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2023 PDA_Training-1988x680

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

May 09 - May 11, 2023
Göttingen, Germany

  • Education
  • Europe

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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.

Overview

In the biomanufacturing world, a huge diversification of products takes place with new therapeutic approaches rising up. 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 to you, then you should sign up to 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 have a look into the manufacturing of single-use bioreactor bags and filters, followed by a visit in the Sartorius Application Center where you can see and test complete process solutions from molecule discovery to large scale biomanufacturing.

Agenda

  • Day 1
  • Day 2
  • Day 3
  • Tuesday, 09 May 2023 - 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
    Coffee Break

    16:45
    Overview on Complete Single-use Bioprocesses From Molecule Development to Final Filling

    • Tour through the Application Center
    • With option for further hands-on tests
  • Wednesday, 10 May 2023

    8:30
    Welcome & Introduction of Participants


    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 on advantages of SUS

    12:15
    Lunch Break

    13:15
    Basics in Single-use Bioprocessing

    • Manufacturing of SU Consumables
    • Different bag functionalities
    • Connection/disconnection technologies

    14:15
    Coffee Break

    14:30
    Hand-on Exercise 2 (Cleanroom)

    • Bag handling (Storage and mixing bags)
    • Connection/Disconnection

    16:30
    Wrap-up Day 1


    17:10
    End of Training Course Day 1


    18:30
    Joint Dinner

  • Thursday, 11 May 2023

    8:30
    Sensors and Automation in Single-use Systems

    • Overview and demonstration

    9:15
    Hand-on Exercise 3

    • Media preparation with automated sterile filtration

    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
    Filtration & CCT

    • Filter Integrity Testing in SUS
    • Bag Assembly Integrity Testing

    12:15
    Lunch Break

    13:15
    Hand-on Exercise 4

    • Filter Integrity Testing

    14:00
    GMP Practical Session

    • failed filter IT - what to do under GMP?
    • What are the differnces between media preparation and final filtration of a drug product prior filling?
    • 'Bioburden Reduction' vs. 'Sterile Filtration'

    14:15
    Coffee Break

    15:00
    Data Recording & Evaluation

    • Data logging
    • Batch monitoring

    15:30
    Filter Integrity Testing Fault Handling – GMP View

    • GMP requirements
    • Pre- and Post-use integrity testing
    • Impact of new EU GMP Annex 1 requirements

    16:00
    Wrap-up Day 2


    16:30
    End of Training Course

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of the training course, the participants:

    • 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
  • Who Should Attend
    • Operators
    • Manufacturing Supervisors
    • QA Managers
    • Manufacturing Managers
    • QC Managers
    • Auditors

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Travel

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Sartorius Stedim Biotech

Otto-Brenner Str. 20
Göttingen, Germany

Sartorius Stedim Biotech
  • Accommodations

    Hotel Nearby

    PDA Europe recommends the reservation at the following hotel.
    The general terms of business are valid at the event hotel.

    Best Western Hotel Am Papenberg
    Hermann-Rein-Straße 2, 37075 Goettingen
    Tel: +49 551 30550

  • Amenities

How to Get Here

By Air

Nearest Airport: Hannover Airport Airport Phone: +49 (0)511 977-0

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Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.895

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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