Quality Assessment of Bioanalytical Quantification of Monoclonal Antibody Drugs

• Wang W , WangEQ, BalthasarJP. Monoclonal antibody pharmacokinetics and pharmacodynamics. Clin. Pharmacol. Ther.84, 548–558 (2008).
   PubMed Web of Science ®Google Scholar
• Findlay JWA , SmithWC, LeeJWet al. Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. J. Pharm. Biomed. Anal. 21, 1249–1273 (2000).
   PubMed Web of Science ®Google Scholar
• Dubois M , FenailleF, ClementGet al. Immunopurification and mass spectrometric quantification of the active form of a chimeric therapeutic antibody in human serum. Anal. Chem. 80, 1737–1745 (2008).
   PubMed Web of Science ®Google Scholar
• Hagman C , RickeD, EwertS, BekS, FalchettoR, BitschF. Absolute quantification of monoclonal antibodies in biofluids by liquid chromatography–tandem mass spectrometry. Anal. Chem.80, 1290–1296 (2008).
   PubMed Web of Science ®Google Scholar
• Heudi O , BarteauS, ZimmerDet al. Towards absolute quantification of therapeutic monoclonal antibody in serum by LC–MS/MS using isotope-labeled antibody standard and protein cleavage isotope dilution mass spectrometry. Anal. Chem. 80, 4200–4207 (2008).
   PubMed Web of Science ®Google Scholar
• Ezan E , DuboisM, BecherF. Bioanalysis of recombinant proteins and antibodies by mass spectrometry. Analyst134, 825–834 (2009).
   PubMed Web of Science ®Google Scholar
• Pandya K , RayCA, BrunnerL, WangJ, LeeJW, DeSilvaB. Strategies to minimize variability and bias associated with manual pipetting in ligand binding assays to assure data quality of protein therapeutic quantification. J. Pharm. Biomed. Anal.53, 623–630 (2010).
   PubMed Web of Science ®Google Scholar
• Tabrizi MA , TsengCM, RoskosLK. Elimination mechanisms of therapeutic monoclonal antibodies. Drug Disc. Today.11, 81–88 (2006).
   PubMed Web of Science ®Google Scholar
• Suntharalingam G , PerryMR, WardSet al. Cytokine storm in a Phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N. Engl. J. Med. 355, 1018–1028 (2006).
   PubMed Web of Science ®Google Scholar
• Pendley C , SchantzA, WagnerC. Immunogenicity of therapeutic monoclonal antibodies. Curr. Opin. Mol. Ther.5, 172–179 (2003).
   PubMedGoogle Scholar
• Ponce R , AbadL, AmaravadiLet al. Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies. Regul. Toxicol. Pharmacol. 54, 164–182 (2009).
   PubMed Web of Science ®Google Scholar
• Rup B , O‘HaraD. Critical ligand binding reagent preparation/selection: when specificity depends on reagents. AAPS J.9, E148–E155 (2007).
   PubMed Web of Science ®Google Scholar
• Kuang B , KingL, WangH. Therapeutic monoclonal antibody concentration monitoring: free or total? Bioanalysis2, 1125–1140 (2010).
   PubMed Web of Science ®Google Scholar
• Yang J , NgC, LowmanHet al. Quantitative determination of humanized monoclonal antibody rhuMAb2H7 in cynomolgus monkey serum using a generic immunoglobulin pharmacokinetic (GRIP) assay. J. Immunol. Meth. 335, 8–20 (2008).
   PubMed Web of Science ®Google Scholar
• Lobo ED , HansenRJ, BalthasarJP. Antibody pharmacokinetics and pharmacodynamics. J. Pharm. Sci.93, 2645–2668 (2004).
   PubMed Web of Science ®Google Scholar
• Mager DE , JuskoWJ. General pharmacokinetic model for drugs exhibiting target-mediated drug disposition. J. Pharmacokinet. Pharmacodyn.28, 507–532 (2001).
   PubMed Web of Science ®Google Scholar
• Mager DE , KrzyzanskiW. Quasi-equilibrium pharmacokinetic model for drugs exhibiting target-mediated drug disposition. Pharm. Res.22, 1589–1596 (2005).
   PubMed Web of Science ®Google Scholar
• Mould DR , SweeneyKR. The pharmacokinetics and pharmacodynamics of monoclonal antibodies – mechanistic modeling applied to drug development. Curr. Opin. Drug Discov. Devel.10, 84–96 (2007).
   PubMed Web of Science ®Google Scholar
• Lee JW , MaH. Specificity and selectivity evaluations of ligand binding assay of protein therapeutics against concomitant drugs and related endogenous proteins. AAPS J.9, E164–E170 (2007).
   PubMed Web of Science ®Google Scholar
• De Silva B , SmithW, WeinerRet al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm. Res. 20, 1885–1900 (2003).
   PubMed Web of Science ®Google Scholar
• Kelley M , DeSilvaB. Key elements of bioanalytical method validation for macromolecules. AAPS J.9, E156–E163 (2007).
   PubMed Web of Science ®Google Scholar
• Rocci ML Jr, Devanarayan V, Haughey DB, Jardieu P. Confirmatory reanalysis of incurred bioanalytical samples. AAPS J.9, E336–E343 (2007).
   PubMed Web of Science ®Google Scholar
• Fast DM , KelleyM, ViswanathanCTet al. Workshop report and follow-up – AAPS workshop on current topics in GLP bioanalysis: assay reproducibility for incurred samples – implications of Crystal City recommendations. AAPS J. 11, 238–241 (2009).
   PubMedGoogle Scholar
• van Amsterdam P , ArnoldM, BansalSet al. Building the ‘Global Bioanalysis Consortium‘ working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation. Bioanalysis 2, 1801–1803 (2010).
   PubMed Web of Science ®Google Scholar
• Chirino AJ , Mire-SluisA. Characterizing biological products and assessing comparability following manufacturing changes. Nature Biotech.22, 1383–1391 (2004).
   PubMed Web of Science ®Google Scholar
• Viswanathan CT , BansalS, BoothBet al. Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand-binding assays. Pharm. Res. 24, 1962–1973 (2007).
   PubMed Web of Science ®Google Scholar
• Salimi-Moosavi H , BurnsD, MillerJet al. A novel approach for the measurement of ‘total and free‘ target proteins in serum samples in the presence of antibody therapeutics. Presented at: AAPS National Biotechnology Conference. Toronto, Ontario, Canada, 24–27 June 2008.
   Google Scholar
• Salimi-Moosavi H , LeeJ, DeSilvaB, DollgastG. Novel approaches using alkaline or acid/guanidine treatment to eliminate therapeutic antibody interference in the measurement of total target ligand. J. Pharm. Biomed. Anal.51, 1128–1133 (2010).
   PubMed Web of Science ®Google Scholar
• Lee JW , KelleyM, KingLEet 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. DOI: 10.1208/s12248-011-9251-3 (2011).
   Web of Science ®Google Scholar
• Findlay JWA , DillardRF. Appropriate calibration curve fitting in ligand binding assays. AAPS J.9, E260–E267 (2007).
   PubMed Web of Science ®Google Scholar
• Shah VP , MidhaKK, DigheSet al. Analytical methods validation: bioavailability, bioequivalence, and pharmacokinetic studies. Pharm. Res. 9, 588–592 (1992).
   Web of Science ®Google Scholar
• Smolec J , DeSilvaB, SmithWet al. Bioanalytical method validation for macromolecules in support of pharmacokinetic studies. Pharm. Res. 22, 1425–1431 (2005).
   PubMedGoogle Scholar
• Hubert P , Nguyen-HuuJJ, BoulangerBet al. Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal – part III. J. Pharm. Biomed. Anal. 45, 82–96 (2007).
   PubMed Web of Science ®Google Scholar
• Ray CA , ZhouL, TsoiJet al. A strategy for improving comparability across sites for ligand binding assays measuring therapeutic proteins. J. Pharm. Biomed. Anal. 53, 729–734 (2010).
   PubMed Web of Science ®Google Scholar
• Akilesh S , ChristiansonGJ, RoopenianDC, ShawAS. Neonatal FcR expression in bone marrow-derived cells functions to protect serum IgG from catabolism. J. Immunol.179, 4580–4588 (2007).
   PubMed Web of Science ®Google Scholar
• Roopenian DC , AkileshS. FcRn: the neonatal Fc receptor comes of age. Nat. Rev. Immunol.7, 715–725 (2007).
   PubMed Web of Science ®Google Scholar
• Hall MP , GeggC, WalkerKet 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, 592–607 (2010).
   PubMed Web of Science ®Google Scholar
• Lowe PJ , TannenbaumS, GautierA, JimenezP. Relationship between omalizumab pharmacokinetics, IgE pharmacodynamics and symptoms in patients with severe persistent allergic (IgE-mediated) asthma. Br. J. Clin. Pharmacol.68, 61–76 (2009).
   PubMed Web of Science ®Google Scholar
• Rudge JS , HolashJ, HyltonDet al. Inaugural article: VEGF trap complex formation measures production rates of VEGF, providing a biomarker for predicting efficacious angiogenic blockade. Proc. Natl Acad. Sci. USA 104, 18363–18370 (2007).
   PubMed Web of Science ®Google Scholar
• Lowe PJ , GautierA. On the ability to predict free ligand suppression when free ligand assays are not available or impossible. Presented at: Annual Meeting of the Population Approach Group in Europe. St Petersburg, Russia, 23–26 June 2009.
   Google Scholar
• Tannenbaum S , GautierA, LowePJ. A mechanism based binding model for the population pharmacokinetics and pharmacodynamics of canakinumab, a monoclonal antibody in development for rheumatoid arthritis. Presented at: AAPS Annual Meeting. Atlanta, GA, USA, 15–20 November (2008).
   Google Scholar
• Ray CA , PatelV, ShihJet al. Application of multi-factorial design of experiments to successfully optimize immunoassays for robust measurements of therapeutic proteins. J. Pharm. Biomed. Anal. 49, 311–318 (2009).
   PubMed Web of Science ®Google Scholar
• Klump W , HillH. Strategies for successful transfer of ligand-binding assays for successful validation and implementation in GXP environment. In: Ligand-Binding Assays Development, Validation, and Implementation in The Drug Development Arena. Khan M, Findlay J (Eds). John Wiley and Sons, Inc., Hoboken, NJ, USA 265–286 (2010).
   Google Scholar
• Zhou H , DavisHM. Risk-based strategy for the assessment of pharmacokinetic drug–drug interactions for therapeutic monoclonal antibodies. Drug Disc. Today14, 891–898 (2009).
   PubMed Web of Science ®Google Scholar

Websites

• EMA. Guidelines on strategies to identify and mitigate risks for first-in-human clinical trials for investigatinal medicinal products (2007). www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002988.pdf
   Google Scholar
• US FDA. Guidance for Industry S6 Preclilnical Safety Evaluataion of Biotechnology-Derived Pharmaceuticals (1997). www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm074957.pdf
   Google Scholar
• US FDA. Guidance for Industry: Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. (2005). www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm078932.pdf
   Google Scholar
• ICH. Final concept paper. S6(R1): preclinical safety evaluation of biotechnology derived pharmaceuticals. Revision of the ICH S6 Guideline (2008). www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S6_R1/Concept_papers/S6_R1Concept_Paper.pdf
   Google Scholar
• US FDA. Guidance for industry on bioanalytical method validation: availability (2001). www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070107.pdf
   Google Scholar