanced, driven by the FDA’s 2017 approval of
Gene therapy holds immense promise for managing or even curing diseases once considered untreatable. Conditions like certain cancers, β-thalassemia, and retinal dystrophy benefit from this
So, what exactly are AAVs? Adeno-associated viruses (AAVs) were first identified in 1965 by Bob Atchison and Wallace Rowe, who observed them as replication-defective particles
Patent protection is a critical form of intellectual property (IP) in the life sciences industry, providing exclusivity to inventors and companies that drive innovation. A
Organoids and spheroids represent a breakthrough in biological research, offering advanced 3D models that more accurately mimic the architecture and function of human tissues than
Isolating single cells is essential for various applications, including cell line development, monoclonal antibody production, single-cell multiomics, and the characterisation of cancer stem cells. To
Imagine dedicating years of research to investigating a disease or testing a novel therapeutic, only to discover that your results were based on misidentified or
Selecting the right mouse model is a critical decision that can shape the success of your research. With the wide variety of available models, each
Singapore has emerged as a global hub for innovation and entrepreneurship, particularly in the life sciences sector. The city-state’s strategic position, robust infrastructure, and supportive
Since their development in the 18th century, vaccines have been highly effective in preventing diseases caused by viruses and bacteria, saving hundreds of millions of
Stem cells are revolutionizing biomedical research and healthcare, offering unprecedented potential for regenerative medicine and disease treatment. Whether you are a seasoned researcher or just
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