Enabling cell & gene therapy raw materials standardisation and regulatory compliancePublished: December 11, 2019
Kasey Kime & Michael Brewer
Kasey Kime has 15 years of global quality and regulatory affairs experience in Life Sciences. She is part of Thermo Fisher Scientific’s regulatory affairs division and is overseeing regulatory compliance of technologies developed for cell and gene therapy applications. Her areas of expertise include raw material risk assessment for biopharmaceutical development and regulatory compliance of instruments and consumables developed for automating cell and gene therapy manufacturing. Kasey holds a Bachelor's degree in Medical Laboratory Science and postgraduate degrees in both Microbiology and Quality Systems Management.
Michael Brewer is the Director, Global Principal Consultant, Regulatory for the BioProduction Division (BPD) at Thermo Fisher Scientific. In this role, Michael is responsible for providing global support to BioProduction customers and serving as the regulatory thought leader and expert across all technology areas within BPD. Prior to moving to this role, he led the team responsible for product applications including Microbiology, Analytical Sciences and Quality control. The products are fully integrated, solutions for Glycan profiling, Bacterial and Fungal identification, Mycoplasma and Viral detection and host cell DNA and protein quantitation. Michael has over 30 years experience in the Biopharma industry, including, Scios, Synergen and Amgen in a variety of roles including Discovery Research, Analytical Sciences and Quality Control. Prior to joining Thermo Fisher Scientific, he led a group at Amgen that developed qualified, validated and implemented molecular methods for host cell DNA quantitation, contaminant (Mycoplasma, Virus and Bacteria) detection, contaminant identification, strain typing and genotypic verification of production cell lines.DOI: 10.18609/cgti.2019.153
Citation: Cell & Gene Therapy Insights 2019; 5(11), 1457–1460.