Lyophilization 2022 - Live Online Conference Opportunities and Challenges for the Pharmaceutical Industry
Course No 19183
This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager". Learn more.
Note: All times mentioned are CEST.
Costs
| ECA-Member*: | EUR 1990,-- |
| Non ECA Member*: | EUR 2190,-- |
| EU/GMP Inspectorates*: | EUR 1095,-- |
| APIC Member Discount*: | EUR 2090,-- |
(All prices excl. VAT)
* also payable by credit card
If you have any questions, please contact us:
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
Prof Alf Lamprecht, University of Bonn, Germany
Andrea Sardella, Stevanato Group, Italy
Dr Beate Reutter, GMP Inspectorate Federal State of Schleswig-Holstein, Germany
Prof Evangelos Tsotsas, University of Magdeburg, Germany
Dr Andrea Weiland-Waibel, Explicat, Germany
Rita Welser, Boehringer Ingelheim, Germany
Richard Denk, SKAN, Switzerland
Maik Guttzeit,Bayer, Germany
Kristien Janssen, Pfizer, Belgium
Prof Alf Lamprecht, University of Bonn, Germany
Andrea Sardella, Stevanato Group, Italy
Dr Beate Reutter, GMP Inspectorate Federal State of Schleswig-Holstein, Germany
Prof Evangelos Tsotsas, University of Magdeburg, Germany
Dr Andrea Weiland-Waibel, Explicat, Germany
Rita Welser, Boehringer Ingelheim, 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 virtual workshop where you can get a hands-on experience in freeze drying yourself. 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 Live Online 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 Live Online Conference is also of interest for participants working in the areas of container development and manufacturing process/packaging.
Technical Requirements
For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programme
Please note:
- Provisional timetable, the actual schedule may vary depending on the Situation
- In certain cases participation may not be possible due to competitive reasons
Programme 17 May 2022
09.00 - 09.15 h Welcome/Introduction
09.15 - 10.15 h
Fundamentals of Freeze Drying
Basic concepts and processes
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
10.15 - 10.30 h Break
10.30 - 11.30 h
Lyo-cycle development and PAT-based Optimization
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
11.30 - 12.00 h
Workshop: 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.
Workshop: 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.
12.00 - 12.30 h
Q&A Session 1
Q&A Session 1
12.30 - 13.30 h Break
13.30 - 14.30 h
Lyophilization Technology - Design Requirements and Technical Solutions
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.)
14.30 - 14.40 h Break
14.40 - 15.15 h
Aseptic Process Simulation (Media Fills)
Aseptic Process Simulation (Media Fills)
- 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
15.15 - 16.00 h
Atmospheric Spray Freeze Drying
Atmospheric Spray Freeze Drying
- Process understanding, monitoring & control
- Design of continuous lyophilization
16.00 - 16.15 h Break
16.15 - 16.45 h
Workshop Tour including visit of shelf manufacturing area, freeze dryer testing as well as simulation and system integration.
Workshop Tour including visit of shelf manufacturing area, freeze dryer testing as well as simulation and system integration.
16.45 - 17.15 h
Q&A Session 2
Q&A Session 2
Programme 18 May 2022
09.00 - 09.30 h
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.
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.
09.30 - 10.15 h
Containment: Lyophilization of Highly Potent Compounds
Freeze dryer equipped with isolator
Containment: Lyophilization of Highly Potent Compounds
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
10.15 - 10.30 h Break
10.30 - 11.15 h
Lyophilizer in Aseptic Production Lines - Challenges and Chances
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
11.15 - 11.45 h
Live Demonstration of Automated Loading and Unloading Systems
Demonstration of fully operative fixed and moveable load/unload system. Additionally, it will be possible to look at a system with special features, including online moisture control.
Live Demonstration of Automated Loading and Unloading Systems
Demonstration of fully operative fixed and moveable load/unload system. Additionally, it will be possible to look at a system with special features, including online moisture control.
11.45 - 12.15 h
Q&A Session 3
Q&A Session 3
12.15 - 13.15 h Break
13.15 - 14.00 h
Implications of the new Annex 1
Implications of the new Annex 1
- EU GMP Annex 1 – What´s new?
- GMP Issues in Inspections & Requirements for
- Sterile manufacturing of Lyo products
- Personnel (e.g. qualification, training, gowning, Monitoring)
- Sterile packaging materials
14.00 - 14.10 h Break
14.10 - 14.45 h
Qualification/Validation - to get the System tested
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
14.45 - 15.30 h
100% Inspection
100% Inspection
- 100% quality monitoring for continuous production process improvement
- Different inspections:
- Container closure integrity (CCIT)
- Visual Inspection (defects / particles)
- AQL testing
15.30 - 15.45 h Break
15.45 - 16.15 h
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.
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.
16.15 - 16.45 h
Q&A Session 4
Q&A Session 4
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
- Good Distribution Practice
- Sterile Manufacturing
- Computer Validation
- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- Impurities
- OOS / OOE / OOT
- Material Testing
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Microbiological Testing
- Technology
- General Manufacturing Topics
- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others