BioPharm International-09-01-2008

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September 01, 2008

There are several challenges associated with protecting patents for personalized medicines.

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September 01, 2008

Statistical methods for calculating confidence intervals, tolerance intervals, and capability analysis to reduce out-of-specification situations.

Scalable method to recover plasmid-DNA.

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September 01, 2008

Every biotech company reaches a point in its development where it must decide what path it will take after it passes the start-up phase. This article discusses what the company must consider to decide what business model it will follow.

How to implement a risk-based approach to eliminating viruses.

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September 01, 2008

The heparin debacle and other crises involving imported drugs and biologics has put pressure on the US FDA to step up its oversight of foreign drug manufacturing.

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September 01, 2008

Risk mitigation should be a key aspect of any contract manufacturing organization's business strategy.

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September 01, 2008

The complexity of Quality by Design leads naturally to questions of how much work it requires, how many companies have the resources to do it, and what the payoff is for anybody.