Overview on biotherapeutic proteins: Impact on bioanalysis

Bioanalysis

Volumn 8, Issue 1, 2016, Pages 1-9

  Zhang, Yan J ^a   Luo, Linlin ^a   Desai, Dharmesh D ^a  

^a BRISTOL MYERS SQUIBB   (United States)

Author keywords

bioanalysis; biotherapeutic proteins; immunogenicity; PK; protein therapeutics

Indexed keywords

CHEMICAL BINDING; CLINICAL TRIAL; HUMAN; IMMUNOGENICITY; PROTEIN PROCESSING; ANIMAL; CHEMICAL ANALYSIS; METABOLISM; PROCEDURES;

PROTEIN;

ANIMALS; CHEMISTRY TECHNIQUES, ANALYTICAL; HUMANS; PROTEIN PROCESSING, POST-TRANSLATIONAL; PROTEINS;

EID: 84952645184     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.15.224     Document Type: Article

References (50)

1. Casadevall A. Passive antibody therapies: progress and continuing challenges. Clin. Immunol. 93(1), 5-15 (1999).
2. Keller MA, Stiehm ER. Passive immunity in prevention and treatment of infectious diseases. Clin. Microbiol. Rev. 13(4), 602-614 (2000).
3. Reynolds T, De Zafra C, Kim A, Gelzleichter TR. Chapter-Overview of biopharmaceuticals and comparison with small-molecule drug development. In:Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics . Plitnick LM, Herzyk DJ (Eds). Academic Press, San Diego, CA, USA, 3-33 (2013).
4. Banting FG, Best CH, Collip JB, Campbell WR, Fletcher AA. Pancreatic extracts in the treatment of diabetes mellitus. Can. Med. Assoc. J. 12(3), 141-146 (1922).
5. Berger M. A history of immune globulin therapy, from the Harvard crash program to monoclonal antibodies. Curr. Allergy Asthma Rep. 2(5), 368-378 (2002).
6. Snydman DR. Historical overview of the use of cytomegalovirus hyperimmune globulin in organ transplantation. Transpl. Infect. Dis. 3(Suppl. 2), 6-13 (2001).
7. Frasier SD. The not-so-good old days: working with pituitary growth hormone in North America, 1956 to 1985. J. Pediatr. 131(Suppl. 1 II), S1-S4 (1997).
8. Kohler G, Milstein C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature 256(5517), 495-497 (1975).
9. Crea R, Kraszewski A, Hirose T, Itakura K. Chemical synthesis of genes for human insulin. Proc. Natl Acad. Sci. USA 75(12), 5765-5769 (1978).
10. Walsh G. Biopharmaceutical Benchmarks 2014. Nat. Biotechnol. 32(10), 992-1000 (2014).
11. Chang CH, Gupta P, Goldenberg DM. Advances and challenges in developing cytokine fusion proteins as improved therapeutics. Expert Opin. Drug Discov. 4(2), 181-194 (2009).
12. Ecker DM, Jones SD, Levine HL. The therapeutic monoclonal antibody market. mAbs 7(1), 9-14 (2015).
13. Löfblom J, Frejd FY, Ståhl S. Non-immunoglobulin based protein scaffolds. Curr. Opin. Biotechnol. 22(6), 843-848 (2011).
14. Sivertsen J, Rosenmeier J, Holst JJ, Vilsboll T. The effect of glucagon-like peptide 1 on cardiovascular risk. Nat. Rev. Cardiol. 9(4), 209-222 (2012).
15. Kaspar AA, Reichert JM. Future directions for peptide therapeutics development. Drug Discov. Today 18(17-18), 807-817 (2013).
16. Jung SK, Deluca PP, Kang CL. Emerging PEGylated drugs. Expert Opin. Emerg. Drugs 14(2), 363-380 (2009).
17. Hamidi M, Rafiei P, Azadi A. Designing PEGylated therapeutic molecules: advantages in ADMET properties. Expert Opin. Drug Discov. 3(11), 1293-1307 (2008).
18. Shimamoto G, Gegg C, Boone T, Quéva C. Peptibodies: a flexible alternative format to antibodies. mAbs 4(5), 586-591 (2012).
19. Sleep D, Cameron J, Evans LR. Albumin as a versatile platform for drug half-life extension. Biochim. Biophys. Acta 1830(12), 5526-5534 (2013).
20. Buss NaPS, Henderson SJ, Mcfarlane M, Shenton JM, De Haan L. Monoclonal antibody therapeutics: history and future. Curr. Opin. Pharmacol. 12(5), 615-622 (2012).
21. Sassoon I, Blanc V. Antibody-drug conjugate (ADC) clinical pipeline: a review. Methods Mol. Biol. 1045, 1-27 (2013).
22. Holt LJ, Herring C, Jespers LS, Woolven BP, Tomlinson IM. Domain antibodies: proteins for therapy. Trends Biotechnol. 21(11), 484-490 (2003).
23. Nagorsen D, Kufer P, Baeuerle PA, Bargou R. Blinatumomab: a historical perspective. Pharmacol. Ther. 136(3), 334-342 (2012).
24. Byrne H, Conroy PJ, Whisstock JC, Okennedy RJ. A tale of two specificities: bispecific antibodies for therapeutic and diagnostic applications. Trends Biotechnol. 31(11), 621-632 (2013).
25. Lipovsek D. Adnectins: engineered target-binding protein therapeutics. Protein Eng. Des. Sel. 24(1-2), 3-9 (2011).
26. Stumpp MT, Amstutz P. DARPins: a true alternative to antibodies. Curr. Opin. Drug Discov. Dev. 10(2), 153-159 (2007).
27. Löfblom J, Feldwisch J, Tolmachev V, Carlsson J, Ståhl S, Frejd FY. Affibody molecules: engineered proteins for therapeutic, diagnostic and biotechnological applications. FEBS Lett. 584(12), 2670-2680 (2010).
28. Lehmann A. Ecallantide (DX-88), a plasma kallikrein inhibitor for the treatment of hereditary angioedema and the prevention of blood loss in on-pump cardiothoracic surgery. Expert Opin. Biol. Ther. 8(8), 1187-1199 (2008).
29. Khoury GA, Baliban RC, Floudas CA. Proteome-wide posttranslational modification statistics: frequency analysis and curation of the swiss-prot database. Sci. Rep. 1, pii: srep00090 (2011).
30. Taggart C, Cervantes-Laurean D, Kim G, et al. Oxidation of either methionine 351 or methionine 358 in alpha 1-antitrypsin causes loss of anti-neutrophil elastase activity. J. Biol. Chem. 275(35), 27258-27265 (2000).
31. Prueksaritanont T, Tang C. ADME of biologics-what have we learned from small molecules? AAPS J. 14(3), 410-419 (2012).
32. Hall MP, Gegg C, Walker K, et al. Ligand-binding mass spectrometry to study biotransformation of fusion protein drugs and guide immunoassay development: strategic approach and application to peptibodies targeting the thrombopoietin receptor. AAPS J. 12(4), 576-585 (2010).
33. Hecht R, Li YS, Sun J, et al. Rationale-based engineering of a potent long-acting FGF21 analog for the treatment of type 2 diabetes. PLoS ONE 7(11), e49345 (2012).
34. Yie J, Wang W, Deng L, et al. Understanding the physical interactions in the FGF21/FGFR/beta-Klotho complex: structural requirements and implications in FGF21 signaling. Chem. Biol. Drug Des. 79(4), 398-410 (2012).
35. Hager T, Spahr C, Xu J, Salimi-Moosavi H, Hall M. Differential enzyme-linked immunosorbent assay and ligandbinding mass spectrometry for analysis of biotransformation of protein therapeutics: application to various FGF21 modalities. Anal. Chem. 85(5), 2731-2738 (2013).
36. Rathore N, Rajan RS. Current perspectives on stability of protein drug products during formulation, fill and finish operations. Biotechnol. Prog. 24(3), 504-514 (2008).
37. Joubert MK, Luo Q, Nashed-Samuel Y, Wypych J, Narhi LO. Classification and characterization of therapeutic antibody aggregates. J. Biol. Chem. 286(28), 25118-25133 (2011).
38. Krishnan S, Raibekas AA. Multistep aggregation pathway of human interleukin-1 receptor antagonist: kinetic, structural, and morphological characterization. Biophys. J. 96(1), 199-208 (2009).
39. Acosta-Sampson L, King J. Partially folded aggregation intermediates of human gammaD-, gammaC-, and gammas crystallin are recognized and bound by human alphaBcrystallin chaperone. J. Mol. Biol. 401(1), 134-152 (2010).
40. Kim D, Yu MH. Folding pathway of human alpha 1-antitrypsin: characterization of an intermediate that is active but prone to aggregation. Biochem. Biophys. Res. Commun. 226(2), 378-384 (1996).
41. Ratanji KD, Derrick JP, Dearman RJ, Kimber I. Immunogenicity of therapeutic proteins: influence of aggregation. J. Immunotoxicol. 11(2), 99-109 (2014).
42. Lee JW. ADME of monoclonal antibody biotherapeutics: knowledge gaps and emerging tools. Bioanalysis 5(16), 2003-2014 (2013).
43. Lin JH. Pharmacokinetics of biotech drugs: peptides, proteins and monoclonal antibodies. Curr. Drug Metabol. 10(7), 661-691 (2009).
44. Lee JW, Kelley M, King LE, et al. Bioanalytical approaches to quantify "total" and "free" therapeutic antibodies and their targets: technical challenges and PK/PD applications over the course of drug development. AAPS J. 13(1), 99-110 (2011).
45. Kuang B, King L, Wang HF. Therapeutic monoclonal antibody concentration monitoring: free or total? Bioanalysis 2(6), 1125-1140 (2010).
46. FDA. Clinical pharmacology data to support a demonstration of biosimilarity to a reference product (2014). www.fda.gov
47. Desilva B, Smith W, Weiner R, et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm. Res. 20(11), 1885-1900 (2003).
48. Casadevall N, Nataf J, Viron B, et al. Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N. Engl. J. Med. 346(7), 469-475 (2002).
49. Svenningsson A, Dring AM, Fogdell-Hahn A, et al. Fatal neuroinflammation in a case of multiple sclerosis with anti-natalizumab antibodies. Neurology 80(10), 965-967 (2013).
50. US Dep. of Health and Human Services, FDA, CDER, CBER. Guidance for industry immunogenicity assessment for therapeutic protein products. (2014). http://www.fda.gov