Single-Use Systems for Sterile & Biotech Applications

Programme

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, Certification
• Risk mitigation practices: process particulate control, Operator training
• Leachables & Extractables: Patient safety evaluation, study design, Support by the supplier

The USP’s Approach to Single-Use Components and Systems used in the Manufacture of Drug Products

• 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 Role of Extractables Data in the Effective 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.

Facility Design Considerations for Single Use Processes

• 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 BPL - Final Fill using 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 Janssen - From Traditional Manufacturing to 100% Single Use Technology

• 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

Case Study GSK Vaccines : Quality requirements for single use systems and filters for the pharmaceutical industry

• 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