Technologies for glycomic characterization of biopharmaceutical erythropoietins

2015-05-01
Hua, Serenus
Oh, Myung Jin
Özcan Kabasakal, Süreyya
Seo, Young Suk
Grimm, Rudolf
An, Hyun Joo
Glycosylation is one of the most critical factors affecting the quality, the safety and the potency of recombinant erythropoietin. Small changes during production can significantly affect glycosylation, and so the potency, of recombinant erythropoietin. Due to patent expirations, we expect biosimilar erythropoietins to play an increasing role in healthcare in coming years. Governmental regulatory agencies and biopharmaceutical companies therefore have an urgent need for reliable methods that can accurately characterize and evaluate these biological products, particularly in terms of their glycosylation. In this review, we provide an overview of current analytical tools for qualitative and quantitative analysis of erythropoietin glycosylation.
TRAC-TRENDS IN ANALYTICAL CHEMISTRY

Suggestions

In-Depth Method for the Characterization of Glycosylation in Manufactured Recombinant Monoclonal Antibody Drugs
Song, Ting; Özcan Kabasakal, Süreyya; Becker, Alicia; Lebrilla, Carlito B. (American Chemical Society (ACS), 2014-06-17)
The glycosylation in recombinant monoclonal antibody (rMab) drugs is a major concern in the biopharmaceutical industry as it impacts the drugs' many attributes. Characterization is important but complicated by the intricate structures, microheterogeneity, and the limitations of current tools for structural analysis. In this study, we developed a liquid chromatography-mass spectrometry (LC-MS) N-glycan library based on eight commercial rMab drugs. A library of over 70 structures was developed for the rapid c...
Optimization of ETV-ICP(TOF)MS and transient signal profiles for reducing isobaric interferences
Ertaş, Gülay (Royal Society of Chemistry (RSC), 2005-01-01)
One of the advantages of the ETV sample introduction is the ability to temporally separate analyte elements in complex mixtures by differences in their vaporization temperatures within the ETV for ICPMS. However, the broadening of the transient peaks in the transport tubing often obscures this temporal resolution. This study shows that decreasing the transport tubing diameter produces little broadening beyond that produced during aerosol production in the ETV. Maintaining such narrow peaks through the trans...
High-Throughput Screening and Quantitation of Target Compounds in Biofluids by Coated Blade Spray-Mass Spectrometry
Tascon, Marcos; Gomez-Rios, German Augusto; Reyes-Garces, Nathaly; Poole, Justen; Boyacı, Ezel; Pawliszyn, Janusz (American Chemical Society (ACS), 2017-08-15)
Most contemporary methods of screening and quantitating controlled substances and therapeutic drugs in biofluids typically require laborious, time-consuming, and expensive analytical workflows. In recent years, our group has worked toward developing microextraction (mu e)-mass spectrometry (MS) technologies that merge all of the tedious steps of the classical methods into a simple, efficient, and low-cost methodology. Unquestionably, the automation of these technologies allows for faster sample throughput, ...
Novel Pt(II) complexes containing pyrrole oxime, synthesis, characterization and DNA binding studies
Altunöz Erdoğan, Deniz; Ozalp-Yaman, Seniz (Elsevier BV, 2014-05-05)
Since the discovery of anticancer activity and subsequent clinical success of cisplatin (cis-[PtCl2(NH3)(2)]), platinum-based compounds have since been widely synthesized and studied as potential chemotherapeutic agents. In this sense, three novel nuclease active Pt(II) complexes with general formula; [Pt(NH3)CI(L)] (1), [Pt(L)(2)] (2), and K[PtCl2(L)] (3) in which L is 1-H-pyrrole-2-carbaldehyde oxime were synthesized. Characterization of complexes was performed by elemental analysis, FT-IR, H-1 NMR and ma...
Historical development of simulated body fluids used in biomedical applications: A review
Yilmaz, Bengi; Pazarçeviren, Ahmet Engin; Tezcaner, Ayşen; Evis, Zafer (Elsevier BV, 2020-06-01)
Simulated body fluid (SBF) is an acellular, protein-free, supersaturated calcium-phosphate solution with ionic composition nearly equal to that of human blood plasma and generally buffered at physiological conditions (pH 7.4 and 36.5 degrees C). Various SBF formulations have been used for decades to: (1) test corrosion and bone-bonding behavior, bioactivity, ion release, swelling and biodegradation rates of biomaterials and (2) deposit calcium phosphates, especially hydroxyapatite, onto the substrates of di...
Citation Formats
S. Hua, M. J. Oh, S. Özcan Kabasakal, Y. S. Seo, R. Grimm, and H. J. An, “Technologies for glycomic characterization of biopharmaceutical erythropoietins,” TRAC-TRENDS IN ANALYTICAL CHEMISTRY, pp. 18–27, 2015, Accessed: 00, 2020. [Online]. Available: https://hdl.handle.net/11511/48302.