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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October 2020

From October 20th to November 19th

 

There is no single vaccine manufacturing approach. There are, however, flexible technologies that can meet each of the challenges during process development and at GMP scale.

 

Accelerating vaccine development and manufacturing by coupling research advances in vaccine technology with systems that support agility through a Quality by Design approach is critical to deliver life-saving immunizations to those in need globally.

 

Diversity in the type of vaccine antigen, along with the inherent variation in the targets, have created challenges for vaccine manufacturers when compared to a relatively small number of platform processes that exist.

 

There are flexible technologies that can meet each of the challenges during PD and at GMP scale.

 

Join this webinar series and learn more about securing process quality with flexible manufacturing solutions.

 

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  • Vaccines development, regulations and manufacturing Parts 1 & 2

 

  • Developing scalable upstream workflows for recombinant and viral vaccine processes

 

  • Downstream process development for vaccine manufacturing

 

  • Implementing single-use technologies in formulation and filling of vaccines
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