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CAR-T

CAR-T products are defined by their process. Variables such as starting cell quality, activation, transduction, and expansion directly influence the final therapy, making process development and technology transfer critical to manufacturing success.

Artis supports autologous and allogeneic CAR-T programs through a modular cGMP platform designed for scalable manufacturing, integrated analytics, and efficient GMP transfer. 

Capabilities

Our Platform Optimized for Scale-up and Transfer (POSTmark) process aligns development and cGMP manufacturing through mirrored equipment, scale-down models, and standardized workflows, enabling faster, lower-risk transfer for CAR-T programs. 

Autologous and Allogeneic Program Support

Fresh and frozen chain-of-custody workflows supporting diverse manufacturing strategies

Modular GMP Manufacturing Suites

Flexible manufacturing spaces supporting diverse CAR-T process strategies 

Quality Control and Fill/Finish

In-house QC testing, release analytics, and GMP fill/finish capabilities 

Boston-Area Clinical Proximity

Located near leading clinical centers and research hospitals to support clinical manufacturing coordination 

Innovation and Development Labs

Mirrored development systems and scale-down models supporting efficient GMP transfer 

POSTmark™ LVV + CAR-T Integration

Coordinated viral vector and CAR-T manufacturing workflows designed to move programs into GMP with fewer scheduling and quality bottlenecks 

Synthetic DNA Starting Material

GMP-ready synthetic DNA as a plasmid alternative for lentiviral vector production, available in as little as 2 weeks

Workflow

CAR-T in just 7-days

POSTmark supports an end-to-end autologous CAR-T workflow aligned from development through cGMP manufacturing 

Enrichment

Patient cell subset selection using Rotea & CliniMACS Plus systems

Activation & Transduction

CAR lentiviral vectors introduced under mirrored development & GMP conditions

Expansion

Autologous expansion in G-Rex systems & allogeneic expansion in Xuri platforms

Formulation & Fill

GMP-compliant formulation & filling into bags or vials

Integrated QC

In-house identity, potency, purity, & persistence testing

Artist BioSolutions’ CAR-T workflow reduces time and costs risks through an end-to-end process. For autologous CAR-T, our workflow is just 7 days from receipt to QC with both cell therapy and lentiviral manufacturing in a single facility.

“Every step is standardized under the POSTmark philosophy, ensuring continuity from early research runs to clinical-grade manufacturing.”
Analytics

CAR-T Analytics

CQA
Attribute
Test Method
Report
Identity
Large cohorts of antibodies/antigens
Single antibody/antigen that is soluble and easy to work with
Frequency (%)
Purity

T cell
Non-T
Viability

Flow cytometry
Flow cytometry
Automated cell counters/ Flow cytometry

Frequency (%)
Frequency (%)
Cells/mL

Potency

In-vitro

Cytotoxicity
Cytokine production

Flow cytometry

Flow cytometry/ELISA

% Cytotoxicity

% positive / Concentration

Safety

Vector copy number
replication competence
Compendial (myco, sterility, endotoxin)

qPCR/ddPCR
qPCR
Assay specific

Copy/Cell
VSVG (Copies/mL)
Detection (Pass/Fail)

Process and Analytical Development

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

Upstream Development
  • Cell source & manipulation strategy
  • Media & culture condition optimization
  • Scalable, reproducible expansion workflows
Downstream Development
  • Harvest, washing, & concentration methods
  • Formulation & cryopreservation strategy
  • Closed & semi-closed workflows for cGMP transfer
Analytical Development
  • Identity, potency, & purity assays
  • Functional & phenotypic characterization methods
  • Methods supporting GMP release testing
  • Assays supporting comparability & technology transfer

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.