Researchers at Children's Hospital Boston (MA, USA) recently announced another group of stem cells that can produce cardiomyocytes (heart muscle cells). It seems hardly a month goes by without some kind of discovery in the fast-moving world of stem cells.
The challenges of ineffective quality monitoring of complaints, investigations and adverse event reporting can lead to patient harm or death, product withdrawal, and negative financial and brand impact to the organization.
Pharmaceutical Technology Europe interviews Bruce Davis, Chairman of the International Society for Pharmaceutical Engineering Board (ISPE), the world's largest not-for-profit association dedicated to educating and advancing pharmaceutical manufacturing professionals and their industry.
Near-infrared spectroscopy (NIR) is suitable for the analysis of pharmaceutical samples in various solid forms, and can be used for determining chemical properties (e.g., content of drug, water), as well as physical properties (e.g., particle size, tablet hardness).
The Pharm Exec 50 report for 2008 accounts for prescription drug sales of more than $510 billion. Interestingly, except for Pfizer, GSK, Sanofi-Aventis (numbers one to three, respectively), and Watson (number 50), every company on the list showed positive growth last year, including some solid double-digit performances.
Biotechnological developments have led to an increased number of recombinant proteins or antibodies in drug development that offer high potential in various diseases, such as cancer, growth disturbances and diabetes.
The pharmaceutical industry is facing the perfect storm. Increasing healthcare costs, a changing regulatory environment and vigorous global competition coupled with the increasing complexity of small molecule and biotech drugs contributing to expensive discovery processes and clinical trials, as well as the resultant manufacturing challenges, all pose major threats to the industry.