- Datum:
-
- Webinar
Single-Use Systems - What you need to know - Live Online Training
- Veranstaltungsort:
- online
- Veranstalter:
- CONCEPT HEIDELBERG GmbH
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 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 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: Implementing Single-Use Systems in Biotech Fill & Finish Operations
- Business Drivers for Implementing Single-Use Systems (SUS)
- Supplier Qualification
- Implementation Process for SUS:
- Risk Management
- On-Site Assembly Qualification and Verification Activities
- Authorization and Usage
- Logistics Control Requirements for SUS
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Deutschland
Telefon: +49 6221 844415
Telefax: +49 6221 844464
eMail: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
