For the past few years, I have covered the IFPAC (International Foundation Process Analytical Chemistry) Annual Meeting for this publication. Prior to that, I attended the meeting, as it roamed around the country. The meeting was originally designed for process chemistry. Slowly, the meeting was “invaded” by pharma/biopharma sessions (only two, at first). As the number of pharma sessions grew, the conference was moved to accommodate FDA attendees (they do not have money to travel to Las Vegas, you know). The conference has become a mostly pharma/biopharma show, now.
The thrust of the meetings were “where are we going?” They featured what the “next, best thing” would be. For more than a decade, the sessions gave us hope that new and exciting techniques were on the horizon: continuous manufacturing (CM), 3-D printing, biosimilars and supply chain integrity. Now, it appears that we have gone from “hope, smoke and mirrors” to actually being encouraged to seek “the man behind the curtain.” This year, the papers were rich with examples and “how-to” presentations; no longer “what we’d like to do.”
Two good examples were last-day papers by GEA (1. Velocity Profiles in Powder Mixtures flowing by Gravity: Phenomenological Modeling based on Cohesion/Adhesion and Bin Geometry; and 2. Predicting the Performance of a Continuous Linear Blender based on Input Material Properties: Single Component Mapping). Papers with long names, but with a special twist: lots of “boring” data. By “boring,” I mean great. There were presentations for both small molecule and biopharma products where meticulous details were covered. What to do, why, and what to see when you did it.
Also, the physical parameters of APIs and excipients have moved from universities to production applications. If continuous manufacturing is to become ubiquitous, the feeding of the ingredients needs to be exquisitely accurate. By having dependable, reproducible analysis-characterization methods, the raw materials may not only be properly weighed, but also the process parameters determined (flowability, particle size/distribution, density, crushability, etc.). The previously mentioned paper (Velocity Profiles in Powder Mixtures flowing by Gravity), presented by Pfizer Chairs Nicolas Abatzoglou, Oumaima Chaib and Ryan Gosselin, addressed these issues. They showed that it was now practical to control dosage forms from process initiation through final packaging.
There were full sessions just on design or experiments: why, how and when. Formerly venues for R&D people and FDA representatives discussing the ICH (International Conference on Harmonization) Q8 – 9 Guidances, they now were populated by both vendors and pharma applications people, explaining how they actually used the concept for pharmaceutical products that have already received approved NDAs or ANDAs.
Not only have a number of large companies added portable Raman units (to complement the smaller, existing companies’ units), but they filled a number of sessions with practical, successful applications. The sheer number of applications are testimony to how far Raman has come as a process tool. They were shown to be effective, not only for raw materials, but also tablet content uniformity, blend uniformity, coating uniformity (of course, for food, but that is another story), and such apps.
There were papers and exhibits of continuous wet granulators and continuous coating units. These two instruments showed that continuous manufacturing need not be restricted to either direct compression of powders or ribbon compactors, nor do they have to be “naked” tablets, but can be made using all the techniques formerly peculiar to batch processing.
All of these topics were intermingled with the rise of the contract manufacturers and research labs. As the larger pharma companies continue to shrink (paring off many functions to contract facilities: research done by universities, clinical trials, production, packaging and distribution) and become “core” units, the supply chain and oversight of CROs and CMOs will be critical. With the tools displayed at IFPAC this year, I am more confident that they will be successful.
