The Cell Manipulations Laboratory's experienced scientists can help you develop and scale up your ex-vivo gene transfer and cell therapy clinical trials or simply transfer your existing at-scale technology to our clean facilities which will enable you to move your research to a safe and effective patient treatment plan.
CML offers more-than-minimally manipulated cell and tissue procedures performed aseptically in our FDA-registered cleanroom in accordance with GMP/GTP quality compliance requirements. All customized support provided by CML is performed on a fee-for-service basis.
- Technology transfer, process development and scale-up
- GMP/GTP-compliant processing: enrichment or depletion of specific cell subsets, ex-vivo antigen priming, cytokine and mAb-based activation, ex-vivo genetic modification (transduction), cell expansion, cryopreservation and/or preparation for fresh infusion
- Primary cell types: hematopoietic stem/progenitor cells, erythroid, myeloid, B/T-lymphoid cells, embryonic and induced pluripotent stem cells (iPS), mesenchymal stem/progenitor cells, dendritic cells and lymphocyte sub-populations, endothelial/epithelial cells, tumor cells
The CML is compliant with GMP (21 CFR 211), GTP (21 CFR 1271), Holds a Type V Master File (MF-BB) with FDA/CBGR and is a Registered Facility
The production facility consists of approximately 1,600 square feet of controlled-access space that includes three independents ISO Class 7 cleanroom suites equipped with biosafety cabinets for aseptic processing.
The facility offers the following features:
- ISO Class 7 production suites with ISO Class 8 support areas
- Unidirectional flow of personnel and materials for multi-suite labs
- Integrated 24/7 Automated Particle Measuring System
- Uninterrupted power supply and emergency power systems
- Independent CO2 and N2 gas supply with automated backup
- Dual Independent HVAC system with redundant fan design
- Integrated Building Management System with personnel Alarm Notification System
- Independent Controlled Access System