GMP Cell Manipulation

Cell Manipulations: Supporting Clinical Trials through Cell Preparation

The Cell Manipulations Lab (CML) partners with researchers to carry potential new cell-based therapies from laboratory research to clinical study.  The CML supports the development and processing of innovative cell based therapies for Phase I/II clinical studies.   The core laboratory ensures reproducible production of large scale quantities of therapeutic cells under strict quality control and safety conditions required by the FDA for human studies.

Cell services include enrichment or depletion of specific cell subsets, ex-vivo antigen priming, cytokine and antibody-based activation, ex-vivo genetic modification (transduction), expansion, cryopreservation and/or preparation for infusion of many different types of extensively manipulated cells. Working in close contact with each Sponsor/PI, we develop a culture process and timeline that meets program needs and regulatory requirements. 

**Researchers in the Cell Manipulations Laboratory have experience culturing a wide variety of primary human cell types including: hematopoietic progenitors and stem cells, mesenchymal stem and progenitor cells, tumors, hematopoietic populations (erythroid, myeloid and B- and T-lymphoid populations).

All more-than-minimally manipulated cell and tissue procedures are performed in the Aseptic Processing Laboratory clean rooms following GMP and GTP quality compliance requirements.  All procedures utilized by the CML were developed to meet FACT standards, and labels are designed to meet the requirements of ISBT-28.

The CML holds a Type V Master File (MF-BB) with the FDA/CBER that describes the details of the facility and process control.   A letter of cross reference to the DMF is available upon request. CML staff have experience in providing investigators support in development of relevant CMC (Chemistry Manufacturing and Control) sections for the gene transfer for both INDs and IMPDs.

Researchers and clinicians can contact us for more information and how we can help you with your cell therapy and gene transfer needs.  Clinical Coordinators should contact to schedule patient procedures.

Selected References

1.  Lutzko C, Senadheera D, Skelton D, Petersen D, Kohn DB.  Lentivirus vectors incorporating the immunoglobulin heavy chain enhancer and matrix attachment regions provide position-independent expression in B lymphocytes.  Journal of Virology 77:7341-7351, 2003

2.  Logan AC, Lutzko C, Kohn DB.  Advances in lentiviral vector design for gene-modification of hematopoietic stem cells.  Current Opinion in Biotechnology 13:429-436, 2002

3.  Lutzko C, Dube ID, Stewart AK.  Recent Advances in gene transfer into hematopoietic stem cells.  Critical Reviews in Oncology and Hematology 30:143-158, 1999

4.  Stewart AK, Sutherland DR, Nanji S, Zhao Y, Lutzko C, Nayar R, Peck B, Ruedy C, McGarrity G, Tisdale J, Dube ID.  Gene marked long term culture cells contribute at low levels to hematopoiesis after autologous transplant.  Human Gene Therapy 10:1953-1964, 1999

5.  Chu P, Lutzko C, Dube ID.  Retrovirus-mediated gene transfer into human hematopoietic stem cells.  Journal of Molecular Medicine 76:184-192, 1998

6.  Dube ID, Kruth S, Abrams-Ogg A, Kamel-Reid S, Lutzko C, Nanji S, Ruedy C, Singaraja R, Wild A, Krygsman P, Chu P, Messner H, Reddy V, McGarrity G, Stweart AK.  Preclinical assessment of human hematopoietic progenitor cell transduction in long-term marrow cultures.  Human Gene Therapy 7:2089-2100, 1996