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Analytical Development Built for GMP Transfer

Robust analytical methods are critical to successful GMP transfer, product characterization, potency assessment, and release testing across advanced therapy programs. 

At Artis, Analytical Development is integrated with Process Development, QC, microbiology, and GMP manufacturing to support reproducible methods, characterization strategies, and GMP-aligned testing throughout development and clinical manufacturing. 

Analytical Development Built for GMP Transfer

Analytical Development Capabilities

Analytical methods and assays are developed to support GMP transfer, product testing, and process understanding across advanced therapy modalities. 

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Assay Development, Qualification, and Validation  

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Identity, Purity, Potency, and Safety Testing  

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In-Process and Release Assay Development  

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Custom Assay Design Using Molecular, Immunoassay, Flow Cytometry, and Biophysical Methods 

Potency Assays

Potency assays are critical for evaluating biological activity and functional performance across advanced therapy modalities. Assay strategies are designed around therapeutic modality, mechanism of action, and stage of development. 

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Cell Therapies

CAR-T, CAR-NK, iPSC-derived therapies, MSCs
  • Artis – Secondary icons_Retrovirus Antigen-specific T-cell activation assays
  • Artis – Secondary icons_Manufacturing Cytokine secretion assays
  • Artis – Secondary icons_Scalable Proliferation assays
  • Artis – Secondary icons_Cell Migration & cytotoxicity assays
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Viral Vectors

AAV. LVV, retroviral, novel viral vectors
  • Artis – Secondary icons_Viral Vector Infectious & transducing titer assays
  • Artis – Secondary icons_Organoids Cell-based transgene expression assays
  • Artis – Secondary icons_Emerging modalities Functional bioassays linked to mechanism of action
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Non-Viral Therapies

LNPs, inorganic nanoparticles, EVs
  • Artis – Secondary icons_Target Cargo delivery & expression assays
  • Artis – Secondary icons_Check – Secondary Mechanism-linked functional bioassays
  • Artis – Secondary icons_Comparability Surrogate potency assays appropriate to development stage

Characterization

Characterization studies help define critical quality attributes (CQAs), assess product consistency, and support comparability across development and scale-up activities. 

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Approaches Include

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Identity, Purity, and Heterogeneity Assessment
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Orthogonal Confirmation of Product Attributes
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Comparability Support Across Process Changes
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CQA Data Generation for Regulatory Submissions and Lifecycle Management

Representative Methods

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Flow cytometry and nano-flow cytometry
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qPCR and ddPCR
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Protein and capsid analytics (ELISA, HPLC/UPLC)
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Biophysical and particle characterization methods

GMP Analytics Support

In-house QC and microbiology laboratories provide GMP-aligned testing to support product quality, safety, and consistency across advanced therapy programs. 

DNA/RNA quantitation with ddPCR & qPCR platforms

Automated cell counting & viability analysis

BSL2 level cell culture for bioassays

Protein analysis using multi-mode approaches

ELISA-based analysis (luminescence, absorbance, fluorescence)

Protein, DNA, & RNA gel electrophoresis and western blot imaging

HPLC/UPLC purity analysis

Flow Cytometry

UV/Vis spectrophotometry & NanoDrop analysis

Visual appearance inspection

Sterility, endotoxin, bioburden, & Gram stain testing

pH and conductivity measurement

Quality and Compliance

Integrated QC and microbiology operations support product safety, data integrity, and regulatory readiness across development and GMP manufacturing. 

  • Method qualification & validation
  • In-process & release analytics
  • Safety & stability testing
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