The GMP manufacturing facilities and services have been purpose-built for advanced therapies.
Manufacturing operations are supported by a phase-appropriate Quality Management System (QMS), integrated Quality Control testing, and digital systems that support traceability, data integrity, and operational oversight across every batch.
Modular and reconfigurable manufacturing operations are designed to support a broad range of advanced therapy modalities, from synthetic DNA through final drug product manufacturing. Because the platform begins with synthetic DNA, programs manufactured with Artis benefit from starting material continuity that few providers can offer.
The fill and finish suite is designed with unidirectional personnel and material flow to minimize contamination risk and support consistent product quality. The suite houses an ISO 5 qualified Biological Safety Cabinet equipped with the Crystal M1 Filling Station.
The Crystal M1 is a functionally closed aseptic filling system utilizing AT-Closed Vial® technology. The platform supports fill volumes from 0.1 mL to 50 mL and high-accuracy filling across multiple vial formats, supporting up to 300 vials per shift.
Integrated QA oversight, on-site QC testing, and documentation packages support GMP batch disposition aligned with IND and clinical manufacturing requirements.
All GMP manufacturing activities operate under a phase-appropriate Quality Management System supported by in-house bioanalytical and microbiology testing capabilities.
The platform supports early clinical manufacturing with scalable quality systems, successful client audits, and experience supporting regulatory engagement activities.
Stem Cells 
CAR-T 
AAV Delivery 
LVV Delivery 
Other Viral Vectors 
Extracellular Vesicles 
Nanoparticles 
