Lyophilization 2020 - Includes Workshop at GEA
Hürth near Cologne, Germany
Course No 17495
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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org
Speakers
Anthony Cannon, MSD, Switzerland
Richard Denk, SKAN, Switzerland
Maik Guttzeit,Bayer, Germany
Kristien Janssen, Pfizer, Belgium
Dr Matthias Kahl, Wilco, Switzerland
Prof Evangelos Tsotsas, University of Magdeburg, Germany
Markus Wahlen, GEA, Germany
Dr Andrea Weiland-Waibel, Explicat, Germany
Rita Welser, Boehringer Ingelheim Pharma, Germany
Richard Denk, SKAN, Switzerland
Maik Guttzeit,Bayer, Germany
Kristien Janssen, Pfizer, Belgium
Dr Matthias Kahl, Wilco, Switzerland
Prof Evangelos Tsotsas, University of Magdeburg, Germany
Markus Wahlen, GEA, Germany
Dr Andrea Weiland-Waibel, Explicat, Germany
Rita Welser, Boehringer Ingelheim Pharma, Germany
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.
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.
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.
Workshops on Thursday, 14 May 2020
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.
Target group of the Course:
Process Engineers, Pharmaceutical Technologists, Pharmaceutical Formulation Scientists, Application Chemists, Drug Development Engineers, Particle Design Engineers
Workshops
Target group of the Course:
Process Engineers, Pharmaceutical Technologists, Pharmaceutical Formulation Scientists, Application Chemists, Drug Development Engineers, Particle Design Engineers
Workshops
- 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 and controls. - 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 (ALUS®)
Demonstration of fully operative stationary load/unload system. Additionally, it will be possible to look at a system with special features, including online moisture control and continuous traceability of primary packaging. - 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 highlight new developments of production freeze dryer and includes technologies for controlled nucleation and continuous freeze drying.
A shuttle bus will bring you to Cologne Central Station at approximately 15.15 h. From Cologne Central Station, frequent airport connections are available.
In certain cases a participation in the workshop may not be possible due to competitive reasons.
In certain cases a participation in the workshop may not be possible due to competitive reasons.
Programme
Fundamentals of freeze drying
- Basic concepts and processes
- General advantages of freeze drying, product quality issues
- Classification and comparison of freeze drying processes
- Freeze drying in vials: Fundamentals of mass and heat transfer
- Role and importance of freezing
- Influence of process parameters, material properties, dryer design
- Process optimization, monitoring and control
- Freeze drying of frozen particles: Fundamentals of heat transfer, influence of mixing
Lyo-cycle development and PAT-based optimization
- Critical quality attributes and critical process parameters:
- assessment of critical process parameters through robustness testing to establish the process boundaries as the basis for the transfer from lab to commercial scale
- Freeze drying scale-up and validation:
- process qualification/validation in lyophilization strategies in relation to FDA/EMA modern process validation guidelines
- Process control strategies:
- hot and cold spot determination to allow for process control by using a product temperature PAT device
Containment: Lyophilization of highly potent compounds
Freeze dryer equipped with isolator
Freeze dryer equipped with isolator
- An introduction to highly potent products
- Which are the critical limits and how are they evaluated?
- Correlation between critical limits and cleaning validation
- Determination of critical process steps
- Hardware solutions
- Examples
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
- Loading and unloading of freeze dryers
- Lead times and campaigning
- Equipment characterizations
- FD cycles monitoring
- Vacuum and silicone oil leak tests
- Maintenance
Media Fill
- Media Fill Design
- Worst-case parameters for Media Fills
- Validation of lyophilization processes with Media Fills
- Requirements for Media Fills
- Trends with regards to Media Fills
Continuous Lyophilization
- PAT for process understanding & process modeling
- PAT for process monitoring & control
- Model based PAT implementation
- Model based design of continuous lyophilization
Lyophilization cycle improvement and control by using mass spectroscopy
- Application of GEA LYOPLUS® for verification of freeze drying batches
- Online data acquisition for monitoring the solution concentration in the freeze drying chamber
- Verification of freeze drying end points for primary and secondary drying
- Investigation of opportunity to use LYOPLUS® as PAT tool during freeze drying cycles
Qualification/validation - to get the system tested
- Risk assessment in the context of qualification and validation
- QbD aspects for successful lyophilization projects
- Tests during qualification and validation
- IQ/OQ/PQ
- Concepts for reduced testing approach
- Definition of scope of supply (URS vs. supplier standard)
- Risk based life cycle approach in accordance with GAMP 5
100% Inspection
- 100% quality monitoring for continuous production process improvement illustrated with a lyo process application.
- Different inspections:
- Container closure integrity before and after the crimping process,
- Cake residual moisture evaluated by means of NIR spectroscopy, combined with product identification and cake defect detection,
- Downstream inline laser coding is clearly identifying the vial as a container which fully complies to all quality requirements.
GMP Conferences by Topics
- Quality Assurance
- GMP in Biotechnology
- Microbiology
- Regulatory Affairs
- GMP in Pharmaceutical Development
- Quality Control
- GDP
- Sterile / Aseptic Manufacturing
- Computer Validation
- Validation
- Technical Operations
- GMP for APIs and Excipients
- Medical Devices
- GMP Basic Training Courses
- Packaging
- Data Integrity