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Stem Cell Therapy

Stem cell therapies hold significant promise across regenerative medicine, gene correction, and engineered cell therapies, with self-renewal and multi-lineage differentiation making them a powerful platform for advanced therapies.

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

Process Development
  • 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
Materials & Process Readiness
  • 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
Analytics

Stem Cells Analytics

CQA
Attribute
Test Method
Report
Titer / Strength

Cell count

Automated cell counters (Vi Cell Blu, NC202), flow cytometry

Viability (%), viable cells/mL

Potency

Biological function

Cell-based assay

Activity / endpoint

Identity

Cell marker

 

Morphology

 

Cellular secretions

 

Genomic integrity 

Flow cytometry

 

Microscopy

 

ELISA

 

Sequencing (outsourced)

% Positive / presence

 

Phenotype

 

Concentration/mL

 

Sequence alignment

Purity

Cell markers

 

Genetic markers

 

Residual process components

Flow cytometry

 

Real-time PCR

 

ELISA, HPLC

Frequency

 

% Positive

 

Residual levels

Quality

Appearance

 

pH

 

Osmolarity

Visual appearance & inspection

 

pH probe

 

Osmometer

Color / clarity

 

pH

 

mOsm/kg

Safety

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.