Dr Simone Biel, Merck
Prof Dr Regine Eibl, Zürcher University of Applied Science
Dr Daniel Müller, Local Government of Germany (Tuebingen)
Nicola Rutigliani, Merck
This online training course gives 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
- High flexibility
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?
- How much responsibility can be transferred to the SU supplier?
- How should Leachable&Extractable Data be evaluated?
These and other questions will be discussed and answered during the course by experts from university, pharmaceutical industry and GMP authorities.
The course is directed at staff from pharmaceutical industry and suppliers from
- Research & Development
- Quality Assurance
who want to learn how Singe-Use Equipment can be implemented in Biotech and Sterile Operations in a GMP-compliant way.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your ame and e-mail address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary Installation is fast and easy.
Single-Use Technology in biopharmaceutical production: An overview from USP to Fill&Finish technologies
- 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
Single-Use Systems – GMP inspector’s view
- 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
Quality Approach in Manufacturing of Single-Use Systems – 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
- Risk mitigation practices
- Process particulate control
- Operator Training
- Leachables & Extractables
- Patient safety evaluation, study design
- Support by the supplier
The Role of Extractables/Leachables in the Adoption of Single-Use Systems
The successful adoption of single-use technologies in a biopharmaceutical process largely relies on confidently selecting the right components for use in the fluid path of a product, within a specific process. An important step in choosing such components requires generating an extractables profile, which can be done
by carefully selecting the solvent streams and extraction conditions to model the product and process steps complemented with the right analytical strategy. This presentation will Focus on:
- The approach to adopt the BioPhorum (BPOG) extractables protocol as a baseline testing strategy.
- How to apply extractables data to a specific process followed by a systematic, risk-based safety assessment approach used for comparing known safety concern thresholds.
- Important stages in the risk assessment process as demonstrated by case studies from typical drug manufacturing processes where single-use components were used.
Case Study Merck: Single-Use Technology in Aseptic Drug Product Manufacturing
- 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