Gene Therapy upstream processing: adherent vs suspension cost modelling and perspectives

 

There is huge pressure on biomanufacturing facilities due to high demand for gene therapy products such as recombinant adeno-associated viral (AAV) vectors made under current good manufacturing practice (GMP) conditions. The constraints of the scale-up process are rarely taken into consideration during clinical process development, with many facilities simply scaling-out adherent cell stack protocols, procedures, and test methods. In order to demonstrate the importance of cost economics linked to the choice of scale-up processes, this study provides a detailed cost modeling analysis comparing viral vector production in adherent cells in cell stacks to viral vectors produced in bioreactors, either in suspension using a stirred bioreactor or adherently in iCELLis® fixed-bed bioreactor.

Speaker

meriem bendouma

Meriem Bendouma

Business Development Manager

Pall Biotech


Graduated from École Nationale d’Agronomie et des Industries Alimentaires in France, with a specialty in Bioprocessing. She first worked in mAbs development for diagnostic applications. She held different positions within PALL Biotech, including project manager for automated purification systems, bioprocess specialist, and now business development manager.

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Listen to our Podcast Today and Learn the Advantages, Challenges and Cost Considerations for Adherent and Suspension Cell Cultures.

 

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May 2021
Overcome Exosome Production Challenges

Biotech | Pall Corporation 웨비나 시리즈

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
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