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AAV Delivery

Adeno-associated virus (AAV) vectors are foundational to in vivo gene therapies, enabling efficient gene delivery across a rapidly expanding pipeline of genetic medicines.

Artis supports AAV development and GMP manufacturing through POSTmark, a platform that aligns development and cGMP manufacturing through standardized workflows to support scalable, reproducible production across clinical stages. AAV expertise is further supported through co-development of a NIIMBL-funded manufacturing platform leveraging next-generation purification technologies. 

Capabilities

End-to-End AAV Manufacturing

Integrated support from process development through GMP production (50 L and 200 L), with in-house analytical development, QC, and fill/finish

Proven GMP Expertise

Artis team has 40+ cumulative years of viral vector manufacturing experience

 

Serotype and Platform Experience

Experience across multiple AAV serotypes, including AAV2 and AAV9

Process and Analytical Development

Expertise in upstream production, downstream purification, and analytical characterization

Accelerated Timelines

R&D supply in 4–8 weeks and GMP AAV in 6–9 months 

Integrated QC and Fill/Finish

Full in-house quality control, release testing, and GMP fill/finish capabilities 

Synthetic DNA Options

GMP-ready synthetic DNA as a plasmid alternative, available in as little as 2 weeks

NIIMBL AAV Platform Innovation

NIIMBL-funded AAV platform leveraging next-gen purification technologies to improve scalability, efficiency, and COGs

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AAV Workflow: From First Run to GMP

Upstream Workflow
  • HEK293 suspension cultures scaled from IDL to 200L
  • Triple-transfection AAV systems
  • Clarification via depth filtration
  • Bioreactors designed for reproducibility & scalability
Downstream Workflow and Formulation
  • Capture & polishing chromatography
  • Concentration & formulation using tangential flow filtration
  • Recovery rates matching or exceeding literature
  • Sterile filtration & fully integrated fill/finish
“POSTmark was developed so your first run is your best run, supporting consistent AAV performance from development through GMP manufacturing as a final therapeutic product.”
Analytics

AAV Analytics

CQA
Attribute
Test Method
Report
Titer / Strength

Genomic titer

 

Capsid titer

 

Infectious titer / potency

q/ddPCR

 

ELISA

 

Flow cytometry

Copies/mL

 

Viral Particles/mL

 

Transducing units/mL

Transduction efficiency %

Purity / Residuals

Size, aggregation  

 

Host cell protein

 

AAV proteins

 

Host cell DNA

 

Plasmid

 

Nuclease

 

Capsid content

MALDS

 

ELISA

 

Western blotting

 

PicoGreen

 

qPCR

 

ELISA

 

Mass photometry

Size (nm), particles/mL

 

µg/mL 

 

Semi-quantitative results

(VP1:VP2:VP3)

 

ng/mL

 

Copies/mL

 

pg/mL

 

% full capsid

Identity

Capsid

 

Viral genome

ELISA

 

Sequencing (outsourced)

Viral particles confirmed

 

Sequence alignment (%)

Compendial / Safety

Appearance

 

pH

 

Osmolarity

 

Sterility

 

Endotoxin

 

Bioburden

 

Mycoplasma

Visual

 

Probe

 

Osmometer

 

Bact/Alert

 

Endosafe MCS reader

 

Microbial enumeration

 

ddPCR

Color / clarity

 

pH

 

mOsm/mL

 

Growth / no growth

 

IU/mL

 

TAMC / TYMC

 

Negative / positive

Process and Analytical Development

Within the POSTmark framework, development and GMP manufacturing are aligned through standardized workflows, supporting efficient technology transfer and scalable production. 

Process Development
  • Plasmid and transfection optimization
  • HEK293 suspension-based upstream workflows
  • Downstream purification strategies to improve purity & recovery
  • Concentration & formulation approaches supporting stability & product quality
  • Processes aligned with GMP manufacturing & technology transfer
Analytical Development
  • Vector genome (vg) titer & infectious titer methods
  • Full/empty capsid ratio & capsid characterization
  • Potency & functional assays
  • Identity, purity, & residual impurity testing
  • Methods developed & qualified to support GMP release

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. 

Related Resources

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