Detailed manufacturing protocols need to be developed to translate cell or biological therapies from the research bench to bedside. The Process Development (PD) Laboratory at the Marcus Center for Cellular Cures will convert your protocols derived from pre-clinical studies into GMP (current Good Manufacturing Process)-aligned manufacturing protocols to achieve high-quality and effective clinical products for use in clinical trials. The process development goals are to define cell manipulation steps, simplify the process, implement GMP grade reagents and components, and reduce production cost. We also establish the assays for release testing and develop potency assays to assess the efficacy of the final product.
Located in downtown Durham in the historical Chesterfield building, the PD team has a spacious and well-equipped lab. We have several biological safety cabinets, cell culture incubators, automated cell counters, flow cytometer analyzers, bioreactors, controlled rate freezers, and other cell processing devices. We have years of experience in generating and expanding cells from various cell sources, such as peripheral blood, cord blood, umbilical cord tissue and tumor tissues for both autologous and allogeneic therapies. The cell production is scalable from small-scale flask systems to larger bioreactors.
Completed manufacturing and release testing protocols are transferred to the GMP and Quality Control teams, respectively. The transfer includes staff training and Standard Operating Procedure (SOP) and batch record writing. The PD team works closely with the research lab, CCBB (Carolinas Cord Blood Bank), GMP, quality control and assurance and regulatory units at MC3 and collaborates with principle investigators internally at Duke and externally.
Tasks performed at the PD Laboratory:
- Cell product protocol development
- Protocol optimizations and troubleshooting
- Reagent replacements
- Release assay development
- Potency assay development
- Device testing
- Standard operating procedure and batch record writing in collaboration with the GMP team
- Formal studies for amendments of FDA-approved protocols
Publications:
Ying Zhou, Pamela Noldner, Liliana Lyniv, Roberta Parrott, Scott Antonia, Beth Shaz. Manufacturing Improvements for Tumor-Infiltrating Lymphocytes from Human Non-Small Cell Lung Cancer. Poster Presentation, ISCT, 2023 May30- Jun02, Paris, France.
Noldner, P., Zhou, Y. Hotchkiss, K., Parrot, R., Fecci, P., Patel, A., Antonia, S., Khasraw, M., Shaz, B. New Approaches for Expanding Glioblastoma Infiltrating Lymphocytes. Poster Presentation, ISCT, 2023 May30- Jun02, Paris, France.
Roberta Parrott, Pamela Noldner, Li Xu, Anthony Filiano, Beth Shaz, Joanne Kurtzberg. Developing a Potency Assay for Cord Tissue MSCs. Poster Presentation, ISCT, 2023 May30- Jun02, Paris, France.
Pamela Noldner, Ying Zhou, Roberta Parrott, Jiaqi Huang, Yihong Yaho, Scott Antonia, Beth Shaz. Rapid Expansion Protocol Optimization for Tumor Infiltrating Lymphocytes. Poster Presentation, ISCT, 2022 May04-May07, San Francisco.
Ozamiz A., Shoulars, K., Noldner P., Shaz, B, Kurtzberg J. Improving Cord Blood Unit Selection and Optimizing Manufacturing of a Unique Cord Blood-Derived Product (DUOC-01). Poster Presentation, Cord Blood Connect, 2022 Sep 9-11, Miami Beach, FL.
Pamela Noldner, Jon Ellis, Joanne Kurtzberg. Source Cell Preparation for the Manufacture of DUOC-01 using a Closed System Cell Processing Device. Poster Presentation at the Cord Blood Connect, second annual international congress of the Cord Blood Association, 2019 Sep.13-15, Miami Beach, FL.
Lynn Cheatham, Pamela Noldner, Barbara Ressler, Joanne Kurtzberg. Optimization of Human Umbilical Cord-derived MSC (hUC-MSC) Growth and Expansion using a Closed-System Hollow Fiber Bioreactor. Poster Presentation at the Cord Blood Connect, second annual international congress of the Cord Blood Association, 2019 Sep.13-15, Miami Beach, FL.
Pamela Noldner, Lynn Cheatham, Barbara Ressler, Paula Scotland, Kevin Shoulars, Joanne Kurtzberg. Expanding and Streamlining Cord Tissue Derived MSC Manufacture. Poster Presentation at the Cord Blood Connect, first annual international congress of the Cord Blood Association, 2018 Sep.14-16, Miami Beach, FL.