Maik Guttzeit
Bayer
Referent:innen
Dr. Andrea Weiland-Waibel
Explicat Pharma
Dr. Frank Sielaff
Hessisches Landesamt für Gesundheit und Pflege
Dr. Benjamin Ledermann
GEA Lyophil
Anthony Cannon
MSD
Kristien Janssen
Pfizer Manufacturing Belgium
Heide Nagel
Novartis Pharma
Dr Bernhard Luy
Meridion Technologies
Dr Luis Padrela
University of Limerick
Zielsetzung
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.
Hintergrund
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.
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.
Zielgruppe
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.
Date / Venue / Presentations / Certificate
Tuesday, 21 October 2025, 12.30 h - 17.45 h,
(Registration and coffee/snack 12.00 h – 12.30 h)
Wednesday, 22 October 2025, 09.00 h - 17.00 h
Thursday, 23 October 2025, 08.001 -14.302 h, 15.153 h)
(Registration and coffee/snack 12.00 h – 12.30 h)
Wednesday, 22 October 2025, 09.00 h - 17.00 h
Thursday, 23 October 2025, 08.001 -14.302 h, 15.153 h)
1 transfer from Mercure Hotel Köln Belfortstrasse to GEA (bus transfer will be provided)
2 approx. end of course
3 approx. arrival at Cologne Central Station (bus transfer will be provided)
In certain cases, participation may not be possible due to competitive reasons.
Venue
Mercure Hotel Köln West
Horbeller Strasse 1
50858 Cologne, Germany
Phone +49 2234 514-0
Email: H0705@accor.com
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
Please note: In certain cases, participation may not be possible due to competitive reasons.
Fundamentals of Lyophilization
(Dr Benjamin Ledermann)
Fundamentals of Lyophilization
(Dr Benjamin Ledermann)
- Introduction and historical review
- Advantages and disadvantages of freeze drying
- Structure and function of a freeze dryer
- The three phases of freeze-drying process
- Process monitoring and optimisation
Increased Efficiency through Optimisation of Lyophilisation Cycles and PAT
(Dr Andrea Weiland-Waibel)
(Dr Andrea Weiland-Waibel)
- CQA and critical process Parameters
- Freeze drying: scale-up and validation
- Process control strategies
Impact of the new Annex 1
(Dr Frank Sielaff)
(Dr Frank Sielaff)
- EU GMP Annex 1 - Effects on Lyo products
- GMP questions during inspections
- Experiences from the perspective of an inspector
Simulation of Lyophilization & CCIT
(Dr Andrea Weiland-Waibel)
(Dr Andrea Weiland-Waibel)
- Simulation techniques and models for the optimisation of Lyophilisation
- Introduction to Container Closure Integrity Testing (CCIT) methods and their importance
- Integration of CCIT in quality control and Quality assurance
Lyophilization Technology- Design Requirements and Technical Solutions
(Anthony J Cannon)
(Anthony J Cannon)
- Main components of a lyo (chamber, condenser, refrigeration skid, vacuum skid, shelves, etc.)
- Purpose of these components
- Design criteria of these components (temperature homogeneity, cooling and heating capacity, sublimation capacity and gas flow, etc.)
Lyophilizer in Aseptic Production Lines - Challenges and Chances
(Kristien Janssen)
(Kristien Janssen)
- Automatic Loading and Unloading of Freeze Dryers
- FD cycles: monitoring and challenges
- Turn-over times
- Lyoplus
- Steps towards higher sustainability
Aseptic Process Simulation (Media Fill)
(Heide Nagel)
(Heide Nagel)
- Media Fill Design
- Worst Case Parameter for Media Fill
- Validation of lyophilisation processes with Media Fill
- Requirements for Media Fill
Spray Freeze Drying
(Bernhard Luy)
(Bernhard Luy)
- Aseptic generation of homogenous, free-flowing lyophilized bulk material
- Spray freezing and dynamic rotary freeze drying
- Process characteristics and product properties
- Case Studies and industrial applications for parenterals
Qualification and Testing of Freeze Dryers
(Maik Guttzeit)
(Maik Guttzeit)
- QbD requirements for successful freeze dryer Projects
- Qualification strategies and critical test requirements
- Involvement of suppliers in the qualification process
Supercritical CO2 Technology as an enabling Approach for the Drying of Biopharmaceuticals
(Luis Padrela)
(Luis Padrela)
- Drying of biomolecules
- Atomization
- Supercritical CO2-based Methods
- Particle size Control
- Stabilization
- Economic and aseptic considerations
WORKSHOPS
On the third conference day, you will have the opportunity to take part in several parallel workshops. For that purpose, several lyophilizers will be available at GEA. Experienced GEA experts will lead you in small groups, providing an intensive experience and directly applicable Know-how.
Hands-on demonstration of production scale freeze dryer design and functions
This workshop will provide each participant with an overview of a state-of-the-art production-scale freeze drying system, including system configuration. Also, a small scale production freeze dryer that is applicable to be integrated into the VARIOSYS® Platform will be demonstrated.
Hands-on demonstration of production scale freeze dryer design and functions
This workshop will provide each participant with an overview of a state-of-the-art production-scale freeze drying system, including system configuration. Also, a small scale production freeze dryer that is applicable to be integrated into the VARIOSYS® Platform will be demonstrated.
Fundamentals of freeze drying, cycle development and scale-up
For effective freeze drying, each product requires a unique recipe (formulation); these formulations are initially developed on a laboratory or pilot-scale unit and it is imperative that formulation development takes both product characteristics and the limitations of pilot and production machines into account. This workshop will examine the procedures and consequences of process development and scale-up.
For effective freeze drying, each product requires a unique recipe (formulation); these formulations are initially developed on a laboratory or pilot-scale unit and it is imperative that formulation development takes both product characteristics and the limitations of pilot and production machines into account. This workshop will examine the procedures and consequences of process development and scale-up.
Live demonstration of automated loading and unloading systems
Demonstration of fully operational fixed and robotic load/unload system. Additionally, it will be possible to look at a system with special features, including online moisture control.
Demonstration of fully operational fixed and robotic load/unload system. Additionally, it will be possible to look at a system with special features, including online moisture control.
Workshop tour including visit of shelf manufacturing area, freeze dryer testing as well as simulation and system integration.
Innovations in freeze drying applications
This workshop will focus on processing Microwave Freeze Drying, as well as the use of environmentally friendly cooling systems and technologies for controlled nucleation and continuous freeze drying.
It is highly recommended that you bring your own safety shoes, if available!
Free transfers on 23 October 2025: A shuttle bus will bring you to Cologne Central Station at approximately 15:15 h. From Cologne Central Station, frequent airport connections are available.
This workshop will focus on processing Microwave Freeze Drying, as well as the use of environmentally friendly cooling systems and technologies for controlled nucleation and continuous freeze drying.
It is highly recommended that you bring your own safety shoes, if available!
Free transfers on 23 October 2025: A shuttle bus will bring you to Cologne Central Station at approximately 15:15 h. From Cologne Central Station, frequent airport connections are available.
| ECA-Member*: | € 2290,- |
| Non ECA Member*: | € 2490,- |
| EU/GMP Inspectorates*: | € 1245,- |
| APIC Member Discount*: | € 2390,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager"
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E-Mail: info@concept-heidelberg.de
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Seminarprogramm als PDF
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