Elvin, et al. Therapeutic antibodies: market considerations, disease targets and bioprocessing. Int. J. Pharm. 2013; 440(1, 2):83–98. http://www.sciencedirect.com/science/article/pii/S0378517311011690.
Carter PJ. Introduction to current and future protein therapeutics: A protein engineering perspective. Exp. Cell Res. 2011;317(9):1261–9.
Plitnick L, Herzyk D.. Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics. Elsevier Science;2013.
Wurch T, Pierré A, Depil S. Novel protein scaffolds as emerging therapeutic proteins: from discovery to clinical proof-of-concept. Trends Biotechnol. 2012;30(11):575–582. http://www.sciencedirect.com/science/article/pii/S0167779912001163.
Gil D, Schrum AG. Strategies to stabilize compact folding and minimize aggregation of antibody-based fragments. Adv. Biosci. Biotechnol. 2013;4:73–84. http://dx.doi.org/10.4236/abb.2013.44A011.
Fast JL, Cordes AA, Carpenter JF, Randolph W, Physical Instability of a Therapeutic Fc Fusion Protein: domain contributions to conformational and colloidal stability. Biochemistry. 2009;48:11724–11736. http://pubs.acs.org/doi/pdf/10.1021/bi900853v.
Kleemann GR, Beierle J, Nichols AC, Dillon TM, Pipes GD, Bondarenko PV. Characterization of IgG1 Immunoglobulins and Peptide-Fc Fusion Proteins by Limited Proteolysis in Conjunction with LC-MS. Anal. Chem. 2008;80:2001–2009. http://pubs.acs.org/doi/pdf/10.1021/ac701629v.
Chang B, Hershenson S. Practical approaches to protein formulation development. In: Carpenter J, Manning M, editors. Rational design of stable protein formulations. USA: Springer;2002. p. 1–25.
Gibson M. Pharmaceutical preformulation and formulation: a practical guide from candidate drug selection to commercial dosage form. CRC Press;2009.
Akers MJ. Excipient–drug interactions in parenteral formulations. J Pharmaceutical Sci. 2002;91(11):2283–2300.
Rathore N, Rajan RS, Current perspectives on stability of protein drug products during formulation, fill and finish operations. Biotechnol. Progress. 2008;24(3):504–514.
Walsh G. Biopharmaceutical benchmarks 2014. Nat. Biotech. 2014;32(10):992–1000.
Harris RJ, Shire SJ, Winter C. Commercial manufacturing scale formulation and analytical characterization of therapeutic recombinant antibodies. Drug Develop. Res. 2004;61(3):137–154.
Kiese S, Papppenberger A, Friess W, Mahler HC. Shaken, not stirred: mechanical stress testing of an IgG1 antibody. J. Pharm. Sci. 2008;97(10):4347–4366.
Ohtake S, Kita Y, Arakawa T. Interactions of formulation excipients with proteins in solution and in the dried state. Adv. Drug Delivery Rev. 2011;63(13):1053–1073.
Chang BS, Kendrick BS, Carpenter JF. Surface-induced denaturation of proteins during freezing and its inhibition by surfactants. J Pharmaceutical Sci. 1996;85(12):1325–1330.
Randolph T, Jones L. Surfactant-Protein Interactions. In: Carpenter J, Manning M. editors Rational design of stable protein formulations. USA: Springer;2002. p. 159–175.
Wang W. Instability, stabilization, and formulation of liquid protein pharmaceuticals. Int. J. Pharm. 1999;185(2):129–188.
Gad SC. Pharmaceutical manufacturing handbook: production and processes. Wiley;2008.
Rathore N, Rajan RS, Freund E. Impact of manufacturing processes on drug product stability and quality. In: Formulation and process development strategies for manufacturing biopharmaceuticals. Wiley;2010. p. 917–940.
Patro SY, Freund E, Chang BS. Protein formulation and fill-finish operations. Biotechnol. Ann. Rev. Elsevier. 2002;8:55–84.
Kolhe P, Badkar A. Protein and solute distribution in drug substance containers during frozen storage and post-thawing: a tool to understand and define freezing–thawing parameters in biotechnology process development. Biotechnol. Progress 2011;27(2):494–504.
Thomas CR, Geer D. Effects of shear on proteins in solution. Biotechnol. Lett. 2011;33(3):443–456.
Lutz H. Rationally defined safety factors for filter sizing. J. Membrane Sci. 2009;341(1–2):268–278.
Biddlecombe JG, Craig AV, Zhang H, Uddin S, Mulot S, Fish BC, Bracewell DG. Determining antibody stability: creation of solid-liquid interfacial effects within a high shear environment. Biotechnol. Prog. 2007;23(5):1218–22.
Pikal M. Freeze-Drying of Proteins. Formulation and delivery of proteins and peptides. Am. Chem. Soc. 1994;567:120–133.
Newton DW. Drug incompatibility chemistry. Am. J. Health Syst. Pharm. 2009;66(4):348–357.
Gikic M, Di Paolo E, Pannatier A, Cotting J. Evaluation of physicochemical incompatibilities during parenteral drug administration in a paediatric intensive care unit. Pharmacy World Sci. 2000;22(3):88–91.
den Engelsman J, Garidel P, Smulders R, Koll H, Smith B, Bassarab S, Seidl A, Hainzl O, Jiskoot W. Strategies for the assessment of protein aggregates in pharmaceutical biotech product development. Pharmaceutical Res. 2011;28(4):920–933.
Ratanji KD, Derrick JP, Dearman RJ, Kimber I. Immunogenicity of therapeutic proteins: influence of aggregation. J. Immunotoxicology. 2014;11(2):99–109.
Sreedhara A, Glover ZK, Piros N, Xiao N, Patel A, Kabakoff B. Stability of IgG1 monoclonal antibodies in intravenous infusion bags under clinical in-use conditions. J. Pharm. Sci. 2012;101(1):21–30.
Kerwin BA. Polysorbates 20 and 80 used in the formulation of protein biotherapeutics: structure and degradation pathways. J. Pharm. Sci. 2008;97(8):2924–2935.
ICH. Final guideline on Pharmaceutical Development Q8. International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. I. I. C. o. Harmonization. 2008.
Bardin C A, Astier A, Vulto G, Sewell J, Vigneron R, Trittler M, Daouphars M, Paul M, Trojniak F, Pinguet P, French Society of Oncology. Guidelines for the practical stability studies of anticancer drugs: a European consensus conference. Ann Pharm Fr. 2011;69(4):221–31.
Sharma M, Cheung J, Dabbara A, Petersen J. Intravenous admixture compatibility for sterile products: challenges and regulatory guidance. In: Kolhe P, Shah M, Rathore N, editors. Sterile product development. New York: Springer;2013. 6:461–474.
Bye J, Platts L, Falconer R. Biopharmaceutical liquid formulation: a review of the science of protein stability and solubility in aqueous environments. Biotechnol. Lett. 2014;36(5):869–75.
Kamerzell TJ, Esfandiary R, Joshi SB, Middaugh CR, Volkin DB. Protein–excipient interactions: Mechanisms and biophysical characterization applied to protein formulation development. Adv Drug Delivery Rev. 2011;63(13):1118–1159.