Characterization of a quantitative method to measure free proprotein convertase subtilisin/kexin type 9 in human serum

References

• Reichert JM. Monoclonal antibodies as innovative therapeutics. Curr Pharm Biotechnol 2008; 9:423 - 30; http://dx.doi.org/10.2174/138920108786786358; PMID: 19075682
   PubMed Web of Science ®Google Scholar
• Fischer SK, Yang J, Anand B, Cowan K, Hendricks R, Li J, Nakamura G, Song A. The assay design used for measurement of therapeutic antibody concentrations can affect pharmacokinetic parameters: Case studies. MAbs 2012; 4:623 - 31; http://dx.doi.org/10.4161/mabs.20814; PMID: 22820463
   PubMed Web of Science ®Google Scholar
• Kuang B, King L, Wang HF. Therapeutic monoclonal antibody concentration monitoring: free or total?. Bioanalysis 2010; 2:1125 - 40; http://dx.doi.org/10.4155/bio.10.64; PMID: 21083212
   PubMed Web of Science ®Google Scholar
• Patel R, Johnson K, Andrien BA, Tamburini PP. IgG Subclass Variation of a Monoclonal Antibody Binding to Human Fc-Gamma Receptors. Amercian Journal of Biochemistry and Biotechnology 2013; 9:206 - 18; http://dx.doi.org/10.3844/ajbbsp.2013.206.218
   Google Scholar
• Wang W, Wang EQ, Balthasar JP. Monoclonal antibody pharmacokinetics and pharmacodynamics. Clin Pharmacol Ther 2008; 84:548 - 58; http://dx.doi.org/10.1038/clpt.2008.170; PMID: 18784655
   PubMed Web of Science ®Google Scholar
• Davda JP, Hansen RJ. Properties of a general PK/PD model of antibody-ligand interactions for therapeutic antibodies that bind to soluble endogenous targets. MAbs 2010; 2:576 - 88; http://dx.doi.org/10.4161/mabs.2.5.12833; PMID: 20676036
   PubMed Web of Science ®Google Scholar
• Roskos LK, Schneider A, Vainshtein I, Schwickart M, Lee R, Lu H, Faggioni R, Liang M. PK-PD modeling of protein drugs: implications in assay development. Bioanalysis 2011; 3:659 - 75; http://dx.doi.org/10.4155/bio.11.28; PMID: 21417734
   PubMed Web of Science ®Google Scholar
• Konrad RJ, Troutt JS, Cao G. Effects of currently prescribed LDL-C-lowering drugs on PCSK9 and implications for the next generation of LDL-C-lowering agents. Lipids Health Dis 2011; 10:38; http://dx.doi.org/10.1186/1476-511X-10-38; PMID: 21352602
   PubMed Web of Science ®Google Scholar
• Alborn WE, Cao G, Careskey HE, Qian YW, Subramaniam DR, Davies J, Conner EM, Konrad RJ. Serum proprotein convertase subtilisin kexin type 9 is correlated directly with serum LDL cholesterol. Clin Chem 2007; 53:1814 - 9; http://dx.doi.org/10.1373/clinchem.2007.091280; PMID: 17702855
   PubMed Web of Science ®Google Scholar
• Banach M, Rizzo M, Obradovic M, Montalto G, Rysz J, Mikhailidis DP, Isenovic ER. PCSK9 inhibition - a novel mechanism to treat lipid disorders?. Curr Pharm Des 2013; 19:3869 - 77; http://dx.doi.org/10.2174/13816128113199990303; PMID: 23286435
   PubMed Web of Science ®Google Scholar
• Chan JC, Piper DE, Cao Q, Liu D, King C, Wang W, Tang J, Liu Q, Higbee J, Xia Z, et al. A proprotein convertase subtilisin/kexin type 9 neutralizing antibody reduces serum cholesterol in mice and nonhuman primates. Proc Natl Acad Sci U S A 2009; 106:9820 - 5; http://dx.doi.org/10.1073/pnas.0903849106; PMID: 19443683
   PubMed Web of Science ®Google Scholar
• Do RQ, Vogel RA, Schwartz GG. PCSK9 Inhibitors: potential in cardiovascular therapeutics. Curr Cardiol Rep 2013; 15:345; http://dx.doi.org/10.1007/s11886-012-0345-z; PMID: 23338726
   PubMed Web of Science ®Google Scholar
• Horton JD, Cohen JC, Hobbs HH. PCSK9: a convertase that coordinates LDL catabolism. J Lipid Res 2009; 50:Suppl S172 - 7; http://dx.doi.org/10.1194/jlr.R800091-JLR200; PMID: 19020338
   PubMed Web of Science ®Google Scholar
• Welder G, Zineh I, Pacanowski MA, Troutt JS, Cao G, Konrad RJ. High-dose atorvastatin causes a rapid sustained increase in human serum PCSK9 and disrupts its correlation with LDL cholesterol. J Lipid Res 2010; 51:2714 - 21; http://dx.doi.org/10.1194/jlr.M008144; PMID: 20525997
   PubMed Web of Science ®Google Scholar
• Careskey HE, Davis RA, Alborn WE, Troutt JS, Cao G, Konrad RJ. Atorvastatin increases human serum levels of proprotein convertase subtilisin/kexin type 9. J Lipid Res 2008; 49:394 - 8; http://dx.doi.org/10.1194/jlr.M700437-JLR200; PMID: 18033751
   PubMed Web of Science ®Google Scholar
• Hansen RJ, Brown RM, Lu J, Wroblewski VJ. Qualification of a free ligand assay in the presence of anti-ligand antibody Fab fragments. MAbs 2013; 5:288 - 96; http://dx.doi.org/10.4161/mabs.23508; PMID: 23396084
   PubMed Web of Science ®Google Scholar
• Lee JW, Kelley M, King LE, Yang J, Salimi-Moosavi H, Tang MT, Lu JF, Kamerud J, Ahene A, Myler H, 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 2011; 13:99 - 110; http://dx.doi.org/10.1208/s12248-011-9251-3; PMID: 21240643
   PubMed Web of Science ®Google Scholar
• DeSilva B, Smith W, Weiner R, Kelley M, Smolec J, Lee B, Khan M, Tacey R, Hill H, Celniker A. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm Res 2003; 20:1885 - 900; http://dx.doi.org/10.1023/B:PHAM.0000003390.51761.3d; PMID: 14661937
   PubMed Web of Science ®Google Scholar
• Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, Shah VP, Skelly JP, Swann PG, Weiner R. Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. Pharm Res 2007; 24:1962 - 73; http://dx.doi.org/10.1007/s11095-007-9291-7; PMID: 17458684
   PubMed Web of Science ®Google Scholar
• US Department of Health and Human Services FaDA, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance to Industry: Bioanalytical Method Validation 2001. 25 p.
   Google Scholar
• Lee JW. Method validation and application of protein biomarkers: basic similarities and differences from biotherapeutics. Bioanalysis 2009; 1:1461 - 74; http://dx.doi.org/10.4155/bio.09.130; PMID: 21083095
   PubMed Web of Science ®Google Scholar
• Lee JW, Wu Y, Wang J. Fit-for-Purpose Method Validation and Assays for Biomarker Characterization to Support Drug Development. AAPS J 2010; 11:385 - 94
   Google Scholar
• Valentin MA, Ma S, Zhao A, Legay F, Avrameas A. Validation of immunoassay for protein biomarkers: bioanalytical study plan implementation to support pre-clinical and clinical studies. J Pharm Biomed Anal 2011; 55:869 - 77; http://dx.doi.org/10.1016/j.jpba.2011.03.033; PMID: 21530130
   PubMed Web of Science ®Google Scholar
• Dias CS, Shaywitz AJ, Wasserman SM, Smith BP, Gao B, Stolman DS, Crispino CP, Smirnakis KV, Emery MG, Colbert A, et al. Effects of AMG 145 on low-density lipoprotein cholesterol levels: results from 2 randomized, double-blind, placebo-controlled, ascending-dose phase 1 studies in healthy volunteers and hypercholesterolemic subjects on statins. J Am Coll Cardiol 2012; 60:1888 - 98; http://dx.doi.org/10.1016/j.jacc.2012.08.986; PMID: 23083772
   PubMed Web of Science ®Google Scholar