BioPharm International-06-02-2006

The polishing process-unlike capturing-is beginning to benefit from technological advances.

The purpose of the PAT initiative is to move analytical laboratory functions close to the manufacturing process to improve manufacturing efficiency and product quality.

Biotech companies are running into production bottlenecks because standard purification and separation technologies lack the capability to remove the elevated levels of biomass from high titer solutions. Recent developments in filter technology offer the biotech industry a cost-effective solution to processing challenges by reducing bottlenecks, thereby accelerating the time-to-market of new drugs.

Using packed columns in process development activities limits the scope for appraising a large and diverse range of media.

Downstream process design can increase facility output through improved overall process yield or higher batch capacity in mass and volume.

The overall average flux rate for the concentration and diafiltration step was 41 L m–2 h–1.