Opportunities and Challenges for the Pharmaceutical Industry
13-15 October 2026, Cologne, Germany
Course No. 22589
Speakers
Dr Andrea Weiland-Waibel
Explicat Pharma
Maik Guttzeit
Freelance Consultant
Heide Nagel
Novartis Pharma
Dr Frank Sielaff
Hessisches Landesamt für Gesundheit und Pflege
Anthony Cannon
MSD
Kristien Janssen
Pfizer Manufacturing Belgium
Dr Benjamin Ledermann
GEA Lyophil
Dr Andrea Hawe
Coriolis Pharma Research
Mathias Montfort
Refolution Industriekälte
Workshops at GEA: Fundamentals, cycle development and Scale-up | Hands on demonstration of production scale freeze dryer design and functions | Automated loading and unloading Systems | Innovations in freeze drying applications
Target Group
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.
Objectives
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.
Background
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.
Programme
Fundamentals of Lyophilization
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
CQA and critical process Parameters
Freeze drying: scale-up and validation
Process control strategies
Impact of the new Annex 1
EU GMP Annex 1 - Effects on Lyo products
GMP questions during inspections
Experiences from the perspective of an inspector
Simulation of Lyophilization & CCIT
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
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
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)
Media Fill Design
Worst Case Parameter for Media Fill
Validation of lyophilisation processes with Media Fill
Requirements for Media Fill
Spray Freeze Drying
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 Validation – to get the System tested (Maik Guttzeit)
QbD requirements for successful freeze dryer Projects
Qualification strategies and critical test requirements
Involvement of suppliers in the qualification process
Sustainable, Reliable, and Energy-Efficient Freeze Drying for Large-Scale Pharmaceutical Production
Sustainability challenges and CO₂ impact of freeze-drying in pharma
Energy efficiency drivers in deep-freeze drying processes
F-gas-free and alternative refrigeration technologies for freeze dryers
Hybrid refrigeration concepts for efficient and reliable large-scale operation
Designing stable lyophilized Formulations for Biologics
Strategic considerations for choosing a lyophilized formulation for different types of biologics
Formulation design principles: role of excipients and packaging material in lyophilized formulations and their impact on product stability during freeze-drying
Critical quality attributes (cQAs) and analytical methods relevant for lyophilized biologics, including lyo-specific methods such as DSC, XRD and freeze-drying microscopy
Lyophilization Process Development for Biologics
Phase-appropriate lyophilization process development strategies for early-stage versus late-stage development
Impact of formulation, packaging material, freezing, primary and secondary drying on product quality
Lyomodelling as tool for lyo process development
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.
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.
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.
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 15 October 2026:
At 8:00 h bus transfer from Mercure Hotel West to GEA At approx.14:30 h end of course At approx.15:15 h arrival at Cologne Central Station. From Cologne Central Station, frequent airport connections are available.
Further Information
Venue Mercure Hotel Köln West Horbeller Strasse 1 50858 Cologne, Germany Phone +49 2234 514-0 H0705@accor.com
Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the conference. Reservation should be made directly with the hotel. Early reservation is recommended.
Fees (per delegate, plus VAT) ECA Members € 2,290 APIC Members € 2,390 Non-ECA Members € 2,490 EU GMP Inspectorates € 1,245 The conference fee is payable in advance after receipt of invoice and includes dinner on first day, lunch on second day and business lunch on third day, and all refreshments. VAT is reclaimable.
Please note: In certain cases, participation may not be possible due to competitive reasons.
Social Event On Tuesday and Wednesday, you are cordially invited to a social event in the city of cologne. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Presentations/Certificate 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.
Conference language The official conference language will be English.
Testimonials
