Biotech Industry Reports a Profit but Many Companies Still Struggle for Survival
Big biotechs will do just fine in the ongoing financial crisis, but the smaller companies will have more difficulty weathering the storm.
A Risk-Based Approach to Deviation Management
Follow a risk-based approach to maintain a state of control.
Funding Biodefense Vaccine Development
Biodefense start-up companies have an abundance of options when seeking funding.
Food and Drug Safety Crises Prompt White House, Congressional Action
The FDA is poised to gain more authority and resources to ensure product quality.
Criteria for Selecting a CMO: A Case Study
"A systematic approach taken by a company involved making an assessment of internal capabilities, strengths, and needs before the selection process."
Expression System Royalties Battle
With all of the new expressions systems being developed, companies must decide what improved production and yield are really worth.
Opalescence of an IgG1 Monoclonal Antibody Formulation is Mediated by Ionic Strength and Excipients
Can increase in ionic strength result in higher viscosity?
Process Validation Guidance—Redux
The 45 comments submitted raised concerns about legacy products and ongoing process monitoring.
Adapting to Opportunity
The biopharmaceutical industry must continuously evolve to keep up with changing trends.
Disposables Cost Contributions: A Sensitivity Analysis
Cost modeling provides valuable insights to support strategic decision-making when implementing disposable technologies.
