Implementing Continuous Manufacturing for the Final Methylation Step in the AMG 397 Process to Deliver Key Quality Attributes

Author:

Tom Janine K.1ORCID,Achmatowicz Michal M.1,Beaver Matthew G.2ORCID,Colyer John1,Ericson Ari1,Hwang Tsang-Lin3ORCID,Jiao Nancy3,Langille Neil F.2,Liu Min3,Lovette Michael A.1,Sangodkar Rahul P.2,Sharvan Kumar Srividya2,Spada Simone2,Perera Damith4,Sheeran Jillian4,Campbell Kiersten4,Doherty Timothy4,Ford David D.4ORCID,Fang Yuan-Qing4ORCID,Rossi Emiliano5,Santoni Gabriella5,Cui Sheng2,Walker Shawn D.2ORCID

Affiliation:

1. Drug Substance Technologies, Process Development, Amgen, Inc., Thousand Oaks, California 91320, United States

2. Drug Substance Technologies, Process Development, Amgen, Inc., Cambridge, Massachusetts 02142, United States

3. Attribute Sciences, Process Development, Amgen, Inc., Thousand Oaks, California 91320, United States

4. Snapdragon Chemistry Inc., Waltham, Massachusetts 02451, United States

5. F.I.S.-Fabbrica Italiana Sintetici S.p.A., Viale Milano 26, 36075 Montecchio Maggiore, Vincenza

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

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