November 25, 2013
For the third consecutive year Gateway had the pleasure of exhibiting at the AAPS Annual Meeting, which was held this year in San Antonio, at the very large Henry B. Gonzalez Convention Center. AAPS members and attendees come from a wide range of areas within pharmaceutical drug development and biopharmaceuticals. In addition to offering free popcorn daily and an open bar on Tuesday night, this year, our focus was to promote analytical services that not only support drug product formulation development but also address manufacturing issues such as particulate contamination and source determination.
What we discovered after talking to many different people in the pharmaceutical development industry is that there is in fact a need to understand chemically-specific differences in their drug products better, especially when analyzing the active pharmaceutical ingredient and excipient interactions.
As an example, in the pharmaceutical drug development industry an analysis such as automated measuring of the size and shape of particles with a Malvern Morphologi G3 will give you visual and statistical interpretation of your data, but it can’t provide chemically-specific spectral and visual information on the particles. This makes it more difficult when you need to determine details such as the chemical makeup of your agglomerates or aggregates. Having the capability to chemically distinguish API from Excipent also comes in handy for our existing customers when trying to determine things like bioequivalence for FDA submission.
As we talked to people on the manufacturing side the issue of glass delamination came up several times, and is also one of the featured investigation services that we offer. Glass delamination occurs when top layers of a glass surface separate and flake off, usually at a scale invisible to the naked eye. We address this issue by utilizing scanning electron microscopy and energy dispersive X-ray analysis that can help confirm whether a contaminant is glass and provide information as to the conditions under which delamination is most likely to have occurred.
Overall it was a very insightful show for us and we enjoyed meeting and discussing latest industry topics and service needs with the many industry experts and professionals we encountered. If you plan to attend the 2014 AAPS Annual Meeting in San Diego next year, stop by and visit us for some popcorn and cocktails at booth #3404