Pharmaceutical Technology - May 2018

Pharmaceutical Technology eBook - Biologics and Sterile Drug Manufacturing

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28 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2018 P h a r mTe c h . c o m Ganguly: Efforts began about four years ago, stem- ming from informal conversation about what we could do to promote industry and academic collab- orations to advance lyophilization. One problem was the fact that there were few or no best practices documents. LyoHub identified some priority areas, focusing on process instrumentation, equipment qualification, and scale-up/tech transfer. Freeze-drying has existed for a while, and while process instruments have improved, quite often the technology is decades old. The question was: Can we provide a set of best practice guidance documents to use with process instrumentation for monitoring lyophilization processes? The first effort was led by Steve Nail at Baxter, and the resulting paper coauthored by eight oth- ers and published in February 2017. It has gener- ated over 3900 downloads since and a great deal of discussion within the industry (2) that has also involved regulator participation. While we realized that it was important to pub- lish this work, the real success would come from seeing these practices implemented across industry. We realized that we needed to find a path and to provide guidelines needed to bring into place some form of standardized practice. Discussions began at the ISLFD conference in Cuba. Ali Afnan, a member of the original FDA Process Analytical Technology (PAT) team and previous chair of ASTM's E-55 committee, sug- gested that standardization would be the best way to go about this. Within a few months, we put to- gether plans for a committee and its scope. The goal was to move from guidance to standard with the different best practice initiatives starting with the document on process instrumentation applied to freeze-drying. Two other best practice papers are now in prog- ress: one on equipment qualification for freeze dry- ers, which I am leading, and another on scaleup and tech transfer which is being led by Serguei Tchessalov and Bakul Bhatnagar at Pfizer. We ex- pect to publish the equipment qualification stan- dard by June 2018 and the tech transfer paper by Spring 2019. Process instrumentation focus PharmTech: What did you focus on, in process in- strumentation? Ganguly: Accurate process monitoring and con- trol for critical process parameters such as pres- sure and temperature is crucial in the freeze-dry- ing process. Yet, we find that there are situations where the choice of instrumentation, its placement, or even the usefulness of the same, leads to lengthy debate. Here we focused broadly on monitoring/ controlling pressure in the freeze dryer during the process and best practices in monitoring the prod- uct temperature. A brief discussion on developing technologies is also presented. PharmTech: What will tomorrow's PAT tools for lyophilization be? Ganguly: Upcoming technologies that are prov- ing to be important in this area include wireless sensors, tunable diode laser absorption spectros- copy (TDLAS) for real-time vapor f low rate moni- toring, and heat-f lux sensors. In addition, mass spectroscopy can provide gas composition and contaminant detection down to few ppm. The best practices papers are meant to be living guidance documents. The year is incorporated into each paper's title so that best practices can evolve as knowledge evolves. Today's best practice may not be tomorrow's. Lyophilization Standards

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