Cell and gene therapies (CGTs) have advanced from conceptual promise to clinical reality, with dozens of approved products and thousands more in development. A unifying feature across this pipeline is the viral vector: an engineered virus optimized to deliver therapeutic payloads with high efficiency.
Stem Cell Therapy
Because stem cell products are highly process-dependent, manufacturing success relies on robust process development and control. Artis supports the translation of stem cell programs from research into GMP-ready processes through integrated development, analytics, and manufacturing execution.
Capabilities
Process Development to GMP Execution
Translation of process and analytical development into GMP manufacturing
Stem Cell Expertise
Experience in expansion and differentiation workflows across iPSCs, MSCs, and organoids
Scaling Strategy and Culture Platforms
Experience across 2D and 3D culture systems, including adherent and suspension formats using multiple vessel types
Upstream and Downstream Workflow Design
Development of expansion, differentiation, harvest, concentration, and formulation workflows
Process and Analytical Integration
Development of fit-for-purpose assays supporting identity, potency, and product quality
Integrated QC and Product Readiness
Analytical support for release testing, stability, and IND-enabling activities
Process Development and GMP Readiness
- Re-engineering RUO protocols into robust, GMP-compatible workflows
- Definition & control of critical process parameters (CPPs) impacting identity, differentiation, and yield
- Standardization of handling, timing, & operator-dependent steps to reduce variability
- Processes designed for direct translation into GMP manufacturing

- Selection of GMP-compatible raw materials and reagents early in development
- Qualification of media, cytokines, & culture components to reduce variability
- Standardization of inputs to support reproducibility & regulatory alignment
- Alignment of materials strategy with downstream GMP manufacturing requirements

Stem Cells Analytics
Cell count
Automated cell counters (Vi Cell Blu, NC202), flow cytometry
Viability (%), viable cells/mL
Biological function
Cell-based assay
Activity / endpoint
Cell marker
Morphology
Cellular secretions
Genomic integrity
Flow cytometry
Microscopy
ELISA
Sequencing (outsourced)
% Positive / presence
Phenotype
Concentration/mL
Sequence alignment
Cell markers
Genetic markers
Residual process components
Flow cytometry
Real-time PCR
ELISA, HPLC
Frequency
% Positive
Residual levels
Appearance
pH
Osmolarity
Visual appearance & inspection
pH probe
Osmometer
Color / clarity
pH
mOsm/kg
Sterility
Mycoplasma
Bioburden
Endotoxin
BACT / Alert
ddPCR
Microbial enumeration
Spectrophotometry
Pass / fail
Copies/mL (detected / not detected)
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.