Investigation of a failed DNA assay leads to identification of an unexpected contaminant in a commonly used chromatography buffer.

Autor: Kuhns ST; Attribute Sciences, Process Development, Drug Substance Technologies, Process Development, Quality Administration, Quality, Amgen Inc., Thousand Oaks, California, USA., Semin DJ; Attribute Sciences, Process Development, Drug Substance Technologies, Process Development, Quality Administration, Quality, Amgen Inc., Thousand Oaks, California, USA., Soice NP; Attribute Sciences, Process Development, Drug Substance Technologies, Process Development, Quality Administration, Quality, Amgen Inc., Thousand Oaks, California, USA., Kappes A; Attribute Sciences, Process Development, Drug Substance Technologies, Process Development, Quality Administration, Quality, Amgen Inc., Thousand Oaks, California, USA., Wong HE; Attribute Sciences, Process Development, Drug Substance Technologies, Process Development, Quality Administration, Quality, Amgen Inc., Thousand Oaks, California, USA., Hwang TL; Attribute Sciences, Process Development, Drug Substance Technologies, Process Development, Quality Administration, Quality, Amgen Inc., Thousand Oaks, California, USA., Soto RJ; Attribute Sciences, Process Development, Drug Substance Technologies, Process Development, Quality Administration, Quality, Amgen Inc., Thousand Oaks, California, USA., Csordas AT; Attribute Sciences, Process Development, Drug Substance Technologies, Process Development, Quality Administration, Quality, Amgen Inc., Thousand Oaks, California, USA., Wu A; Attribute Sciences, Process Development, Drug Substance Technologies, Process Development, Quality Administration, Quality, Amgen Inc., Thousand Oaks, California, USA., Martinez-Cano D; Attribute Sciences, Process Development, Drug Substance Technologies, Process Development, Quality Administration, Quality, Amgen Inc., Thousand Oaks, California, USA., Babayan M; Attribute Sciences, Process Development, Drug Substance Technologies, Process Development, Quality Administration, Quality, Amgen Inc., Thousand Oaks, California, USA., Pelayo Y; Attribute Sciences, Process Development, Drug Substance Technologies, Process Development, Quality Administration, Quality, Amgen Inc., Thousand Oaks, California, USA., Hammond MR; Attribute Sciences, Process Development, Drug Substance Technologies, Process Development, Quality Administration, Quality, Amgen Inc., Thousand Oaks, California, USA., Nashed-Samuel Y; Attribute Sciences, Process Development, Drug Substance Technologies, Process Development, Quality Administration, Quality, Amgen Inc., Thousand Oaks, California, USA., Goudar CT; Attribute Sciences, Process Development, Drug Substance Technologies, Process Development, Quality Administration, Quality, Amgen Inc., Thousand Oaks, California, USA.

Publikováno v: Biotechnology progress [Biotechnol Prog] 2023 Mar; Vol. 39 (2), pp. e3307. Date of Electronic Publication: 2022 Nov 04.

State-of-the-art and emerging trends in analytical approaches to pharmaceutical-product commercialization.

Autor: Blue LE; Attribute Sciences, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA., Guan X; Attribute Sciences, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA., Joubert MK; Attribute Sciences, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA., Kuhns ST; Attribute Sciences, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA., Moore S; Attribute Sciences, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA., Semin DJ; Attribute Sciences, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA., Wikström M; Attribute Sciences, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA., Wypych J; Attribute Sciences, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA., Goudar CT; Attribute Sciences, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA. Electronic address: cgoudar@amgen.com.

Publikováno v: Current opinion in biotechnology [Curr Opin Biotechnol] 2022 Dec; Vol. 78, pp. 102800. Date of Electronic Publication: 2022 Sep 28.

Enabling development, manufacturing, and regulatory approval of biotherapeutics through advances in mass spectrometry.

Autor: Apostol I; Attribute Sciences, Process Development, Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA 91320, United States., Bondarenko PV; Attribute Sciences, Process Development, Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA 91320, United States., Ren D; Attribute Sciences, Process Development, Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA 91320, United States., Semin DJ; Attribute Sciences, Process Development, Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA 91320, United States., Wu CH; Attribute Sciences, Process Development, Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA 91320, United States., Zhang Z; Attribute Sciences, Process Development, Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA 91320, United States., Goudar CT; Attribute Sciences, Process Development, Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA 91320, United States. Electronic address: cgoudar@amgen.com.

Publikováno v: Current opinion in biotechnology [Curr Opin Biotechnol] 2021 Oct; Vol. 71, pp. 206-215. Date of Electronic Publication: 2021 Sep 08.

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Detection system for reaction-rate analysis in a low-volume proteinase-inhibition assay.

Autor: Ambrose WP; Los Alamos National Laboratory, Los Alamos, New Mexico 87545, USA., Semin DJ, Robbins DL, Van Orden A, Kashem MA, Hamilton SA, Nelson RM, Jett JH, Keller RA

Publikováno v: Analytical biochemistry [Anal Biochem] 1998 Oct 15; Vol. 263 (2), pp. 150-7.