Pharmaceutical Technology Europe-03-01-2006

The PAT guidance indicates a variety of risk-based approaches to managing the introduction of on-line analysers into existing processes with the aim of minimizing the regulatory burden for the manufacturer and encouraging innovation.

Human plasma provides a rich source of therapeutic medicines, including gamma globulins, coagulation factors, albumin, alpha anti-trypsin and others. In 2001, sales of immuno gamma-globulin (IgG) were estimated at $2 billion with a production rate of 50 metric tons for the year.1 A number of therapeutic products have been introduced including Gammimune from Bayer, RhoPhylac from ZLB Behring and Octagam from Octapharma.

Clean rooms are areas in which it is essential that microorganisms are not allowed to proliferate because they could contaminate pharmaceuticals and directly affect human health.

So could the online auction formula be extended to the pharmaceutical industry? It might be a great way to make some big savings.

The manufacturing process used for an API’s production is a crucial factor determining its quality.

FDA data indicate expenditure by pharmaceutical companies on R&D has doubled since 1996. Why is intensive research yielding so few patented inventions and so few new drugs?

Pharma companies are forming alliances with less established biotech companies, which significantly drive the technological innovation and the overall market growth.