BioPharm International-04-01-2006

Featured Article

April 01, 2006

The type of reactive moiety controls the site and stability of the covalent link and also the total number of PEGylation sites on a given protein.

RFID is currently the most advanced tracking technology, but manufacturers need to pursue a multilayered approach . . .

Columns and Departments

April 01, 2006

Coming from Wall Street. I'm often asked what "professional" investors think about the life sciences industry.

Columns and Departments

April 01, 2006

Interestingly, it is companies that already have the most capacity available to them that are building even more.

Columns and Departments

April 01, 2006

In recent years, FDA has made positive moves to foster innovation by streamling regulation. But the agency's recent proposal to exempt manufacturing for phase 1 clinical trials from GMP requirements seems ill advised.

Articles

April 01, 2006

Of all the protein products on the US market, at most 75 are likely to become genericized.

In the pharmaceutical industry, ultrafiltration (UF) membranes are used extensively in the downstream purification of recombinant proteins or monoclonal antibodies. However, the fouling of membranes after a unit operation?especially when recombinant proteins or monoclonal antibodies are highly concentrated?is a common problem. Typically, normalized water permeability (NWP) of a membrane can be reduced to about 20 percent of its original permeability at the end of an ultrafiltration-diafiltration (UF-DF) operation.

On January 17, 2006, the FDA released new regulations, effective June 1, 2006, which affect the production of most investigational drug and biologic products intended for phase 1 clinical trials. These regulations are much broader in scope than the Exploratory IND guidance released on the same day, and which apply only to low-risk, CDER-regulated clinical studies.