Course Descriptor

This course will provide an introduction to the theory and practice of biopharmaceutical lyophilisation.  It will first introduce learners to the key principles of lyophilisation before focusing on its use in the context of sterile fill-finish manufacturing.  What are the critical process parameters to consider during a fill finish operation of a lyophilised biologic?  How do these relate to critical quality attributes?  How does formulation impact on the process?  These questions and others will be considered during the course which will be delivered through a combination of classroom lectures and workshops supported by hands-on practical sessions with our pilot-scale lyophiliser (Lyobeta 3PS), fill finish line and  other supporting equipment.

Course delivery method: Fully onsite in NIBRT

Introduction to Lyophilisation for Biopharmaceutical Fill-Finish Operations

SKU: Introduction-to-Lyophilisation-for-Biopharmaceutical-Fill-Finish-Operations Category:

1,900.00

Dates:
  • 07/09/2023 - 08/09/2023

    8 Places Remaining

  • 08/05/2023 - 09/05/2023

    8 Places Remaining

Fee:
€1900
Suitable for:

Bioprocessing Operators working in the fill finish and lyophilisation space and anyone who wants an introduction to the concept and principles of biopharmaceutical lyophilisation in the context of sterile biopharmaceutical fill-finish operations.  Experience working in an aseptic processing environment would be an advantage but is not required to attend this course.

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Who should attend

Bioprocessing Operators working in the fill finish and lyophilisation space and anyone who wants an introduction to the concept and principles of biopharmaceutical lyophilisation in the context of sterile biopharmaceutical fill-finish operations.  Experience working in an aseptic processing environment would be an advantage but is not required to attend this course.

Key topics covered

  • Principles of Lyophilisation
  • Lyophilisation in the context of sterile biopharmaceutical fill finish operations
  • Formulation for Lyophilisation of Biopharmaceuticals
  • Lyophilisation Equipment checks and validation and verification overview

Learning outcomes

  • Describe the principles of Lyophilisation
  • Explain how process parameters impact on lyophilised product quality
  • Describe key considerations for formulation of lyophilised biologics
  • Describe key considerations for validation of Lyophilisation cycle
  • Describe key equipment verification procedures

Assessment

A competency based assessment will be undertaken at the end of the course.

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