Biodisposables Utility and Technological Advances : Market Research Report

Biodisposables Utility and Technological Advances

Published by: Drug and Market Development Publishing

Published: Jun. 1, 2006 - 166 Pages

Chapter 1: Executive Summary
Chapter 2: Economics of Biodisposables: Efficient, Fast and Flexible: Product Development; Disposable Technology and Contract Manufacturing (CMOs); Drivers for Single-Use Disposable Systems; Disposable Bag Technology—Pacific GMP, AppTec, Stedim; Market Implementation; Industrial Advantages of Disposable Components; Return of Investment (ROI) Options; Process Comparison Models; Disposables Reduce Overall Cost of Manufacture; Conversion from Stainless Steel Equipment to Disposable Filtration; Disposable Filters—For Use in Chromatography; Summary
Chapter 3: Disposable Bioreactors: Scaling Up Logistics; Comparison and Validation of Disposable Bioreactor Systems; Growing Cells in Bags—Wave Cellbags® Characteristics; Factors that Amplify the Bioreactor’s Yield; Disposable Bioreactor Flasks, Bottles, and Other Containers; Multi Laminate Plastic Bags
Chapter 4: Downstream Processing and Separation Sciences: Disposable Downstream Processing; Disposable Mixing, Filling and Sampling—HyNetic, Alfa Laval Biokinetic, Millipore, LevTech, Acerta, Nova Aseptic; Sterile Connectors and Clean Room Technology; Separation Sciences: Filtration and Chromatography; Sterile Filtration—Sartorius, Millipore, Pall Corp; Disposable Filter Capsules and Chromatography Columns; Affinity Chromatography and Antibody Purification; Inline Filters for Disposable Bioreactors; Recovery of Cell Products through Chromatography; Cross/Tangential Flow Filters in Cell Processing and Diafiltration; Blood and Serum Fractionation; Biosep Accoustic Technology—Applikon
Chapter 5: Biodisposables—Facility Design and: Future Developments; Facility Design Capabilities with Disposables; Multi-Component Systems; Functional and Environmental Constraints; Optimizing Facility Design; Regulatory Considerations for Disposable Component Validation; Future Outlook of Disposables; Market Projections
Table of Exhibits: Exhibit 2.1. Strategic Outlook for Biodisposables; Exhibit 2.2. Disposable Components and Suppliers for Manufacturing of Biologicsand Pharmaceuticals; Exhibit 2.3. Hierarchical Representation of Biomanufacturing Tasks; Exhibit 2.4. Reasons for Implementing Biodisposables; Exhibit 2.5. Costs of a.Model Monoclonal Antibody Plant; Exhibit 2.6. Cost of Goods Cap-Ex,.Materials,.and Labor in a.Disposable Module Plant; Exhibit 2.7. COGS from 100 L Plant; Exhibit 2.8. COGS from 1,000L Plant; Exhibit 2.9. COGS from 10,000 L Plant; Exhibit 2.10. Analysis Reported by the FDA CBER on Cost Manufacturing; Exhibit 2.11. Capital Required and Cost Savings of Disposable Model; Exhibit 2.12. Cost Analysis of Reusable Fermenters vs..Disposable Bioreactors; Exhibit 2.13. Input and Output Parameters of an Analysis Tool; Exhibit 2.14. Disposable Technology and Conventional Pilot Plant COG Analyses; Exhibit 2.15. Comparison of Equipment and Consumables in the Model Study; Exhibit 2.16. Annual.(COG/g).on a.Cost Category Basis for Pilot Plant,Disposables-based.(DISP).Pilot Plant,.and Hybrid.(HYB).Pilot Plant; Exhibit 2.17. Comparison of Set-up Times and Cost of Single-use CartridgeFilter and Stainless Steel Housing; Exhibit 2.18. Comparison of Process Time and Cost for Traditional Column andMembrane Chromatography Capsule; Exhibit 3.1. Types of Disposable Bioreactors; Exhibit 3.2. Principle of the Wave Bioreactor; Exhibit 3.3. Cellbag Connectors and Biocompatibility Testing; Exhibit 3.4. Research,.Pilot,.and Production Scale Wave Bioreactors; Exhibit 3.5. Comparison of Daily Recombinant Protein Yields.(mg/L).for Three WaveBioreactors; Exhibit 3.6. Monoclonal Antibody Yields for System20/50EH; Exhibit 3.7. Carriers Used to Cultivate Attachment-dependent Cells in theWave Bioreactor; Exhibit 3.8. Adenovirus Production and Recovery in HEK293 Cells using aWave Bioreactor with Cytodex-3 Micro Carriers; Exhibit 3.9. Use of Floating Perfusion Filter with Perfusion Controller inWave Bioreactor; Exhibit 3.10. Comparison of Batch and Perfusion Modes for MAb Production in theWave Bioreactor.(System 20/50EH); Exhibit 3.11. Comparisons of Batch and Perfusion MAb Production with 2L Cellbag; Exhibit 3.12. Tsunami Multiple Wave Agitated Culture System; Exhibit 3.13. Excellerex Disposable Bioreactors; Exhibit 3.14. AppliFlex Disposable Cell Culture Bag System; Exhibit 3.15. LifeReactor Plant Cell Bag Culture System; Exhibit 3.16. Cellexus Biosystems Optimized Cell Growing Chamber; Exhibit 3.17. Bags are more Stable than Bottles; Exhibit 3.18. Integra CELLine Disposable Bioreactor Flask; Exhibit 3.19. Cost and Yield for Monoclonal Production in CELLine and Other Systems; Exhibit 3.20. Comparisons of CellLine,.Roller Bottle Grown,.and Bioreactor; Exhibit 3.21. FiberCell Module and Flowpath Assembly with Medium Reservoir Bottle; Exhibit 3.22. Rotary Perfusion RCCS-D and.-4D Disposable Bioreactors; Exhibit 3.23. Cellstation High-throughput Bioreactor with Disposable Culture Vessels; Exhibit 3.24. RollerCell40 Automated Bottle System; Exhibit 3.25. Corning’s CellCube®.System; Exhibit 3.26. Growth of Cells under Different Seeding Densities in the CellCube System; Exhibit 3.27. Flexel 3D Bag Bioreactor Harvesting System; Exhibit 3.28. Composition of Flexel 3D Bags; Exhibit 3.29. Xcellerex Disposable Bags and Mixing Systems; Exhibit 4.1. Downstream Processing Applications for Disposables; Exhibit 4.2. Disposable Fluid Paths:.Final Fill and Finish; Exhibit 4.3. Acerta 4 Head Filler; Exhibit 4.4. NovAseptic Sampling System with 9-Port NovaSeptum Connector; Exhibit 4.5. Pall’s Kleenpak Sterile Disposable Connector System; Exhibit 4.6. Millipore’s Lynx S2S.“Sliding Gate”.Sterile Connector; Exhibit 4.7. Ready to Run SIP Connected System:.Sterilization of theConnection Between Millipore’s Lynx ST and SS Tank Interface; Exhibit 4.8. NovAseptic SIP Connected System with Welded Connectors andDisposable Sampling; Exhibit 4.9. Matching Downstream Processing to Disposable Product; Exhibit 4.10. Disposables in Separation Sciences; Exhibit 4.11. Applications of Sterile Filtration; Exhibit 4.12. Applications of CUNO’s LifeAssure Filters; Exhibit 4.13. Disposable Manifolded Filtration System with SupraClean Depth Filters; Exhibit 4.14. Phases of Biomanufacturing Utilizing Disposable Filters andChromatography Units; Exhibit 4.15. Typical Production Scale Enzyme Purification with Multiple Filtration Steps; Exhibit 4.16. Sartorius SingleSep Disposable.“Multiuse”.(Autoclavable).Capsules; Exhibit 4.17. Virus Elimination from Monoclonal Antibody Preparation.(Eluate from AffinityColumn).Prior to Sterile Filtration and Fill:.High LRV and MAb Recovery; Exhibit 4.18. Antibody Downstream Processing; Exhibit 4.19. Inline Filters for Disposable Bioreactors; Exhibit 4.20. Online Affinity Purification System; Exhibit 4.21. CUNO’s Bioassure PES Filters for Cell and Immunoglobulin Recovery; Exhibit 4.22. CFF Process Modes Affecting Cell Yield; Exhibit 4.23. Cross Flow Hollow Fiber Membrane System for Aseptic Cell Processing; Exhibit 4.24. Purification of Biopharmaceuticals Using AmershamBiosciences CFF Columns; Exhibit 4.25. SciLog’s Automated Bioprocessing System with Disposable TFF Filtration; Exhibit 4.26. Disposable CUNO Filter Types Used In Multilevel Blood Fractionation; Exhibit 4.27. Comparison of Single-use and Stainless Steel BSA Purification Systems; Exhibit 4.28. BioSep Cell Retention System; Exhibit 5.1. Single-use Technology Implementation Approach; Exhibit 5.2. Layout of Facility Implementing Disposables with Functional andEnvironmental Classifications; Exhibit 5.3. Disposable Design Optimization; Exhibit 5.4. Validation Testing Methods and Standards; Exhibit 5.5. Automated Remote FlexFactory Operation

Abstract

D&MD's Growth and Technological Advances of the Biodisposables Market is valuable tool. The report details and reviews the implementation, cost-effectiveness, utility and applications, including advances in specific apparatus, for disposable biotechnology equipment including filters, mixers, dispensers, connectors, storage bags and bioreactors.

The report provides the market research necessary to design and implement a disposable biotech facility including the latest disposable technologies and applications from leading industry users. In addition, detailed examples for analyzing cost of goods and savings are provided to assist professionals attempting to determine the utility of disposables in their own facility.

The report details and reviews the implementation, cost-effectiveness, utility and applications, including advances in specific apparatus, for disposable biotechnology equipment including filters, mixers, dispensers, connectors, storage bags and bioreactors. As such, the compendium provides an indispensable resource for start-up biotech companies and Contract Manufacturing Organizations (CMOs) wishing to switch to disposable products from stainless steal and multi-use devices.

Unique to this publication is the extensive showcasing of all applicable biotech disposable products and categories. Professionals will not be limited in selecting and understanding the principles of disposable technology, but will have available resources at hand to make informed choices and design specifications. Multiple expert opinions and case studies have been synthesized to provide the reader with a firm knowledge base on how to utilize disposables from the research and pilot scales to large-scale production. Personal experience of the writers with disposables ensures adequate presentation of the advantages and disadvantages.

Questions Answered

Why the use of biodisposables is growing?
Why conventional biotech labs should implement disposable technology?
What are the benefits of utilizing biodisposables including industry drivers?
How to validate and implement disposable technology?
Who are the key players and participants in the disposable market?

Market Opportunities

The value of the primary and secondary US biomanufacturing market in 2006 is estimated to be approximately $50 billion with a healthy growth rate almost approaching double digits due to the escalating number of biotech drugs in the pipeline and skyrocketing sales of approved high value, life saving biopharmaceticals. Cartridges used for filtering liquids represent a $10.8 billion dollar market now but by 2009 sales will reach an annual level of $14.2 billion. The market for membrane technology used in biopharmaceutical discovery, development and commercial production, estimated at $740 million dollars in 2004, is expected to rise at an average annual growth rate (AAGR) of 10.7% to over $900 million in 2008 and to $1.23 billion in 2009. The biopharmaceutical industry in the US has grown by an average of 11% annually from 1993 to 2003.

This publication is valuable to start-up biotech as a how-to and resource management guide for implementing biodisposables in their manufacturing or research facilities. The topic is also viable in regards to the huge spike in biodisposable products flooding the market. Not only are producers of biologics able to benefit from this report, but those designing and manufacturing biodisposables can benefit from this report by careful analysis of the competition and all described applications.

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Biodisposables Utility and Technological Advances

Table of Contents

Abstract