BioPharm International-07-01-2006

BioPharm International

Final Word: Using Molecular Tools for Biopharmaceutical Quality Control and Plasmid DNA

July 01, 2006

Columns and Departments

19

7

For decades now, it has been said that "the process is the product" for biologics. Great care and consistency must be applied in their upstream manufacture-during fermentation, harvest, and early purification-to preserve their complex structure, which confers their activity and specificity. As the product moves to late-stage purification, however, the relative concentration of impurities and altered product forms is diminished. Also, the final dosage form of most large molecule biopharmaceuticals is the relatively simple liquid formulation of parenteral dosage form. In contrast, manufacturing the solid dosage forms common for small-molecule drugs involves more complex processes, such as mixing dry powders, granulation, manufacturing controlled-release matrices, and tableting.

From the Editor in Chief: A Shot In The Arm

July 01, 2006

Columns and Departments

19

7

The approvals of two groundbreaking vaccines in the last month is encouraging news. Vaccines have long been undervalued because they haven't been as profitable as other pharmaceuticals. So it's good to see them getting deserved attention that goes beyond fears of flu outbreaks.