Specializing In:Technology Transfer (transition of research into GMP; internal and external partners) Cell therapy manufacturing (CAR-T and CAR-NK, DC) Virus (RV/LV) Manufacturing Manufacturing and Quality Systems Standards and Good Manufacturing Practice (GMP Quality Assurance Change Control Deviations / CAPA Process Development Process Improvement Training Program Audits Regulatory requirements: FDA, EMA, FACT Master Batch Records (MBR) Standard Operating Procedure (SOP) GMP Facility (Phase I/II clinical trials) Chemistry, Manufacturing and Control/Investigational New Drug
Special Interests:Cell therapy has become one of the fastest-growing segments of life science and has been my interest for many years. Being a part of that progress strengthened my interests in emerging cellular therapies that aim to manufacture cell products for clinical
About Joanna Stanson
Tumor Immunology and Immunotherapy, with a particular emphasis on the development of anticancer vaccines, has been my research focus since joining the research laboratory of Dr. Theresa Whiteside and learning the molecular biology techniques in the laboratory of Dr. Carol Dahl. This early experience gave me insight into the basic and clinical research world and ultimately solidified my career goal to work in the field of clinical research. My many years of work at the Cellular Products (CPL) and Gene Therapy Laboratory (GTL), which processed somatic cells and genetically modified these cells in support of clinical and research protocols at the University of Pittsburgh Medical Center, has prepared me for a career in a clinical stage biotechnology company. I worked to develop the manufacturing platform for the company's cutting-edge cell therapy CAR-T product candidates, GMP scale-up, and then ran the technology transfer to multiple large Contract Manufacturing Organizations (CMOs). Later, as a Director of Contract Manufacturing Relation, I have gained a deep understanding of the strategic and daily operation of the GMP facility. I have been involved in assay development and its movement from the research lab to the quality analytical units, where it was standardized and validated for clinical trial use and commercial lunch. My training and previous research experience have prepared me for overseeing the manufacturing of new clinical products. I have the expertise, leadership ability, training, experience, and motivation necessary to manage the GMP manufacturing facility at the Translational Immuno-Oncology Shared Resource in the Division of Translational Immuno-Oncology at Roswell Park Comprehensive Cancer Center.
Roswell Park Comprehensive Cancer Center
- Director of Operations
- Translational Immuno-Oncology Shared Resource
- Department of Translational Immuno-Oncology
Education and Training:
- 1998 - MS - Human Genetics, University of Pittsburgh, Pittsburgh PA
- 1985 - BS - Molecular Biology, University of Lodz, Lodz, Poland
- 2004 - Certificate in Clinical Flow Cytometry, University of Pittsburgh Cancer Institute, University of Pittsburgh, Pittsburgh PA
- 2002 - Certificate in Business Essentials for Bioscientists, Katz Graduate School of Business University of Pittsburgh, Pittsburgh PA
- International Society of Cell & Gene Therapy
- 2021–present - Director of Operations, Translational Immuno-Oncology, Roswell Park Comprehensive Cancer Center, Buffalo, NY
- 2020–2021 - Consultant, Gene and Cell Therapy, Houston, TX
- 2019–2020 - Director, Process Development, Bellicum Pharmaceuticals, Houston, TX
- 2018–2020 - Director, Contract Manufacturing Relations, Bellicum Pharmaceuticals, Houston, TX
- 2016–2018 - Associate Director, Manufacturing, Bellicum Pharmaceuticals, Houston, TX
- 2015–2016 - Associate Director, Process Development, Bellicum Pharmaceuticals, Houston, TX
- 2014–2015 - Manufacturing Manager, Bellicum Pharmaceuticals, Houston, TX
- 2012–2015 - Development Scientist, Bellicum Pharmaceuticals, Houston, TX
- 2006–2011 - Research Scientist, Cellular Products Laboratory, University of Pittsburgh Cancer Institute, Pittsburgh, PA
- 2006–2011 - Senior Coordinator, Immunologic Monitoring & Cellular Products Laboratory, University of Pittsburgh Cancer Institute, Pittsburgh, PA
- 2000–2006 - Research Specialist, Immunologic Monitoring & Cellular Products Laboratory, University of Pittsburgh Cancer Institute, Pittsburgh, PA
- 1995–2000 - Research Associate, Immunologic Monitoring & Cellular Products Laboratory, University of Pittsburgh Cancer Institute, Pittsburgh, PA
- 1987–1995 - Research Associate, Immunologic Monitoring and Diagnostic Library, Pittsburgh Cancer Institute, Pittsburgh, PA
1. Whiteside TL, Griffin DL, Stanson J, Gooding W, McKenna D, Sumstad D, Kadidlo D, Gee A, Durett A, Lindblad R, Wood D, Styers D. Shipping of therapeutic somatic cell products. Cytotherapy. 2011 Feb;13(2):201-13. doi: 10.3109/14653249.2010.506507. Epub 2010 Aug 26. PubMed PMID: 20795760; PubMed Central PMCID: PMC7982143.
2. Whiteside TL, Piazza P, Reiter A, Stanson J, Connolly NC, Rinaldo CR Jr, Riddler SA. Production of a dendritic cell-based vaccine containing inactivated autologous virus for therapy of patients with chronic human immunodeficiency virus type 1 infection. Clin Vaccine Immunol. 2009 Feb;16(2):233-40. doi: 10.1128/CVI.00066-08. Epub 2008 Nov 26. PubMed PMID: 19038780; PubMed Central PMCID: PMC2643533.
3. Artusio E, Hathaway B, Stanson J, Whiteside TL. Transfection of human monocyte-derived dendritic cells with native tumor DNA induces antigen-specific T-cell responses in vitro. Cancer Biol Ther. 2006 Dec;5(12):1624-31. doi: 10.4161/cbt.5.12.3353. Epub 2006 Dec 5. PubMed PMID: 17172816.
4. Whiteside TL, Gambotto A, Albers A, Stanson J, Cohen EP. Human tumor-derived genomic DNA transduced into a recipient cell induces tumor-specific immune responses ex vivo. Proc Natl Acad Sci U S A. 2002 Jul 9;99(14):9415-20. doi: 10.1073/pnas.142302399. Epub 2002 Jun 21. PubMed PMID: 12080146; PubMed Central PMCID: PMC123155.
5. Taylor DD, Bender DP, Gerçel-Taylor C, Stanson J, Whiteside TL. Modulation of TcR/CD3-zeta chain expression by a circulating factor derived from ovarian cancer patients. Br J Cancer. 2001 Jun 15;84(12):1624-9. doi: 10.1054/bjoc.2001.1847. PubMed PMID: 11401315; PubMed Central PMCID: PMC2363678.