Skip To The Main Content
2023 PDA_Training-1988x680

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

Jan 30 - Feb 01, 2024
Göttingen, Germany

  • Education
  • Europe
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 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.

Agenda

  • Day 1
  • Day 2
  • Day 3
  • Tuesday, 30 January 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
    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

    17:30
    End of Facility Tour


    19:00
    Joint Dinner

  • Wednesday, 31 January 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 on 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
    Hand-on Exercise 2 (Cleanroom)

    • Connection/Disconnection

    16:30
    Wrap-up Day 1


    17:00
    End of Training Course Day 1


    19:00
    Joint Dinner

  • Thursday, 01 February 2024

    8:30
    Sensors and Automation in Single-use Systems

    • Overview and demonstration

    9:15
    Hand-on 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
    Hand-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 differnces 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

Trainers

Dominic Parry
Dominic Parry
Inspired Pharma Training

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

Got a Question? We have answers

Contact Us

Travel

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

Sartorius Stedim Biotech

How to Get Here

By Air

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

By Car

More information coming soon.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €2.090

* 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.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

Sponsors

Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information

Exhibitors

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

Request Information

Media Partners

Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10
[email protected]

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

PDA Members Save Substantially