Metabolism of biologics: Biotherapeutic proteins

Bioanalysis

Volumn 4, Issue 2, 2012, Pages 189-195

  Hamuro, Lora L ^a   Kishnani, Narendra S ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT; BRENTUXIMAB VEDOTIN; CYTOTOXIC AGENT; DRUG METABOLITE; GEMTUZUMAB OZOGAMICIN; INSULIN ASPART; INSULIN DETEMIR; INSULIN GLARGINE; INSULIN GLULISINE; INSULIN LISPRO; MACROGOL; MONOMETHYL AURISTATIN F; UNCLASSIFIED DRUG; VEDOTIN;

ANTIGEN BINDING; BIOASSAY; BIOLOGICAL THERAPY; DEAMINATION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG CONJUGATION; DRUG EFFICACY; DRUG HALF LIFE; DRUG MECHANISM; DRUG OXIDATION; DRUG RECEPTOR BINDING; HUMAN; ISOMERIZATION; LIGAND BINDING; MACROMOLECULE; MASS SPECTROMETRY; METABOLITE; MOLECULAR INTERACTION; NONHUMAN; PROTEIN DEGRADATION; REVIEW;

ANIMALS; BIOLOGICAL AGENTS; DRUG DESIGN; HUMANS; RECOMBINANT PROTEINS;

EID: 84856043744     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.11.304     Document Type: Review

References (30)

1. European Medicines Agency. ICH Guideline S6 (R1)-preclinical safety evaluation of biotechnology-derived pharmaceuticals (1998).
2. European Medicines Agency. Guideline on the Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins. (2007).
3. Braeckman R. Pharmacokinetics and pharmacodynamics of peptide and protein drugs, in pharmaceutical biotechnology: an introduction for pharmacists and pharmaceutical scientists. Crommelin D, Sindelar R (Eds). Taylor & Francis, PA, USA 429 (2002).
4. Wang W, Wang EQ, Balthasar JP. Monoclonal antibody pharmacokinetics and pharmacodynamics. Clin. Pharmacol. Ther. 84(5), 548-558 (2008).
5. Roach P. New insulin analogues and routes of delivery: pharmacodynamic and clinical considerations. Clin. Pharmacokinet. 47(9), 595-610 (2008).
6. Potocka E, Baughman RA, Derendorf H. Population pharmacokinetic model of human insulin following different routes of administration. J. Clin. Pharmacol. 51(7), 1015-1024 (2010).
7. Duckworth WC, Hamel FG, Peavy DE. Hepatic metabolism of insulin. Am. J. Med. 85(5A), 71-76 (1988). (Pubitemid 19012375)
8. Heinemann LW. Pharmacokinetics and glucodynamics of insulin lispro. Drugs of Today 34 (Supplement C), 23-36 (1998).
9. Goykhman S, Drincic A, Desmangles JC et al. Insulin glargine: a review 8 years after its introduction. Expert Opin. Pharmacother. 10(4), 705-718 (2009).
10. Kuerzel GU, Shukla U, Scholtz HE et al. Biotransformation of insulin glargine after subcutaneous injection in healthy subjects. Curr. Med. Res. Opin. 19(1), 34-40 (2003). (Pubitemid 36378318)
11. US FDA. Pharmacology Review of Application 21-081, Hoechst Marion Roussel (insulin glargine). 7-10 (2000).
12. Kurtzhals P, Schaffer L, Sorensen A et al. Correlations of receptor binding and metabolic and mitogenic potencies of insulin analogs designed for clinical use. Diabetes 49(6), 999-1005 (2000). (Pubitemid 30349423)
13. Sommerfeld MR, Muller G, Tschank G et al. In vitro metabolic and mitogenic signaling of insulin glargine and its metabolites. PLoS One 5(3), e9540 (2010).
14. Agin A, Jeandidier N, Gasser F et al. Glargine blood biotransformation: in vitro appraisal with human insulin immunoassay. Diabetes Metab. 33(3), 205-212 (2007). (Pubitemid 46863409)
15. Ehninger G, Schmidt AH, Putting insulin glargine and malignancies into perspective. Oncologist 14(12), 1169-1174 (2009).
16. US FDA. Pharmacology Review of Application 21-536, Novo Nordisk Pharmaceuticals (Insulin Detemir). 13-16 (2005).
17. Modi M, Fulton J, Buckmann D. Clearance of PEGylated (40 kDa) interferon alfa-2a (PEGASYS) is primarily hepatic (abstract). Hepatology 32, 371A (2000).
18. Herold DA, Keil K, Bruns DE. Oxidation of polyethylene glycols by alcohol dehydrogenase. Biochem. Pharmacol. 38(1), 73-76 (1989). (Pubitemid 19029156)
19. rd. The absorption and excretion of a liquid polyethylene glycol. J. Am. Pharm. Assoc. Am. Pharm. Assoc. 39(6), 340-344 (1950).
20. Bendele A, Seely J, Richey C et al. Short communication: renal tubular vacuolation in animals treated with polyethylene-glycol-conjugated proteins. Toxicol. Sci. 42(2), 152-157 (1998). (Pubitemid 28211143)
21. Beck A, Haeuw JF, Wurch T et al. The next generation of antibody-drug conjugates comes of age. Discov. Med. 10(53), 329-339 (2010).
22. Ducry L, Stump B. Antibody-drug conjugates: linking cytotoxic payloads to monoclonal antibodies. Bioconjug. Chem. 21(1), 5-13 (2010).
23. Okeley NM, Miyamoto JB, Zhang X et al. Intracellular activation of SGN-35, a potent anti-CD30 antibody-drug conjugate. Clin. Cancer Res. 16(3), 888-897 (2010).
24. Teshima G, Hancock W, Canova-Davis E. Effect of deamidation and isoaspartate formation on the activity of proteins. In: Deamidation and Isoaspartate Formation in Peptides and Proteins. Aswad D (Ed.). CRC Press: Boca Raton, CA, USA, 259 (1995).
25. Katsila T, Siskos AP, Tamvakopoulos C. Peptide and protein drugs: the study of their metabolism and catabolism by mass spectrometry. Mass Spectrom. Rev. doi:10.1002/mas.20340 (2011) (Epub ahead of print).
26. Campbell JL, Le Blanc JC. Peptide and protein drug ana lysis by MS: challenges and opportunities for the discovery environment. Bioana lysis 3(6), 645-657 (2011).
27. Mesmin C, Fenaille F, Ezan E et al. MS-based approaches for studying the pharmacokinetics of protein drugs. Bioana lysis 3(5), 477-480 (2011).
28. Copley K, McCowen K, Hiles R et al. Investigation of exenatide elimination and its in vivo and in vitro degradation. Curr. Drug Metab. 7(4), 367-374 (2006).
29. Thevis M, Thomas A, Schanzer W. Mass spectrometric determination of insulins and their degradation products in sports drug testing. Mass Spectrom. Rev. 27(1), 35-50 (2008). (Pubitemid 350279865)
30. Zhang CX, Weber BVJ, Thammavong et al. Identifcation of carboxyl-terminal peptide fragments of parathyroid hormone in human plasma at low-picomolar levels by mass spectrometry. Anal. Chem. 78(5), 1636-1643 (2006). (Pubitemid 43346303)