BioPharm International-09-01-2008

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

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

Scalable method to recover plasmid-DNA.

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.

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.

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

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.