Biopharmaceuticals are a growing and complex class of drugs with significant potential to treat disease. However, the manufacturing of antibodies, therapeutic proteins and vaccines poses special risks to drug quality. Raw-materials contamination, viral contamination of production strains and variation in product quality have cost firms millions of dollars, halted operations and led to supply chain interruptions of life saving medicines. In some cases, these events have posed direct safety risks to patients.
In part, this situation exists because a systematic understanding of contamination risks does not exist across the industry. Further, there are few rapid bioanalytical techniques available for real-time detection of protein quality.
During this summit, current risks in biopharmaceutical manufacturing will be discussed and MIT research into novel technologies for the rapid assessment of consistent, high-quality production and systems-based evaluation of viral contamination risks will be detailed.
For full details and to register, visit http://web.mit.edu/cbi/research/bioman/2010/111710.html