Understanding the Role of Critical Quality Attributes along the Commercialization Pathway

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Anna Gilbert

Raw Materials for Cell & Gene Therapy: Getting it Right from the Start


Anna Gilbert has over 20 years of experience in Quality Assurance in Biotechnology, with the last 8 years focused in cell therapy. Anna is currently the Director of Quality at Nohla Therapeutics, Inc. Prior to Nohla, Anna has prior experience at several biotech companies. Most recently she started in January 2014 at Juno Therapeutics as one of the earliest employees and the first in Quality Assurance. She established the first quality systems for Juno and managed the GMP quality compliance program. At Dendreon, Anna managed all aspects of GMP and GTP quality compliance, including internal and external auditing as well as compliance oversight of apheresis sites. She joined Dendreon in 2009 and participated in the successful pre-approval inspection of the first US commercial cell therapy, Provenge. Anna is an ASQ Certified Quality Auditor and a member of the Parenteral Drug Association (PDA). She delivers an annual lecture on the topic of GMP
auditing at University of Washington’s Master of Science in Biomedical Regulatory Affairs program.

DOI: 10.18609/cgti.2018.023
Citation: Cell Gene Therapy Insights 2018; 4(3), 227-230.
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