Niels Alber, TRIPLAN Ingenieur AG
Dr Simone Biel, Merck
Prof Dieter Eibl, Zürich University of Applied Science
Prof Regine Eibl, Zürich University of Applied Science
Oliver Küttner, Shire
Dr Daniel Müller, GMP Inspector, Local Government Tübingen
Dr Alicja Sobantka, Octapharma
Dirk Tillich, Finesse Solutions
Sue Walker, Merck Martillac
This course aims at giving an overview on available Single-Use Technology and how this
technology can be implemented in the GMP manufacturing environment.
The use of single use technology increases in many biotechnological processes as well as in sterile filling processes. There are different reasons for this development, i.e.
- Avoiding cleaning and cleaning validation
- Reducing time to market by omitted construction activities
- Simplified scale-up procedures
- On the other side – especially in comparison to stainless steel – new questions arise like
- How to qualify and validate the technology?
- What are the consequences at the GMP Level?
- What about automation and process controls?
- How much responsibility can be transferred to the SU supplier?
These questions will be answered during the course by experts from pharmaceutical companies and leading suppliers and GMP authorities.
The course is directed at staff from pharmaceutical industry and suppliers from
- Research & Development
- Quality Assurance
who want to learn about the technical possibilities offered by Disposables and how Single-Use Equipment can be implemented in a GMP-compliant way.
Single-Use Technology in biopharmaceutical production: An overview from USP to
Quality Approach in Manufacturing of Single-Use Systems
- 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
Facility Design Considerations for Single Use Processes
- How to assure performance, robustness, and sterility of single use systems
- Single-use assembly validation: Qualification of components, Sterilization qualification,
- Manufacturing processes
- Quality control: Release testing, Certification
- Risk mitigation practices: Process particulate control, Operator training
- Leachables & Extractables: Patient safety evaluation, study design , Support by the supplier
Single-Use Systems - GMP inspector’s view
- Definition of project scope
- Overall layout and room classification
- Personnel and material flows
- Warehouse and waste management
- Differences from a stainless steel facility
Flexible Automation of Single Use Equipment
- Overview and evaluation of latest regulatory documents: Official guidelines, pharmacopoeias & other papers, Recent developments, Selected highlights
- 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
Structured approach for efficient implementation of a single-use system for filling
- What are the requirements for the process control of Single Use equipment?
- How to adopt the automation to new process requirements, i.e. for CMOs or
- multi-product suites?
- What is needed for a fully continuous GMP production in Single Use?
- Is Industry 4.0 a matter to consider for the Facilities of the Future?
- Can Single Use facilities utilise MES systems in a meaningful manner?
- How to get a GMP production facility planned and running at a minimum of risk, time and investment?
of large volume parenterals
Case Study: Merck Biodevelopment - Key Learnings from Five Years of Operation of a Single-Use MAb Production Facility
- Overview structured approach: breakdown of requirements, classification and
- assignment of accordant tasks
- Expenses vs. benefits
- Role / involvement of supplier
- Extractables & leachables, i.e.: product and patient safety
Case Study Novartis: Single Use equipment for Fill/Finish
- Description of the facility and staged conversion from stainless steel to single use
- Process template and associated equipment
- Validation considerations
- Daily operation
Quality Assurance concerning SU suppliers & incoming inspections
- Challenge of filling low volumes / Rational for the change to a peristaltic pump
- Project timelines
- Cooperation with the supplier: allocation of tasks
- Implementation of the new filling system in the GxP environment
- Pros & Cons of the peristaltic filling technique in combination with SU equipment
- Business Case: what has been the added value of the project
- Supplier qualification
- Incoming inspection: own testing vs. supplier certificates
- Handling of changes at the single-use supplier (materials, facility, ..)