Integrity of Single-Use Systems
Integrity of Single-Use Systems
Single-use technologies (SUT) have evolved into commercial operations, and drug manufacturers are looking for solutions to industrialize their usage in a safe and reliable way.
With SUT adoption, quality ownership involves shared responsibilities between supplier and end user. Additional parts of the supply and quality chain shift to supplier.
Join us as we present existing good practices to ensure critical quality attributes (CQAs) of the SUS throughout their life cycle.
Participants will learn:
- How to implement and validate SUS using Quality Risk Management (QRM)
- Define a reliable integrity strategy for SUS
- Pre-Use Post Sterilization Integrity Test (PUPSIT) for filters in SUS
- Simplify validation and toxicological assessment using standardized extractable data sets
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 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.
Senior Principle Engineer
Patrick Evrard joined Pall Biotech in 2017, as Senior Director, SLS Single-Use Technologies, to manage the technical team providing expert technical support to Pall Biotech's customers. Before joining Pall, he led for more than 10 years a global technical team in charge of developing and implementing single-use technologies in GSK Vaccines' commercial manufacturing operations. Patrick and his team implemented at global level single-use technologies in critical sterile applications and re-engineered several vaccines processes, switching from classical grade A open processes to closed systems.
White paper: A risk based approach to validation studies for sterilizing filtration. Download Now.
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