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In the dynamic bioprocessing regulatory landscape, the development of a commercial manufacturing process that is compliant with regulatory expectations hinges on strategic planning and meticulous attention to raw material selection. Even the most foundational regulatory requirements can sometimes leave room for interpretation.
The regulatory and raw material experts of this roundtable discuss how to navigate important quality decisions associated with raw material selection throughout the biologics manufacturing process. They consider options designed to help drive the most efficient regulatory submission and review during your development journey from pre-clinical to licensure.
Learning objectives:
- Understanding raw material qualification and validation of a process
- Using quality attributes to help inform future decisions for scale‑up
- Distinguishing regulatory differences between excipients and other raw materials
- Selection criteria for raw materials and suppliers
Speakers:
Dion Aviki
Roundtable Moderator
Sr. Director/General Manager, Production Chemicals and Services, BioProduction
Thermo Fisher Scientific
Dion Aviki is the General Manager of the Production Chemicals and Services business at Thermo Fisher Scientific, which serves the Life Sciences sector. She holds a bachelor's degree in chemical engineering from Auburn University and an MBA in health sector management from Duke University. Beyond her role at Thermo Fisher Scientific, she is dedicated to supporting lifelong learners at both alma maters. Dion is passionate about helping biopharma professionals move toward resilient chemical supply chains with value‑added support strategies to help them achieve their biologics' milestones.
Kasey Kime
Director, Regulatory Affairs—Cell, Gene & Advanced Therapies
Thermo Fisher Scientific
With 15+ years of experience, Kasey Kime is a seasoned professional in global quality and regulatory affairs within the Life Sciences sector. She presently holds the role of Director of Regulatory Affairs at Thermo Fisher Scientific, where her focus is centered on technology and tools essential for cell and gene therapy manufacturing. Kasey's specific interests lie in areas such as CMC (Chemistry, Manufacturing, and Controls), advanced manufacturing, and companion diagnostics. Her education comprises a bachelor’s degree in medical laboratory science, complemented by post‑graduate degrees in Medical Microbiology, Quality Systems Management, and Business Administration. Beyond her role at Thermo Fisher Scientific, Kasey remains actively engaged by contributing to the industry, notably through her roles in the Australia and New Zealand ISCT Regulatory Committee and the Alliance for Regenerative Medicine (ARM) CMC Advisory Group.
Mike Brewer
Director and Global Principal Consultant, BioProduction
Thermo Fisher Scientific
Michael Brewer is the Director, Global Principal Consultant, Regulatory for the BioProduction Group (BPG) 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 Pharma Analytics business, a team responsible for development and commercialization of testing applications for Microbiology, Analytical Sciences and Quality control. The products are fully integrated, solutions for 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. Additionally, his group supported regulatory submissions including IND, NDA, and CMC updates, Regulatory inspections, NC/CAPA investigations, contamination investigations and remediation and developed regulatory strategy for implementation of new methods.
Jai Murthy, PhD
Director of Product Management for CGMP Chemical Sourcing
Thermo Fisher Scientific
Jai Murthy has a PhD in molecular biology and 20+ years of experience in the life science industry. His areas of expertise are in bioprocessing workflows, molecular diagnostics, and life sciences tools. Jai is passionate about helping biopharma companies streamline and scale pre‑production processes, so they can accelerate critical milestones.
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