GMP-compliant manufacturing in a closed-system automated bioreactor with a novel cell culture medium
On demand

GMP-compliant manufacturing in a closed-system automated bioreactor with a novel cell culture medium

Tuesday 08:00 PST / 11:00 EST / 16:00 GMT / 17:00 CET
GMP-compliant manufacturing in a closed-system automated bioreactor with a novel cell culture medium

The availability of Advanced Therapies (ATMP) in current clinical practice is still very limited due to the relatively high cost of these novel therapeutics and the great process variability underlying their manufacture.  Improvement of ATMP manufacturing is one of the key elements necessary to make these therapies not only standardized and compliant to GMP, but also scalable and cost-effective. Therefore, a different approach should be considered with respect to the current state-of-the-art of cell therapy production.

The use of automated bioreactors for cell expansion is a straightforward solution to tackle these manufacturing issues, and it brings several advantages, including the possibility to expand the cells in closed systems in Grade D areas, process standardization, as well as the reduction of labor required for these operations and the opportunity for process scalability.

Likewise, removing undefined components from the ancillary materials that define the critical attributes of a cellular product is critical to keep the process in a state of control. This is particularly relevant for cell culture media, where serum supplementation is common in the early stages of preclinical and even clinical development of a cell therapy product, posing an often insurmountable source of process variability, particularly at scale.

This webinar will discuss:

  • The current limitations with ATMP manufacture due to high costs and necessity of manufacturing process standardization 
  • Utilization of a fully-closed system facilitating ATMP manufacturers to meet the compliance with cGMP standards
  • Ability of automation to reduce costs and increase scalability of cell therapy manufacturing
  • A novel cell culture media for MSCs that overcomes the challenges linked to serum-based media and has been validated in a GMP-compliant setting
Gonçalo Regalo
Gonçalo Regalo
Strategic Business Development Manager, FUJIFILM Life Sciences

Gonçalo Regalo, Ph.D., Strategic Business Development Manager, FUJIFILM Lifesciences, brings 8 plus years of Cell and Gene Therapy expertise from manufacturing, and quality assurance, to compliance. His focus is on translating complex biology into compliant scalable workflows and providing solutions that lead to successful collaborations for both our internal and external partners. Goncalo holds a PhD, in Human Biology, from Universidade do Porto, Portugal, and completed his postdoctoral fellowship at the Max Delbrueck Center, Berlin specializing in cell and cancer biology.

Francesco Vitrani
Francesco Vitrani
Marketing Manager, VivaBioCell

Francesco Vitrani, Marketing Manager, VivaBioCell, completed his Master’s Degree in Biotechnology, focusing his studies on stem cells and regenerative medicine. After 2 years as R&D Scientist in the same field, he gained extensive experience as International Product Manager and Marketing Manager, and in 2019 he joined VivaBioCell as head of Marketing And Business Development, with the specific task of launching onto the market the novel technologies for cell therapy manufacturing developed by the company.