BioPharm International, April 2009 - BioPharm International

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BioPharm International, April 2009
Cover
Opalescence of an IgG1 MAb Formulation is Mediated by Ionic Strength and Excipients
By Ning Wang , Binghua Hu , Roxana Ionescu , Henryk Mach , Joyce Sweeney , Christopher Hamm , Marc J. Kirchmeier , Brian K. Meyer
Can increase in ionic strength result in higher viscosity?
Features
A Risk-Based Approach to Deviation Management
By Gail Bredehoeft , Judy OHara
Follow a risk-based approach to maintain a state of control.
Funding Biodefense Vaccine Development
By Sandy Weinberg, PhD
Biodefense start-up companies have an abundance of options when seeking funding.
Columns and Departments
Biotech Industry Reports a Profit but Many Companies Still Struggle for Survival
By G. Steven Burrill
Big biotechs will do just fine in the ongoing financial crisis, but the smaller companies will have more difficulty weathering the storm.
Process Validation Guidance—Redux
By Laura Bush
The 45 comments submitted raised concerns about legacy products and ongoing process monitoring.
Disposables Cost Contributions: A Sensitivity Analysis
By Andrew Sinclair , Miriam Monge
Cost modeling provides valuable insights to support strategic decision-making when implementing disposable technologies.
Adapting to Opportunity
By Mollie Shields-Uehling
The biopharmaceutical industry must continuously evolve to keep up with changing trends.
Expression System Royalties Battle
By Eric S. Langer
With all of the new expressions systems being developed, companies must decide what improved production and yield are really worth.
Food and Drug Safety Crises Prompt White House, Congressional Action
By Jill Wechsler
The FDA is poised to gain more authority and resources to ensure product quality.
Criteria for Selecting a CMO: A Case Study
By David Moyer
"A systematic approach taken by a company involved making an assessment of internal capabilities, strengths, and needs before the selection process."

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