In addition to the discussion and exhibition of novel drug discovery technologies at the annual Drug Discovery Conference in Boston this week, a number of informal talks with attendees centered around creating drug/device combination products and performing QA/QC of biotherapeutics. Both are activities that take place well beyond drug discovery operations in new drug development.
BCC Research estimates that the total market for drug-device combinations was $5.4 billion in 2004 and is expected to rise at an average annual growth rate of 13.6% to $11.5 billion in 2010. The key category is drug-eluting stent market which could total $8 billion in two years.
While many drug device combination products appear to rely on synthetic device matrices, companies like Cook Biotech are working on biological grafts to deliver drugs such as antimicrobials, anti-inflammatories and analgesics. Cook touts this approach as simulating a more natural in vivo environment.
This seems to make a good deal of sense. Questions: Any possible downside to using biological grafts for drug delivery? Does anyone know of other companies following this strategy for developing novel drug device combinations?
Another topic of interest was a discussion by researchers at Beckman Coulter which noted an increasing interest in and acceptance of capillary electrophoresis (CE) by scientists for QA/QC analysis of biotherapeutics. Although Amgen reportedly substituted CE for gel electrophoresis for QC assays back in 2005, it looks like the technology has not yet gained a greater foothold in the bioindustry for this application.
Proponents of CE, such as Dr. Alireza Shafaati, Associate Professor, Pharmaceutical Chemistry, School of Pharmacy, Shaheed Beheshti University of Medical Sciences, cite a number of advantages of the technique, including high separation efficiency, small sample size requirements, fast separations, easy and predictable selectivity, automation, reproducibility, and the ability to be coupled to a mass spectrometer.
Question: Any thoughts on why CE has been slow in being adopted by QC scientists in biotherapeutic development?