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Automated Single-use Processing: Bringing Control and Flexibility to Manufacturing

As single-use technology is moving into more complex unit operations and commercial applications, there is a need from the industry to automate single-use operations to combine the benefits of single-use processing with the reliability of automation.

The Allegro™ MVP single-use system offers fully automated processing across a range of direct flow filtration (DFF) applications and procedures requiring pH adjustment (eg low pH hold for virus inactivation, media/buffer preparation). The flexible step configurator software on the system allows the end user to create many different recipes and process steps. The system capabilities will be shown using the example of a buffer preparation with pH adjustment using the Allegro MVP single-use system and the Allegro 200 L single-use mixer. Participants will learn:

  • Design approach to produce a flexible system for multiple single-use processes.
  • How to carry out buffer prep, pH adjustment and sterile filtration.
    • Review of recipe creation and selection of single-use sensors (eg pressure, flow, conductivity, UV).
    • Review of the batch records and the audit trail that help maintain the 21CFR Part 11 compliance.
  • The key benefits of automation.

Presenters and Participants in the Panel Discussion and Q & A

Moderator & Presenter

Jon Petrone
Vice President
SLS Global Technical Support
Pall Life Sciences
(Westborough, MA, USA)

Jon Petrone manages a team responsible for the field-based applications development and support of Pall’s direct flow filtration, tangential flow filtration, and chromatographic sorbent, membrane, and column technologies. Prior to joining Pall nine years ago, Jon worked at Wyeth BioPharma where he was the head of the membrane based separations group. This group was responsible for the development, scale up, and manufacturing support of all membrane based and centrifugation process steps. Before joining Wyeth, Jon worked for fifteen years in large scale membrane and HPLC process and equipment development, applications engineering, and systems sales. Jon has a BS and MS in chemical engineering from Worcester Polytechnic Institute in Worcester, MA.

Presenter & Panelist

Pauline Nicholson, Ph.D, M.B.A.
Product Manager
Allegro Single-use Systems
Pall Life Sciences
(Portsmouth, UK)

During Pauline Nicholson's 15 years at Pall, she has worked in the Laboratory Sales Division, providing small scale filtration and purification solutions for many laboratory applications areas. As a member of the Biopurification team, she provided specialist support to process development groups in the biotech and biopharmaceutical industry in a range of bioprocess applications, but with a strong focus on TFF. Pauline is currently a global product manager in the Pall Allegro™ single-use systems team. Her responsibility is in bringing automated solutions to the single-use market, for upstream and downstream processing.

Presenter & Panelist

Kevin Thompson
Technical Director
Pall Advanced Separation Systems
Pall Life Sciences
(Portsmouth, UK)

Kevin Thompson manages the Advanced Separation Systems Team which is a group of project managers, process engineers and commissioning engineers, all of whom undertake process projects within the Biopharmaceutical Industry. His group specifically supports the design, development and manufacture of chromatography columns & complex single-use process solutions. Kevin has specific management responsibility for major process projects using Pall’s separation technology, as well as the global design authority for complex single- use solutions. Prior to joining Pall nine years ago, Kevin worked at Centocor (Johnson & Johnson), Serono Bio-tech production facility, Merck Sharp & Dohme Pharmaceutical Manufacturing Facility, Pfizer and other companies managing various engineering projects. He also has over 15 years of experience in both in Engineering and Commissioning in the, Oil & Gas and Chemical & Polymer Industries. Kevin is qualified in; Mechanical & Electrical Engineering, Control & Instrumentation Engineering and Executive Management from the Henley Business School.

Panelist

Zander Hack
Bio-Process Engineer
Pall Advanced Separation Systems
Pall Life Sciences
(Portsmouth, UK)

Zander Hack project managed the development of the Pall Allegro™ MVP System, the Pall Allegro Single-Use TFF System, the single-use AutoPak sorbent handling system for packing columns and the single- use virus filtration skid. Prior to joining Pall 3 years ago, Zander worked within GMP manufacture and process validation of Phase 2 and 3 API's for 10 years at Avecia Biologics, Wyeth BioPharma and Lonza Biologics. At Avecia Biologics, Zander was responsible for the transfer of R&D processes into manufacturing and coordinated the validation of new equipment and the generation of new batch records. Zander worked within upstream and downstream processing in both mammalian and microbiological cell lines. Zander's brings end user experience directly into Pall product design. Zander has a BSc in Biotechnology from Reading University.

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