Publications by authors named "Michael Ronk"

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Recommendation of Single Time Point Leachables Testing for Lyophilized Biotechnology Products Stored in Rubber Stoppered Glass Vial Systems.
Alejandra Gallegos, Jian Liu, Michael Ronk, Li Qi, Kim Li

J Pharm Sci· June 2022

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Observation and Mitigation of Leachables from Non-Product Contact Materials in Electromechanical Delivery Devices for Biotechnology Products.
Jian Liu, Michael Ronk, Yanxin Luo, Jette Wypych, Zhongqi Zhang

J Pharm Sci· December 2021

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A Holistic Approach of Extractables and Leachables Assessment of Rubber Stoppered Glass Vial Systems for Biotechnology Products.
Li Qi, Jian Liu, Michael Ronk, Alejandra Gallegos, Kiyoshi Fujimori

J Pharm Sci· November 2021

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Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products.
Michael Ronk, Jian Liu, Alejandra Gallegos, Yanxin Luo, Kiyoshi Fujimori

PDA J Pharm Sci Technol· September 2021

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A Risk-Based Approach to Evaluate and Control Elemental Impurities in Therapeutic Proteins.
Yanxin Luo, Chandra Sekhar, Hans Lee, Kiyoshi Fujimori, Michael Ronk

J Pharm Sci· November 2020

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Determination of interactions between antibody biotherapeutics and copper by size exclusion chromatography (SEC) coupled with inductively coupled plasma mass spectrometry (ICP/MS).
Yanxin Luo, Michael Ronk, Marisa K Joubert, David Semin, Yasser Nashed-Samuel

Anal Chim Acta· November 2019

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Extractables analysis of single-use flexible plastic biocontainers.
Liliana Marghitoiu, Jian Liu, Hans Lee, Lourdes Perez, Kiyoshi Fujimori, Michael Ronk

PDA J Pharm Sci Technol· January 2018

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Characterization of Protein Aggregating Tungstates: Electrospray Mass Spectrometry Analysis of Extracts from Prefilled Syringes and from Tungsten Pins Used in the Manufacture of Syringes.
Michael Ronk, Hans Lee, Kiyoshi Fujimori, Ping Yeh, Yasser Nashed-Samuel

PDA J Pharm Sci Technol· January 2018

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Ambient analysis of leachable compounds from single-use bioreactors with desorption electrospray ionization time-of-flight mass spectrometry.
Jian Liu, Joseph H Kennedy, Michael Ronk, Liliana Marghitoiu, Hans Lee

Rapid Commun Mass Spectrom· November 2014

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Application of two-dimensional selective-TOCSY HMBC for structure elucidation of impurities in mixture without separation.
Tsang-Lin Hwang, Michael Ronk, Jacqueline E Milne

Magn Reson Chem· February 2013

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A Multidisciplinary Investigation to Determine the Structure and Source of Dimeric Impurities in AMG 517 Drug Substance.
Maria Victoria Silva Elipe, Zhixin Jessica Tan, Michael Ronk, Tracy Bostick

Int J Anal Chem· July 2011

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Highly enantioselective hydrogenation of styrenes directed by 2'-hydroxyl groups.
Xiang Wang, Anil Guram, Seb Caille, Jack Hu, J P Preston, Michael Ronk

Org Lett· April 2011

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Toward top-down determination of PEGylation site using MALDI in-source decay MS analysis.
Chul Yoo, Detlev Suckau, Volker Sauerland, Michael Ronk, Minhui Ma

J Am Soc Mass Spectrom· February 2009

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