NMR spectroscopy as a characterization tool enabling biologics formulation development

Ma, Jinyuan; Pathirana, Charles; Liu, David Q.; Miller, Scott

doi:10.1016/j.jpba.2022.115110

Cited by 9 publications

(1 citation statement)

References 101 publications

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“…These parameters offer insights into functional groups, adjacent nuclei, dynamics and electron spin, and quantity, respectively. Despite the extensive literature covering theoretical aspects [14][15][16][17] and detailed spectral analyses of specialized fields like polymers, 18,19 natural products, 20,21 and macromolecules, 22,23 this review focuses on the characterization of transition metal complexes employing diverse NMR spectroscopic methods.…”

Section: Basics and Practical Aspectsmentioning

confidence: 99%

NMR spectroscopic investigations of transition metal complexes in organometallic and bioinorganic chemistry

Shin,

Lim,

Han

2024

Bulletin Korean Chem Soc

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The field of coordination chemistry has evolved to intersect with organic chemistry and biochemistry, giving rise to the disciplines of organometallic and bioinorganic chemistry. Nuclear magnetic resonance (NMR) spectroscopy can be applied for characterizing transition metal complexes, spanning both diamagnetic and paramagnetic complexes prevalent in organometallic compounds and metalloproteins. This review offers a comprehensive overview of a wide variety of characterization techniques, ranging from basic 1H and 13C NMR spectroscopy to advanced methods such as heteronuclear experiments, polarization transfer techniques, relaxometry, and multidimensional NMR spectroscopy. The diverse array of NMR spectroscopic methods outlined here promises to enhance our comprehension of transition metal complexes, facilitating the development of innovative catalysts and therapeutics.

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Section: Basics and Practical Aspectsmentioning

confidence: 99%

NMR spectroscopic investigations of transition metal complexes in organometallic and bioinorganic chemistry

Shin,

Lim,

Han

2024

Bulletin Korean Chem Soc

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Application of NMR and Chemometric Analyses to Better Understand the Quality Attributes in pH and Thermally Degraded Monoclonal Antibodies

Beaumont,

Liu,

Shi

et al. 2023

Pharm Res

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Purpose Nuclear magnetic resonance (NMR) spectroscopy provides the sensitivity and specificity to probe the higher order structure (HOS) of monoclonal antibodies (mAbs) for potential changes. This study demonstrates an application of chemometric tools to measure differences in the NMR spectra of mAbs after forced degradation relative to the respective unstressed starting materials. Methods Samples of adalimumab (Humira, ADL-REF) and trastuzumab (Herceptin, TRA-REF) were incubated in three buffer-pH conditions at 40°C for 4 weeks to compare to a control sample that was left unstressed. Replicate 1D 1H and 2D 1H-13C HMQC NMR spectra were collected on all samples. Chemometric analyses such as Easy Comparability of HOS (ECHOS), PROtein FIngerprinting by Lineshape Enhancement (PROFILE), and Principal Component Analysis (PCA) were applied to capture and quantitate differences between the spectra. Results Visual and statistical inspection of the 2D 1H-13C HMQC spectra of adalimumab and trastuzumab after forced degradation conditions shows no changes in the spectra relative to the unstressed material. Chemometric analysis of the 1D 1H NMR spectra shows only minor changes in the spectra of adalimumab after forced degradation, but significant differences in trastuzumab. Conclusion The chemometric analyses support the lack of statistical differences in the structure of pH-thermal stressed adalimumab, however, it reveals conformational changes or chemical modifications in trastuzumab after forced degradation. Application of chemometrics in comparative NMR studies enables HOS characterization and showcases the sensitivity and specificity in detecting differences in the spectra of mAbs after pH-thermal forced degradation with respect to local and global protein structure.

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High-Throughput Fluorometric Assay For Quantifying Polysorbate In Biopharmaceutical Products Using Micelle Activated Fluorescence Probe N-Phenyl-1-Naphthylamine

Dow,

Gao,

Sperduto

et al. 2024

Pharm Res

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NMR spectroscopy as a characterization tool enabling biologics formulation development

Cited by 9 publications

References 101 publications

NMR spectroscopic investigations of transition metal complexes in organometallic and bioinorganic chemistry

NMR spectroscopic investigations of transition metal complexes in organometallic and bioinorganic chemistry

Application of NMR and Chemometric Analyses to Better Understand the Quality Attributes in pH and Thermally Degraded Monoclonal Antibodies

High-Throughput Fluorometric Assay For Quantifying Polysorbate In Biopharmaceutical Products Using Micelle Activated Fluorescence Probe N-Phenyl-1-Naphthylamine

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