Single-Use Systems in Sterile & Biomanufacturing

8./9. April 2025, Wiesbaden/Germany

Objectives

The aim of the event is to bring you up to date with the latest developments and possible applications of SU Systems. One important aspect besides overcoming technical issues is ensuring the quality of single-use systems.

Registration

Register as a congress delegate for just 690 EUR/day!
This special offer is only valid until 31 December 2024!

Background

Single-use systems have become established in biotechnology and are increasingly used in sterile pharmaceutical manufacturing. Reasons include significantly lower costs compared to stainless steel systems, and reduced expenses for cleaning and cleaning validation. Additionally, time-to-market can be shortened due to the elimination of construction activities and faster scale-up. For ‘small batch products’ and ATMPs, there are sometimes no other solutions available. SUS is also increasingly being used in the production of clinical material.

Regulatory requirements for single-use systems are becoming more defined, but true harmonization is still lacking despite industry efforts. Challenges beyond GMPs include extended delivery times for single-use equipment, reduced raw material availability, and high dependence on suppliers. These and other topics will be addressed at the Single-Use Systems Conference and discussed with experts from authorities, pharmaceutical manufacturing, single-use suppliers and universities.

Moderator

Prof Dr Regine Eibel, Zurich University of Applied Science

Speakers

Detailed Programme

Tuesday, 8 April 2025

09.00 - 18.00 h

Single-Use Systems – GMP Inspector's View
Dr Daniel Müller, Local Government Baden-Württemberg, Germany

  • Overview and Evaluation of latest Regulatory Documents
    • Official Guidelines, Pharmacopoeias & other Documents
    • Recent Developments
    • Selected important Documents
  • Single-use Systems versus Multi-Product Equipment
    • Important Requirements for GMP-Compliance
    • Regulatory View on both Types of Systems
  • Managing Suppliers of Single-Use Systems
    • Requirements for Supplier Qualification
  • GMP Inspections
    • Typical Issues and Deficiencies

Single-Use Technology in biopharmaceutical Production: An Overview from USP to Fill&Finish Technologies
Prof Dr Regine Eibl, Zurich University of Applied Sciences

  • Categorisation of available Single-Use Systems
  • Disposables in Upstream-Processing
    • Media Preparation
    • Cell Expansion and Fermentation
  • Disposables in Downstream-Processing
    • Filtration and Chromatography
    • Buffer Preparation and Storage
  • Disposables in Formulation and Filling
  • Freeze Technology
  • Hybrid/Closed Technology Platforms

Live Demos

NEW Shadow board for sterile filtration of drug product (optimized for PUPSIT)
Cytiva

Simplifying the qualification journey of Single-Use Systems
Merck


Quality Approach in Manufacturing of Single-Use Systems: How to assure Performance, Robustness, and Sterility of Single-Use System
Dr Simone Biel, Merck

  • Single-Use Assembly Validation
    • Qualification of Components
    • Sterilization Qualification
    • Manufacturing Processes
  • Quality
    • In-process Controls
    • Release Testing
  • Risk Mitigation Practices
    • Process Particulate Control
    • Operator Training

Wednesday, 9 April 2025

09.00 - 17.45 h

Case Study Merck: Single-Use Technology in Aseptic Drug Product Manufacturing
Nicola Rutigliani, Merck

  • Reasons for using SUT
  • Process: Pooling, Filtration, Filling
  • Project: Facility and Equipment Pre-Requisites, Qualification and Implementation of SUS
  • Risk Identification when using SUT and Mitigation Strategy (e.g. integrity assurance)
  • Lessons learned and Best Practice when moving from Traditional Filling to SUT

HIGHLIGHTS

Case Study BioNTech: CCS for Processing Frozen Sterile Drug Products in a Single-Use Assembly
Angus Liu, BioNTech

  • Background of Lipoplex Drug Products
  • Challenges in Processing Sterile Bulk Drug Products
  • QRM approach to Meeting the Challenges
  • Design, Challenges and Results of the Qualification Studies
  • Future steps

Case Study Sanofi: Optimization of Single-Use Systems for Fill-Finish Manufacturing Operations to the new Requirements
Dr Rebecca Geyer, Sanofi

  • Improvement of Fill-Finish SUS design in accordance with Annex I Requirements and Implementation Strategy.
  • New Design to simplify Set-up and improve Change-over Speed


E&L Testing of Process Materials used in Bioproduction – Case Studies on Study Design and showing the practical Hurdles when performing E&L Studies
Dr Koen Smets, Nelson Labs

Extractables and leachables (E&L) testing is key to assess process materials for release of substances that can potentially affect patient safety, product quality and/or process performance.

USP <665> and BioPhorum standard extraction protocols specify the design parameters for extractables studies, including the extraction solutions, temperature, time and surface-area-to-extract-volume ratio. In the current presentation, a brief overview of the design parameters of an E-study on process materials is given. Next, the study design and practical hurdles when testing process materials at a laboratory scale will be discussed and illustrated with ‘real-world’ case studies. The case studies will include the testing of filters, tubings and process bag systems, and will not only focus on study design but also on the interpretation of extractables data from a toxicological point of view (evaluation versus the AET) and a material point of view (relationship between the materials of construction of the test item and the reported extractables).

Particle Cleanliness Assessment of SUS
Gerald Dallmann, SGS Institut Fresenius GmbH

  • Definition of the Project Targets (like particle size) which define significantly the required Efforts
  • Sample Preparation (washing procedure, agents, conditions)
  • Particle Characterization (number, size and shape of particles)
  • Particle Identification by means of FTIR, µRAMAN, SEM/EDX
  • Typical Case Studies

Case Study: Manufacturing of a Monoclonal Antibody with SUT
Jyotsna Agnihotry, Flavine Europe

  • Product/Process Requirements and SUT Selection Process (closed system for highly active materials, moisture control and scalability)
    • Containment considerations & measurements
    • Cost Savings (Time, energy, instrumentation/utilities
  • Process Environment and Facility Conditions (contamination control, containment, air filtration in & out, support areas)

Programme last upated: 19 December 2024

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