Developing Scalable Upstream Workflows For Recombinant And Viral Vaccine Processes
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.
Speakers
Helene Pora
VP Technical Communication & Regulatory Strategy
Pall Biotech
Helene has been instrumental in the development of Pall single-use technologies for the last 20 years, while getting heavily involved in manufacturing, quality and regulatory aspects. She has over 30 years of experience working for the biopharmaceutical industry, the last 29 years within Pall Corporation. She speaks regularly at conferences about single-use technology with a strong focus on validation and overall process integration aspects. She is also involved in different industry interested group with a strong focus on BPOG, and she is sitting on the board of BPSA.
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
Odette Becheau
Principal Scientist, Scientific and Laboratory Services
Odette joined Pall 4 years ago and is currently Principal Bioprocess Application Specialist within Pall Biotech’s Sales and Laboratory Services organization. Her role is to support customer to optimize, scale-up and transfer processes to produce stem cells, viral vectors and virus vaccines for preclinical and clinical grade manufacturing.
She has 6 years of experience within the vaccine industry including positions in both R&D and Manufacturing groups at GSK Vaccines. She obtained her Master Degree in Biotechnology Engineering at Bordeaux Engineering Institute of Biotechnology, in France.
Vaccine Production: Securing process quality with flexible manufacturing solutions
Pall’s innovative process technologies have been an important contributor to the success of many vaccine production processes, and we are constantly working with the industry to enhance our solutions to meet new vaccine development and manufacturing challenges
Biotech | Pall Corporation webinar series
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