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Cellular Therapy Integrated Services
Leadership:
Hillard Lazarus, MD
Medical Director
Luis Solchaga, PhD
Scientific Director
Jane Reese, MBA, MS
Director of Operations
Robert Fox, ND
Lab Supervisor
Joanne Carlson, RN
Cell Infusions, Backup Cell Processor
Services:
- Coordinates cell therapy at University Hospitals Case Medical Center and Case Western Reserve University School of Medicine
- Brings together the activities of the Blood and Marrow Processing Laboratory (located on the third floor of Wearn) and the Cell Production Facility (located on the sixth floor of Wolstein)
- Offers a broad range of cell therapy expertise, including clinical, scientific, technical, and regulatory support
- Coordinates activities to support the needs of investigators throughout the region
- Provides an infrastructure that supports compliance with FDA guidelines and includes a Quality Management Program, class 10,000 clean rooms, and an environmental monitoring program
Regulatory Compliance with FDA:
- Guidance on preparation of the CMC (Chemistry, Manufacturing, and Control) section of IND's
- Guidance on preparation of clinical protocols
- Assistance in preparing communications to FDA
- Assistance on preparing communications to IRB
Cell Therapy Core Support Activities :
- Quality and Compliance
- Standard Operating Procedure Development
- Operations, Quality and Materials Management
- Clinical Trial Budget Preparation
- IND Preparation
- Equipment Management
- Document Control
- Process Development
- Qualification/Validation
Resources:
- Preparation of standard-of-care cell products for cell therapy (e.g., UCB, PBMC, BM)
- Cell products for experimental IND-based cell therapy (e.g., MSC, MAPC, CD34-enriched, AC133-enriched, etc.)
- Full-spectrum service from minimally manipulated to extensively cultured cells
- Responsive team that develops competency in all cell manipulations, including purification, culture and cytokine expansion, antigen exposure, cell differentiation protocols, and gene transfer
- Comprehensive support--starting with IND preparation and regulatory guidance to development of Standard Operating Procedures and product delivery reimbursed by users
- Quality management, including quality assurance, quality control, and quality oversight committee
- Reporting to regulatory agencies, sponsors, and IRB's of record
Technical Capabilities:
- Cell cryopreservation and storage
- Stem cell processing and infusion
- HSC, MSC, Islet, UCB
- Positive and negative cell selection
- Cell expansion
- Lentiviral gene transfer
- Validated product shipping procedures
Current Clinical Trials:
- MSC-GVHD (Phase I)
- LV-P140K MGMT (Phase I)
- CCTRN consortium trials (Phase II)
- MSC-MS (Phase I)
- Pancreatic islet cell preparation for transplantation
- Athersys, Inc.
Fees:
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