BioPharm International-10-01-2003

Columns and Departments

October 01, 2003

Helium Out-Detects Soap and Water

Biotech companies are among the most intensive instrumentation users of any FDA-regulated business. Because of the complex nature of these companies' research and manufacturing, they typically have a larger number of instruments per employee.

With the biotechnology industry in the early phases of commercialization, many bioprocess companies are just beginning to build and operate commercial-scale production facilities.

New proposals encourage computerized systems and aim to simplify post-approval changes and avoid problems with sterile products.

Congratulations - your emerging biotechnology company is within sight of its first Biological License Application (BLA). This is the culmination of years of research and clinical development.

Columns and Departments

October 01, 2003

Outsourcing is in the public eye as politicians debate the lag in job growth despite a recovering economy, and the Bush Administration seeks to ?competitively source? more agency activities.

The biotechnology and pharmaceutical industries have some overriding concerns, namely regulatory and compliance issues, insufficient manufacturing capacity, and the economic challenges of producing niche drugs and therapies.

When analyzing data, you will sometimes find one value that is far from the others. Such a value is called an outlier. When you encounter an outlier, you may be tempted to delete it from the analysis. Assuming that the data point is not attributable to obvious experimental mistakes, do you keep it or delete it?