PDA EU00161 Single-Use-Systems – A New Age of Drug Making
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Program Highlights
Using single-use systems in GMP regulated biomanufacturing – a practical approach
This course will take place at the Sartorius Stedim facilities in Göttingen.
In the biomanufacturing world, a huge product diversification occurs place with new therapeutic approaches rising. Novartis e.g., recently released a new gene therapy drug for two Million Euros per dose, while other companies are still in the development phase for drugs targeting the same disease. Wouldn’t it be great for them to have released these drugs faster to be the first one and to make two Million Euros per dose themselves? And what technologies might have helped to reach this goal?
One possibility to get drugs faster to the market is the use of single-use systems. But are they robust enough when the product contact layer is made from polymers? And what will the authorities say? If the equation SUS plus GMP results in SOS, then you should sign up for this two-day course. Here you will learn and discuss with technical trainers and specialists for data handling and GMP regulations how to implement and operate single-use technologies in a GMP-controlled environment.
During an optional third day, you can look into the manufacturing of single-use bioreactor bags and filters, followed by a visit to the Sartorius Application Center where you can see and test complete process solutions from molecule discovery to large-scale biomanufacturing.
Who Should Attend
- Operators
- Manufacturing Supervisors
- QA Managers
- Manufacturing Managers
- QC Managers
- Auditors
Learning Objectives
Upon completion of this course, attendees will be able to:
- have understood the regulations and relevant guidelines for single-use system (SUS) handling
- can explain basics in single-use processing, bag functionalities, connection-disconnection technologies
- can operate bags, tubings, filters, and sensors
- have understood Data Integrity and Data Analysis / Monitoring for SUS handling
- have understood possible setups for filter and container closure integrity testing in single-use assemblies
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Member Price
€ 2.090Non-Member
€ 2.090
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. [email protected]
PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.
Day 1
Monday, 30 September 2024 - Optional Facility Tour
13:00 - 14:00
Lunch
14:00
Insight Into the Production of Bag Assemblies
- Injection molding of components (e.g. connectors, filter housings, etc.)
- Production of 50 and 200 L bags for SU bioreactors (STR)
15:00
Insight Into the Production of Filters
- Membrane production
- Cartridge, capsule, and filter modules production
16:30
Break
16:45
Overview of Complete Single-use Bioprocesses From Molecule Development to Final Filling
- Tour through the Application Center
- With the option for further hands-on tests
17:30
End of Facility Tour
19:00
Joint Dinner
Day 2
Tuesday, 01 October 2024
8:30
Welcome & Introduction of Participants; Safety Briefing
9:00
Introduction to Single-use Bioprocessing
9:45
GMP Update on SUS (Part 1)
- Current GMP regulation
- FDA requirements
- Technical guidelines
- Regulatory expectations
10:30
Coffee Break
10:45
GMP Update on SUS (Part 2)
- New Annex 1
11:15
Hands-on Exercise 1
- Gowning
- Experiment with the advantages of SUS
12:15
Lunch Break
13:15
Basics in Single-use Bioprocessing Focus on Bags
- Manufacturing of SU Consumables
- Different bag functionalities
14:15
Coffee Break
14:30
Hands-on Exercise 2 (Cleanroom)
- Connection/Disconnection
16:30
Wrap-up Day 1
17:00
End of Training Course Day 1
19:00
Joint Dinner
Day 3
Wednesday, 02 October 2024
8:30
Sensors and Automation in Single-use Systems
- Overview and demonstration
9:15
Hands-onof Exercise 3
- Overview bag types
10:15
Coffee Break
10:30
Data Integrity, Data Analysis and Monitoring
- Regulatory requirements and guidelines
- ALCOA
- Data integrity for computer, paper, and hybrid systems
- Control of meta-data
- Data integrity strategies for compliance
- Checking for Data Integrity issues in practice
- Experimental approach
11:30
Lunch Break
12:15
Filtration & CCT
- Filter Integrity Testing in SUS
- Bag Assembly Integrity Testing
13:15
Hands-on Exercise 4
- Filter Integrity Testing
14:00
Coffee Break
14:15
Filter Integrity Testing Fault Handling – GMP View
- GMP requirements
- Pre- and Post-use integrity testing
- Impact of new EU GMP Annex 1 requirements
14:45
GMP Practical Session
- Failed filter IT - what to do under GMP?
- What are the differences between media preparation and final filtration of a drug product prior filling?
- 'Bioburden Reduction' vs. 'Sterile Filtration'
15:30
Data Recording & Evaluation
- Data logging
- Batch monitoring
16:00
Wrap-up Day 2
16:30
End of Training Course
Featured Trainers
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Alexander Paesch
Sartorius Stedim
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Alexander Paesch
Sartorius Stedim
Alexander Paesch has become a dedicated specialist in the biopharmaceutical industry over the last few years. With a strong foundation in chemistry, evidenced by his PhD in the field, Alexander began his career as a project manager at a CDMO’s pharmaceutical development, where he honed his skills in project management and gained valuable industry experience.
His growing interest in biopharmaceutical production processes led him to transition into a role as a training specialist at Sartorius, a leading provider of equipment and services for the sector. In this capacity, Alexander applies his extensive knowledge to educate and train industry professionals, ensuring they are well-equipped to meet the challenges of biopharmaceutical production.
At Sartorius, Alexander continues to specialize in upstream processing and single-use technologies, areas critical to the advancement of biopharmaceuticals. His role as a training specialist allows him to contribute significantly to the industry by sharing his expertise and promoting best practices in these innovative fields.
With a strong educational background and practical experience, Alexander Paesch stands out as a knowledgeable and committed professional in the biopharmaceutical industry, dedicated to enhancing the skills and competencies of those working within it.
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Dominic Parry
Inspired Pharma Training
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Dominic Parry
Inspired Pharma Training
Dominic Parry has worked in the pharmaceutical industry since 1992 and is a leading pharmaceutical quality management specialist. He initially worked for Evans Medical Limited (now Novartis Vaccines) as a Production Development Scientist. He then moved to Hoechst Marion Roussel (now Patheon UK) where he worked as a Quality Assurance Officer and then Validation Manager for the sterile manufacturing operations. Over the past 15 years he has worked as a leading pharmaceutical trainer and Quality Management System specialist. He works closely with pharmaceutical companies and their suppliers on evaluating, developing and continually improving their quality systems so that they add real-value to organisations. Dominic is Managing Director of Inspired Pharma Training, a GXP and Quality Management training company. -
Andreas Prediger
Sartorius Stedim
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Andreas Prediger
Sartorius Stedim
Andreas Prediger is working in Product Development as Manager for SU Sensors, based in Göttingen. Andreas joined Sartorius in 2013 as a Scientist in the Process Analytical Technologies Team.
He has since been responsible for sensor development projects in various roles ranging from project management to qualification expert. In 2017 he took over the lead for the SU sensor development team. Andreas has about 15 years of professional experience in Life Science – mainly focused on bioprocess monitoring.
Prior to joining Sartorius he performed his doctoral thesis at the Institute of Technical Chemistry at the University of Hannover.
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Tanja Sedlacek
Sartorius Stedim
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Tanja Sedlacek
Sartorius Stedim
Tanja Sedlacek has been a valuable member of the Sartorius team for six years, serving as a Field Application Specialist for Fluid Management.
Since 2020, Tanja has been based in Göttingen focusing on extensive customer projects in Central Germany, internal projects and trainings. Tanja possess a profound knowledge of the application of single use equipment in the customers’ entire production processes and setups - from upstream to downstream.
In 2013, Tanja was awarded the Singapore International Pre-Graduate Award by the Agency for Science, Technology and Research A*STAR. As part of an international research team, Tanja was involved in a sustainability project on the research of bacteria for biorefining purposes.
Tanja holds a Master of Science in Biotechnology with focus on molecular engineering from the Technical University Braunschweig, Germany.
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Mathias Siebner, PhD
Sartorius Stedim Biotech GmbH
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Mathias Siebner, PhD
Sartorius Stedim Biotech GmbH
Mathias Siebner has been working for Sartorius since 1996, where he is Product Specialist for normal flow filtration and integrity testing. He earned a diploma in chemistry at the “Technical university of Braunschweig” and holds a PhD in biotechnology from the “GBF - Gesellschaft für Biotechnologische Forschung” in Braunschweig. Mathias started his career in the field sales. For all his years with Sartorius he was always working in technical positions around filtration with close customer contact. Five years he was working as a project manager in the Confidence® Validation Service. For more than 10 years he was leading the Field Application Specialist team for Separation Technology for EMEA. For the last years he is focused on the Technical Support and Trainings for the Application Specialists.
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Henry Weichert
Sartorius Stedim
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Henry Weichert
Sartorius Stedim
Henry Weichert is a Technology Consultant PAT, based in Göttingen. Henry originally joined Sartorius in 2010 as a Product Manager in Integrated Solution responsible for cross functional parts, especially single use sensors. In 2011 he transitioned into the new created group of PAT & Automation, taking care for the sensor and analytical system part. In 2018 he moved in the global role as Technology Consultant with the responsibility to strengthen the Sartorius portfolio in PAT.
Henry possesses over 25 years of progressive experience in cell culture, fermentation, cell line development and corresponding analytics. Prior to joining Sartorius, Henry runs his own company for 13 years focused on fermentation and cell line development. Henry holds a PhD in Immunology from the University Leipzig.
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Sartorius Stedim Biotech
Otto-Brenner Str. 20Göttingen, Germany 37079, Germany
Reservation Instructions
PDA Europe recommends to reserve a hotel room close to the trainings location.
Best Western Hotel Am Papenberg
Hermann-Rein-Straße 2
37075 Göttingen
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