BioInsights - Scalable AAV manufacturing – Addressing challenges across the workflow
Oct
29
2020
On demand

Scalable AAV manufacturing – Addressing challenges across the workflow

Sponsor
Scalable AAV manufacturing – Addressing challenges across the workflow

The field of gene therapy has made a major comeback over the last decade, resulting in a significant paradigm shift in medicine. Due to improved safety and efficacy, the Adeno-Associated Virus (AAV) has emerged as one of the most important vectors for the development of gene therapies. With a handful of approved therapies available in Europe and US, and an extensively growing pipeline of clinical trials, it is evident that scalable and efficient solutions across the production workflow are needed.

Each production process for viral vectors has its own unique impediments and AAV is no exception. A successful viral manufacturing pipeline must deliver a consistent, pure, and high-titer product that exhibits good safety and efficacy to meet regulatory expectations.

During this webinar, upstream and downstream solutions across the AAV production workflow, are outlined. Scalable, high-titer AAV production is demonstrated in two cell host systems: a helper free 293F-based suspension system and the insect-cell based ExpiSf™ Expression System. In addition, we outline the benefits of implementing affinity chromatography in the downstream purification of AAV, including the viral clearance potential. Furthermore, we will address regulatory requirements for safety and purity testing during the AAV production process and discuss the benefits of implementing automated systems to save time and demonstrate product quality and safety.

  • Learn more on AAV production in mammalian and insect cells using a new helper free 293F suspension system and the ExpiSf™ Expression System, respectively
  • Understand how utilization of the POROS™ CaptureSelect™ AAVX resin results in significant improvement to the downstream process of AAV
  • Learn more on ways to confirm purity using industry recognized and regulatory accepted real-time PCR residual host cell DNA solutions, such as resDNASEQ
  • Understand mycoplasma testing regulatory requirements for lot release and how the MycoSEQ Rapid mycoplasma detection system has been validated and accepted by regulators in multiple modalities Sponsored by Thermo Fisher Scientific
 Dr Kenneth Thompson

Dr Kenneth Thompson

Manager, R&D, Cell Biology, Thermo Fisher Scientific

Kenneth Thompson, PhD is a Manager of Cell Biology R&D in the Life Sciences Solutions Group at Thermo Fisher Scientific in Frederick, MD (USA). Dr. Thompson leads a team of scientists focused on developing new products for cell biology applications including Baculovirus-based insect systems for protein expression and virus production. Dr. Thompson received his PhD in Molecular and Cellular Biology and B.S. in Biological Sciences from the University of Maryland, Baltimore County.

Dr Chao Yan Liu

Dr Chao Yan Liu

Senior Manager, R&D, Cell Biology, Thermo Fisher Scientific

Chao Yan Liu is a R&D Senior Manager, Cell Biology at the Life Sciences Solutions Group based in Frederick (MD - USA). Chao Yan Liu received the M.D. degree from the Hebei Medical University (Hebei, China) and the Master degree in Pathology from the Academy of Medical Sciences in Beijing, China. She got her post-doctoral training at Blood Research Institute, Medical school of Wisconsin and then became research assistant professor at the University of Buffalo, New York. After being very active for more than ten years in academic research in the field of cellular biology and immunology, in 2005 she joined the Research and Development department of the former Life Technologies. She has made great contributions to more than ten of the GIBCO® brand Cell Culture Essential products including AlgiMatrix™ 3D Culture System, OpTmizer™ CTS™ T-Cell Expansion SFM, TrypLE™ Select Enzyme, ES Cell Qualified FBS, GlutaMAX™ media supplement, FreeStyle™ F17 Expression Medium and CD FortiCHO™ Medium. She has extensive experiences in mammalian cell culture, serum and protein free, chemical defined medium formulation, as well as protein expression. She served as leading scientist to develop two novel transient transfection systems, Expi293™ and ExpiCHO™ Expression Systems. In the past two years, she and her team focused on both protein expression and viral production system development.

Dr John Li

Dr John Li

Staff Scientist, Downstream Purification, Bioproduction, Thermo Fisher Scientific

John Li holds a B.S.c. in Biochemistry and a PhD in Structural Biology from the University of Toronto, Canada. Today, John is a Staff Scientist at Thermo Fisher Scientific where he focuses on downstream purification process development for monocolonal antibodies, AAV, and other biotherapeutic modalities.?Before joining Thermo Fisher, John was a Process Development Scientist at Immunogen where he evaluated new downstream platform designs for antibody and antibody drug conjugates.

Michael Brewer

Michael Brewer

Director, Global Principal Consultant, Regulatory for the BioProduction Division (BPD), Thermo Fisher Scientific

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 BPD 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.

SPEAKERS

Kenneth Thompson
Kenneth Thompson
Manager, R&D, Cell Biology at Thermo Fisher Scientific
Chao Yan Liu
Chao Yan Liu
Senior Manager, R&D, Cell Biology at Thermo Fisher Scientific
John Li
John Li
Staff Scientist at Thermo Fisher Scientific
Michael Brewer
Michael Brewer
Director, Global Principal Consultant, Regulatory, BioProduction at Thermo Fisher Scientific

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