BioPharm International, July 2010 - BioPharm International

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BioPharm International, July 2010
Features
The Effect of Limiting Phosphate Using the HMS174 Cell Line
By Garner G. Moulton , Thomas S. Vedvick
The HMS174 strain, in the absence or presence of excess phosphate, can metabolize acetate efficiently.
Robust Experimental Strategies for Improving Upstream Productivity
By Ronald D. Snee, PhD
Identify the best experimentation methods for the data you need.
Large-Scale Freezing of Biologics: Understanding Protein and Solute Concentration Changes in a Cryovessel—Part 2
By Parag Kolhe , Elisabeth Holding , Alanta Lary , Steven Chico , Satish K. Singh
How to Apply Risk Assessment Techniques to Outsourcing
By Dawn Schofield
Apply risk management principles to monitor outsourced activities.
What the Pharmaceutical Industry Can Learn From Toyota's Recalls
By Robert N. Borghese
Twelve lessons of what to do and what not to do to avoid quality problems.
Regulatory Beat
FDA Seeks Transparency in Data and Decisions
By Jill Wechsler
More information may be available on drug approvals, prices, and research to expand public understanding of regulatory policies.
Final Word
Industry Input Needed on Bioassay Standards
By Tina S. Morris, PhD
USP is advancing efforts to develop a guidance for evaluating bioassays.
From the Editor
Highly Similar
By Laura Bush
A single standard should apply to all comparability exercises for biologics, be they for biosimilars or manufacturing changes.
Perspectives on Outsourcing
How Outsourcing Can Accelerate Early CMC Development
By Jim Miller , Susan Dana Jones
How much to spend on early development, whether to use your CMO's proprietary cell line, and other outsourcing advice.
Compliance Notes
How to Reduce Unnecessary Compliance Costs
By James P. Catania
By identifying and eliminating non-value-added activities, drug manufacturers can avoid falling into the same cost-traps in the future.
Burrill on Biotech
Capital Market's Woes Weigh Heavily on Biotech
By G. Steven Burrill
After a bright start to the year, some of biotech's blue chip companies have seen their early gains turn into losses.

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