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 manufacturing suites. Teams experienced in production of cellular as well as RNA based starting materials.
Immunomonitoring
Immunomonitoring multi-color flow cytometry capabilities to support studies of mechanism of action, discovery or validation of prognostic and predictive markers of disease.
Warehouse management
Quarantine and controlled monitored storage at ambient, refrigerated -20, -86 and ultra-deep freeze conditions in agreement with biological and chemical safety standards. Inventory management system with cycle counting capabilities.
Research and Development
Our expertise in cellular immunology and molecular biology with proven record of publishing our own science in peer reviewed journals is available to help customers for rational, science-based development of their products and process as well as quality tests and monitoring during clinical trial.
Logistics
Kit production, labeling and clinical supply, Assuring clinical supply of kits for delivery of biological products including international deliveries, Chain of identity systems, Cold chain transport and logistics
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.
Project Management
Strong point of contact with our customers. Operating a cross functional team at CoImmune tailored to the needs of the specific program. Regular and transparent communication with our customers.
Qualification/Validation
Equipment installation, qualification, calibration and validation programs.
