/ BIOPHARM

BioPharm International - January 2012

Wed, 04 Jan 2012 09:08:16 -0500

Your digital edition of BioPharm International - January 2012 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - January 2012
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Perspectives on Outsourcing
- Burrill on Biotech
- Compliance Notes
- Therapeutic Vaccine Outlook
- The Conception and Production of Conjugate Vaccines Using Recombinant DNA Technology
- Ice Fog as a Means to Induce Uniform Ice Nucleation
- Part I: An Overview of Risk Assessment Strategies for Extractables and Leachables
- Ad Index
- New Technology Showcase
- Product Spotlight
- Final Word

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BioPharm International - December 2011

Mon, 05 Dec 2011 20:24:01 -0500

Your digital edition of BioPharm International - December 2011 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - December 2011
- Contents
- Guest Editorial
- Global News
- Regulatory Beat
- Perspectives on Outsourcing
- The Employment Outlook Brightens
- Efficient Prion Removal From Gonadotropin Solutions by Nanofiltration Membranes
- Methods for the Automated Manufacturing of An Autologous Dendritic-Cell Immunotherapy
- New Technology Showcase
- Product Spotlight
- Final Word

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BioPharm International - December 2011

Mon, 05 Dec 2011 20:23:57 -0500

BioPharm International - November 2011 Supplement

Mon, 07 Nov 2011 14:50:24 -0500

Your digital edition of BioPharm International - November 2011 Supplement is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - November 2011 Supplement
- Contents
- Foreword
- Bioreactors
- Single Use
- Vaccine Production and Facilities
- Environmental Impact

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BioPharm International - November 2011

Mon, 07 Nov 2011 14:27:23 -0500

Your digital edition of BioPharm International - November 2011 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - November 2011
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Perspectives on Outsourcing
- Compliance Notes
- Disposables Advisor
- CMOs Ratchet up use of Single-Use Devices
- Biobetters and the Future Biologics Market
- Development and Commercialization in India
- Integrity Testing of Flexible Containers
- Industrializing Design, Development, and Manufacturing
- New Technology Showcase
- Final Word

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BioPharm International - October 2011

Fri, 07 Oct 2011 15:36:24 -0400

Your digital edition of BioPharm International - October 2011 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - October 2011
- Contents
- Guest Editorial
- Global News
- Regulatory Beat
- Burrill on Biotech
- Perspectives on Outsourcing
- Survey Examines Trends in the Outsourcing Relationship
- Trends in Biologics Outsourcing
- Who’s Spending What, and Where?
- Characterization of TrypZean: a Plant-Based Alternative to Bovine-Derived Trypsin
- Perspectives in MicroRNA Therapeutics
- New Technology Showcase
- Spotlight on Separation and Purification
- Final Word

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BioPharm International - October 2011 - Supplement

Fri, 07 Oct 2011 15:34:03 -0400

Your digital edition of BioPharm International - October 2011 - Supplement is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

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BioPharm International - September 2011

Thu, 08 Sep 2011 15:53:30 -0400

Your digital edition of BioPharm International - September 2011 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- Biopharm International - September 2011
- Contents
- Retrospection and Introspection at FDA
- Global News
- Regulatory Beat
- Perspectives on Outsourcing
- Compliance Notes
- Organizing Process Development
- Downstream Processing
- Downstream Technologies
- New Technology Showcase
- Spotlight on Disposables
- Final Word

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BioPharm International - September 2011 Supplement

Tue, 06 Sep 2011 07:33:23 -0400

Your digital edition of BioPharm International - September 2011 Supplement is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - September 2011 Supplement
- Table of Contents
- Inside the National Institutes of Health
- Navigating the Biosimilars Market
- Challenges and Innovations with Prefilled Syringes
- Trends in Prefills
- Single-use Technology: Balancing the Risks and Rewards
- Perception and Cost of Biotech Innovation

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BioPharm International - August 2011

Tue, 02 Aug 2011 15:49:12 -0400

Your digital edition of BioPharm International - August 2011 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - August 2011
- Table of Contents
- From the Editor
- Global News
- Regulatory Beat
- Perspectives on Outsourcing
- Disposables Advisor
- Global Biomanufacturing Facilities
- Efficient Multiproduct Process Development: A Case Study of Enzyme Replacement Therapies
- Challenging the Cleanroom Paradigm for Biopharmaceutical Manufacturing of Bulk Drug Substances
- USP Insights
- New Technology Showcase
- Spotlight on: Fermentation and Cell Culture
- Final Word

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BioPharm International - August 2011 Supplement

Tue, 02 Aug 2011 15:49:06 -0400

Your digital edition of BioPharm International - August 2011 Supplement is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - August 2011 Supplement
- Table of Contents
- Characterizing Biologics Using Dynamic Imaging Particle Analysis
- Analysis of PEGylated Protein by Tetra Detection Size Exclusion Chromatography
- Structural Characterization of Monoclonal Antibodies

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BioPharm International - July 2011

Tue, 21 Jun 2011 16:31:08 -0400

Your digital edition of BioPharm International - July 2011 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - July 2011
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Compliance Notes
- Perspectives on Outsourcing
- Burill on Biotech
- Biopharmaceutical Manufacturing Using Blow-Fill-Seal Technology
- Fermentation Process Technology Transfer for Production of a Recombinant Vaccine Component
- New Technology Showcase
- Spotlight on: Outsourced Services
- Ad Index
- Final Word

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BioPharm International - June 2011

Fri, 27 May 2011 12:21:49 -0400

Your digital edition of BioPharm International - June 2011 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - June 2011
- Contents
- Guest Editorial
- Global News
- Regulatory Beat
- Disposables Advisor
- Perspectives on Outsourcing
- Top 1000 Biomanufacturing Facilities
- Nontuberculosis Mycobacterium Contamination of a Mammalian Cell Bioreactor Process for Biologics Manufacture
- More Data or Smarter Approach?
- The Use of the ATF System to Culture Chinese Hamster Ovary Cells in a Concentrated Fed-Batch System
- Best Practices for Technology Transfer of the Biopharmaceutical Manufacturing Process
- Product Spotlight
- New Technology Showcase
- Final Word

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BioPharm International - May 2011

Fri, 29 Apr 2011 15:28:48 -0400

Your digital edition of BioPharm International - May 2011 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - May 2011
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Compliance Notes
- Outsourcing Insights
- Considerations in Identification and Qualification of Spectrophotometer Equipment for Microbial Fermentations
- Bioengineered Protein A Polymer Beads for High- Affinity Antibody Purification
- Outsourcing Lean Quality Manufacturing
- New Technology Showcase
- Spotlight On: Disposables
- Ad Index/Calendar
- Final Word

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BioPharm International - May 2011 Supplement

Fri, 29 Apr 2011 13:52:33 -0400

Your digital edition of BioPharm International - May 2011 Supplement is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - May 2011 Supplement
- Contents
- Increasing Efficiency in Protein Supply and Cell Production by Combining Single- Use Bioreactor Technology and Perfusion
- Application of Ion Chromatography with Electrochemical Detection in Optimization and Control of Fermentation and Cell Culture
- The Potential Application of Hollow Fiber Bioreactors to Large-Scale Production
- Plants As an Innovative and Accelerated Vaccine-Manufacturing Solution

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BioPharm International - April 2011

Wed, 30 Mar 2011 09:46:25 -0400

Your digital edition of BioPharm International - April 2011 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - April 2011
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Burrill on Biotech
- Perspectives on Outsourcing
- New Binary Gas Integrity Test Improves Membrane Quality Assurance
- Practical Considerations for Demonstrating Drug Substance Uniformity
- Accelerating Bioprocess Optimization
- New Technology Showcase
- Spotlight on: Fermentation & Cell Culture
- Ad Index/Calendar
- Final Word

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BioPharm International - April 2011 - Supplement

Wed, 30 Mar 2011 09:46:21 -0400

Your digital edition of BioPharm International - April 2011 - Supplement is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - April 2011 - Supplement
- Contents
- Innovation and the Art of Downstream Processing
- Addressing the Challenges in Downstream Processing Today and Tomorrow
- Benefits of a Revised Approach to Anion Exchange Flow-Through Polish Chromatography
- Meningitis Vaccine Manufacturing: Fermentation Harvest Procedures Affect Purification

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BioPharm International - March 2011

Tue, 15 Mar 2011 00:00:00 -0400

Your digital edition of BioPharm International - March 2011 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - March 2011
- Table of Contents
- From the Publisher
- Global News
- Regulatory Beat
- Outsourcing Insights
- Compliance Notes
- PDA’s New Technical Report for Biotech Cleaning Validation
- Demonstrating Comparability of Stability Profiles Using Statistical Equivalence Testing
- Risk-Analysis Tools in Process Validation of Biopharmaceutical Drugs
- How Multipurpose is a Disposable Bioreactor?
- Industrialized Production of Human iPSC-Derived Cardiomyocytes for Use in Drug Discovery and Toxicity Testing
- New Technology Showcase
- Spotlight On: Outsourcing
- Ad Index, Calendar
- Final Word

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BioPharm International - March 2011 Supplement

Mon, 14 Mar 2011 10:46:58 -0400

Your digital edition of BioPharm International - March 2011 Supplement is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - March 2011 Supplement
- Contents
- Sponsor-CMO Conflict Management for Clinical-Phase Biologics
- Successful Technology Transfer, Process Validation, and Partnership with a CMO
- Key Considerations When Outsourcing Cell-Culture Medium Development
- Supply-Chain Transformation: Strategic Necessity for the Life Sciences

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BioPharm International - February 2011

Fri, 25 Feb 2011 00:00:00 -0500

Your digital edition of BioPharm International - February 2011 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - February 2011
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Perspectives on Outsourcing
- The Disposables Advisor
- Special Report: Q&A with SFDA
- The Quality Product Steward Model: The Genentech Approach
- Achieving Process Intensification by Scheduling and Debottlenecking Biotech Processes
- An Economic Comparison of Three Cell Culture Techniques: Fed-Batch, Concentrated Fed-Batch, and Concentrated Perfusion
- New Technology Showcase
- Spotlight On: Separation and Purification
- Ad Index, Calendar
- Final Word

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BioPharm International - Feburary 2011 Supplement

Wed, 16 Feb 2011 08:18:16 -0500

Your digital edition of BioPharm International - Feburary 2011 Supplement is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

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BioPharm International - January 2011

Mon, 17 Jan 2011 15:46:39 -0500

Your digital edition of BioPharm International - January 2011 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - January 2011
- Table of Contents
- From the Editor
- Global News
- Regulatory Beat
- Outsourcing Insights
- Burrill on Biotech
- BioPharm International’s 5th Annual Employment Survey
- Comparing Fed-Batch Cell Culture Performances of Stainless Steel and Disposable Bioreactors
- Comparability of Biopharmaceutical Glycosylation During Scale-Up
- New Technology Showcase
- Spotlight On: Disposables
- Ad Index, Calendar
- Final Word

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BioPharm International - January 2011 - Advances in Vaccine Development and Manufacturing

Mon, 17 Jan 2011 14:58:33 -0500

Your digital edition of BioPharm International - January 2011 - Advances in Vaccine Development and Manufacturing is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- Advances in Vaccine Development and Manufacturing
- Table of Contents
- Evolution of Live-Attenuated HIV Vaccines
- Virosomes: A Novel Strategy for Drug Delivery and Targeting
- Toll-Like Receptor Agonists: Not Just for Vaccines Anymore
- Novartis’s Influenza Vaccine Program

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BioPharm International - December 2010

Mon, 06 Dec 2010 08:13:19 -0500

Your digital edition of BioPharm International - December 2010 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - December 2010
- Table of Contents
- From the Editor
- Global News
- Regulatory Beat
- Outsourcing Insights
- The Disposables Advisor
- Safe Freeze–Thaw of Protein Drug Products: A QbD Approach
- Managing Raw Materials in the QbD Paradigm, Part 2: Risk Assessment and Communication
- Getting Better at Making Stuff
- New Technology Showcase
- Spotlight On: Fermentation and Cell Culture
- Ad Index, Calendar
- Final Word

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BioPharm International - November 2010

Tue, 09 Nov 2010 16:07:39 -0500

Your digital edition of BioPharm International - November 2010 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - November 2010
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Compliance Notes
- Systematic Approaches to Develop Chemically Defined Cell Culture Feed Media
- Managing Raw Materials in the QbD Paradigm, Part 1: Understanding Risks
- High-Throughput Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
- New Technology Showcase
- Spotlight on: Outsourced Services
- Classifieds
- Ad Index, Calendar
- Final Word

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BioPharm International - November 2010 Supplement

Mon, 08 Nov 2010 13:40:33 -0500

Your digital edition of BioPharm International - November 2010 Supplement is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - November 2010 Supplement
- Contents
- Regulatory Expectations and Consensus Industry Recommendations for Extractables Testing of Single-Use Process Equipment
- Evaluation of a Single-Use Bioreactor for the Fed-Batch Production of a Monoclonal Antibody
- Disposable Bioreactors for Viral Vaccine Production: Challenges and Opportunities
- An Economic Analysis of Single-Use Tangential Flow Filtration for Biopharmaceutical Applications
- Implementing Single-Use Technology in Tangential Flow Filtration Systems in Clinical Manufacturing

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BioPharm International - October 2010

Wed, 13 Oct 2010 11:34:46 -0400

Your digital edition of BioPharm International - October 2010 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - October 2010
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Outsourcing Insights
- Downstream Trends
- Burrill on Biotech
- Biopharmaceutical Approval Trends in 2009
- The Role of Noncritical Process Parameters in Quality by Design
- New Technology Showcase
- Spotlight On: Separation and Purification
- Ad Index
- Classifieds
- Final Word

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BioPharm International - October 2010 Supplement

Fri, 08 Oct 2010 10:12:37 -0400

Your digital edition of BioPharm International - October 2010 Supplement is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - October 2010 Supplement
- Contents
- An Alternative Platform for Rapid Production of Effective Subunit Vaccines
- Characterization of Aluminum Hydroxide Gel and Oil-in-Water Emulsion Formulations Containing CpG ODNs
- Sterilizing Filtration of Adjuvanted Vaccines: Ensuring Successful Filter Qualification
- Release and Stability Testing Programs for a Novel Virus-Like Particle Vaccine

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BioPharm International - September 2010

Thu, 09 Sep 2010 16:00:17 -0400

Your digital edition of BioPharm International - September 2010 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - September 2010
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Perspectives on Outsourcing
- Compliance Notes
- Design Space Development for Lyophilization Using DOE and Process Modeling
- Label-Free and Labeled Technology for Protein Characterization and Quantitation
- Biosimilars Approvals in the US: The Path Forward
- Spotlight on: Disposables
- New Technology Showcase
- Classifieds
- Calendar
- Ad Index

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BioPharm International - September 2010 - Buyer's Guide

Wed, 08 Sep 2010 10:08:36 -0400

Your digital edition of BioPharm International - September 2010 - Buyer's Guide is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - September 2010 - Buyer's Guide
- Contents
- Product Index
- Cell Culture Media
- Biochemicals & Organic Raw Materials
- Outsourcing
- Contract Consulting & Pharmaceutical Services
- Controlled Environments
- Engineering & Facilities
- Fermentation and Cell Culture Equipment
- Fermentation & Cell Culture
- IT, Automation, and Process Control
- Information Technology
- Laboratory Products and Equipment
- Laboratory Products & Equipment
- Single-Use Bioprocessing Equipment
- Manufacturing Systems
- Downstream Processing
- Separation & Purification
- Company Index

BioPharm International - August 2010

Thu, 12 Aug 2010 00:00:00 -0400

Your digital edition of BioPharm International - August 2010 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - August 2010
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Outsourcing Insights
- Downstream Trends
- The Disposables Advisor
- Development of a Novel Rolling-Tube Cell Culture Platform and Demonstration of System Feasibility
- Meningitis Vaccine Purification: Quality Control of Ultrafiltration Membrane Porosity
- Technical and Economic Benefits of Membrane Chromatography During Polishing Steps
- USP Mycoplasma Tests: A New Regulation for Mycoplasma Testing
- New Technology Showcase
- Spotlight on: Fermentation & Cell Culture
- Calendar
- Ad Index
- Final Word

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BioPharm International - July 2010

Wed, 11 Aug 2010 00:00:00 -0400

Your digital edition of BioPharm International - July 2010 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - July 2010
- Table of Contents
- From the Editor
- Global News
- Regulatory Beat
- Perspectives on Outsourcing
- Compliance Notes
- Burrill on Biotech
- Robust Experimental Strategies for Improving Upstream Productivity
- The Effect of Limiting Phosphate Using the HMS147 Cell Line
- Large-Scale Freezing of Biologics: Understanding Protein and Solute Concentration Changes in a Cryovessel—Part 2
- How to Apply Risk Assessment Techniques to Outsourcing
- What the Pharmaceutical Industry Can Learn from Toyota’s Recalls
- New Technology Showcase
- Spotlight on: Outsourced Services
- Classifieds
- Calendar, Ad Index
- Final Word

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BioPharm International - August 2010 - Supplement

Wed, 04 Aug 2010 16:30:59 -0400

Your digital edition of BioPharm International - August 2010 - Supplement is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - August 2010 - Supplement
- Contents
- Overview
- Comparability
- Biosimilars
- Hydrogen Deuterium Exchange
- NMR Spectroscopy

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BioPharm International - June 2010

Tue, 08 Jun 2010 15:00:34 -0400

Your digital edition of BioPharm International - June 2010 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - June 2010
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Outsourcing Insights
- Downstream Trends
- Manufacturing Economics
- Cleaning Validation
- Manufacturing Equipment
- Process Development
- New Technology Showcase
- Spotlight on Separation & Purification
- Classifieds
- Calendar, Ad Index
- Final Word

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BioPharm International - June 2010 - Supplement

Tue, 08 Jun 2010 10:14:40 -0400

Your digital edition of BioPharm International - June 2010 - Supplement is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - June 2010 - Supplement
- Contents
- Best Practices for Microbial Fermenter Equipment Characterization
- Developing an Automatically Controlled Feeding Process in an E. coli Fermentation Process for Recombinant Protein Production
- Using Information Technology to Enhance Upstream Productivity
- Balancing Media Development with Patient Safety
- Partial Replacement of Chemically Defined Media with Plant-Derived Protein Hydrolysates

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BioPharm International - May 2010

Fri, 30 Apr 2010 10:52:34 -0400

Your digital edition of BioPharm International - May 2010 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - May 2010
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Perspectives on Outsourcing
- Designing in Quality: Approaches to Defining the Design Space for a Monoclonal Antibody Process
- Applying Computational Fluid Dynamics Technology in Bioprocesses—Part 2
- Building Partnerships Between Academia and Biosciences Companies
- New Technology Showcase
- Spotlight On: Disposables
- Classifieds
- Calendar, Ad Index
- Final Word

BioPharm International - April 2010

Mon, 05 Apr 2010 11:56:50 -0400

Your digital edition of BioPharm International - April 2010 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - April 2010
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Outsourcing Insights
- Downstream Trends
- Burrill on Biotech
- A Study of Leachables for Biopharmaceutical Formulations Stored in Rubber-Stoppered Glass Vials
- Applying Computational Fluid Dynamics Technology in Bioprocesses—Part 1
- Developing a MAb Aggregate Removal Step by High Throughput Process Development
- New Technology Showcase
- Spotlight On: Fermentation and Cell Culture
- Classifieds
- Calendar, Ad Index
- Final Word

BioPharm International - March 2010

Thu, 04 Mar 2010 15:51:44 -0500

Your digital edition of BioPharm International - March 2010 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - March 2010
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Perspectives on Outsourcing
- Downstream Trends
- Compliance Notes
- Characterizing the Formulation Design Space
- Mathematical Programming for the Design and Analysis of a Biologics Facility—Part 2
- The Role of Process History in Establishing Clear Technology Transfer Criteria
- New Technology Showcase
- Spotlight On: Outsourcing
- Trends: Contract Manufacturing & Analytical Services
- Classifieds
- Calendar, Ad Index
- Final Word

BioPharm International - February 2010

Wed, 03 Feb 2010 10:42:15 -0500

Your digital edition of BioPharm International - February 2010 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - February 2010
- Table of Contents
- From the Editor
- Global News
- Regulatory Beat
- Outsourcing Insights
- The Disposables Advisor
- Mathematical Programming for the Design and Analysis of a Biologics Facility—Part 1
- Statistical Equivalence Testing for Assessing Bench-Scale Cleanability
- The Purification of Plasmid DNA for Clinical Trials Using Membrane Chromatography
- New Technology Showcase
- Spotlight On: Separation and Purification
- Classifieds
- Ad Index, Calendar

BioPharm International - January 2010

Mon, 11 Jan 2010 12:03:02 -0500

Your digital edition of BioPharm International - January 2010 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - January 2010
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Perspectives on Outsourcing
- Compliance Notes
- Burrill on Biotech
- Can Biopharma Steer Through the Stormy Seas?
- Quality by Design for Biotechnology Products—Part 3
- Setting Specifications for a Biotech Therapeutic Product in the Quality by Design Paradigm
- New Technology Showcase
- Spotlight on: Disposables
- Classifieds
- Ad Index, Calendar
- Final Word

BioPharm International - December 2009

Mon, 07 Dec 2009 11:31:07 -0500

Your digital edition of BioPharm International - December 2009 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - December 2009
- Contents
- From the Editor
- Letters to the Editor
- Global News
- Regulatory Beat
- Outsourcing Insights
- Expression Systems
- The Disposables Advisor
- Quality by Design for Biotechnology Products—Part 2
- The Impact of Disposables on Project Economics in a New Antibody Plant: A Case Study
- Freeze-Thaw Performance and Robustness Assessment of Celsius FFT 6 L
- New Technology Showcase
- Spotlight on: Fermentation & Cell Culture
- Trends: Cell Culture Media
- Calendar, Ad Index
- Final Word

Biopharm International 2010 Media Kit

Thu, 03 Dec 2009 09:37:32 -0500

Your digital edition of Biopharm International 2010 Media Kit is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- Biopharm International 2010 Media Kit
- Branding
- Circulation
- Readership
- Electronic Advertising
- Purchasing Influence
- Supplements
- Columns
- Editorial Calendar
- BioPharm International - US Rates
- BioPharm International - Euro Rates
- Terms and Conditions

BioPharm International - November 2009

Wed, 11 Nov 2009 12:43:13 -0500

Your digital edition of BioPharm International - November 2009 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

BioPharm International - October 2009

Tue, 13 Oct 2009 13:28:37 -0400

Your digital edition of BioPharm International - October 2009 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - October 2009
- From the Editor
- Regulatory Beat
- Outsourcing Insights
- Burrill on Biotech
- Implementing Toyota’s LEAN Systems in Bioprocessing
- A New Technique to Solve Capacity and Quality Concerns
- Biopharmaceutical Approval Trends
- Classifieds
- Advertisers in this Issue
- Final Word

BioPharm International - October 2009 - Sartorius Supplement

Tue, 13 Oct 2009 08:34:51 -0400

Your digital edition of BioPharm International - October 2009 - Sartorius Supplement is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- BioPharm International - October 2009 - Sartorius Supplement
- Contents
- Introduction
- Precipitation
- Salt Tolerant Chromatography
- A Two-Column Platform
- Future Technologies
- HIC Membranes
- AEX Membranes
- Viral Clearance
- Economic Considerations

BioPharm International - September 2009

Thu, 24 Sep 2009 11:53:02 -0400

Your digital edition of BioPharm International - September 2009 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- Contents
- BioPharm International - September 2009
- Quality Risk Management Demystified at CMC Strategy Forum
- The Proper Use of 47-mm Flat Disc Filters in Filter Sizing Studies
- Comparison of Camelid Antibody Ligand to Protein A for Monoclonal Antibody Purification
- Breaking the Rapid Microbiological Method Financial Barrier
- From the Editor
- Global News
- Regulatory Beat
- Perspectives on Outsourcing
- New Technology Showcase
- Spotlight on: Disposables
- Classifieds
- Advertisers in this Issue
- Calendar
- Final Word

BioPharm International - September 2009 Buyer's Guide

Fri, 11 Sep 2009 10:44:23 -0400

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- BioPharm International - September 2009 Buyer's Guide
- Contents
- Product Index
- Cell Culture Media
- Biochemicals & Organic Raw Materials
- Outsourcing
- Contract Consulting & Pharmaceutical Services
- Cleanrooms and Facilities
- Controlled Environments
- Engineering & Facilities
- Fermentation and Cell Culture Equipment
- Fermentation & Cell Culture
- IT, Automation, and Process Control
- Information Technology
- Laboratory Products and Equipment
- Laboratory Products & Equipment
- Single-Use Bioprocessing Equipment
- Manufacturing Systems
- Downstream Processing
- Separation & Purification
- Company Index

BioPharm International - August 2009

Mon, 10 Aug 2009 07:54:31 -0400

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- BioPharm International - August 2009
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Outsourcing Insights
- Expression Systems
- Disposables Advisor
- Quality
- Process Monitoring
- Continuous Improvement
- Manufacturing Economics: Process Modeling
- New Technology Showcase
- Spotlight on: Fermentation & Cell Culture
- Classifieds
- Advertisers in this Issue
- Calendar
- Final Word

BioPharm International - July 2009

Mon, 06 Jul 2009 12:16:18 -0400

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- BioPharm International - July 2009
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Perspectives on Outsourcing
- Compliance Notes
- Burrill on Biotech
- Site-Directed Engineering of Defined Chromosomal Sites for Recombinant Protein and Virus Expression
- High-Cell-Density Culture to Produce Plasmid DNA for Gene Therapy in E. Coli
- Moving Toward a Biosimilars Pathway: The Lines are Drawn in Congress
- New Technology Showcase
- Spotlight on: Outsourced Services
- Classifieds
- Advertisers, Calendar
- Final Word

BioPharm International - June 2009

Mon, 08 Jun 2009 00:00:00 -0400

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- BioPharm International - June 2009
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Outsourcing Insights
- The Disposables Advisor
- Expression Systems
- Best Practices for the Formulation and Manufacturing of Biotech Drug Products
- Using Fluorescence-Based Sensing to Accelerate Process Development
- New Technology Showcase
- Spotlight on: Separation & Purification
- Classifieds
- Advertisers, Calendar
- Final Word

BioPharm International - May 2009

Wed, 03 Jun 2009 00:00:00 -0400

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- BioPharm International - May 2009
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Outsourcing Insights
- Compliance Notes
- Process Monitoring
- Operational Excellence
- Quality By Design
- Outsourcing
- Intellectual Property
- New Technology Showcase
- Spotlight on: Disposables
- Classifieds
- Advertisers, Events Calendar
- Final Word

BioPharm International - April 2009

Thu, 02 Apr 2009 15:40:47 -0400

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- BioPharm International - April 2009
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Perspectives on Outsourcing
- Expression Systems
- Disposables Advisor
- Burrill on Biotech
- Opalescence of an IgG1 Monoclonal Antibody Formulation is Mediated by Ionic Strength and Excipients
- A Risk-Based Approach to Deviation Management
- Funding Biodefense Vaccine Development
- New Technology Showcase
- Spotlight on: Fermentation and Cell Culture
- Classifieds
- Advertisers, Events Calendar
- Final Word

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BioPharm International - March 2009

Mon, 09 Mar 2009 09:56:38 -0400

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- BioPharm International - March 2009
- Contents
- Facility Design
- Cleaning Validation
- Process Chromatography
- Depth Filtration
- From the Editor
- Global News
- Regulatory Beat
- Expression Systems
- New Technology Showcase
- Spotlight on: Outsourced Services
- Classifieds
- Advertisers/Events Calendar
- Final Word

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BioPharm International - February 2009

Wed, 11 Feb 2009 11:14:16 -0500

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- BioPharm International - February 2009
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Outsourcing Insights
- Disposables Advisor
- Versatility of a Single-Use Bioreactor Platform for Culture of Diverse Cell Types
- Upcoming Technologies to Facilitate More Efficient Biologics Manufacturing
- New Technology Showcase
- Spotlight On: Separation and Purification
- Classifieds
- Industry Calendar
- Advertisers in this Issue
- Final Word

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BioPharm International - January 2009

Tue, 20 Jan 2009 12:38:31 -0500

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- BioPharm International - January 2009
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Perspectives on Outsourcing
- GMP Compliance
- Burrill on Biotech
- Salary Survey
- Quality by Design
- Downstream Processing
- Risk Management
- New Technology Showcase
- Spotlight On
- Classifieds
- Industry Calendar
- Advertisers in this Issue
- Final Word

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BioPharm International - December 2008

Mon, 22 Dec 2008 12:21:47 -0500

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- BioPharm International - December 2008
- Contents
- From the Editor
- Regulatory Beat
- India Today
- The Disposables Advisor
- Quality by Design: Industrial Case Studies on Defining and Implementing Design Space for Pharmaceutical Processes—Part 1
- How to Make the Business Case for Quality by Design
- Antibody Purification Using Membrane Adsorbers

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BioPharm International - November 2008

Fri, 21 Nov 2008 11:02:38 -0500

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- BioPharm International - November 2008
- Contents
- From the Editor
- Regulatory Beat
- Outsourcing Insights
- Statistics Essentials
- Aggregates in MAbs and Recombinant Therapeutic Proteins: A Regulatory Perspective
- Applying Operational Excellence Concepts to Biopharmaceutical Processing

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BioPharm International - October 2008

Wed, 29 Oct 2008 09:16:13 -0400

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- BioPharm International - October 2008
- Contents
- From the Editor
- Regulatory Beat
- Perspectives on Outsourcing
- Burrill on Biotech
- Biopharmaceuticals: Approval Trends in 2007
- Where is Biopharmaceutical Manufacturing Heading?
- Final Word

BioPharm International - September 2008

Tue, 23 Sep 2008 09:23:56 -0400

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- BioPharm International - September 2008
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Outsourcing Insights
- Compliance Notes
- Plasmid DNA Recovery Using Size-Exclusion and Perfusion Chromatography
- Virus Clearance Strategy Using a Three-Tier Orthogonal Technology Platform

BioPharm International - August 2008

Tue, 19 Aug 2008 16:09:48 -0400

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- BioPharm International - August 2008
- Contents
- From the Editor
- Regulatory Beat
- India Today
- Modeling of Biopharmaceutical Processes—Part 2: Process Chromatography Unit Operation
- A Rational Approach for Setting and Maintaining Specifications for Biological and Biotechnology-Derived Products—Part 3
- Final Word

BioPharm International - July 2008

Wed, 16 Jul 2008 13:13:21 -0400

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- BioPharm International - July 2008
- Contents
- From the Editor
- Regulatory Beat
- India Today
- A Rational Approach to Specifications
- Best Methods to Optimize Tangential Flow Filtration Yield
- Final Word

Biopharm Intl_Novozymes Biopharma UK LTD - Reprint 49286013

Mon, 14 Jul 2008 11:41:45 -0400

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BioPharm International - June 2008

Tue, 17 Jun 2008 11:38:14 -0400

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- BioPharm International - June 2008
- Contents
- From the Editor
- Regulatory Beat
- Burrill on Biotech
- A Rational Approach for Setting and Maintaining Specifications for Biological and Biotechnology–Derived Products—Part 1
- Modeling of Biopharmaceutical Processes— Part 1: Microbial and Mammalian Unit Operations
- Final Word

BioPharm International - May 2008

Tue, 27 May 2008 17:05:24 -0400

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- BioPharm International - May 2008
- Contents
- From the Editor
- Outsourcing Insights
- India Today
- Compliance Notes
- Harvest and Recovery of Monoclonal Anitbodies from Large-Scale Mammalian Cell Culture
- Impact of Lot-to-Lot Variability of Cation Exchange Chromatography Resin on Process Performance
- Final Word

BioPharm International - April 2008

Fri, 25 Apr 2008 13:43:26 -0400

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- BioPharm International - April 2008
- Contents
- From the Editor
- Regulatory Beat
- India Today
- Disposables Advisor
- Legal Briefs
- Leveraging Fermentation Heat Transfer Data to Better Understand Metabolic Activity
- Filter Clogging Issues in Sterile Filtration
- Final Word

BioPharm International - March 2008

Thu, 27 Mar 2008 09:54:40 -0400

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- BioPharm International - March 2008
- Contents
- From the Editor
- Regulatory Beat
- Burrill on Biotech
- Evaluation of Dendritic Cell Products Generated for Human Therapy and Post-Treatment Immune Monitoring
- Cleaning Validation for Biopharmaceutical Manufacturing at Genentech: Part 2
- Final Word

BioPharm International - February 2008

Wed, 27 Feb 2008 07:47:53 -0500

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- BioPharm International - February 2008
- Contents
- From the Editor
- Regulatory Beat
- Cleaning Validation for Biopharmaceutical Manufacturing at Genentech: Part 1
- Extractables and Leachables Study Approach for Disposable Materials Used in Bioprocessing
- Final Word

BioPharm International - January 2008

Mon, 28 Jan 2008 11:02:51 -0500

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- BioPharm International - January 2008
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Compliance Notes
- Salary Survey: Satisfied, Well Paid, and Secure
- Quality: Elements of Quality By Design in Development and Scale-Up of Freeze-Dried Parenterals
- Final Word

BioPharm International - December 2007

Thu, 20 Dec 2007 12:05:29 -0500

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- BioPharm International - December 2007
- Contents
- From the Editor
- Global News
- Regulatory Beat
- Quality: Quality by Design in the CMO Environment
- Validation: Developing a Sound Process Validation Strategy
- Final Word

BioPharm International - November 2007

Mon, 26 Nov 2007 11:54:10 -0500

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- BioPharm International - November 2007
- Contents
- From the Editor
- Global News
- Regulatory Beat
- China Today
- What Follow-on Biologics Mean for the Future of the Biotechnology Industry
- Engineering Biopharmaceuticals
- A History of the OOS Problem
- Final Word

BioPharm International - October 2007

Fri, 26 Oct 2007 10:51:20 -0400

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- BioPharm International - October 2007
- Contents
- From the Editor
- Biotechnology: Past, Present, and Future
- The Evolution of Protein Expression and Cell Culture
- Biotech Manufacturing Grows Up
- The Changing Landscape of Global Vaccine Development and Market Potential
- Final Word

Supplement to: BioPharm International - October 2007

Thu, 18 Oct 2007 07:12:30 -0400

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- Supplement to: BioPharm International - October 2007
- Table of Contents
- Introduction
- Alternatives to Protein A
- Endotoxin Reduction
- Flux Decay
- Integration of Disposables
- Membrane Chromatography
- Disposables: Cost Analysis
- Perspective

BioPharm International - September 2007

Mon, 24 Sep 2007 07:42:11 -0400

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- Contents
- From the Editor
- Global News
- Regulatory Beat
- Outsourcing Insights
- Lifetime Studies for Membrane Reuse: Principles and Case Studies
- Evaluation of an Instantaneous Microbial Detection System in Controlled and Cleanroom Environments
- Final Word

BioPharm International - August 2007

Fri, 24 Aug 2007 13:55:38 -0400

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- Contents
- From the Editor
- Global News
- Deals
- Regulatory Beat
- China Today
- Street Talk
- Think Like a Scientist - Behave Like a Business
- Patent Strategies for Biotechnology Enterprises
- Final Word

BioPharm International - July 2007

Mon, 30 Jul 2007 14:33:02 -0400

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- Contents
- From the Editor
- Global News
- Regulatory Beat
- China Today
- Outsourcing Insights
- Maximizing Process Data From Development to Manufacturing
- Regulatory Considerations Regarding Quality Aspects of Monoclonal Antibodies
- The Biovest AutovaxID: Enabling the Promise of Personalized Medicine

BioPharm International - June 2007

Mon, 25 Jun 2007 07:57:02 -0400

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- Contents
- From the Editor
- Global News
- Global Deals
- Regulatory Beat
- Using Tolerance Intervals for Setting Process Validation Acceptance Criteria
- Biopharmaceutical Disposables as a Disruptive Future Technology
- Final Word

BioPharm International - May 2007

Fri, 25 May 2007 15:19:52 -0400

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- Contents
- From the Editor
- Global News
- Global Deals
- Regulatory Beat
- Outsourcing Insights
- A Two-Column Process to Purify Antibodies Without Protein A
- Endotoxin Reduction Using Disposable Membrane Adsorption Technology in cGMP Manufacturing
- Final Word

BioPharm International - April 2007

Tue, 24 Apr 2007 13:52:30 -0400

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- Contents
- From the Editor
- Global News
- Regulatory Beat
- Street Talk
- Design Space for Biotech Products
- Biopharmaceutical Operations Roadmap 2007
- The Effect of Flux Decay on a 20-nm Nanofilter for Virus Retention
- Final Word

BioPharm International - March 2007

Thu, 29 Mar 2007 13:03:09 -0400

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- Contents
- From the Editor
- Global News
- Regulatory Beat
- China Today
- Outsourcing Insights
- Platform Technology forDeveloping Purification Processes
- Global Deals
- Generating Stable, High-Expressing Cell Lines forRecombinant Protein Manufacture

Biopharm International - February 2007

Mon, 26 Feb 2007 15:10:25 -0500

Your digital edition of Biopharm International - February 2007 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- Contents
- From the Editor
- Global News
- Regulatory Beat
- Outsourcing Insights
- Biologics Manufacturing: The CMO Advantage
- Using Risk Analysis in Process Validation
- Patent or Padlock: Patents and Trade Secrets Form the Heart of an Effective IP Strategy
- Final Word

BioPharm - January 2007

Tue, 30 Jan 2007 13:39:24 -0500

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- Contents
- From The Editor
- Global News
- Regulatory Beat
- Street Talk
- China Today
- Outstourcing Insights
- IP Briefs
- Is Your Paycheck as Robust as Your Proteins?
- A Revalidation Study of Viral Clearance in the Purification of Monoclonal Antibody CB.Hep-1
- Final Word

BioPharm International - December 2006

Thu, 28 Dec 2006 12:39:15 -0500

Your digital edition of BioPharm International - December 2006 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- Contents
- From the Editor
- Global News
- Global Deals
- Operations Excellence
- Street Talk
- Regulatory Beat
- Analytical Methods
- Quality Control
- Final Word
- Outsourcing

BioPharm International - November 2006

Wed, 15 Nov 2006 09:02:13 -0500

Your digital edition of BioPharm International - November 2006 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- Contents
- From the Editor
- Global News
- Global Deals
- Legal Forum
- Street Talk
- Regulatory Beat
- Setting Acceptance Criteria From Statistics of the Data
- Improving Productivity in Downstream Processing
- Economic Analysis Applied to Harvest of a High Cell-Density Fermentation
- Make Technology Transfer a Competitive Advantage
- Technology Showcase
- Final Word

BioPharm International - October 2006

Thu, 26 Oct 2006 12:58:17 -0400

Your digital edition of BioPharm International - October 2006 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- Contents
- From the Editor
- Global News
- Global Deals
- Street Talk
- Regulatory Beat
- Outsourcing
- Virus Removal by Filtration: Points to Consider
- A Guide for Testing Biopharmaceuticals. Part 2: Acceptance Criteria and Analytical Maintenance
- Enhanced Packaging and Reformulations Give New Life to Biologics
- Successful Technology Transfer Requires More Than Technical Know-How
- Technology Showcase
- Final Word