Psygen’s purpose-built, GMP-compliant facility was designed to manufacture your drug. By combining industry-leading experience in psychedelic chemistry with a dedicated facility, the ideal partner for psychedelic and neuroplastogen CMC needs emerges.
Our 17,000-sq-ft facility includes a 6,000-sq-ft ISO8 clean lab offering robust process research and development capabilities and capacity for large-scale synthesis of psychedelics and psychedelic-inspired analogues. We offer the capacity and flexibility to efficiently transition your compounds from lead identification to clinical trials and beyond.
Facility Overview
Our Facility /
R&D Lab
Psygen’s R&D Lab is utilized for process development leading to scale-up, our processes follow a Quality by Design approach.
Process Development:
Route scouting
Process optimization
Purification studies
Establishment of Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs)
Reproducibility studies
Early scale-up studies
Impurity profiling
Batch manufacture suitable for GLP toxicology studies, preclinical studies, and formulation development
Production Lab Psygen’s GMP manufacturing suite.
Process Validation & API Manufacture:
Process qualification
Process validation (equipment, facility/utilities, analytical methods, etc.)
GMP API production under defined Master Batch Record
Process optimization
Large-scale non-GMP and GLP batch production
Analytical Lab Psygen’s analytical lab is the foundation of our products, our QC team supports manufacturing activities and ensures the quality of our products at every stage.
Process Development & Validation:
Analytical Method Development and Validation
Establish Quality Target Product Profile and Critical Quality Attributes (CQA)
Monitor Critical Material Attributes impacting CQAs
In-process testing and support throughout development and scale-up
Responsible for release testing of Psygen’s products
Generation of CMC documentation (phase-appropriate)
Stability program development and management
Strategic Partnerships /
Your Partner in Early-Stage Development and Clinical Manufacturing
Psygen offers contract development and manufacturing services across the pharmaceutical development pipeline. Psygen is an ideal partner for organizations requiring early-stage development and clinical manufacturing services for psychedelics and neuroplastogens.
