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.

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March 2021
Case Study: Swissfillon’s Approach to Single-Use Formulation & Filling

Biotech | Pall Corporation 웨비나 시리즈

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:

  1. How working in partnership with a supplier can be part of a QbD approach to minimize risk
  2. Strategies & design improvements for single-use systems to reduce risk in the process
  3. How a shadowboard can be used to make single-use system leak tests, PUPSIT and the filtration process fast, safe and simple
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