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LVV Delivery

Lentiviral vectors (LVVs) are foundational to modern cell and gene therapies, enabling stable gene delivery across ex vivo and in vivo applications and underpinning many CAR-T programs.

Artis supports LVV development and GMP manufacturing through POSTmark, a platform that aligns development and cGMP manufacturing through mirrored equipment, scale-down models, and standardized workflows to support scalable production and lower-risk technology transfer. 

Capabilities

End-to-End LVV Manufacturing

Integrated support from process development through GMP production (50 L & 200 L), with in-house analytical development, QC, and optional cell therapy manufacturing 

Proven GMP Expertise

Artis team has 40+ cumulative years of viral vector manufacturing experience, including GMP production of complex LVV constructs (>9 kb) 

Scalable Process Development

Expertise in suspension upstream processing, downstream purification, and analytical characterization 

Accelerated Timelines

R&D supply in 4–8 weeks and GMP LVV in 6–9 months enabled by standardized, transfer-ready workflows

Integrated QC and Fill/Finish

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

Synthetic DNA Option

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

 

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LVV Workflow: From First Run to GMP

Upstream Workflow
  • HEK293 suspension cultures scaled from IDL to 200L.
  • Third-generation LVV plasmid systems
  • Bioreactors designed for reproducibility & scalability
  • Clarification via depth filtration
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, enabling consistent LVV performance from development through GMP, as a final product or for downstream applications.
Analytics

LVV Analytics

CQA
Attribute
Test Method
Report
Titer

Genomic Titer

 

Capsid Titer

 

Infectious Titer

qPCR / ddPCR

 

ELISA (p24)

 

Genomic Intragration (qPCR or ddPCR), Protein expression (Flow Cytometry)

Viral Genomes (VG)/mL

 

Viral Particles/mL

 

Transducing Units (TU/mL)

Potency

Gene/Protein Expression, Biological Function

Flow Cytometry/PCR/ELISA/In Cell Western

Relative Potency (% Reference)

Identity

Lentivirus (transgene capsid proteins)

PCR, ELISA, Western blot (p24, p17, transgene)

Qualitative confirmation

Purity (Residuals)

Viral particles

 

Aggregation

 

Host cell protein

 

Host cell DNA

 

Residual plasmid

Peak detection . discrimination (UHPLC)

 

DLS

 

ELISA

 

PicoGreen, qPCR

 

qPCR

Qualitative (UV/FL)

 

Size, composition

 

Detection (ng/mL)

 

Detection (pg/mL)

 

Detection (copies/mL)

Safety

Replication competence

 

Compendial (myco, sterility, endotoxin)

qPCR

 

Assay specific

VSVG (copies/mL)

 

Detection (pass / fail)

Process and Analytical Development

Within the POSTmark framework, development and GMP manufacturing are aligned through standardized workflows, mirrored equipment, and scale-down models, supporting efficient technology transfer and scalable production. 

Process Development
  • Transfection & production optimization
  • HEK293 suspension-based upstream workflows
  • Downstream purification & formulation strategies
  • Processes aligned with GMP manufacturing & technology transfer
Analytical Development
  • Infectious & physical titer methods
  • Potency & functional assays
  • Identity, purity, & residual impurity testing
  • Methods developed & qualified to support GMP release & comparability

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. 

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