Alexander PA, He Y, Chen Y, Orban J, Bryan PN (2007) The design and characterization of two proteins with 88 % sequence identity but different structure and function. Proc Natl Acad Sci USA 104:11963–11968PubMedCrossRef

Anderson DE, Becktel WJ, Dahlquist FW (1990) pH-induced denaturation of proteins: a single salt bridge contributes 3–5 Kcal/Mol to the free energy of folding of T4 lysozyme. Biochemistry 29:2403–2408PubMedCrossRef

Anfinsen CB (1973) Principles that govern the folding of protein chains. Science 181:223–230PubMedCrossRef

Appa RS, Theill C, Hansen L, Moss J, Behrens C, Nicolaisen EM, Klausen NK, Christensen MS (2010) Investigating clearance mechanisms for recombinant activated factor VII in a perfused liver model. Thromb Haemost 104:243–51PubMedCrossRef

Aucamp JP, Cosme AM, Lye GJ, Dalby PA (2005) High-throughput measurement of protein stability in microtiter plates. Biotechnol Bioeng 89:599–607PubMedCrossRef

Baudys M, Uchio T, Mix D, Wilson D, Kim SW (1995) Physical stabilization of insulin by glycosylation. J Pharm Sci 84:28–33PubMedCrossRef

Bee JS, Randolph TW, Carpenter JF, Bishop SM, Dimitrova MN (2011) Effects of surfaces and leachables on the stability of biopharmaceuticals. J Pharm Sci 100:4158–4170CrossRef

Benoit G, Machuca E, Heidet L, Antignac C (2010) Hereditary kidney diseases: highlighting the importance of classical Mendelian phenotypes. Ann N Y Acad Sci 1214:83–98PubMedCrossRef

Bentham J, Bhattacharya S (2008) Genetic mechanisms controlling cardiovascular development. Ann N Y Acad Sci 1123:10–19PubMedCrossRef

Bolen DW, Baskakov IV (2001) The osmophobic effect: natural selection of a thermodynamic force in protein folding. J Mol Biol 310:955–963PubMedCrossRef

Braeckmans K, Buyens K, Bouquet W, Vervaet C, Joye P, De VF, Plawinski L, Doeuvre L, Angles-­Cano E, Sanders NN et al (2010) Sizing nanomatter in biological fluids by fluorescence single particle tracking. Nano Lett 10:4435–4442PubMedCrossRef

Braun A, Kwee L, Labow MA, Alsenz J (1997) Protein aggregates seem to play a key role among the parameters influencing the antigenicity of interferon alpha (IFN-Alpha) in normal and transgenic mice. Pharm Res 14:1472–1478PubMedCrossRef

Capriotti E, Fariselli P, Casadio R (2005) I-Mutant2.0: predicting stability changes upon mutation from the protein sequence or structure. Nucleic Acids Res 33:W306–W310PubMedCrossRef

Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJ, Middaugh CR, Winter G, Fan YX, Kirshner S, Verthelyi D, Kozlowski S et al (2009) Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality. J Pharm Sci 98:1201–1205PubMedCrossRef

Carpenter J, Cherney B, Lubinecki A, Ma S, Marszal E, Mire-Sluis A, Nikolai T, Novak J, Ragheb J, Simak J (2010a) Meeting report on protein particles and immunogenicity of therapeutic proteins: filling in the gaps in risk evaluation and mitigation. Biologicals 38:602–611PubMedCrossRef

Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJ, Middaugh CR, Winter G (2010b) Potential inaccurate quantitation and sizing of protein aggregates by size exclusion chromatography: essential need to use orthogonal methods to assure the quality of therapeutic protein products. J Pharm Sci 99:2200–2208PubMedCrossRef

Castro PM, Ison AP, Hayter PM, Bull AT (1995) The macroheterogeneity of recombinant human interferon-gamma produced by Chinese-hamster ovary cells is affected by the protein and lipid content of the culture medium. Biotechnol Appl Biochem 21:87–100PubMed

Cheng J, Randall A, Baldi P (2006) Prediction of protein stability changes for single-site mutations using support vector machines. Proteins 62:1125–1132PubMedCrossRef

Cromwell ME, Hilario E, Jacobson F (2006) Protein aggregation and bioprocessing. AAPS J 8:E572–E579PubMedCrossRef

den Engelsman J, Garidel P, Smulders R, Koll H, Smith B, Bassarab S, Seidl A, Hainzl O, Jiskoot W (2011) Strategies for the assessment of protein aggregates in pharmaceutical biotech product development. Pharm Res 28:920–933CrossRef

Dresser DW (1962) Specific inhibition of antibody production. II. Paralysis induced in adult mice by small quantities of protein antigen. Immunology 5:378–388PubMed

Edgell MH, Sims DA, Pielak GJ, Yi F (2003) High-precision, high-throughput stability determinations facilitated by robotics and a semiautomated titrating fluorometer. Biochemistry 42:7587–7593PubMedCrossRef

Elia AE, Albanese A (2010) Emerging parkinsonian phenotypes. Rev Neurol 166:834–840PubMedCrossRef

England JL, Haran G (2011) Role of solvation effects in protein denaturation: from thermodynamics to single molecules and back. Annu Rev Phys Chem 62:257–277PubMedCrossRef

Ericsson UB, Hallberg BM, Detitta GT, Dekker N, Nordlund P (2006) Thermofluor-based high-­throughput stability optimization of proteins for structural studies. Anal Biochem 357:289–298PubMedCrossRef

Fares FA, Suganuma N, Nishimori K, LaPolt PS, Hsueh AJ, Boime I (1992) Design of a long-­acting follitropin agonist by fusing the C-terminal sequence of the chorionic gonadotropin beta subunit to the follitropin beta subunit. Proc Natl Acad Sci USA 89:4304–8PubMedCrossRef

Filipe V, Hawe A, Jiskoot W (2010) Critical evaluation of nanoparticle tracking analysis (NTA) by nanosight for the measurement of nanoparticles and protein aggregates. Pharm Res 27:796–810PubMedCrossRef

Filipe V, Poole R, Kutscher M, Forier K, Braeckmans K, Jiskoot W (2011) Fluorescence single particle tracking for the characterization of submicron protein aggregates in biological fluids and complex formulations. Pharm Res 28:1112–1120PubMedCrossRef

Fraunhofer W, Winter G (2004) The use of asymmetrical flow field-flow fractionation in pharmaceutics and biopharmaceutics. Eur J Pharm Biopharm 58:369–383PubMedCrossRef

Garrod A (1908) The Croonian lectures on inborn errors of metabolism, lecture II: alkaptonuria. Lancet 2:73–79

Gaudet M, Remtulla N, Jackson SE, Main ER, Bracewell DG, Aeppli G, Dalby PA (2010) Protein denaturation and protein: drugs interactions from intrinsic protein fluorescence measurements at the nanolitre scale. Protein Sci 19:1544–1554PubMedCrossRef

General Chapter <1 > Injections (2012) USP 35-NF 30, pp 33–37

General Chapter <787 > Subvisible particulate matter in therapeutic protein injections [New] (USP36-NF31 1S) (2012) Pharmacopeial Forum 38(3)

General Chapter <788 > Particulate Matter in Injections (2012) USP 35-NF 30, pp 339–342

General Chapter <790 > Visible particulates in injections [New] (USP36-NF31 1S) (2012) Pharmacopeial Forum 38(2)

Ghaemmaghami S, Oas TG (2001) Quantitative protein stability measurement in vivo. Nat Struct Biol 8:879–882PubMedCrossRef

Gilis D, Rooman M (2000) PoPMuSiC, an algorithm for predicting protein mutant stability changes: application to prion proteins. Protein Eng 13:849–856PubMedCrossRef