Alignment to Standardized Extractables Testing, Facilitating Single-Use Adoption
A primary concern limiting the rapid adoption and implementation of single-use technology has centered on standardizing single-use component extractables data packages to be used for end user risk assessments. Experimental findings and insights from execution of both the BPOG and USP <665> extractables protocols on multiple single-use components will be shared, including similarities and differences in extraction profiles. Case studies will also be presented illustrating how Pall’s growing portfolio of BPOG extractables datasets can be used to help support component qualification and overall toxicological risk assessment for single-use systems.
Moderator
Hélène Pora, Ph.D.
Vice President, Single Use Technology
Pall Corporation
Speakers
James Hathcock, Ph.D.
Senior Director, Regulatory and Validation ConsultingTeam
Pall Biotech
Alignment to Standardized Extractables Testing, Facilitating Single-Use Adoption
White paper: A risk based approach to validation studies for sterilizing filtration.
Biotech | Pall Corporation webinar series
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