Pharmaceutical Technology - May 2018

Pharmaceutical Technology eBook - Biologics and Sterile Drug Manufacturing

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Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2018 29 PharmTech: What are some of the themes that are driving new research? Ganguly: Lyo is a batch process, and, as FDA pushes the industry to consider continuous pro- cessing, we are seeing greater interest in looking into continuous lyophilization processes. Another industry trend is the move to smaller batches. In the future, we will need equipment that can deal with custom batches of varying sizes. Yet another major trend for the future is the move to patient self-administered devices, which will require different vials and container systems, cartridges, syringes, and specialized devices/ equipment. And then there is the move to per- sonalized medicine. Each of these areas poses more challenges, and today, most processing equipment is still largely based on legacy designs. PharmTech: Where is work going on to develop continuous lyophilization processes? Ganguly: A number of academic groups are look- ing into developing continuous lyophilization, including the University of Ghent, MIT, and the University of Torino. PharmTech: What will be needed to facilitate use of dual chamber syringes and cartridges and smaller batches? Ganguly: Work began in this area over 10 years ago years ago. One of the first papers was from the University of Lyons, and there have been sev- eral contributions from the late Prof Mike Pikal's research group at Purdue, as well as from the University of Munich, Vetter, and Pfizer to name just a few. As far as the move to smaller batches are concerned, we surely will see a move towards smaller, more efficient systems with better reli- ability and control enabled by PAT from today. PharmTech: What are your goals for the commit- tee, in the short and mid term? Ganguly: Short term, we are inviting members to contribute to E-55.05. We want the group to reflect the different voices involved in different points of view , including members from industry, academia, tech equipment vendors, vial manufacturers, ex- cipient manufacturers, and regulatory profession- als. Mid-term goals will be to convert best prac- tices paper issues into fundamental standards and standard practice within the industry. We've had good conversations so far within the industry on the first best practices paper. PharmTech: Your PhD work involved modeling for pressure and vapor f low. Is the industry becoming more accepting of advanced modeling and control for lyophilization? G a n g u l y: As I see it, t he lyo com mu nit y is showing increasing levels of confidence in using modeling to understand processes, equipment, and product (3). Specific examples include use of t he LyoCa lcu lator or a li ke physics based models, computational f luid dynamics to better understand processes, and qualif y equipment and address any gaps in understanding of its characteristics. References 1. PharmTech Editors, "Experts Set a 10-Year Roadmap for Op- timizing Lyophilization,", September 14, 2017, lyophilization-0 2. S. Nail et al., "Best Practices for Process Monitoring Instrumenta- tion of Pharmaceutical Freeze-drying," AAPS PharmSciTech, 18 (7), 2379-2393 (October 2017). 3. S. Tchessalov et al., "An Industry Perspective on the Applica- tion of Modeling to Lyophilization Process Scaleup and Transfer,", www.americanpharmaceu- tive-on-the-Application-of-Modeling-to-Lyophilization-Process- Scale-up-and-Transfer/PT

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