Cellular Therapy Integrated Services (CTIS)
Lan Zhou, MD, PhD
Jane Reese-Koc, MBA, MT
The National Center for Regenerative Medicine Cellular Therapy Integrated Service (CTIS) supports cellular therapy investigators by providing technology transfer of research based cell therapies to clinical scale products, including IND support, technology transfer, quality oversight and GMP compliant cell manufacturing.
Cellular therapy protocols that intend to use CTIS are reviewed by an Institutional Cellular Therapy Review and Monitoring Committee under the auspices of University Hospitals Cleveland Medical Center. View open clinical trials.
Cellular Therapy Lab
The Cellular Therapy Laboratory, located on the 6th floor of the Wolstein Research Building on the campus of Case Western Reserve University and University Hospitals Cleveland Medical Center is a 3,000-square-foot facility that includes six fully equipped ISO 7 cleanroom suites. The Lab complies with regulations promulgated by the FDA and is accredited by the Foundation for Accreditation of Cellular Therapy (FACT). In addition to manufacturing, the lab supports lot release testing, quality control of clinical products, lab correlates and process development. Laboratory staff have extensive GMP compliant manufacturing, quality management and regulatory experience to ensure FDA compliance.
CTIS Activities at a Glance
- Preparation and/or processing of cell products for experimental IND-based cell therapies.
- Full-spectrum service from minimally manipulated to extensively cultured cells produced in compliance with FDA mandated guidelines.
- Competency in all cell manipulations including purification, culture, expansion, cell differentiation, and gene transfer.
- Comprehensive support starting with IND preparation and regulatory guidance to development of Standard Operating Procedures
- A defined Quality Management program, including quality assurance, quality control and an independent Quality Oversight Committee
CTIS Staff Expertise
The Cellular Therapy Lab staff have extensive experience in handling minimal and more than minimal cellular therapy products and compliance with cGMP guidelines. CTIS staff have the experience to assist with the following:
- Pre-clinical study development
- Reagent sourcing
- SOP development
- IND assistance
- Cell cryopreservation and storage
- Stem cell processing and infusion
- Enrichment of specific cell types
- Cell expansion
- Gene transfer
- Dendritic cell vaccines manufacture
- CART cell manufacture
- NK cell manufacture
- Marrow stromal cell expansion
- Viral specific T cell selection
Core Support Activities
- cGMP-compliant manufacturing of clinical-grade cell and/or tissue engineering products
- Quality infrastructure, including Quality Assurance activities
- Project consultation for regulatory compliance and submission (IND, IRB, NIH, IBC)
- Standard Operating Procedure Development
- Operations, Quality, and Materials Management
- Budget development for grant proposals
- Clinical trial budget preparation
- IND preparation
- Equipment Management
- Document Control
Want to know more about the Cellular Therapy Manufacturing Lab? Watch this video to learn more about the facility, its technology and the rigorous processes required to manufacture high-quality cellular products.