Chapter 9: Leveraging the Multi-attribute Method (MAM) to Improve Biotherapeutic Development-Reference-Cited by-同舟云学术

Chapter 9: Leveraging the Multi-attribute Method (MAM) to Improve Biotherapeutic Development

Published:2020 Issue: Volume: Page:215-231
ISSN:2210-7371
Container-title:Development of Biopharmaceutical Drug-Device Products
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Author:

Connell-Crowley Lisa,Kerwin Bruce,Ketchem Randal,McGrew Jeff,Rogers Richard S.

Publisher

Springer International Publishing

Link

http://link.springer.com/content/pdf/10.1007/978-3-030-31415-6_9

Reference31 articles.

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3. Bongers J, Cummings JJ, Ebert MB, Federici MM, Gledhill L, Gulati D, et al. Validation of a peptide mapping method for a therapeutic monoclonal antibody: what could we possibly learn about a method we have run 100 times? J Pharm Biomed Anal [Internet]. 2000 [cited 2017 Nov 19];21(6):1099–128. Available from: http://www.ncbi.nlm.nih.gov/pubmed/10708395 .

4. Dougherty J, Mhatre R, Moore S. Using peptide maps as identity and purity tests for lot release testing of recombinant therapeutic proteins. Process Dev [Internet]. 2003;54. Available from: http://alfresco.ubm-us.net/alfresco_images/pharma/2014/08/22/4e9452e7-dfb9-40e7-a143-fd92a0ab6183/article-54510.pdf .

5. Challener CA. Mass spectrometry measures up to analytical challenges. BioPharm Int [Internet]. 2017;30(2):14–7. Available from: http://www.biopharminternational.com/mass-spectrometry-measures-analytical-challenges .