BioPharm International-02-01-2007

A series of ICH guidances are encouraging industry to adopt quality-based approaches for achieving the "desired state" of drug and biotech manufacturing: more efficient and flexible operations that can reliably produce high quality therapies with less regulatory oversight.

The recent FDA decision that meat from cloned animals is safe for human consumption seems logical enough. A protein is a protein. But even if we can eat such meat, it doesn't necessarily make economic or ecological sense to do so.

Utility patents are granted to anyone who invents any new and useful process, machine, article of manufacture, composition of matter, or any new improvement thereof.

In the September 2006 issue I wrote about the ticklish issue of CEO pay and how shareholder groups, especially the powerful pension and other institutional groups, are growing sick and tired of CEO overpayment and underperformance.

The changes in biologics manufacturing regulations contained in the 1997 FDA Modernization Act significantly bolstered the growth of CMOs.

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.

China today represents a $15-billion market for pharmaceutical products. China's pharmaceutical industry has been expanding at about 20% over the past five years. It has been predicted that China will become the world's fifth largest single pharmaceutical market by 2010. With such a fast-growing market segment and a huge population, simply getting pharmaceuticals to the patients and healthcare providers is becoming a daunting task. Biopharmaceuticals distributers face the same challenge, with the added complications associated with cold-chain management, shelf-life, and product stability.

All of the primary unit operations for cell culture and purification had scores greater than the action threshold.