Development of the Amorphous Compound Analysis Tool for a high-added-value commercial use

According to the AstraZeneca 2012 report, Developing Amorphous Pharmaceuticals: Opportunity and Necessity, amorphous pharmaceuticals represent both the opportunity to improve bioavailability via the use of an amorphous form (rather than a crystalline form ) of a pharmaceutical and the unfortunate necessity, as (rather often), no crystalline form is available and production of the drug is the amorphous form is the only option. From our industrial interviews conducted in European and American Electron Micr oscopy Laboratories (EMLs), there is the need to analyze at least 50,000 amorphous samples per year in Europe, around 50-60,000 samples in the USA and up to 50,000 samples per year in the Rest of the World (RoW). The commercial drivers for the analysis in dustry are (1) the cost of analysis; (2) waiting time for analysis; (3) time for analysis and (4) quality of analysis data. Commercial prices range between EUR 3,000 and 5,000 per sample, making total annual assay market worth up to EUR 250Mn in EU, up to EUR 300Mn in the US and up to EUR 250Mn in the RoW. The analysis of the amorphous pharmaceutical compounds requires advanced solutions that are either relatively slow (around 8 hours for the abundant laboratory X-ray installation) and provide relative ly poor quality of data but allow reducing waiting time for analysis to several days or fast and provide superior data but require exceptionally long waiting time to analysis (6-12 month waiting time for a synchrotron analysis). Hence, our AMORPHOUS-X m ethod offers an excellent opportunity to analyze amorphous samples with any commercially available Transmission Electron Microscope (TEM) and obtain data quality comparable to that of synchrotron with the waiting time comparable to the laboratory X-ray un der 10-15 minutes. Our cost estimates suggest that we could analyze an amorphous sample at a cost of under EUR 1,000 and therefore offer attractive commercial prices of EUR 1,500 to 2,000 per sample.