GMP manufacturing of quality ancillary reagents for cell and gene therapy
Cell and gene therapy manufacturers face challenges to achieving quality, consistency, and safety in the final product, mandating risk-based management of ancillary materials to help meet those goals.
Safety, quality, consistency and effectiveness are defining features of cell and gene therapy therapeutic products. Achieving these features requires controlled and reproducible manufacturing workflows supported by rigorous, traceable documentation and consistent high-quality ancillary materials.
Ancillary materials influence the eventual success and quality of the cell product; therefore, effective management and a deep understanding of the risks associated with the use of ancillary materials in the manufacturing of cell products are necessary.
While guidelines and frameworks to manage ancillary materials have been established, Jessie Ni, VP of Product Development, and Bob Schmidt, GMP Bioprocessing Quality Systems Director, will discuss a risk-based strategy to assess challenges associated with the use of these reagents in cell and gene therapy applications.
What will you learn?
- Definition of ancillary materials
- Management of suppliers and qualification challenges of raw materials in ATMP manufacturing
- Risk tolerance considerations and risk mitigation strategies in the use of ancillary materials
- Framework and guidelines for ancillary material manufacturing
Who may this interest?
- Translational researchers
- Cell and gene therapy product developers, manufacturers and Quality Control scientists
- Scientists and engineers working in early cell and gene therapy manufacturing process development
- Supply chain management
- Quality Assurance/Regulatory Affairs specialists
Speakers
Robert Schmidt
GMP Bioprocessing Quality Systems Director
BioLegend (CA, USA)
Bob joined BioLegend in May of 2019 as the Director of Quality Assurance and has recently moved into the newly created GMP Bioprocessing Quality role. Prior to joining BioLegend, Bob was Senior Quality Assurance Director for Alere Incorporated (MA, USA) and Quidel Corporation (CA, USA) for 14 years. Bob has more than 40 years of experience in the in vitro diagnostics industry, including scientific and management positions in research and development, technical operations and quality. Other companies Bob has worked for include Abbott Laboratories (IL, USA), Ciba Corning (MA, USA), Bayer Diagnostics (MA, USA), Quest Diagnostics (CA, USA) and Biosite Incorporated (CA, USA). Bob received a Bachelor of Science in Microbiology from the University of Illinois (USA) and a Master of Business Administration from Loyola University in Chicago (USA).
Jessie Ni
Vice President, Product Development
BioLegend (CA, USA)
Jessie Ni joined BioLegend in August of 2019 as the Vice President, Product Development. Prior to joining BioLegend, Dr Ni served as Chief Scientific Officer in FUJIFILM Irvine Scientific (CA, USA) for seven years and was Senior Director of the Antibody Division and Stem Cell Department in Research and Development Systems, affiliate of Bio-Techne (MN, USA) from 2006 to 2012. Dr Ni brings more than twenty years of expertise in developing, manufacturing and commercializing ancillary reagents and custom services for life science applications, including GMP-grade recombinant proteins, antibodies and serum-free, chemically defined cell culture media serving the cell and gene therapy community. Jessie received her PhD in Molecular Biology and post-doctoral training in Immunology from the University of Minnesota (USA). She also has a Master of Science degree in Management of Technology from the Carlson School of Management, University of Minnesota.
This webinar was recorded on 27 August, 2024
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