edited by Regine Eibl
Single-Use Technology in Biopharmaceutical Manufacture covers commonly-used disposables in the manufacture of biopharmaceuticals, their working principles, characteristics, engineering aspects, economics, and applications.
The book is divided into two parts – the first is related to basic knowledge about disposable equipment; and the second discusses applications through case studies that illustrate manufacturing, quality assurance, and environmental influence.
Contents
Part I: Basics
- Single-use equipment in biopharmaceutical manufacture: A brief introduction
- Single-use bag systems for storage, transportation, freezing and thawing
- Bag mixing systems for single-use
- Single-use bioreactors
- Systems for coupling and sampling
- Disposable sensor systems
- Bio-informatics and single-use
- Single-use downstream equipment
- Single-use technology for formulation and filling applicationvProduction of disposable Bags: A manufacturer’s report
- Disposable filter devices
- Biopharmaceutical manufacturing facilities integrating single-use systems
- An introduction to the validation and qualification of disposables used in biomanufacture - a user’s perspective
- Waste generation, treatment options and the environmental impact of single use systems
- Next generation single-use bioreactor technology and the future of biomanufacturing: A summary from manufacturer’s and user’s perspective
- Single-Use Technology in Biopharmaceutical Manufacture
Part II: Application reports and case studies
- Disposable SuperSpinner: Characteristics and typical applications
- A new scale-down approach for the rapid development of Sf21/BEVS-based processes - a case study
- Practical aspects of establishing pharmaceutical recombinant proteins from research to development in disposable bioreactors
- Single-use stirred tank reactor BIOSTAT CultiBag STR: Characterization and applications
- Single-use bioreactor platform for microbial fermentation
- Growth of BY-2 suspension cells and plantibody production in single-use bioreactors
- CFD as a tool to characterize single-use bioreactors
- Automated disposable systems: Application reports
- New single-use sensors for online measurement of glucose and lactate, the answer to the PAT Initiative
- Disposable Chromatography for large-scale biomanufacturing
- Single-use virus clearance technologies in biopharmaceutical manufacturing: Case studies
- A single-use technology platform for downstream processing: Mobius FlexReady Solutions
- The manufacture of MAbs - a comparison of performance and process time between traditional and ready-to-use, disposable systems
- Going fully disposable - current possibilities: A case study from CrucellvProduction Costs in Biotech Facilities: Single Use vs. Multiple Use Equipment for Antibody Manufacture
Index