Quality by Design: Industrial Case Studies on Defining and Implementing Design Space for Pharmaceutical Processes (Part 2)
Understanding the relationship between the process and CQAs.
Revitalization, Reform Ahead for The FDA
FDA aims to regain public confidence in 2009.
Buckle-Up Biopharma
Will the global economic crisis affect your job? BioPharm International's third annual salary survey finds out.
Protein Peptide Purification using the Multicolumn Countercurrent Solvent Gradient Purification (MCSGP) Process
A new method for MAb purification.
Facilitating Technology Transfer to Your CMO
How to ensure smooth technology transfers.
Small-Cap Biotech Companies Conserve Cash to Ride Out The Prevailing Economic Conditions
Small biotechs were forced to restructure and downsize.
Integrating Risk Management as an Effective Approach to Root Cause Analysis
Optimize time and cost of product development by managing risk.
Taking on 2009
Looking ahead at the biopharmaceutical industry into 2009.
Serving Two Masters: Reconciling EMEA/GAMP 5 and FDA/cGMP Phase 1
QbD can help satisfy FDA and EMEA requirements.
Standardized, Hands-on Biomanufacturing Training is Essential
The development of a skilled labor force is essential for an expanding biopharmaceutical industry.
