Cell therapy manufacturing and 21 CFR Part 11 compliance: Overview and considerations for instrument software

Ashley D. Smith joined Thermo Fisher Scientific in 2021 as a Regulatory Affairs Manager in the Cell & Gene Therapy Business Unit. Her primary role is to serve as the regulatory lead on new product introduction teams, supporting both product development and customer use of the Cell Therapy Systems™ (CTS™) products. Dr. Smith began her regulatory affairs career as a product reviewer within CBER at FDA where she focused on Chemistry, Manufacturing and Controls (CMC) of biologic products. Upon leaving the FDA, Dr. Smith moved into the private sector where she contributed to the development and implementation of clinical, nonclinical, and CMC regulatory strategies at various-sized biotechnology companies in the fields of oncology and cell therapy. She holds a B.S. in Biomedical Sciences from Texas A&M University – Corpus Christi and a Ph.D. in Microbiology and Immunology from the University of North Texas Health Science Center.

Brianna Volk joined Thermo Fisher Scientific in 2014 as a member of the Global Service & Support team providing on-site customer support across RUO, IUO, and IVD products. She joined the Cell & Gene Therapy team in 2020 to further support the establishment of Thermo Fisher’s Cell Therapy Systems (CTS) product line. As the Product Manager for the Gibco™ CTS™ Rotea™ Counterflow Centrifugation system, cell processing customer needs are regularly reviewed and evaluated for opportunities of easing customer-communicated workflow challenges. Brianna began her career in medical device development and later assisted with genetic research for addressing agronomical solutions before bringing her skills to Thermo Fisher customers. She holds a B.S.E. in Biomedical Engineering from University of Iowa.