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The application of QbD to Freeze-Drying
1 May 2015
The application of QbD to Freeze-Drying

Quality by Design (QbD) is an approach that has been implemented in many manufacturing settings and across a broad range of industrial sectors. Its application is ever widening to cover a large number of processes that may previously have been considered to be outside its remit or grasp. In recent years, the application of the QbD approach to freeze-drying has been the subject of a small number of published studies, although there is arguably a long way to go before Best Practice can be agreed and opinions harmonized.

 

This half-day Workshop on QbD in Lyophilization will cover a number of aspects of the QbD approach and how it might be successfully applied to the freeze-drying process, as well as upstream activities (formulation, filling, loading) and postdrying issues.
 

Topics to be covered include:

  • Can the QbD appraoch be applied to formualtion and cycle development as an integrated process?
  • How can the different risks arising within the freezing and drying stages of the process be assessed/accommodated?
  • Is it possible to find a good balance of desktop studies and practical freeze-drying that won't be unnecessarily onerous?
  • What level of detail should we go in to assessing the risk and generating supporting data?

FEATURED SPEAKERS

Kevin Ward

Kevin Ward

Director of R&D , BioPharma Technology

Kevin Ward

Director of R&D , BioPharma Technology
Kevin Ward

Workshop agenda

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8:30

Registration & Coffee

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9:00

Welcome and Opening Remarks

Kevin Ward

Kevin Ward, Director of R&D , BioPharma Technology

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9:10

Basic Principles of QbD and what it means for lyophilization

Kevin Ward

Kevin Ward, Director of R&D , BioPharma Technology

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9:30

Defining Critical Quality Attributes and a Target Product Profile for a lyophilized product

Kevin Ward

Kevin Ward, Director of R&D , BioPharma Technology

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10:00

Risk minimization and "Risk Dynamics" in Freeze-Drying

Kevin Ward

Kevin Ward, Director of R&D , BioPharma Technology

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10:30

Morning Coffee

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11:00

Building a Design Space:

Kevin Ward

Kevin Ward, Director of R&D , BioPharma Technology

  • The interplay between equipment, formulation and process
  • Integration of formulation and process design/development
  • Looking at the balance between desktop studies and lab trials
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    12:00

    Final interactive discussion session and summing up

    Kevin Ward

    Kevin Ward, Director of R&D , BioPharma Technology

    clock

    12:30

    End of Workshop


    Director of R&D
    BioPharma Technology

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