Case Study: Swissfillon’s Approach To Single-Use Formulation & Filling
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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
Duration: 2 hours
VP Technical Communication & Regulatory Strategy
Hélène 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 35 years of experience working for the biopharmaceutical industry, the last 30 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 interest groups with a strong focus on BPOG, and BPSA.
Chief Technical Officer
The CTO of Swissfillon AG, Rainer Glöckler is responsible for the perfect process in the production of the filling line. He has acquired the necessary skills in over 20 years of professional experience in pharmaceutical production. After completing his studies in biotechnology, he applied for a job at Lonza AG in Visp, where he held various positions, including production manager. Rainer Glöckler joined Swissfillon AG with relevant professional and management experience.
Kevin is a Technical Director in the Pall Advanced System Solutions (PASS) team, delivering customer focused process engineering and project management for integrated solutions to the pharmaceutical industry. Kevin is located within the Pall Harbourgate offices in Portsmouth UK, where he manages a group of project managers, process engineeers and commissioning engineers that support global projects. Most recently his team has been dedicated to the Astra Zeneca / Oxford COVID-19 vaccine project where their involvement started in the early process development phase.
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