Lyophilization 2026 – Includes Workshop at GEA
13 October 2026 - 15 October 2026
Lyophilization 2026
Opportunities and Challenges for the Pharmaceutical Industry
[ This seminar will be conducted in English. ]
Meet Tempris at the Lyophilization 2026 Seminar in Cologne
ECA Academy Course No. 22589
This course is part of the GMP Certification Programme “ECA Certified Pharmaceutical Engineer”
This conference addresses specialists and executives working in the fields of pharmaceutical manufacture, research and development and quality control, as well as engineers, project/facility engineers, especially those involved in the implementation of new monitoring methods for controlled nucleation, risk-based scale-up models and process technology for freeze drying processes. The conference is also of interest for participants working in the areas of container development and manufacturing process/packaging.
Take advantage of the opportunity to focus on freeze drying technologies and processes and get a first-hand demonstration of solutions for diverse requirements. Further, benefit from the workshop where you can get a hands-on experience in freeze drying yourself. In small groups, you will learn how the freeze drying output is affected by different equipment, parameter changes, solvents, etc.
Lyophilization (or freeze drying) is one of the most exciting technologies in the pharmaceutical industry, although it is a very old process for the preservation of unstable materials. Trends are growing towards using non-aqueous Systems.
Additionally, Process Analytical Technology (PAT) / RTRT (Real Time Release Testing, Annex 17 of the EU GMP Guide) systems for in-line process monitoring are used to control and determine critical processing parameters. PAT plays also an important role in continuous lyophilization processes. According to ICH´s new guideline Q13 “continuous manufacturing (CM) has potential for improving the efficiency, agility, and flexibility of drug substance and drug product manufacturing”. Regulatory agencies have seen more companies engaged in the development and implementation of CM in recent years than in the past.
Modern QbD (Quality by Design) development following ICH Q8, Q9 and Q10 is based on the objective to design a lyophilization cycle applying a systematic and scientific approach instead of trial and error. Sufficient process understanding is essential to achieve a robust production process and efficient handling of post-approval changes (life cycle management according to ICH Q12) of a freeze drying process.
There is an increasing trend in aseptically produced lyophilized products, including peptides and proteins. Owing to the nature of these biological products, the lyo-cycle is more complicated and, in most cases, even longer than for other medicinal products.
The utility of lyophilization goes far beyond the vial. Principles of low temperature, low pressure can be applied to stabilize substances ranging from high potent APIs, novel medical devices, biologics and nanomaterials, freeze drying offers multiple opportunities.