PAT SUPPLEMENT


of the latest advances in tools and technologies as well as short courses and ad hoc evening discussion groups on technical matters that attendees choose to hold because of the concentration of leading implementers present. Recent IFPAC meetings have had FDA co-chairs to maintain this attention. The high level of one- on-one interaction at IFPAC is simply not possible at other technical venues. PPAR – The Pharmaceutical Process Analysis


Roundtable is an informal annual conclave of process analysis specialists from leading pharmaceutical manufacturers. These meetings generally attract 25 - 30 people representing a dozen or more manufacturers. In addition, CPAC, NIST and NIH are normally represented at these gatherings. The first PPAR was hosted by Eli Lilly in 2000. Lilly will host the 12th meeting in 2012. The 11th PPAR was hosted by Amgen in 2011. Over the years, dozens of the industry’s leading specialists have participated, including several IFPAC co-chairs, at PPAR sessions hosted by Pharmacia, Pfizer, Genentech, Biogen Idec, Merck, Novartis, Vertex in addition to Amgen and Lilly. These gatherings feature a two day program of free-form discussion topics


designed to foster technology interchange on non-proprietary subjects. A tour of a working PAT deployment at the host’s facility is a highlight of each PPAR gathering. In 2009, MannKind Corporation broke


ground on a USD 163 Million cGMP facility in Danbury for the production of AFREZZA, an inhalable form of insulin. Inhalation delivers the drug directly to the circulatory system


safeguard the safety and efficacy of the US drug supply ”


“ FDA’s mission is to


circumventing the need for injections of drugs that are metabolised by stomach acids. MannKind’s edge is its proprietary Technosphere delivery platform based on a class of organic molecules designed to self-assemble into small particles onto which drug molecules can be loaded. Key operating parameters are Technosphere particle size (on-stream particle- size analyser) and AFREZZA loading on the particles (on-stream Raman spectrometer).


These PAT measurements insure that an appropriate, consistent, controllable dosage is administered. FDA approval was received in early 2011. FDA’s mission is to safeguard the safety and


efficacy of the US drug supply. Early emphasis on the tools (The PAT Initiative) was clearly peripheral to this mission but necessary to redirect industry’s attention. This having been largely accomplished, the larger QbD objective has stepped to the forefront. PAT tools are the means but robust processes within proscribed operating boundaries (QbD) are the desired ends. Dr. Hussain’s overriding goal was to instill scientific understanding into the pharmaceutical industry’s manufacturing methods. Verifiably doing what you intend to do is, in fact, the essence of validation. A perusal of the IFPAC/2012 technical


program confirms this progression. Newer analytical technologies continue to populate the PAT firmament such as the application of process NMR by Pfizer and Process NMR Associates but QbD applications and projects are now the major focus. The battle is on-going. Victory can never be declared but progress is being made.


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