Last November we published POSTmark CAR-T: Delivering Therapies Without Delay, arguing that manufacturing continuity—not biology—is the rate-limiting step for most CAR-T programs. This year at ASGCT, just months later, it was abundantly clear that the conversation has shifted under everyone’s feet.
CAR-T
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
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.
CAR-T Analytics
T cell
Non-T
Viability
Flow cytometry
Flow cytometry
Automated cell counters/ Flow cytometry
Frequency (%)
Frequency (%)
Cells/mL
In-vitro
Cytotoxicity
Cytokine production
Flow cytometry
Flow cytometry/ELISA
% Cytotoxicity
% positive / Concentration
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.
- Cell source & manipulation strategy
- Media & culture condition optimization
- Scalable, reproducible expansion workflows
- Harvest, washing, & concentration methods
- Formulation & cryopreservation strategy
- Closed & semi-closed workflows for cGMP transfer
- 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.