Capabilities
coIMMUNE’s core team is highly experienced with greater than 17 years of preclinical and clinical development of cell therapy products. coIMMUNE has centralized manufacturing model with distribution capabilities to clinical sites in the United States, Canada, Europe and Israel.
Processing Suites
Eleven ISO 7 processing rooms for processing and aseptic fill/finish of cellular products.
Warehouse management
Warehouse with inventory management and cycle counting systems.
Immunomonitoring
Immunomonitoring multi-color flow cytometry capabilities to support studies of mechanism of action, discovery or validation of prognostic and predictive markers of disease.
Research Development
Research laboratories with expertise in cellular immunology and molecular biology.
Logistics
Biological material collection and logistics. Ability to maintain patient-specific cell therapy chain of identity.
Quality Control
Two quality control laboratories equipped to support environmental monitoring program, in-process and release testing of cellular product and genetic material-based products, stability programs, raw material testing and qualification. Expertise in novel method validation.
Qualification/Validation
Equipment installation, qualification, calibration and validation programs.
Shipping
On time delivery of cryopreserved product for administration.
