Michael Ronk - Department of Analytical Research and Development, Amgen Inc

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论文共 17 篇作者统计合作学者相似作者

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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,David Semin,Yasser Nashed-Samuel

JOURNAL OF PHARMACEUTICAL SCIENCESno. 6 (2022): 1599-1604

引用1浏览0WOS引用

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, Joel Perez-Pacheco, Ellen Jin,Bhavana Shah,Jason Richardson,Kim Li,David Semin,Yasser Nashed-Samuel

Journal of Pharmaceutical Sciences（2021）

引用2浏览0WOS引用

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,Yanxin Luo,Kim Li,Hans Lee,Yasser Nashed-Samuel

Journal of Pharmaceutical Sciences（2021）

引用6浏览0WOS引用

A Risk-Based Approach to Evaluate and Control Elemental Impurities in Therapeutic Proteins

Yanxin Luo, Chandra Sekhar,Hans Lee,Kiyoshi Fujimori,Michael Ronk,David Semin,Yasser Nashed-Samuel

Journal of Pharmaceutical Sciences（2020）

引用5浏览0WOS引用

Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products

Michael Ronk,Jian Liu, Alejandra Gallegos,Yanxin Luo,Kiyoshi Fujimori,Kim Li,Hans Lee,Yasser Nashed-Samuel

PDA journal of pharmaceutical science and technologyno. 6 (2020): 627-643

引用6浏览0WOS引用

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

Analytica Chimica Acta（2019）

引用9浏览0WOS引用

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 journal of pharmaceutical science and technology（2016）

引用6浏览0WOS引用

Extractables Analysis of Single-Use Flexible Plastic Biocontainers

Liliana Marghitoiu,Jian Liu,Hans Lee,Lourdes Perez,Kiyoshi Fujimori,Michael Ronk,Matthew R Hammond,Heather Nunn, Asher Lower,Gary Rogers,Yasser Nashed-Samuel

PDA journal of pharmaceutical science and technology（2015）

引用16浏览0WOS引用

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,Yasser Nashed-Samuel

Rapid communications in mass spectrometry/RCM Rapid communications in mass spectrometry（2014）

引用12浏览0WOS引用

Freeze-Dry Mediated Formation of 5-(Hydroxylmethyl)furfural

Kelly Fitzpatrick,Brent Kendrick, Camilla Santos, Pat Green,Bing Zhang, Deanna Hunt,Michael Ronk,Ying Luo

ACS symposium seriespp.129-145, (2013)

引用3浏览0引用

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