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ISPE D/A/CH YP Webinar: Single-Use Technology – Drivers for Successfull Implementation

18. Oktober / 11:00 - 12:30

Introduction

The demands on biotechnological production of pharmaceutically active compounds differ vastly from traditional chemical ones. Especially, physiological process conditions lead to an increased risk of microbial contamination. These issues have been addressed through implementation of the (current) Good Manufacturing Practice (cGMP) with its high requirements for sterility and precise documentation of cleaning validation.

Additionally, in recent years, the idea of utilizing Single Use Systems (SUS) as a standard operating platform for biopharmaceutical manufacturing became more and more popular. The use of polymeric compounds rather than stainless steel has lowered the initial investment cost and reduced operating time, thus enabling high degree of flexibility concerning the supply of product.

Simone Biel and Gerrit Priller, Field Marketing Specialists in Single-Use Technology at Merck KGaA, will give an overview of the current state of Single-Use Technologies with an emphasize on key drivers, regulatory landscape and considerations for successful implementation.

What?

– Free webinar

When?

– 18th October 2018, 11:00-12:30 am (CEST)

Content overview

– What are single-use system?

  • Gamma-irradiated and pre-assembled plastic fluid path that are ready-to-use
    (Mixing system, filtration and filling system, bioreactors, transfer systems etc.)
  • – Why single-use?

  • Key drivers and trends of the industry
  • Lower capital investment in facility and equipment
  • Less energy and water used
  • Faster campaign turnaround time
  • Flexible plant
  • Closed system to reduce risk of contamination
    (Product and Patient safety)
  • – Example of a monoclonal antibody process and how single-use systems can be used

    – Regulatory landscape and Industry associations

    – Key considerations of successfully implementation in biopharmaceutical processes?

  • Qualification of single-use components and assemblies
  • Quality Control
  • Extractables and Leachables
  • Operator training
  • Supply chain consideration
  • Standardization of single-use components
  • Additional information on Gerrit Priller and Simone Biel:

    Simone Biel is European Field Marketing Specialist in Single Use Technology.
    In her role she investigates the market needs in single-use systems, product performance, regulatory compliance, and quality to optimize SUS used in final filling application to fit for purpose and to meet regulatory requirements.
    Simone holds a PhD from the University of Frankfurt in Microbiology.

    Gerrit Priller is European Field Marketing Specialist in Single Use Technology
    In her role she investigates the market needs in single-use systems and product performance with a focus on single-use connectors, standardization of single-use assemblies and integrity testing of single-use assemblies, and she supports the internal training program.
    Gerrit holds a Master of Science in Technical Chemistry at Graz University of Technology, Austria (Chemical and Process Engineering)

    Registration here!

    Details

    Datum:
    18. Oktober
    Zeit:
    11:00 - 12:30
    Veranstaltungkategorie:

    Veranstaltungsort

    Webinar
    Webinar, Deutschland

    Veranstalter

    ISPE D/A/CH YPs