There may well be a pending revolution in biopharmaceutical expression systems. Nearly 50% of biomanufacturers today are demanding a whole lot more from their primary expression systems than they have during the past 30 years.
The EU has changed history and set the pace for future productrelated legislation with its Registration, Evaluation and Authorization of Chemicals (REACH) Regulation no. 1907/2006, which came into effect in June 2007.
The latest growth forecast for the 2009 pharmaceutical market might have come as a shock to many, but there is still hope for the industry in the form of new product launches and potential blockbusters.
In 2005, a small delegation (myself included) of the European Fine Chemicals Group (EFCG) met with the deputy head of the cabinet of Commissioner Kyprianou (the then Commissioner responsible for health and consumer protection). Our mission was simple - we were there to raise a red flag.
Modern medicines have dramatically improved the health of millions of people worldwide, but the healthcare situation in industrialized countries is a stark contrast to that in the least developed countries where neglected diseases are still prevalent.
Despite the fact that regulatory compliance is fundamental to the pharmaceutical industry, too many manufacturers lose millions of euro in revenue because of poorly or incorrectly validated facilities. With increasingly demanding global regulations and guidance, rising manufacturing costs and dwindling product portfolios, it is vital to achieve efficient and effective compliance of facilities, processes and equipment to retain market competitiveness.
Cells function as highly accurate quality control (QC) machines to ensure that only correctly folded proteins are released into the physiological milieu to perform their designated functions. The efficient removal of damaged or incorrectly folded/misfolded proteins at the correct time keeps a cell viable and functioning.