Extracellular Vesicles

Extracellular Vesicles

Extracellular vesicles (EVs) are emerging as a powerful therapeutic modality for the delivery of proteins, nucleic acids, and signaling molecules across regenerative medicine, immunotherapy, and gene delivery applications.

EV manufacturing presents unique challenges in product characterization, process consistency, and scalability. By combining stem cell biology, process development, analytics, and GMP manufacturing, Artis supports EV programs from research through clinical manufacturing.

Capabilities

Integrated EV Production and Analytics

Integrated production and analytical capabilities supporting development, characterization, and GMP manufacturing

EV Production Across Cell Sources

Experience across primary cells, iPSC-derived cells, and differentiated cell types

Adherent and Suspension Production Platforms

Expertise across adherent and suspension systems, including process translation

Scalable Production Systems

Scale-up experience from shake flasks to bioreactor platforms

Upstream and Downstream Process Integration

Integrated development of production, harvest, purification, and recovery

Purification and Recovery Strategies

Chromatographic and membrane-based approaches supporting EV recovery and purity

Advanced EV Analytics

Flow-based and orthogonal analytical methods supporting EV characterization, comparability, and product quality

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Workflow

Upstream Production

iMSC, MSC (iPSC-derived or MSC directly), HSC, MKSC
HEK293T
Adherent vs. suspension
Shake flask vs. bioreactor

EV Purification

Harvest clarification to collect EV-rich media
TFF concentration
Column chromatography
Sterile filtration
Formulation

EV Characterization

Flow cytometry (VSSC)
Particle Analysis by NTA & Zetasizer
Western blot

Process and Analytical Development

Integrated process and analytical development support scalable EV manufacturing and consistent product characterization.

Process Development

Optimization of EV production across adherent & suspension systems
Translation of adherent workflows into scalable suspension processes
Development of harvest, concentration, & purification workflows
Scale-up strategies designed to maintain EV integrity, yield, & consistency

Analytical Development

Particle size & concentration analysis (e.g., NTA, DLS)
EV identity & biomarker profiling (e.g., flow cytometry, Western blot, ELISA)
Potency & functional assays
Purity & impurity assessment, including residual host cell protein & DNA
Orthogonal methods supporting comparability & GMP readiness

Analytics

Extracellular Vesicles Analytics

CQA

Attribute

Test Method

Report

Titer / Strength

Concentration

Size

Target protein

DSL, NTA

Quantitative Western blotting

Particles/mL

Concentration

Potency

Biological function

Cell-based assay

Activity / Endpoint

Identity

EV markers (CD9, CD61)

Flow cytometry, microscopy, Western blot, ELISA

% Positive / presence

Purity

Residual host cell protein

Residual host cell DNA

Size, aggregation, stability

ELISA

NGS, PicoGreen

HPLC (SEC), DLS/NTA

µg/mL

Copies/mL, ng/mL

Size / profile

Quality

Appearance

Osmolarity

Visual inspection

pH probe

Osmometer

Color / clarity

mOsm/kg

Safety

Sterility

Mycoplasma

Bioburden

Endotoxin

BACT/Alert

ddPCR

Microbial enumeration

Spectrophotometry

Pass / fail

Copies/mL

CFU/mL

EU/mL

Quality and Compliance

cGMP facilities and operations are designed to meet applicable US FDA regulations (including 21 CFR Parts 11, 210, 211, 610, and 1271) and relevant ICH quality guidelines.