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Meet the training leaders

  • Kevin Smith
  • Technical Director
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  • Kevin Ward
  • Director of R&D
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  • Edmond Ekenlebie
  • Scientist
  • Biopharma
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Course description

A successfully optimized freeze-drying cycle will provide reliable, safe processing in an efficient manner. Each stage of the process – freezing, primary drying and secondary drying – poses its own challenges. Many factors influence the design of the cycle, including the specific thermal characteristics of the product, the type and amount of product per batch or container, and the capabilities of the processing equipment to be used. This training course provides an overview of how to develop an optimized freeze-drying process, from freezing, primary and secondary drying to what is required to successfully move the cycle to scale-up for production. It will go through each critical stage required to optimize a cycle including: an overview of the freeze drying process, formulation design of freeze dried products, characterization of the formulation in the frozen state prior to freeze drying, cycle development and scale up for freeze drying process (including the iterative approach and also the use of “new” SMART software), and the use of PAT (Process Analytical Technology) for monitoring the process. We will be including a presentation of how to approach the submissions to regulatory authorities.

Key topics

Microscopy and thermal analysis in formulation characterisation

Cycle development & scale-up

PAT in freeze-drying process

Regulatory submissions

Analysing the freeze-dried product

Key takeaways

Gain a basic understanding of the freeze-drying process, together with the factors that influence the product and process.

Characterization to determine a product critical temperature prior to freezedrying.

Review formulation development to gain understanding of typical excipients and their purpose in a formulation.

Comprehend what clients, vendors, employees, healthcare professionals, patients and Data Protection Authorities might require for GDPR.

Learn about typical CQAs in freeze dried products, what factors influence these attributes, and methods of monitoring and controlling attributes.

Learn how to develop a freeze-drying process using the traditional iterative (stepwise) approach and how this compares to the use of SMART software.

Discover some suggestions that can help any regulatory submission be more readily accepted (e. g. what data to be included and how to layout the information).

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Delegate Fee

from 1396 € Buy

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