Cellular Therapy Integrated Services (CTIS)
Overview of Facilities
Multiple cell therapy trials conducted by National Center for Regenerative Medicine investigators utilize the Center’s Cellular Therapy Integrated Service (CTIS). CTIS provides regulatory, quality oversight, GMP-compliant cell manufacturing for Phase I/II studies as well as technical and environmental control expertise to support novel investigational therapies. The preparation and use of cellular products requires adherence to the rigorous regulations set forth by the FDA. Regulations such as Good Tissue Practices (cGTP), for minimally manipulated cell products and Good Manufacturing Practices (cGMP), for those which undergo more manipulation are stringently followed.
CTIS also includes a 3,000 square foot Cellular Therapy Manufacturing lab with 6 state-of-the-art ISO7 cleanroom to support investigator initiated trials and produces high clinical grade cellular therapy products. This facility is one of only three facilities within an academic center in the State of Ohio that supports GMP –compliant therapy cell manufacturing.
All 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.
Our Expertise & Services
- Cell cryopreservation and storage
- Stem cell processing and infusion
- Positive and negative cell selection
- Cell expansion
- Gene transfer
- Validated product shipping procedures
- Environmental Monitoring
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
- Process Development/Qualification/Validation
- Guidance on preparation of the CMC (Chemistry, Manufacturing and Control) section of INDs
- Guidance on preparation of clinical protocols
- Assistance in preparing communications to FDA
- Assistance on preparing communications to IRB
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 proximal to University Hospitals Cleveland Medical Center, is a 3,000-square-foot facility that includes six fully equipped ISO 7 cleanroom suites. In addition, laboratory space and equipment is available to perform lot release testing, QC of cell products and lab correlate studies. Laboratory staff has extensive GMP compliant manufacturing, QA and regulatory experience to ensure FDA compliance. In addition to cell manufacturing, they support transfer of technologies from the research lab to the clinical setting, scale up and validation studies, competency and proficiency assessments.
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 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.
- A defined Quality Management program, including quality assurance, quality control and a Cellular Therapy Review and Monitoring Board.
Our technical, development, regulatory, and quality expertise ensure that all FDA requirements related to cell products are satisfied. The Cellular Therapy Lab staff have extensive experience in all aspects of cellular therapy and cGMP Phase I/II manufacturing of autologous and allogenic cellular products. CTIS staff have the experience to assist with the following:
- Pre-clinical study development
- Reagent sourcing
- SOP development
- IND assistance
In addition, CTIS provides support for the development of novel cell therapies such as
- Dendritic cells
- Hematopoietic stem cells
- T cells
- Mesenchymal stromal
Our cell expertise also includes preparation of cell products for standard stem cell transplantation.
Robert Fox, ND Sr. Cell Processor
Karen Lingas, BA, Sr. Cell Processor
Kaelee Jonick, BA, Cell Processor