Scalable Upstream Process Development of Biotherapeutics
In this case study, Celltheon demonstrates a workflow using the Celltheon SMART♦ Technology Platform in combination with the Allegro™ STR bioreactor range. The time from cDNA to RCB was reduced to less than 4 months while ensuring scalability between 3L to 200L pilot scale, with a pre-defined upstream and downstream processing platform for monoclonal antibodies and difficult to express proteins.
Participants will learn about:
- Improvements in current mammalian expression platforms
- Cell line development and scalability workflows
- Key features and advantages of using the Allegro STR bioreactors
Moderator: Andreia Pedregal
Bioreactor Applications Manager (EMEA), Scientific and Laboratory Services
Andreia is the manager of the Pall Bioreactor Application Scientist team in Europe. In her role she supports clients implementing Pall’s bioreactors for development and manufacturing of therapeutics focused on cell and gene, oncolytic, vaccine, monoclonal antibody therapies and others. Andreia holds a Master’s degree in Biotechnology Engineering from the Science and Technology Faculty of Algarve University, Portugal. She has over 10 years of experience in mammalian cell culture, and bioprocess design and optimization, acquired in her previous positions at the Laboratory of Animal Cell Biotechnology and Laboratory of Experimental Medicine at the private research university, ULB, in Brussels, Belgium.
Divya Goel, MBS
VP of Business Development
As the VP of Business Development, Divya Goel oversees platform development and technology licensing for Celltheon. As a bioprocess engineer by training, Divya is not only involved in external facing business opportunities, she also works with the technical staff to evaluate new bioprocessing technologies and develop efficient workflows that can be leveraged by the greater Pharmaceutical Industry. Divya regularly attends scientific conferences to present the Celltheon SMART ♦ Technology platform and discuss other advances that Celltheon has made in bioprocessing.
Divya holds a BS in Biology from Drexel University and a Master’s in Business and Science (MBS) from Keck Graduate Institute in Bioprocess Engineering and Business. Since joining Celltheon, many of the client molecules she has overseen have advanced into late stages of development. Divya is committed to overseeing the application of Celltheon’s novel technologies to develop high titer, high quality products and ensuring seamless tech transfer.
Global Product Manager
Sid Gupta is a Global Product Manager at Pall Biotech. He is responsible for lifecycle management and new product development within the Allegro STR family of bioreactors. Sid has 8 years of experience with cell and gene therapy, including positions in Process Development and Product Lifecycle Management at Juno Therapeutics and the Lonza Group. He has co-authored several peer reviewed articles, book chapters, and holds one patent. Sid obtained his graduate and undergraduate degrees in Biomedical Engineering from the Johns Hopkins University and the Indian Institute of Technology, Guwahati, respectively.
Shape Your Future Using Single-Use Bioreactors
In 2019 Swissfillon were inspected and approved by the FDA to supply drug products into the USA, following on from EU approval in 2018. This young fill finish CMO was started in Switzerland in 2013 and built a state-of-the-art cGMP production facility from the ground up.
Swissfillon recognized early on that single-use systems met their requirements for multi-product manufacturing and would help their clients get their drugs to market faster.
During this case-study webinar, participants will learn:
- How working in partnership with a supplier can be part of a QbD approach to minimize risk
- Strategies & design improvements for single-use systems to reduce risk in the process
- How a shadowboard can be used to make single-use system leak tests, PUPSIT and the filtration process fast, safe and simple