BioPharm International, July 2010 Issue (PDF)
Robust Strategies to Optimize Processes
How to Apply Risk Assessment Techniques to Outsourcing
Apply risk management principles to monitor outsourced activities.
Capital Market's Woes Weigh Heavily on Biotech
After a bright start to the year, some of biotech's blue chip companies have seen their early gains turn into losses.
How Outsourcing Can Accelerate Early CMC Development
How much to spend on early development, whether to use your CMO's proprietary cell line, and other outsourcing advice.
Robust Experimental Strategies for Improving Upstream Productivity
Identify the best experimentation methods for the data you need.
How to Reduce Unnecessary Compliance Costs
By identifying and eliminating non-value-added activities, drug manufacturers can avoid falling into the same cost-traps in the future.
Large-Scale Freezing of Biologics: Understanding Protein and Solute Concentration Changes in a Cryovessel—Part 2
Highly Similar
A single standard should apply to all comparability exercises for biologics, be they for biosimilars or manufacturing changes.
Industry Input Needed on Bioassay Standards
USP is advancing efforts to develop a guidance for evaluating bioassays.
The Effect of Limiting Phosphate Using the HMS174 Cell Line
The HMS174 strain, in the absence or presence of excess phosphate, can metabolize acetate efficiently.
What the Pharmaceutical Industry Can Learn From Toyota's Recalls
Twelve lessons of what to do and what not to do to avoid quality problems.
FDA Seeks Transparency in Data and Decisions
More information may be available on drug approvals, prices, and research to expand public understanding of regulatory policies.
