From Aseptic Processing to Enrichment of Virus-specific Tcells: Nationwide Children's Hospital and The Ohio State University are Increasing cGMP Training Efficacy through a Competency-based Learning Management System for Cell Processing Specialists

Background & Aim Our innovative technician training program provides a competency-based, blended-learning model that creates flexibility in pace, content, and place of learning while increasing accountability and standardization. The initial thirty training modules comprise the full training plan of a new cell processing technician. Examples of initial training modules include: aseptic technique to ensure the integrity, viability and sterility of cellular products, QC testing: cytotoxicity assay, PCR and endotoxin, CofA generation and product release. Additionally, there are ten specialized cell manipulation modules. Personalized learning pathways support the participants’ unique training needs and learning style preferences. The content of each module is developed by subject-matter experts. Modules include cGMP skills in a variety of formats: interactive simulations, video, text, and assessments. The consistency of content delivery increases the fidelity and efficiency of cGMP training. The anytime, anywhere learning design provides flexibility with staff allocation and learner engagement. Embedded assessments calibrate levels of mastery in each competency with alternative resources and additional remedial assessment opportunities. Mastery of a module results in a digital badge which is sharable social platforms. Methods, Results & Conclusion Here we present our initial specialized module: Expansion, Purification, and Functional Assessment of Human Peripheral Blood Natural Killer (NK) Cells. Limited ability to expand in vitro has restricted development of NK cell immunotherapy. This module describes a method to efficiently expand vast quantities of functional NK cells ex vivo using K562 cells expressing membrane-bound IL21, as an artificial antigen-presenting cell. This module will be deployed online via a Learning Management System March 2019. This process utilizes prerequisite cGMP module skills and is designed for cell technicians manufacturing NK therapeutics for early Phase I clinical trials. Nationwide Children's Hospital and The Ohio State University utilize the manufacturing process described in this module for multiple Phase I investigator initiated expanded NK cell clinical trials. Additional discussion of the process to identify the appropriate training components, define the learning outcomes, ensure an appropriate duration for each module, calibrate a reliable assessment component, and our lessons learned will be shared.