FEATURED ARTICLES

• Preparing For The Clinic: Qualifying Analytical Methods

  Learn how to qualify analytical methods before entering clinical trials, including regulatory expectations, key parameters, and a hands-on walkthrough of the qualification process.

• iPSC-Derived MSCs Show Comparable Expansion, EV Production, And Immunomodulatory Potential To Primary MSCs

  iPSC-derived MSCs match primary MSCs in expansion, surface marker expression, EV output, and immunomodulatory function, offering a scalable path to standardized cell therapy manufacturing.

• Industrializing iPSC Feed Streams Via Critical Process Parameter And Raw Materials Optimization

  Explore how an optimized bioprocess with purpose-designed medium and GMP-compatible reagents achieved 10,000-fold iPSC expansion in under two weeks while maintaining pluripotency and a weekend-free workflow.

• Quantifying CD73 Content And Function Across A Scalable MSC-EV Process

  Discover how orthogonal analytical assays for CD73 content and enzymatic function can serve as critical quality attributes in scalable MSC-EV manufacturing.

• Advanced Analytical Profiling Of MSC-EVs: Tissue- And Donor-Dependent Heterogeneity

  Tissue source and donor identity drive measurable differences in MSC-EV quality attributes. See how analytical profiling reveals what varies and why it matters for scalable manufacturing.

• GMP Reagent Enables 10x Improvement In MSC-EV Downstream Processing Recovery

  Filter fouling during EV purification can eliminate over 95% of your starting material. See how a novel GMP-compatible reagent changes the recovery equation entirely.

• The Spirit Of MISEV

  MISEV guidelines help extracellular vesicle researchers design robust experiments through transparent reporting and rigorous characterization rather than rigid checklists.

• To 10X & Beyond, AgentV™-DSP Arrives Ready To Rock

  Filter fouling has limited exosome therapeutic scalability—until now. Explore how a breakthrough reagent achieves 50% particle recovery versus 5% traditionally, enabling affordable clinical manufacturing.

• Galvanizing Large And Small For Clinical Success

  See how two academic investigators accelerated corneal regeneration and lung fibrosis therapies from preclinical research to clinical trials by leveraging scalable GMP solutions and regulatory-ready materials.

• When Data Blooms: Insights Into MSC-EV Bioprocessing

  Explore how bone marrow, umbilical cord, and adipose MSCs produce extracellular vesicles with distinct characteristics, and why 3D culture systems consistently outperform 2D platforms in productivity.

• EV Content vs. Function: Using Analytical Tools To Reveal The Connection

  See how downstream processing affects CD73 expression and function on MSC-EVs through orthogonal analytical methods that connect vesicle content to biological activity and therapeutic potential.

• Introducing AgentV: A Scalable Solution For 10X Exosome Yield

  Understand how a downstream treatment prevents filter fouling during exosome purification, enabling 40-70% particle recovery compared to traditional 5-10% yields while maintaining quality attributes.

• A Highly Productive, Chemically Defined Exosome Media System

  Explore how chemically defined media and optimized bioreactor protocols increase exosome yields 40-fold while reducing commercial manufacturing costs from $10,000 to under $1,000 per dose.

• Deference To The Differences Between Fibroblasts And MSCs

  What separates fibroblasts from MSCs when both express identical markers and differentiate into bone, fat, and cartilage? Molecular profiling reveals they exist on a functional spectrum of plasticity.

• Analytical Comparison Of MSC-EV Quality Attributes Across Tissue Sources And Production Platforms

  Explore comprehensive analytics comparing MSC-EV quality attributes across tissue sources, donors, and scalable production platforms to identify critical manufacturing variables.

• Harnessing NanoFlow Cytometry For Quantitative Surface Marker Analysis

  Explore quantitative single-vesicle profiling methods that reveal tissue-specific surface marker expression patterns invisible to bulk EV analysis, with molecular-level resolution across three MSC sources.

• The Complex Journey Of EVs Toward Clinical Translation

  Understand how single-vesicle analysis exposes critical EV heterogeneity, why MSC-EVs face manufacturing hurdles, and what regulators expect from developers pursuing clinical translation.

• How hMSCs Are Helping Power Organ-On-A-Chip Science

  Explore how hMSCs power organ-on-chip systems through multipotency and scalability—from Georgia Tech's bone marrow models to ISS microgravity experiments and precision bioprinting innovations.

• Balancing The Scale From The Cellular Bank

  Understand how early cell banking strategy and manufacturing platform selection influence regulatory timelines, cost structures, and scalability from Phase I through commercial production for MSC therapies.

• When Is An Exosome Not An Exosome?

  What separates genuine exosomes from microvesicles, apoptotic bodies, or lipoproteins? Explore the markers, assays, and biogenesis pathways that define these particles beyond popular terminology.