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Lymphoma (NHL), and Chronic Lymphocytic Leukemia (CLL). Ryan’s experience in commercial scale-up of cell therapy products and thorough understanding of FDA regulations for cell therapies is an invaluable asset for the GBF. In December we hired Chris Garbe as the Director of Quality. Chris came to us from Fred Hutchison Cancer Research Center where he was the Director, Quality Control/Analytical Development for Cellular Therapeutics. Chris’ experience in setting up quality systems for an academic GMP facility that provides both process development services and GMP manufacturing for cell therapies and protein products is directly applicable to GBF operations. While we were strengthening our management team, Matt Seefeldt oversaw both protein and cell therapy projects to keep our pipeline of customers moving towards GMP production runs in 2018. Our team of experienced project managers, system operators and quality engineers grew from 20 at the beginning of 2017 to 33 at the end of the year.
In November of 2017, the GBF hired an outside consulting firm to perform an analysis of its GMP readiness, after having completed its equipment validations and drafted its
Facility Master File, Quality Manual and all of its Standard Operating Procedures. The consultant’s report indicated that the GBF had designed and implemented a very robust quality management system and that an identified number of final tasks for GMP readiness could be completed in the first month of 2018. In preparation for delivering products for clinical trials in early 2018 the University put in place an Immunotherapy Advisory Committee to coordinate University sponsored clinical trials and advise University GMP production facilities on regulatory and compliance issues. The GBF appointed Ryan Crisman as Interim Facility Director and Roger Giller, M.D., as its Medical Director to add to its clinical trial capabilities and position it for long term Foundation for the Accreditation of Cell Therapy (FACT) accreditation.
Looking forward to 2018, the GBF has a healthy pipeline of both University and outside clients ready to do clinical trials, combined with an experienced staff and a strong quality system. This positions us well to fulfill our mission, which is “To help our clients accelerate the translation of their discoveries into human clinical trials as efficiently and cost effectively as possible.”
The Cell Therapy team’s creative picture was one of the top three entries in Drexel University’s work category photo contest.
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