Full-text resources of PSJD and other databases are now available in the new Library of Science.
Visit https://bibliotekanauki.pl

PL EN


Preferences help
enabled [disable] Abstract
Number of results

Journal

2014 | 95 | 1 | 17-26

Article title

Validation of a flow cytometry-based assay for monitoring complement-dependent cytotoxicity of an anti-CD20 biosimilar candidate antibody

Title variants

Languages of publication

EN

Abstracts

EN
Appropriate validation of any bioassay to be used in the characterization of biological products is critical. In this study, we report a validation study of a flow cytometry-based assay to measure the complement-dependent cytotoxicity (CDC) of a biosimilar candidate monoclonal antibody (Mab) directed to CD20 antigen, as indicative of its biological activity. The assay was validated by examining: assay robustness, specificity, repeatability and intermediate precision. It demonstrated to be robust for all factors evaluated. It also showed a high level of specificity and was found to be free of interference through the validation process. The degree of precision (Cvs < 7%) obtained in this study was satisfactory. The presented work demonstrated that a flow cytometry-based cytotoxicity assay is a suitable method in the lot to lot quality control monitoring of the culture supernatant and an active pharmaceutical ingredient of 1B8 Mab.

Discipline

Journal

Year

Volume

95

Issue

1

Pages

17-26

Physical description

Dates

published
2014

References

  • Abid N.B.S., Rouis Z., Nefzi F., Souelah N., Aouni M. (2012) Evaluation of Dimethylthiazol Diphenyl Tetrazolium Bromide and Propidium Iodide Inclusion Assays for the Evaluation of Cell Viability by Flow Cytometry. J. Appl. Pharm. Sci. 2(5): 10-14.
  • Blanco R., CedeńoM., GonzálezN., RodríguezR., SánchezJ., RengifoE. (2012) Phenotypic heterogeneity in the NCIH125 cell line affects biological activity using the epidermal growth factor receptor as target. Acta Pharm. 62: 581- 591.
  • Cedeńo-Arias M., Sánchez-Ramírez J., Blanco-Santana R., Rengifo-Calzado E. (2011) Validation of a Flow Cytometry Based Binding Assay for Evaluation of Monoclonal Antibody Recognizing EGF Receptor. Sci. Pharm. 79(3): 569-581.
  • Chu R. (2009) Biogenerics or Biosimilars? Discussing the Present, Considering the Future. Stockholm Network.
  • Dorvignit D., Palacios J.L., Merino M., Hernández T., Sosa K., Casaco A., López-Requena A., Mateo de Acosta C. (2012) Expression and biological characterization of an antiCD20 biosimilar candidate antibody: A case study. Mabs4(4): 488-496.
  • Ermer J. (2001) Validation in pharmaceutical analysis. Part I: An integrated approach. J. Pharm. Biomed. Anal. 24: 755- 767.
  • Enter J., MonsonM. (2005) Evaluation of cellular viability with propidium iodine or 7-amino-actinomycin D.Cell. Anal. Bussin. Center, BeckmanCoulter, Inc, 33196.
  • European Medicines Agency (EMEA) (2008) Guideline on human cell-based medicinal products. Available in: http:// www.emea.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2009/09/WC500003894.pdf
  • Ederveen J.C. (2010) A Practical Approach to Biological Assay Validation. Progress report number 08090.
  • Findlay J.W.A., SmithW.C., LeeJ.W., Nordblom G.D., DasI., DeSilvaB.S., KhanM.N., BowsherR.R. (2000) Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. J. Pharm. Biomed. Anal. 21: 1249-1273.
  • Food and Drug Administration (FDA) (2001) Guidance for Industry. Bioanalytical Method Validation. Available in: http://www.fda.gov/downloads/Drugs/GuidanceComplia nceRegulatoryInformation/Guidances/ucm070107.pdf
  • Fernández-Marrero Y., Roque-Navarro L., Hernández T., DorvignitD., Molina-PérezM., GonzálezA., SosaK., LópezRequenaA., PérezR., de AcostaC.M. (2011) A cytotoxic humanized anti-ganglioside antibody produced in a murine cell line defective of N-glycolylated-glycoconjugates. Immunobiology16(12): 1239-1247.
  • Food and Drug Administration (FDA) Center for Biologics Evaluation and Research. BLA 97-0244 (Genentech). Available in: http://www.fda.gov/downloads/Drugs/ Deve lopmentApprovalProcess/HowDrugsareDevelopedandA pproved/ApprovalApplications/TherapeuticBiologicAppl ications/ucm107743.pdf
  • Herbrand U., Scotti S. (2007) Analytical Methods. European Biopharmaceutical Review. Available in: http://www. samedanltd.com//?mod=magazine&id=12&page=article &issid=169&pid=3210&post
  • International conference on the harmonization (ICH) (1999) Specifications: test procedures and acceptance criteria for biotechnological/biological products. Q6B. Available in: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Pr oducts/Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf
  • International conference on the harmonization (ICH) (2005) Validation of analytical procedures, Q2 (R1): Text and Methodology. Step 4. Available in: http://www.ifpma.org/ ich1.html
  • Smith M.R. (2003) Rituximab (monoclonal anti-CD20 antibody): mechanisms of action and resistance. Oncogene22: 7359-7368.
  • Vander H., NijhuisA., Smeyers-VerbekeJ., VandeginsteB.G.M., MassartD.L. (2001) Guidance for robustness/ ruggedness test in methods validation. J. Pharm. Biomed Anal. 24: 723-753.
  • Walfish S. (2006)Analytical Methods: A Statistical Perspective on the ICH Q2A and Q2B Guidelines for Validation of Analytical Methods. BioPharm International. Available in: http://statisticaloutsourcingservices.com/Methval.pdf
  • Winiarska M., Bil J., Wilczek E., Wilczynski G.M., Lekka M., Engelberts P.J., Mackus W.J.M., Gorska E., Bojarski L., Stoklosa T. et al. (2008) Statins impair antitumor effects of Rituximab by inducing conformational changes of CD20. Plos Medicine5(3): 0502-0517.

Document Type

paper

Publication order reference

Identifiers

YADDA identifier

bwmeta1.element.psjd-0860-8896-2014-95-1-2
JavaScript is turned off in your web browser. Turn it on to take full advantage of this site, then refresh the page.