Pharmaceutical Technology Europe-03-01-2006

Pharmaceutical Technology Europe

A practical approach to PAT implementation

March 01, 2006

PAT

18

3

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.

Viral filtration of plasma-derived human IgG

March 01, 2006

Filtration

18

3

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.