Introduction to Lyophilisation for Biopharmaceutical Fill-Finish Operations

Overview

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 pilotscale lyophiliser (Lyobeta 3PS), fill finish line and other supporting equipment.

Key topics covered

  • The key principles of lyophilisation.
  • The Lyophilisation cycle including stages, terminology, and key parameters.
  • Lyophilisation in the context of sterile. biopharmaceutical fill finish operations. 
  • Formulation for Lyophilisation of Biopharmaceuticals.
  • Detailed walk down of Lyophilisation Equipment including equipment components and instrumentation key to lyophilisation cycle control.

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

What do Attendees Obtain on Completion?

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

Register

Introduction to Lyophilisation for Biopharmaceutical Fill-Finish Operations

1,960.00

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Course Format

Onsite Training at NIBRT

2 full days onsite training at NIBRT facility

Dates & Price

Dates:
  • Course 1
    07/10/2024 - 08/10/2024

    NIBRT Onsite Course

    1,960.00

    Out of stock

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