References
- Reichert JM. Antibody-based therapeutics to watch in 2011. mAbs 2011;3:76–99
- Allison SD, Manning MC, Randolph TW, et al. Optimization of storage stability of lyophilized actin using combinations of disaccharides and dextran. J Pharm Sci 2000;89:199–214
- Chen T, Oakley DM. Thermal analysis of proteins of pharmaceutical interest. Thermochim Acta 1995;248:229–244
- Lu X, Pikal MJ. Freeze-drying of mannitol-trehalose-sodium chloride-based formulations: the impact of annealing on dry layer resistance to mass transfer and cake structure. Pharm Dev Technol 2004;9:85–95
- Carpenter JF, Pikal MJ, Chang BS, Randolph TW. Rational design of stable lyophilized protein formulations: some practical advice. Pharm Res 1997;14:969–975
- Wang W. Lyophilization and development of solid protein pharmaceuticals. Int J Pharm 2000;203:1–60
- Serno T, Geidobler R, Winter G. Protein stabilization by cyclodextrins in the liquid and dried state. Adv Drug Deliv Rev 2011;63:1086–1106
- Koushik KN, Bandi N, Kompella UB. Interaction of [D-Trp6, Des-Gly10] LHRH ethylamide and hydroxy propyl beta-cyclodextrin (HPbetaCD): thermodynamics of interaction and protection from degradation by alpha-chymotrypsin. Pharm Dev Technol 2001;6:595–606
- Shire SJ, Shahrokh Z, Liu J. Challenges in the development of high protein concentration formulations. J Pharm Sci 2004;93:1390–1402
- Cleland JL, Lam X, Kendrick B, et al. A specific molar ratio of stabilizer to protein is required for storage stability of a lyophilized monoclonal antibody. J Pharm Sci 2001;90:310–321
- Kim M-S, Kim J-S, You Y-H, et al. Development and optimization of a novel oral controlled delivery system for tamsulosin hydrochloride using response surface methodology. Int J Pharm 2007;341:97–104
- Kul M, Oskay KO, Şimşir M, et al. Optimization of selective leaching of Zn from electric arc furnace steelmaking dust using response surface methodology. Trans Nonferrous Met Soc China 2015;25:2753–2762
- De Beer TRM, Wiggenhorn M, Hawe A, et al. Optimization of a pharmaceutical freeze-dried product and its process using an experimental design approach and innovative process analyzers. Talanta 2011;83:1623–1633
- Meyer JD, Nayar R, Manning MC. Impact of bulking agents on the stability of a lyophilized monoclonal antibody. Eur J Pharm Sci 2009;38:29–38
- Guo C, Stine KJ, Kauffman JF, Doub WH. Assessment of the influence factors on in vitro testing of nasal sprays using Box–Behnken experimental design. Eur J Pharm Sci 2008;35:417–426
- Laemmli UK. Cleavage of structural proteins during the assembly of the head of bacteriophage T4. Nature 1970;227:680–685
- Ramezani V, Vatanara A, Najafabadi AR, et al. A comparative study on the physicochemical and biological stability of IgG1 and monoclonal antibodies during spray drying process. Daru 2014;22:31
- Uversky VN, Fink AL. Protein misfolding, aggregation and conformational diseases: protein aggregation and conformational diseases. New York (NY): Springer Science+Business Media, LLC; 2006. [WorldCat]
- Faghihi H, Vatanara A, Najafabadi AR, et al. The use of amino acids to prepare physically and conformationally stable spray-dried IgG with enhanced aerosol performance. Int J Pharm 2014;466:163–171
- Dou F, Netzer WJ, Tanemura K, et al. Chaperones increase association of tau protein with microtubules. Proc Natl Acad Sci USA 2003;100:721–726
- Brummitt RK. Urea-induced dissociation of non-native aggregates of alpha-chymotrypsinogen: kinetics, thermodynamics, and competing pathways. Charleston, South Carolina, USA: BiblioBazaar; 2012
- Jameel F, Hershenson S. Formulation and process development strategies for manufacturing biopharmaceuticals. New York (NY): John Wiley & Sons; 2010. [WorldCat]
- Charman SA, Mason KL, Charman WN. Techniques for assessing the effects of pharmaceutical excipients on the aggregation of porcine growth hormone. Pharm Res 1993;10:954–962
- Jovanovic N, Bouchard A, Hofland GW, et al. Stabilization of IgG by supercritical fluid drying: optimization of formulation and process parameters. Eur J Pharm Biopharm 2008;68:183–190
- Serno T, Carpenter JF, Randolph TW, Winter G. Inhibition of agitation-induced aggregation of an IgG-antibody by hydroxypropyl-beta-cyclodextrin. J Pharm Sci 2010;99:1193–1206
- Jones LS, Randolph TW, Kohnert U, et al. The effects of Tween 20 and sucrose on the stability of anti-l-selectin during lyophilization and reconstitution. J Pharm Sci 2001;90:1466–1477
- Sane SU, Wong R, Hsu CC. Raman spectroscopic characterization of drying-induced structural changes in a therapeutic antibody: correlating structural changes with long-term stability. J Pharm Sci 2004;93:1005–1018
- Sundaramurthi P, Patapoff TW, Suryanarayanan R. Crystallization of trehalose in frozen solutions and its phase behavior during drying. Pharm Res 2010;27:2374–2383
- Carpenter JF, Crowe JH. An infrared spectroscopic study of the interactions of carbohydrates with dried proteins. Biochemistry 1989;28:3916–3922
- Heljo VP, Filipe V, Romeijn S, et al. Stability of rituximab in freeze-dried formulations containing trehalose or melibiose under different relative humidity atmospheres. J Pharm Sci 2013;102:401–414