Final Word - BioPharm International


Final Word

How to Develop a Pool of Talented People

November 1, 2007

CMOs must take a proactive approach to ensure the availability of local talent

Back to the Future

October 1, 2007

One company even connected hollow fiber cell culture chambers to living cows.

Final Word: Outsourcing in Today's Risk-Based Environment

June 1, 2007

Outsourcing has been a cornerstone of our industry for decades.

Final Word: Should You Need FDA Approval to Make Manufacturing Changes?

February 1, 2007

The pharmaceutical industry is well aware that FDA is trying to take a risk-based approach to enforcing the current good manufacturing practices (cGMP) regulations. This approach is driven by an economic reality: FDA simply does not have the resources to inspect every facility every other year. The organization doesn't even have the resources to inspect facilities every three years. Likewise, it is not cost-effective for our companies to carry out a complete, documentation-oriented revalidation for every process change, regardless of its significance or risk.

Final Word: Regulatory Evolution

January 1, 2007

How much do regulatory agencies know about nanotechnology or microfluidics? Yesterday, the answer was probably, "not much." Tomorrow, it may be "a lot." The reason is that new technologies push the agencies to expand their expertise.

Final Word: New Organization Forms to Help FDA Fulfill its Mission

December 1, 2006

A key to bolstering FDA and its mission is securing balanced and consistent funding.

Final Word: Outsourcing to Developing Countries

November 1, 2006

In the rush to save money, the consequences of potential problems often are ignored.

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

July 1, 2006

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.

Final Word: The US is Falling Behind on Generic Biopharmaceuticals

June 1, 2006

Without generic competition, the US is at risk of losing its position of leadership in biopharmaceuticals.



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