1,591
Views
0
CrossRef citations to date
0
Altmetric
Editorial

Selectivity of Ligand-Binding Assays in Relationship to The Measurement of Biologics: How Much Does it Matter?

Pages 1525-1530 | Published online: 20 Aug 2010

Bibliography

  • Addendum to ICH S6, Preclinical Safety Evaluation of Biotechnology: Preclinical Safety Evaluation of Biotechnology Products, Derived Pharmaceutics . S6(R1) (2009).
  • Huang L , LuJ, WroblewskiVJ, BealsJH, RigginRM. In vivo deamidation characterization of monoclonal antibodies by LC–MS/MS. Anal. Chem. 77, 1432–1439 (2005).
  • Chen X , LiuYD, FlynnGC. The effect of Fe Glycan forms on human IgGZ antibody clearance in humans. Glycolobiology19(3), 240–249 (2009).
  • Selby C . Interference in immunoassay. Ann. Clin. Biochem. 36, 704–721 (1999).
  • Lee JW . Method validation and application of protein biomarkers; basic similarities and differences from biotherapeutics. Bioanalysis1(8), 1461–1474 (2009).
  • Ezan E , DuboisM, BeckerF. Bioanalysis of recombinant proteins and antibodies by mass spectrometry. Analyst134(5), 825–834 (2009).
  • Phillips P . The preparation of International Biological Standards. J. Anal. Chem. 360(3/4), 473–475 (1998).
  • 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(11), 1885–1900 (2003).
  • Lee J , MaH. Specificity and selectivity evaluations of ligand binding assay of protein therapeutics against concomitant drugs and related endogenous protein. AAPS J. 9(2), E164–E170 (2007).
  • Yuen C-T , StorringPL, TipladyRJet al. Relationships between the N-glycan structures and biological activities of recombinant human erythropoietins produced using different culture conditions and purification procedures. Br. J. Haematol. 121, 511–526 (2003).
  • Egrie JC , BrowneJR. Development and characterization of novel erythropoiesis stimulating protein (NESP). Nephrol. Dial Transplant. 16, 3–13 (2001).
  • Catlin DH , BreidbachA, ElliottS, GlaspyJ. Comparison of the isoelectric focussing pattern of darbepoetin α, recombinant human erythropoietin and endogenous erythropoietin from human plasma. Clin. Chem. 48, 2057–2059 (2002).
  • Moore JA , WroblewskiVJ. Pharmacokinetics and Metabolism of Protein Hormones. In:Protein Pharmacokinetics and Metabolism. Ferraiolo BL, Mohler MA, Glo CA (Eds). Plenum Press (1992).
  • Hall M , LeeJ, OrtizRet al. Ligand binding – mass spectrometric methods to investigate biotransformation of protein therapeutics and impact on ligand binding assays. Poster presented at: 2009 AAPS National Biotechnology Conference. Seattle, Washington, DC, USA, 21–24 June 2007.
  • Lee JK , LeeEH, YunYPet al. Truncation of NH2 – terminal amino acid residues increases potency of leukotactin-1 on CC chemokine receptors 1 and 3. J. Biol. Chem. 277(17), 14757–14763 (2002).
  • Mukku V . USP bioassay standards – general guidance and product specific assays, an ipdate. Presented at: IPC-USP 8th Annual Scientific Meeting. Hyderabad, India, 11–12 February 2009.
  • Gray E . (NIBSC) Challenges for international standardization and traceability biologicals. Presented at:JCTLM Symposium 11th Asia Pacific Congress for Clinical Biochemistry. Beijing, China, 16 October 2007.
  • Ekins RP . Ligand assays: from electrophoresis to miniaturized microarrays. Clin. Chem. 44, 2015–2030 (1998).
  • Kumar V , BarnbridgeDR, Chen L-Set al. Quantification of serum 1–84 parathyroid hormone in patients with hyperparathyroidism by immunocapture, in situ digestion liquid chromatography–tandem mass spectrometry. Clin. Chem. 56, 306–313 (2010).

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.