Dr Simone Biel, Merck
Dr Thomas Centner, io-consultants
Dr Michael Eakins, USP Expert Committee Member
Prof Dieter Eibl, Zürich University of Applied Science
Prof Regine Eibl, Zürich University of Applied Science
Steve Hughes, BPL – Bio Products Laboratory
Bianca van Leeuwen, Janssen Pharmaceutica
Dr Daniel Müller, GMP Inspector, Local Government Tübingen
Dr Julian Roland, GSK, Supplier Quality Manager
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 Singe-Use Equipment can be implemented in a GMP-compliant way.
Single-Use Technology in biopharmaceutical production: An overview from USP to
Single-Use Systems - GMP inspector’s view
- 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
Quality Approach in Manufacturing of Single-Use Systems
- 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
How to assure performance, robustness, and sterility of single use systems
The USP’s Approach to Single-Use Components and Systems used in the Manufacture of Drug Products
- 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
The Role of Extractables Data in the Effective Adoption of Single-Use Systems
- Review of USP’s latest draft of Chapter <665> and the accompanying General Information Chapter <1665>
- Explanation of the assessment process, the initial assessment and the risk assessment for materials and systems
- Description and explanation of the extraction solutions
- Description of the extraction process for various components
- Comparison of the extraction solutions with other protocols
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.
Facility Design Considerations for Single Use Processes
Case Study BPL - Final Fill using Single Use Technology
- Definition of project scope
- Overall layout and room classification
- Personnel and material flows
- Warehouse and waste management
- Differences from a stainless steel facility
Case Study Janssen - From Traditional Manufacturing to 100% Single Use Technology
- Traditional vs Modern filling of sterile products
- Trials and Tribulations
- Implementation of a SU filling system in a GMP environment
- Final Design
- Continuous improvement & Lessons learned
Case Study GSK Vaccines : Quality requirements for single use systems and filters for the pharmaceutical industry
- In 10 years from traditional stainless steel production to 100% SU technology
- Start-up of a 100% single use virus manufacturing facility
- Process development parallel to qualification of single use items
- Process-fit-to plant
- Partnership with vendors
- GSK Vaccines & QSIM : structure and mission
- Single Use Systems at GSK Vaccines
- Single Use Systems Compliance Qualification
- Concrete example of Compliance Qualification
- GSK Vaccines expectations