Comprehensive analysis of monoclonal antibody therapeutics involves an ever expanding cadre of technologies. Lifecycle-appropriate application of current and emerging techniques requires rigorous testing followed by discussion between industry and regulators in a pre-competitive space, an effort that may be facilitated by a widely available test metric. Biopharmaceutical quality materials, howe...

Clinical trials are essential for the successful development of new medicines that save and improve lives and provide hope for millions of patients. Biopharmaceutical companies are committed to the continuous improvement of clinical trials to bring innovative medicines to the patients who need them. This includes protecting the safety of study participants, overcoming barriers to greater partic...

Given the time, cost and risk associated with drug development, biopharmaceutical companies typically need to have a portfolio of drugs in development to be successful. Current pressures of cost and speed to market are driving the need for more effective means of assessing the value and risks of such drug portfolios. This paper presents research to generate a prototype computer tool developed t...

This Article addresses the question of how the tools of patent and antitrust law can best be used to foster the cumulative process that is biopharmaceutical innovation. This issue is of particular moment because we have begun in recent years to see a substantial amount of vertical and horizontal integration in the biopharmaceutical industry. The Article argues that although horizontal concentra...

Endotoxin is a type of pyrogen that can be found in Gram-negative bacteria. Endotoxin can form a stable interaction with other biomolecules thus making its removal difficult especially during the production of biopharmaceutical drugs. The prevention of endotoxins from contaminating biopharmaceutical products is paramount as endotoxin contamination, even in small quantities, can result in fever,...

The aims of the present study were to evaluate the performance of the main methods proposed for the comparison of percentage dissolved versus time curves and to recommend a more biorelevant combined approach for the comparison of dissolution profiles of multisource drug products. In vitro dissolution tests of four brands of oxcarbazepine (OxCBZ) tablets were performed, and the resulting profile...

For satisfying the network trend and intelligent demand of biopharmaceutical, we proposed the energy optimization consumption and management scheme of the drug green crowd data in the biological pharmaceutical cloud environment. First, the biopharmaceutical process are mapped to the cloud platform, which can not only adapt to the revolutionary changes in the way of biopharmaceutical research an...