Lyophilization in Pharma & Biotech

This course is not currently scheduled but may be offered at your company site.
Please contact Fleming for more information.

Training features

Interactive discussions and Q&A sessions
Individual discussion & consultancy with the trainer

Case studies from the trainer's experience
Certificate of completion issued by the trainer
Comprehensive course documentation

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 the updated European Annex 1 guidelines associated with Good Manufacturing Practice for the manufacture of sterile medicinal products.

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Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

Lyophilization in Pharma & Biotech training organized by Fleming_Agenda Cover
Lyophilization in Pharma & Biotech online live training organized by Fleming_Agenda Cover
Lyophilization in Pharma & Biotech online live training organized by Fleming_Agenda Cover
key training

Topics

Freeze drying process overview

Primary & secondary drying

Formulation design of freeze-dried products

Formulation characterisation methods

Cycle development, scale-up & robustness testing

Process monitoring and analytical technologies

Annex 1 (2022) Guidelines for GMP and its relevance to freeze-dried sterile medicinal products

Analysing the final product: moisture, thermal and mechanical properties

Benefits of attending

Testimonials

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Training ticket

This course is not currently scheduled but may be offered at your company site.
Please contact Fleming for more information.

Delegate Fee
FROM
2396

Venue

Flemings Hotel Wien-Stadthalle

Neubaugürtel 26-28,
A-1070 Wien, Österreich
Phone: +43 1 227 37-0

Flemings Hotel Wien-Stadthalle

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