Standardized Extractables Testing for Single-Use Systems

Standardized Extractables Testing for Single-Use Systems

Single-use technologies (SUT) have evolved into commercial operations and drug manufacturers look for solutions to industrialize its usage in a safe and reliable way.

 

With single-use systems (SUS) 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.

 

In this webinar, the fundamental principles of Quality Risk Management (QRM) applied to SUS adoption and validation will be discussed.  In addition, participants will gain an in-depth understanding of how to define an integrity strategy for their critical SUS, as well as on how to safely Pre-Use Post Sterilization Integrity Test (PUPSIT) filters in SUS.  By the conclusion of the session, all attendees should be able to define a risk mitigation strategy for SUS.

Speaker

 

 

Charlotte Masy

Hélène Pora

VP Technical Communication & Regulatory Strategy
Pall Biotech

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.

 

 

Charlotte Masy

Sarah Jeffkins

Laboratory Manager
Pall Biotech

Sarah Jeffkins has been working in the Biotechnology Industry since 1988 when she joined Beecham Pharmaceuticals (now GSK) as a Fermentation Analyst.

 

During her 29 years working for GSK, she has undertaken a variety of roles within Upstream Operations (Fermentation), Downstream Processing (Extraction & Purification), Analytical and Quality. Sarah also had a role as Analytical Team Leader within a Technical Group where she developed her skills for managing a team, motivating and developing people whilst meeting tough objectives.

 

Sarah became the manager of the Analytical Laboratory at Pall Harbourgate facility in 2018, where she co-ordinates the extractable and leachable testing for Europe.

 

 

Learn how Pall's Accelerator Validation Services Can Support You on Your Validation Journey

Download the brochure to learn more about Pall's depth of validation expertise, consultancy services, testing capabilities and analytical methods

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November 2020

From November 3rd 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.

 

Webinars available

 

  • 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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