A novel approach to sterile pharmaceutical freeze-drying

References

• Novais JL, Titchener-Hooker NJ, Hoare M. Economic comparison between conventional and disposables-based technology for the production of biopharmaceuticals. Biotechnol Bioeng 2001;75:143–53
   PubMed Web of Science ®Google Scholar
• Rao G, Moreira A, Brorson K. Disposable bioprocessing: the future has arrived. Biotechnol Bioeng 2009;102:348–56
   PubMedGoogle Scholar
• Farid SS. Process economics of industrial monoclonal antibody manufacture. J Chromatogr B 2007;848:8–18
   PubMed Web of Science ®Google Scholar
• Patel SM, Pikal MJ. Emerging freeze-drying process development and scale-up issues. AAPS PharmSciTech 2011;12:372–8
   PubMed Web of Science ®Google Scholar
• Patel SM, Pikal MJ. Freeze-drying in novel container systems: characterization of heat and mass transfer in glass syringes. J Pharm Sci 2010;99:3188–204
   PubMed Web of Science ®Google Scholar
• Fehr A, Thurmann P, Razum O. Drug development for neglected diseases: a public health challenge. Trop Med Int Health 2006;9:1335–8
   Google Scholar
• Melnikova I. Rare diseases and orphan drugs. Nature Rev Drug Discov 2012;11:267–8
   PubMed Web of Science ®Google Scholar
• Cote TR, Xu K, Parsier AR. Accelerating orphan drug development. Nature Rev Drug Discov 2010;9:901–2
   PubMed Web of Science ®Google Scholar
• Sharma A, Jacob A, Tandon M, Kumar D. Orphan drug: development trends and strategies. J Pharm Bioallied Sci 2010;2:290–9
   PubMedGoogle Scholar
• Taylor R, Boardman CFB, Wallis RG. Sterile freeze-drying in an unclean environment. J Appl Chem Biotechnol 1978;28:213–16
   Google Scholar
• Gassler M, Rey L. Development of a new concept for bulk freeze-drying: lyoguard freeze-dry packaging. In: Rey L, May JC, eds. Freeze-drying/lyophilization of pharmaceutical and biological products. Chapter 12. London: Informa Healthcare; 2004:325–48
   Google Scholar
• Barbaree JM, Sanchez A. Cross contamination during lyophilization. Cryobiology 1982;19:443–7
   PubMed Web of Science ®Google Scholar
• Adams GDJ. The loss of substrate from a vial during freeze-drying using Escherichia coli as a trace organism. J Chem Tech Biotechnol 1991;52:511–8
   Web of Science ®Google Scholar
• Nolan PJ. Sterile medical device package development. In: Kutz M, ed. Standard handbook of biomedical engineering and design. Chapter 7. New York: McGraw-Hill; 2009:181–224
   Google Scholar
• DuPont. DuPont medical packaging guide technical reference guide. Wilmington, DE: DuPont; 2009
   Google Scholar
• Patel SM, Pikal M. Process analytical technologies (PAT) in freeze-drying of parenteral products. Pharm Dev Technol 2009;14:567–87
   PubMed Web of Science ®Google Scholar
• Pikal MJ. Use of laboratory data in freeze-drying process design: heat and mass transfer coefficients and the computer simulation of freeze-drying. J Parenter Sci Technol 1985;39:115–38
   PubMedGoogle Scholar
• Pikal MJ, Roy ML, Shah S. Mass and heat transfer in vial freeze-drying of pharmaceuticals: the role of the vial. J Pharm Sci 1984;73:1224–37
   PubMed Web of Science ®Google Scholar
• Wagner W, Saul A, Pruss A. International equations for the pressure along the melting and along the sublimation curve of ordinary water substance. J. Phys Chem Ref Data 1994;23:515
   Web of Science ®Google Scholar
• Searles JA. Optimizing the throughput of freeze-dryers within a constrained design space. In: Rey L, May JC, eds. Freeze-drying/lyophilization of pharmaceutical and biological products. Chapter 18. London: Informa Healthcare; 2010:425–40
   Google Scholar
• Hottot A, Vessot S, Andrieu J. Determination of mass and heat transfer parameters during freeze-drying cycles of pharmaceutical products. PDA J Pharm Sci Technol 2005;59:138–53
   PubMedGoogle Scholar
• Curd J, Smith TW, Jaton JC, Haber E. The isolation of digoxin specific antibody and its use in reversing the effects of digoxin. Proc Natl Acad Sci USA 1971;68:2401–6
   PubMed Web of Science ®Google Scholar
• Rawat S, Laing G, Smith DC, et al. A new antivenom to treat Eastern coral snake (Micrurus fulvius fulvius) envenoming. Toxicon 1994;32:185–90
   PubMed Web of Science ®Google Scholar
• Al-Abdulla I, Garnvwa JM, Rawat S, et al. Formulation of a liquid ovine Fab-based antivenom for the treatment envenomation by the Nigerian carpet viper (Echis Ocellatus). Toxicon 2003;42:399–404
   PubMedGoogle Scholar
• Eckhardt BM, Oeswein JQ, Yeung DA, et al. A turbidimetric method to determine visual appearance of protein solutions. J Pharm Sci Technol, 1994;48:64–70
   PubMedGoogle Scholar
• US FDA. Lyophilization of parenterals (7/93), guide to inspections of lyophilization of parenterals. Silver Spring (MD): US FDA; 2009
   Google Scholar
• European Commission. EU guidelines to good manufacturing practice medicinal products for human and veterinary use. Vol. 4. Annex 1, manufacture of sterile medicinal products, 2010. Available from: http://ec.europa.eu/health/files/eudralex/vol-4/2008_11_25_gmp-an1_en.pdf [last accessed 31 Dec 2012]
   Google Scholar
• Corbitt AJ, Bennion N, Forsythe SJ. Adenylate kinase amplification of ATP bioluminescence for hygiene monitoring in the food and beverage industry. Lett App Microbiol 2000;30:443–7
   PubMed Web of Science ®Google Scholar
• Tang X, Pikal MJ. Design of freeze-drying processes for pharmaceuticals: practical advice. Pharm Res 2004;21:191–200
   PubMed Web of Science ®Google Scholar
• Adams GDJ. Freeze-drying of biological materials. Drying Technol 1991;9:891–925
   Web of Science ®Google Scholar
• Rambthatla S, Pikal MJ. Heat and mass transfer scale up issues during freeze-drying, I: atypical radiation and edge vial effect. AAPS PharmSciTech 2003;4:E14
   Google Scholar
• Tang X, Nail SL, Pikal MJ. Evaluation of manometric temperature measurement, a process analytical tool for freeze-drying: part I. Product temperature measurement. AAPS PharmSciTech 2006;7:14
   PubMed Web of Science ®Google Scholar
• Tang X, Nail SL, Pikal MJ. Evaluation of manometric temperature measurement, a process analytical tool for freeze-drying: part II measurement of dry layer resistance. AAPS PharmSciTech 2006;7:93
   PubMed Web of Science ®Google Scholar
• Tang X, Nail SL, Pikal MJ. Evaluation of manometric temperature measurement, a process analytical tool for freeze-drying: part III: heat and mass transfer measurement. AAPS PharmSciTech 2006;7:97
   PubMed Web of Science ®Google Scholar
• Tang X, Nail SL, Pikal MJ. Freeze-drying process design by manometric temperature measurement: design of a smart freeze-dryer. Pharm Res 2005;22:685–700
   PubMed Web of Science ®Google Scholar
• Kuu WY, Hardwick LM, Akers M. Rapid determination of dry layer mass transfer resistance for various pharmaceutical formulations during primary drying using product temperature profiles. Int J Pharm 2006;313:99–113
   PubMed Web of Science ®Google Scholar
• Johnson RE, Oldroyd ME, Ahmed SS, et al. Use of manometric temperature measurements (MTM) to characterize the freeze-drying behavior of amorphous protein formulations. J Pharm Sci 2010;99:2863–73
   PubMed Web of Science ®Google Scholar