On the use of model-based tools to optimize in-line a pharmaceuticals freeze-drying process

References

• Mellor, J.D. Fundamentals of Freeze-Drying; Academic Press: London, 1978.
   Google Scholar
• Carpenter, J.F.; Pikal, M.J.; Chang, B.S.; Randolph, T.W. Rational design of stable lyophilized protein formulations: Some practical advice. Pharmaceutical Research 1997, 14, 969–975.
   PubMed Web of Science ®Google Scholar
• Jennings, T.A. Lyophilization: Introduction and Basic Principles; Interpharm/CRC Press: Boca Raton, FL, 1999.
   Google Scholar
• Oetjen, G.W.; Haseley, P. Freeze-Drying, 2nd ed.; Wiely-VHC: Weinheim, 2004.
   Google Scholar
• Franks, F. Freeze-Drying of Pharmaceuticals and Biopharmaceuticals; Royal Society of Chemistry: Cambridge, UK, 2007.
   Google Scholar
• Fissore, D. Freeze-drying of pharmaceuticals. In Encyclopedia of Pharmaceutical Science and Technology, 4th ed.; Swarbrick, J. Ed.; CRC Press: London, 2013; 1723–1737.
   Google Scholar
• Costantino, H.R.; Pikal, M.J. Lyophilization of Biopharmaceuticals; AAPS Press: Arlington, VA, 2004.
   Google Scholar
• Bellows, R.J.; King, C.J. Freeze-drying of aqueous solutions: Maximum allowable operating temperature. Cryobiology 1972, 9, 559–561.
   PubMed Web of Science ®Google Scholar
• Tsourouflis, S.; Flink, J.M.; Karel, M. Loss of structure in freeze-dried carbohydrates solutions: Effect of temperature, moisture content and composition. Journal of the Science of Food and Agriculture 1976, 27, 509–519.
   Web of Science ®Google Scholar
• Adams, G.D.J.; Irons, L.I. Some implications of structural collapse during freeze-drying using Erwinia caratovora L-asparaginase as a model. Journal of Chemical Technology and Biotechnology 1993, 58, 71–76.
   PubMed Web of Science ®Google Scholar
• Pikal, M.J. Freeze-drying of proteins: Process, formulation, and stability. In Formulation and Delivery of Proteins and Peptides; Cleland, J.L.; Langer, R. Eds., American Chemical Society: Washington, DC, 1994; 120–133.
   Google Scholar
• Franks, F. Freeze-drying of bioproducts: Putting principles into practice. European Journal of Pharmaceutics and Biopharmaceutics 1998, 45, 221–229.
   PubMed Web of Science ®Google Scholar
• Wang, D.Q.; Hey, J.M.; Nail, S.L. Effect of collapse on the stability of freeze-dried recombinant factor VIII and alpha-amylase. Journal of Pharmaceutical Sciences 2004, 93, 1253–1263.
   PubMed Web of Science ®Google Scholar
• Pisano, R.; Fissore, D.; Barresi, A.A. In-line and off-line optimization of freeze-drying cycles for pharmaceutical products. Drying Technology 2013, 31, 905–919.
   Web of Science ®Google Scholar
• Milton, N.; Pikal, M.J.; Roy, M.L.; Nail, S.L. Evaluation of manometric temperature measurement as a method of monitoring product temperature during lyophilisation. PDA Journal of Pharmaceutical Science and Technology 1997, 51, 7–16.
   PubMedGoogle Scholar
• Liapis, A.I.; Sadikoglu, H. Dynamic pressure rise in the drying chamber as a remote sensing method for monitoring the temperature of the product during the primary drying stage of freeze-drying. Drying Technology 1998, 16, 1153–1171.
   Web of Science ®Google Scholar
• Chouvenc, P.; Vessot, S.; Andrieu, J.; Vacus, P. Optimization of the freeze-drying cycle: A new model for pressure rise analysis. Drying Technology 2004, 22, 1577–1601.
   Web of Science ®Google Scholar
• Velardi, S.A.; Rasetto, V.; Barresi, A.A. Dynamic parameters estimation method: Advanced manometric temperature measurement approach for freeze-drying monitoring of pharmaceutical. Industrial & Engineering Chemistry Research 2008, 47, 8445–8457.
   Web of Science ®Google Scholar
• Fissore, D.; Pisano, R.; Barresi, A.A. On the methods based on the pressure rise test for monitoring a freeze-drying process. Drying Technology 2011, 29, 73–90.
   Web of Science ®Google Scholar
• Barresi, A.A.; Velardi, S.A.; Pisano, R.; Rasetto, V.; Vallan, A.; Galan, M. In-line control of the lyophilization process. A gentle PAT approach using software sensors. International Journal of Refrigeration 2009, 32, 1003–1014.
   Web of Science ®Google Scholar
• Barresi, A.A.; Pisano, R.; Fissore, D.; Rasetto, V.; Velardi, S.A.; Vallan, A.; Parvis, M.; Galan, M. Monitoring of the primary drying of a lyophilization process in vials. Chemical Engineering & Processing 2009, 48, 408–423.
   Web of Science ®Google Scholar
• Pisano, R.; Fissore, D.; Velardi, S.A.; Barresi, A.A. In-line optimization and control of an industrial freeze-drying process for pharmaceuticals. Journal of Pharmaceutical Sciences 2010, 99, 4691–4709.
   PubMed Web of Science ®Google Scholar
• Pisano, R.; Fissore, D.; Barresi, A.A. Freeze-drying cycle optimization using model predictive control techniques. Industrial & Engineering Chemistry Research 2011, 50, 7363–7379.
   Web of Science ®Google Scholar
• Barresi, A.A.; Fissore, D. In-line product quality control in freeze drying of pharmaceuticals. In Modern Drying Technology – Volume 3: Product Quality and Formulation; Tsotsas, E.; Mujumdar, A.S. Eds.; Verlag GmbH & Co. KGaA: Weinheim, 2011; 91–154.
   Google Scholar
• Velardi, S.A.; Hammouri, H.; Barresi, A.A. In line monitoring of the primary drying phase of the freeze-drying process in vial by means of a Kalman filter based observer. Chemical Engineering Research and Design 2009, 87, 1409–1419.
   Web of Science ®Google Scholar
• Bosca, S.; Fissore, D. Design and validation of an innovative soft-sensor for pharmaceuticals freeze-drying monitoring. Chemical Engineering Science 2011, 66, 5127–5136.
   Web of Science ®Google Scholar
• Velardi, S.A.; Hammouri, H.; Barresi, A.A. Development of a high gain observer for inline monitoring of sublimation in vial freeze-drying. Drying Technology 2010, 28, 256–268.
   Web of Science ®Google Scholar
• Bosca, S.; Corbellini, S.; Barresi, A.A.; Fissore, D. Freeze-drying monitoring using a new process analytical technology: Toward a “zero defect” process. Drying Technology 2013, 31, 1744–1755.
   Web of Science ®Google Scholar
• Bosca, S.; Barresi, A.A.; Fissore, D. Use of a soft-sensor for the fast estimation of dried cake resistance during a freeze-drying cycle. International Journal of Pharmaceutics 2013, 451, 23–33.
   PubMed Web of Science ®Google Scholar
• Bosca, S.; Fissore, D. Monitoring of a pharmaceuticals freeze-drying process by model-based process analytical technology tools. Chemical Engineering & Technology 2014, 37, 240–248.
   Web of Science ®Google Scholar
• Bosca, S.; Barresi, A.A.; Fissore, D. Use of soft-sensors to monitor a pharmaceuticals freeze-drying process in vials. Pharmaceutical Development and Technology 2014, 19, 148–159.
   PubMed Web of Science ®Google Scholar
• Bosca, S.; Barresi, A.A.; Fissore, D. Design of a robust soft-sensor to monitor in-line a freeze-drying process. Drying Technology 2015, 33, 1039–1050.
   Web of Science ®Google Scholar
• Bosca, S.; Barresi, A.A.; Fissore, D. Fast freeze-drying cycle design and optimization using a PAT based on the measurement of product temperature. European Journal of Pharmaceutics and Biopharmaceutics 2013, 85, 253–262.
   PubMed Web of Science ®Google Scholar
• Velardi, S.A.; Barresi, A.A. Development of simplified models for the freeze-drying process and investigation of the optimal operating conditions. Chemical Engineering Research and Design 2008, 86, 9–22.
   Web of Science ®Google Scholar
• Patel, S.M.; Doen, T.; Pikal, M.J. Determination of end point of primary drying in freeze-drying process control. AAPS PharmSciTech 2010, 11, 73–84.
   PubMed Web of Science ®Google Scholar
• Pisano, R.; Fissore, D.; Barresi, A.A. Heat transfer in freeze-drying apparatus. In Developments in Heat Transfer; dos Santos Bernardes, M.A. Ed.; InTech – Open Access Publisher: Rijeka, Croatia, 2011; 91–114.
   Google Scholar
• Grassini, S.; Parvis, M.; Barresi, A.A. Inert thermocouple with nanometric thickness for lyophilization monitoring. IEEE Transactions on Instrumentation and Measurement 2013, 62, 1276–1283.
   Web of Science ®Google Scholar
• Parvis, M.; Grassini, S.; Fulginiti, D.; Pisano, R.; Barresi, A.A. Sputtered thermocouple array for vial temperature mapping. In Proceedings of IEEE International Instrumentation and Measurements Technology Conference “I2MTC 2014”, Uruguay, Montevideo, May 12–15; Institute of Electrical and Electronics Engineers: Piscataway, NJ, 2014, 1465–1470.
   Google Scholar
• Oddone, I.; Fulginiti, D.; Barresi, A.A.; Grassini, S.; Pisano, R. Non-invasive temperature monitoring in freeze drying: Control of freezing as a case study. Drying Technology 2015, 33, 1621–1630.
   Web of Science ®Google Scholar
• Vallan, A.; Corbellini, S.; Parvis, M. A Plug&Play architecture for low-power measurement systems. In Proceedings of Instrumentation and Measurement Technology Conference – IMTC 2005, Ottawa, Canada, May 16–19; Institute of Electrical and Electronics Engineers: Piscataway, NJ, 2005, 565–569.
   Google Scholar
• Schneid, S.; Gieseler, H. Evaluation of a new wireless temperature remote interrogation system (TEMPRIS) to measure product temperature during freeze-drying. AAPS PharmSciTech 2008, 9, 729–739.
   PubMed Web of Science ®Google Scholar
• Corbellini, S.; Parvis, M.; Vallan, A. A low-invasive system for local temperature mapping in large freeze dryers. In Proceedings of Instrumentation and Measurement Technology Conference – I2MTC 2009, Singapore, May 5–7; Institute of Electrical and Electronics Engineers: Piscataway, NJ, 2009, 80–85.
   Google Scholar
• Corbellini, S.; Parvis, M.; Vallan, A. In-process temperature mapping system for industrial freeze-dryers. IEEE Transaction on Instrumentation and Measurement 2010, 59, 1134–1140.
   Web of Science ®Google Scholar