1,618
Views
17
CrossRef citations to date
0
Altmetric
Report

Validation of an automated method for compounding monoclonal antibody patient doses

Case studies of Avastin® (bevacizumab), Remicade® (infliximab) and Herceptin® (trastuzumab)

, , &
Pages 162-170 | Published online: 19 Dec 2012

References

  • Remicade Summary of Product Characteristics. . www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000240/WC500050888.pdf
  • Herceptin Summary of Product Characteristics. . www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000278/WC500074922.pdf
  • Demeule B, Palais C, Machaidze G, Gurny R, Arvinte T. New methods allowing the detection of protein aggregates: a case study on trastuzumab. MAbs 2009; 1:142 - 50; http://dx.doi.org/10.4161/mabs.1.2.7632; PMID: 20061815
  • Hermeling S, Crommelin DJ, Schellekens H, Jiskoot W. Structure-immunogenicity relationships of therapeutic proteins. Pharm Res 2004; 21:897 - 903; http://dx.doi.org/10.1023/B:PHAM.0000029275.41323.a6; PMID: 15212151
  • US pharmacopeia. USP/NF general chapter particulate matter in injections. in: U.S. pharmacopeia, ed. national formulary, USP29-NF-24 (suppl 2) USP; 2006.
  • Cromwell ME, Hilario E, Jacobson F. Protein aggregation and bioprocessing. AAPS J 2006; 8:E572 - 9; http://dx.doi.org/10.1208/aapsj080366; PMID: 17025275
  • Lowe D, Dudgeon K, Rouet R, Schofield P, Jermutus L, Christ D. Aggregation, stability, and formulation of human antibody therapeutics. Adv Protein Chem Struct Biol 2011; 84:41 - 61; http://dx.doi.org/10.1016/B978-0-12-386483-3.00004-5; PMID: 21846562
  • Nelson AL, Dhimolea E, Reichert JM. Development trends for human monoclonal antibody therapeutics. Nat Rev Drug Discov 2010; 9:767 - 74; http://dx.doi.org/10.1038/nrd3229; PMID: 20811384
  • Capelle MA, Brügger P, Arvinte T. Spectroscopic characterization of antibodies adsorbed to aluminium adjuvants: correlation with antibody vaccine immunogenicity. Vaccine 2005; 23:1686 - 94; http://dx.doi.org/10.1016/j.vaccine.2004.09.031; PMID: 15705473
  • Demeule B, Lawrence MJ, Drake AF, Gurny R, Arvinte T. Characterization of protein aggregation: the case of a therapeutic immunoglobulin. Biochim Biophys Acta 2007; 1774:146 - 53; http://dx.doi.org/10.1016/j.bbapap.2006.10.010; PMID: 17142116
  • Demeule B, Gurny R, Arvinte T. Detection and characterization of protein aggregates by fluorescence microscopy. Int J Pharm 2007; 329:37 - 45; http://dx.doi.org/10.1016/j.ijpharm.2006.08.024; PMID: 17005340
  • Palais C, Capelle M, Arvinte T. Studies of loose protein aggregates by flow field-flow fractionation (FFF) coupled to multi-angle laser light scattering (MALLS). In: Kim S, Williams R, Caldwell KD, eds. Field-Flow Fractionation in Biopolymer Analysis: Springer, 2012:103-112.

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.