There were many sessions today, but the one that captivated me and held me in my seat was on imaging. The session, organized by Carl Anderson (Duquesne University) and Steve Hammond (Pfizer), consisted of nine disparate talks tied together by the theme of imaging. Some of the highlights:
Ralf Marbach (VTT, Finland) used his novel math treatment in conjunction with a new Fabry-Perot filter instrument to analyze the components in a multi-API tablet. Both the instrument and math treatment were novel and worth mentioning.
Benoit Inge (Duquesne) carried on the tradition of excellent graduate students at that school doing incisive work. He shared his work on following the “relaxation” of tablets after production using chemical imaging. There is a common knowledge that compression, followed by relaxation causes tablet properties to change over time, but this is the first in-depth study I have seen that approaches the problem in a planned, scientific manner.
Timo Hyvarinen (SPECIM, Sweden) spoke about and showed a fast, relatively inexpensive imaging system, suitable for process analysis. Their instrument has capabilities of thousands of scans/second. The video showed was of tablets moving down a conveyor belt and instantly being imaged and viewed in real time. The cost is below a simple bench-top NIR system.
Zhenqi Shi (Duquesne) shared some very interesting two-dimensional localization research results. There was some very interesting math used that was a touch above my pay grade.
I also managed to sit and chat with a number of people from both the FDA and industry. There were many, many encouraging comments, but a few discords, too. Several biotech people commented that there were no concrete QbD submission examples. While several good technical papers were presented, no one simply said, “This was done for Widget CR.” The other comments related to the economy: several people were worried that massive layoffs are often indiscriminant and the necessary people for PAT/QbD would be thrown out with the bathwater.
Thursday is the last day, but by no means less important. There are a number of strong speakers I look forward to hearing.
