147
Views
0
CrossRef citations to date
0
Altmetric
Review

Tools for the analysis and characterization of therapeutic protein species

, &
Pages 17-24 | Published online: 05 May 2016

References

  • Walsh G. Biopharmaceutical benchmarks 2010. Nat Biotechnol. 2010;28(9):917–924. doi: 10.1038/nbt0910–0917.
  • Carter PJ. Introduction to current and future protein therapeutics: A protein engineering perspective. Exp Cell Res. 2011;317(9):1261–1269.
  • Walsh G. Biopharmaceutical benchmarks 2014. Nat Biotechnol. 2014;32(10):992–1000.
  • Lad L, Clancy S, Kovalenko M, et al. High-throughput kinetic screening of hybridomas to identify high-affinity antibodies using bio-layer interferometry. J Biomol Screen. 2015;20(4):498–507.
  • Jacobs PP, Callewaert N. N-glycosylation engineering of biopharmaceutical expression systems. Curr Mol Med. 2009;9(7):774–800.
  • Shukla AA, Jiang C, Ma J, Rubacha M, Flansburg L, Lee SS. Demonstration of robust host cell protein clearance in biopharmaceutical downstream processes. Biotechnol Prog. 2008;24(3):615–622. doi: 10.1021/bp070396j. Epub 2008 Apr 15.
  • Aboulaich N, Chung WK, Thompson JH, Larkin C, Robbins D, Zhu M. A novel approach to monitor clearance of host cell proteins associated with monoclonal antibodies. Biotechnology Prog. 2014; 30(5):1114–1124.
  • Mihara K, Ito Y, Hatano Y, et al. Host cell proteins: the hidden side of biosimilarity assessment. J Pharm Sci. 2015;104(12):3991–3996.
  • Bracewell DG, Francis R, Smales CM. The future of host cell protein (HCP) identification during process development and manufacturing linked to a risk-based management for their control. Biotechnol Bioeng. 2015;112(9):1727–1737.
  • Blackstone EA, Joseph PF. The economics of biosimilars. Am Health Drug Benefits. 2013;6(8):469–478.
  • Blackstone EA, Fuhr JP, Jr. Innovation and competition: will biosimilars succeed? The creation of an FDA approval pathway for biosimilars is complex and fraught with hazard. Yes, innovation and market competition are at stake. But so are efficacy and patient safety. Biotechnol Healthc. 2012;9(1):24–27.
  • Beck A, Debaene F, Diemer H, et al. Cutting-edge mass spectrometry characterization of originator, biosimilar and biobetter antibodies. J Mass Spectrom. 2015;50(2):285–297. doi: 10.1002/jms.3554.
  • Tsiftsoglou AS, Ruiz S, Schneider CK. Development and regulation of biosimilars: current status and future challenges. Bio Drugs. 2013; 27(3):203–211.
  • Thelwell C, Longstaff C. Biosimilars: the process is the product. The example of recombinant streptokinase. J Thromb Haemost. 2014;12(8):1229–1233.
  • Beck A, Wagner-Rousset E, Ayoub D, Van Dorsselaer A, Sanglier-Cianferani S. Characterization of therapeutic antibodies and related products. Anal Chem. 2013;85(2):715–736.
  • Staub A, Guillarme D, Schappler J, Veuthey JL, Rudaz S. Intact protein analysis in the biopharmaceutical field. J Pharm Biomed Anal. 2011;55(4):810–822.
  • Sandra K, Vandenheede I, Sandra P. Modern chromatographic and mass spectrometric techniques for protein biopharmaceutical characterization. J Chromatogr A. 2014;1335:81–103.
  • Levy NE, Valente KN, Choe LH, Lee KH, Lenhoff AM. Identification and characterization of host cell protein product-associated impurities in monoclonal antibody bioprocessing. Biotechnol Bioeng. 2014;111(5):904–912.
  • Buyel JF, Twyman RM, Fischer R. Extraction and downstream processing of plant-derived recombinant proteins. Biotechnol Adv. 2015; 33(6 Pt 1):902–913.
  • Wang X, Hunter AK, Mozier NM. Host cell proteins in biologics development: identification, quantitation and risk assessment. Biotechnol Bioeng. 2009;103(3):446–458.
  • Zhang W, Wu M, Menesale E, Lu T, Magliola A, Bergelson S. Development and qualification of a high sensitivity, high throughput Q-PCR assay for quantitation of residual host cell DNA in purification process intermediate and drug substance samples. J Pharm Biomed Anal. 2014;100:145–149.
  • Leader B, Baca QJ, Golan DE. Protein therapeutics: a summary and pharmacological classification. Nat Rev Drug Discov. 2008;7(1):21–39.
  • Bomans K, Lang A, Roedl V, et al. Identification and monitoring of host cell proteins by mass spectrometry combined with high performance immunochemistry testing. PLoS One. 2013;8(11):e81639.
  • Tscheliessnig AL, Konrath J, Bates R, Jungbauer A. Host cell protein analysis in therapeutic protein bioprocessing – methods and applications. Biotechnol J. 2013;8(6):655–670.
  • Zhu-Shimoni J, Yu C, Nishihara J, et al. Host cell protein testing by ELISAs and the use of orthogonal methods. Biotechnol Bioeng. 2014;111(12):2367–2379.
  • Xu D, Mane S, Sosic Z. Characterization of a biopharmaceutical protein and evaluation of its purification process using automated capillary Western blot. Electrophoresis. 2015;36(2):363–370.
  • Schenauer MR, Flynn GC, Goetze AM. Identification and quantification of host cell protein impurities in biotherapeutics using mass spectrometry. Anal Biochem. 2012;428(2):150–157.
  • Kaltashov IA, Bobst CE, Abzalimov RR, Wang G, Baykal B, Wang S. Advances and challenges in analytical characterization of biotechnology products: mass spectrometry-based approaches to study properties and behavior of protein therapeutics. Biotechnol Adv. 2012;30(1):210–222.
  • Shapiro HM. Multiparameter flow cytometry of bacteria: implications for diagnostics and therapeutics. Cytometry. 2001;43(3):223–226.
  • Reisinger V, Toll H, Mayer RE, Visser J, Wolschin F. A mass spectrometry-based approach to host cell protein identification and its application in a comparability exercise. Anal Biochem. 2014;463:1–6.
  • He Y, Isele C, Hou W, Ruesch M. Rapid analysis of charge variants of monoclonal antibodies with capillary zone electrophoresis in dynamically coated fused-silica capillary. J Sep Sci. 2011;34(5):548–555.
  • Redman EA, Batz NG, Mellors JS, Ramsey JM. Integrated microfluidic capillary electrophoresis-electrospray ionization devices with online MS detection for the separation and characterization of intact monoclonal antibody variants. Anal Chem. 2015;87(4):2264–2272.
  • Hogwood CEM, Bracewell DG, Smales CM. Measurement and control of host cell proteins (HCPs) in CHO cell bioprocesses. Curr Opin Biotechnol. 2014;30:153–160.
  • Vihinen M. Types and effects of protein variations. Hum Genet. 2015;134(4):405–421.
  • Herring LE, Grant KG, Blackburn K, Haugh JM, Goshe MB. Development of a tandem affinity phosphoproteomic method with motif selectivity and its application in analysis of signal transduction networks. J Chromatogr B Analyt Technol Biomed Life Sci. 2015;988:166–174.
  • Lynaugh H, Li H, Gong B. Rapid Fc glycosylation analysis of Fc fusions with IdeS and liquid chromatography mass spectrometry. MAbs. 2013;5(5):641–645.
  • Roth Z, Yehezkel G, Khalaila I. Identification and quantification of protein glycosylation. Int J Carbohydr Chem. 2012:10.
  • Hua S, Nwosu CC, Strum JS, et al. Site-specific protein glycosylation analysis with glycan isomer differentiation. Anal Bioanal Chem. 2012;403(5):1291–1302.
  • Li Y, Silva JC, Skinner ME, Lombard DB. Mass spectrometry- based detection of protein acetylation. Methods Mol Biol. 2013; 1077:81–104.
  • Wiggins B, Liu-Shin L, Yamaguchi H, Ratnaswamy G. Characterization of cysteine-linked conjugation profiles of immunoglobulin g1 and immunoglobulin g2 antibody-drug conjugates. J Pharm Sci. 2015;104(4):1362–1372.
  • Marcoux J, Champion T, Colas O, et al. Native mass spectrometry and ion mobility characterization of trastuzumab emtansine, a lysine-linked antibody drug conjugate. Protein Sci. 2015;24(8):1210–1223.
  • Debaene F, Boeuf A, Wagner-Rousset E, et al. Innovative native MS methodologies for antibody drug conjugate characterization: high resolution native MS and IM-MS for average DAR and DAR distribution assessment. Anal Chem. 2014;86(21):10674–10683.
  • Barnett GV, Qi W, Amin S, et al. Structural changes and aggregation mechanisms for anti-streptavidin IgG1 at elevated concentration. J Phys Chem B. 2015;119(49):15150–15163.
  • Yu CM, Mun S, Wang NH. Phenomena of insulin peak fronting in size exclusion chromatography and strategies to reduce fronting. J Chromatogr A. 2008;1192(1):121–129.
  • Hong P, Koza S, Bouvier ES. Size-exclusion chromatography for the analysis of protein biotherapeutics and their aggregates. J Liq Chromatogr Relat Technol. 2012;35(20):2923–2950.
  • Iavicoli P, Urban P, Bella A, Ryadnov MG, Rossi F, Calzolai L. Application of asymmetric flow field-flow fractionation hyphenations for liposome-antimicrobial peptide interaction. J Chromatogr A. 2015;1422:260–269.
  • Kashid SB, Tak RD, Raut RW. Antibody tagged gold nanoparticles as scattering probes for the pico molar detection of the proteins in blood serum using nanoparticle tracking analyzer. Colloids Surf B Biointerfaces. 2015;133:208–213.
  • Chen X, Choudhari SP, Kumar P, et al. Biophysical characterization of the Type III secretion system translocator proteins and the translocator proteins attached to bacterium-like particles. J Pharm Sci. 2015;104(12):4065–4073.
  • Safari MS, Vorontsova MA, Poling-Skutvik R, Vekilov PG, Conrad JC. Differential dynamic microscopy of weakly scattering and polydisperse protein-rich clusters. Phys Rev E Stat Nonlin Soft Matter Phys. 2015;92(4):042712.
  • McCamish M, Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther. 2012;91(3):405–417.
  • Rustandi RR, Wang F, Hamm C, Cuciniello JJ, Marley ML. Development of imaged capillary isoelectric focusing method and use of capillary zone electrophoresis in hepatitis B vaccine RECOMBIVAX HB(R). Electrophoresis. 2014;35(7):1072–1078.
  • Rustandi RR, Peklansky B, Anderson CL. Use of imaged capillary isoelectric focusing technique in development of diphtheria toxin mutant CRM197. Electrophoresis. 2014;35(7):1065–1071.
  • Anderson CL, Wang Y, Rustandi RR. Applications of imaged capillary isoelectric focussing technique in development of biopharmaceutical glycoprotein-based products. Electrophoresis. 2012;33(11):1538–1544.
  • Stoll DR, Harmes DC, Danforth J, et al. Direct identification of rituximab main isoforms and subunit analysis by online selective comprehensive two-dimensional liquid chromatography-mass spectrometry. Anal Chem. 2015;87(16):8307–8315.
  • Uliyanchenko E. Size-exclusion chromatography-from high-performance to ultra-performance. Anal Bioanal Chem. 2014;406(25):6087–6094.
  • Brower KP, Ryakala VK, Bird R, et al. Single-step affinity purification of enzyme biotherapeutics: a platform methodology for accelerated process development. Biotechnol Prog. 2014;30(3):708–717.
  • Silva AM, Vitorino R, Domingues MR, Spickett CM, Domingues P. Post-translational modifications and mass spectrometry detection. Free Radic Biol Med. 2013;65:925–941.
  • Huang J, Wang F, Ye M, Zou H. Enrichment and separation techniques for large-scale proteomics analysis of the protein post-translational modifications. J Chromatogr A. 2014;1372C:1–17.
  • Le Fourn V, Girod PA, Buceta M, Regamey A, Mermod N. CHO cell engineering to prevent polypeptide aggregation and improve therapeutic protein secretion. Metab Eng. 2014;21:91–102.
  • Zhao SS, Chen DD. Applications of capillary electrophoresis in characterizing recombinant protein therapeutics. Electrophoresis. 2014;35(1):96–108.
  • Qiu F, Hou T, Huang D, et al. Evaluation of two high-abundance protein depletion kits and optimization of downstream isoelectric focusing. Mol Med Rep. 2015;12(5):7749–7755.
  • Tipton JD, Tran JC, Catherman AD, Ahlf DR, Durbin KR, Kelleher NL. Analysis of intact protein isoforms by mass spectrometry. J Biol Chem. 2011;286(29):25451–25458.
  • Zhang H, Cui W, Gross ML. Mass spectrometry for the biophysical characterization of therapeutic monoclonal antibodies. FEBS Lett. 2014;588(2):308–317.
  • Liu Y, Huttenhain R, Collins B, Aebersold R. Mass spectrometric protein maps for biomarker discovery and clinical research. Expert Rev Mol Diagn. 2013;13(8):811–825.
  • Sajic T, Liu Y, Aebersold R. Using data-independent, high-resolution mass spectrometry in protein biomarker research: perspectives and clinical applications. Proteomics Clin Appl. 2015;9(3–4):307–321.
  • Orellana CA, Marcellin E, Schulz BL, Nouwens AS, Gray PP, Nielsen LK. High-antibody-producing Chinese hamster ovary cells up-regulate intracellular protein transport and glutathione synthesis. J Proteome Res. 2015;14(2):609–618.
  • Zhang Z, Pan H, Chen X. Mass spectrometry for structural characterization of therapeutic antibodies. Mass Spectrom Rev. 2009;28(1):147–176.
  • van den Broek I, Niessen WM, van Dongen WD. Bioanalytical LC-MS/MS of protein-based biopharmaceuticals. J Chromatogr B Analyt Technol Biomed Life Sci. 2013;929:161–179.
  • Mao Y, Valeja SG, Rouse JC, Hendrickson CL, Marshall AG. Top-down structural analysis of an intact monoclonal antibody by electron capture dissociation-Fourier transform ion cyclotron resonance-mass spectrometry. Anal Chem. 2013;85(9):4239–4246.
  • Thompson NJ, Rosati S, Heck AJ. Performing native mass spectrometry analysis on therapeutic antibodies. Methods. 2014;65(1):11–17.
  • Lanucara F, Holman SW, Gray CJ, Eyers CE. The power of ion mobility-mass spectrometry for structural characterization and the study of conformational dynamics. Nat Chem. 2014;6(4):281–294.
  • Wang D, Wynne C, Gu F, et al. Characterization of drug-product-related impurities and variants of a therapeutic monoclonal antibody by higher energy C-trap dissociation mass spectrometry. Anal Chem. 2015;87(2):914–921.
  • Johnson CM. Differential scanning calorimetry as a tool for protein folding and stability. Arch Biochem Biophys. 2013;531(1–2):100–109.
  • Chiu MH, Prenner EJ. Differential scanning calorimetry: an invaluable tool for a detailed thermodynamic characterization of macromolecules and their interactions. J Pharm Bioallied Sci. 2011;3(1):39–59.