BioPharm International-07-01-2006

Many CMO relationships are established while a product is early in clinical or preclinical development.

Federal regulations are broad and open to interpretation. Most have not caught up with advancements in technology.

Disposables require less space than conventional equipment, and they can be assembled offsite into complete process trains.

A novel calibration approach was developed that not only calibrates the X-axis, but also calibrates the peak shape.

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.

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.

Food and Drug Administration is encouraging public–private collaborations to more fully explore the physical and chemical characteristics of nanoparticles.

The lack of biomanufacturer acquisitions seems surprising.

The courts regard biotechnology as highly unpredictable