Consultation during early and mid-phase development.
- Identification of acceptable reagent and material sources
- Assistance to prepare for FDA pre-IND meeting
- Scale-up and/or transition to clinical grade product
- Assist with writing of the chemistry, manufacturing, and controls (CMC) section of IND Application
- Preparation of FDA compliant SOPs, work forms/batch records, and reports for product preparation and testing
- Assist with the selection and validation of assays to ensure product safety, purity, and potency during phase I and II.
- Production of products for clinical use and product storage
- Release testing
- Shipment to external sites
- Prep and delivery of products for infusion
- Post infusion immune monitoring with Flow Cytometry Shared Resource
Shared Resource Director, Carolyn A. Taylor, PhD, is a transplant immunologist with extensive experience (>30 year) in transplant immunology and cellular therapy product processing. She has been chosen for leadership roles in two professional societies, the International Society for Cellular Therapy (ISCT) and the American Society for Blood and Marrow Transplantation (ASBMT), of which she was a founding member and active participant in committee activities.
Fenlu Zhu, PhD, Research Scientist I, graduated from college with a Veterinary Science degree in China, went on to earn a Master’s Degree in Microbiology and Immunology at the same institution followed by a Doctoral Degree in 1994 in Beijing. Dr. Zhu focused on the immunology of hepatitis G virus through research scientist and post-doctoral fellowships in China then came to the US in 2000 to work on the immunology of hepatitis C virus at the BloodCenter of Wisconsin and in the Department of Pediatrics at the Medical College of Wisconsin until he joined the BMT Program Research Laboratory in 2009.
Huiqing Xu, MD, MS, Senior Research Technologist I, earned her MD in medicine from Hebei University of Medical Sciences in China in 1991 and her Master’s Degree from Munich University of Technology in Germany in 2004. She spent two years as a Research Associate in the Department of Pathology at the University of Massachusetts Medical School where she worked on projects related to EBV and influenza virus immunity, including eliciting T cell responses using viral peptides.
Larry Luib MS, Cell Therapy Specialist LPL, has recently joined the LPL from a position at Fischer Scientific where he gained manufacturing experience with biological products, including GMP laboratory methods, product development, SOP development, product testing, regulatory and compliance activities. He is currently undergoing training for the production of multi-virus CTL line production under the supervision of Dr. Zhu.
Steve Konings, MS CPL and LPL Laboratory Manager, has held the position as manager of the BMT clinical laboratories, including the LPL and CPL, since 2004. Prior to this he served from 1996 to 2004 as the senior technologist in the LPL and was largely responsible for the initial LPL projects using CMV T cell clones, retrovirus transduction of primary T cells, and the production of EBV-specific cell lines for clinical use.
Sarah M. Heidtke, BS CPL and LPL QA/QC Specialist, has held the role of QA/QC Specialist for the BMT laboratories since March 2011. Prior to this she served as a Cell Therapy Specialist in the CPL from May 2006. She is in charge of the Quality Management Program for the entire laboratory and has direct oversight of the Material Management System, which is critical to the production of products under GMP.