PDA EU00161 Single-Use-Systems – A New Age of Drug Making

Göttingen, Germany
Ask a Question Exhibitor Standard Contract Clause
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

Standard Pricing

Standard Member Price

€ 2.090

Non-Member

€ 2.090

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. registration-europe@pda.org

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 registration-europe@pda.org 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

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Sartorius Stedim Biotech

Otto-Brenner Str. 20
Göttingen, 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

How to Get Here
By Air Nearest Airport: Hannover Airport Airport Phone: +49 (0)511 977-0
By Other Options By Train: Around 25 minutes away from station Göttingen.