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.

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.

2017-06-29T18:00:00.000Z
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May 2021
Overcome Exosome Production Challenges

Biotech | Pall Corporation 웨비나 시리즈

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
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