Characterization of the mass transfer of lyophilized products based on X-ray micro-computed tomography images

References

• Mhatre, R.; Rathore, A.S. Quality by design: An overview of the basic concepts. In Quality by Design for Biopharmaceuticals: Principles and Case Studies; Rathore, A.S., Mhatre, R., Eds.; Wiley: Hoboken, NJ 2009.
   Google Scholar
• Rathore, A.S.; Winkle, H. Quality by design for biopharmaceuticals. Nature Biotechnology 2009, 27(1), 26–34.
   PubMed Web of Science ®Google Scholar
• Oddone, I.; Pisano, R.; Bullich, R.; Stewart, P. Vacuum-induced nucleation as a method for freeze-drying cycle optimization. Industrial & Engineering Chemistry Research 2014, 53(47), 18236–18244.
   Web of Science ®Google Scholar
• Franks, F. Freeze-drying of bioproducts: putting principles into practice. European Journal of Pharmaceutics and Biopharmaceutics 1998, 45(3), 221–229.
   PubMed Web of Science ®Google Scholar
• Pisano, R.; Fissore, D.; Barresi, A.A.; Rastelli, M. Quality by design: Scale-up of freeze-drying cycles in pharmaceutical industry. AAPS PharmSciTech 2014, 14(3), 1137–1149.
   Web of Science ®Google Scholar
• Bellows, R.J.; King, C.J. Freeze-drying of aqueous solutions: Maximum allowable operating temperature. Cryobiology 1972, 9(6), 559–561.
   PubMed Web of Science ®Google Scholar
• Patel, S.M.; Pikal, M.J. Emerging freeze-drying process development and scale-up issues. AAPS PharmaSciTech 2011, 12(1), 372–378.
   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(8), 905–919.
   Web of Science ®Google Scholar
• Hottot, A.; Vessot, S.; Andrieu, J. Determination of mass and heat transfer parameters during freeze-drying cycles of pharmaceutical products. PDA Journal of Pharmaceutical Science and Technology 2005, 59(2), 138–153.
   PubMedGoogle Scholar
• Gieseler, H.; Kessler, W.J.; Finson, M.; Davis, S.J.; Mulhall, P.A.; Bons, V.; Debo, D.J.; Pikal, M.J. Evaluation of tunable diode laser absorption spectroscopy for in-process water vapor mass flux measurements during freeze drying. Journal of Pharmaceutical Sciences 2007, 96(7), 1776–1793.
   PubMed Web of Science ®Google Scholar
• Kuu, W.Y.; Nail, S.L.; Sacha, G. Rapid determination of vial heat transfer parameters using tunable diode laser absorption spectroscopy (TDLAS) in response to step-changes in pressure setpoint during freeze-drying. Journal of Pharmaceutical Sciences 2009, 98(6), 1136–1154.
   PubMedGoogle Scholar
• Pisano, R.; Fissore, D.; Barresi, AA. Heat transfer in freeze-drying apparatus. In Heat Transfer; Dos Santos Bernardes, M.A., Ed.; Intech: Rijeka, 2011; 91–114.
   Google Scholar
• Kuu, W.Y.; Hardwick, L.M.; Akers, M.J. Rapid determination of dry layer resistance to various pharmaceutical formulations during primary drying using product temperature profiles. International Journal of Pharmaceutics 2006, 313(1), 99–113.
   PubMed Web of Science ®Google Scholar
• Kuu, W.Y.; Obryan, K.R.; Hardwick, L.M.; Paul, T.W. Product mass transfer resistance directly determined during freeze-drying cycle runs using tunable diode laser absorption spectroscopy (TDLAS) and pore diffusion model. Pharmaceutical Development and Technology 2011, 16(4), 343–357.
   PubMed Web of Science ®Google Scholar
• Kodama, T.; Sawada, H.; Hosomi, H.; Takeuchi, M.; Wakiyama, N.; Yonemochi, E.; Terada, K. Determination for dry layer resistance of sucrose under various primary drying conditions using a novel simulation program for designing pharmaceutical lyophilization cycle. International Journal of Pharmaceutics 2013, 452(1–2): 180–187.
   PubMed Web of Science ®Google Scholar
• Fissore, D.; Pisano, R.; Barresi, A.A. Model-based framework for the analysis of failure consequences in a freeze-drying process. Industrial & Engineering Chemistry Research 2012, 51(38), 12386–12397.
   Web of Science ®Google Scholar
• Nakagawa, K.; Murakami, W.; Hatanaka, T. Redistribution of protein biological activity in a freeze-dried cake. Drying Technology 2013, 31(1), 102–111.
   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 and Processing 2009, 48(1), 408–423.
   Web of Science ®Google Scholar
• Sheehan, P.; Liapis, A.I. Modeling of the primary and secondary drying stages of the freeze drying of pharmaceutical products in vials: Numerical results obtained from the solution of a dynamic and spatially multi-dimensional lyophilization model for different operational policies. Biotechnology and Bioengineering 1998, 60(6), 712–728.
   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(1A), 9–22.
   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(1), 73–90.
   Web of Science ®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(13), 1621–1630.
   Web of Science ®Google Scholar
• Oddone, I.; van Bockstal, P-J.; de Beer, T.; Pisano, R. Impact of vacuum-induced surface freezing on inter- and intra-vial heterogeneity. European Journal of Pharmaceutics and Biopharmaceutics 2016, 103(1), 167–178.
   PubMedGoogle Scholar