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
This webinar was recorded by BioPharma Asia and first published on their website. https://biopharma-asia.com. It is made available here by kind permission of BioPharma Asia and the presenters. Scroll down to see a transcript of the webinar question and answer session.
Hailed as the “next frontier” in cell therapy and regenerative medicine, exosomes are a type of extracellular vesicle and play a key role in the regulation of the intercellular communication processes.
David Haylock of VivaZome will present on upstream production of angiogenic exosomes using the iCELLis® nano fixed bed bioreactor. This will be followed by a presentation by Roberto Ciboldi of Pall Corporation on a platform solution including cell culture, purification and sterile filtration of exosomes.
Participants will be able to:
- Compare the performance of the iCELLis Nano bioreactor to traditional flasks for exosome production from adherent cell culture
- Understand how an integrated end to end platform delivers highly purified and consistently-sized exosomes
- Discover an innovative cGMP scalable manufacturing platform for exosomes