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

Pharma QA/QC when using Single-Use Equipment
Dr Alicja Sobantka, Octapharma

• Certificate Check vs. In-house Qualification “Is the Single-Use Equipment fit for its intended use?”
• Potential Particles in SU Equipment and Particle Testing
• Leak Testing: Components and Assemblies
• Qualification of SU Equipment - What needs to be done compared to Stainless Steel Equipment?
• Dealing with Changes at the SU Supplier: Lilfecycle Management
• Material Aging and Shelf-Life
• USP 665

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
  
  

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 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)