A5069624159- Protein purification and stability
- Monoclonal and Polyclonal Antibodies Research
- Protein Structure and Dynamics
- Advanced NMR Techniques and Applications
- Glycosylation and Glycoproteins Research
- Microfluidic and Capillary Electrophoresis Applications
- NMR spectroscopy and applications
- Analytical Chemistry and Chromatography
- Viral Infectious Diseases and Gene Expression in Insects
- Electron Spin Resonance Studies
- Molecular spectroscopy and chirality
- Enzyme Structure and Function
- Mass Spectrometry Techniques and Applications
- Advanced Biosensing Techniques and Applications
- Advanced MRI Techniques and Applications
- Solid-state spectroscopy and crystallography
- Cell Image Analysis Techniques
National Institute of Standards and Technology
2015-2023
Institute for Bioscience and Biotechnology Research
2018-2020
Bristol-Myers Squibb (United States)
2015
Johns Hopkins University
2009-2013
The increased interest in using monoclonal antibodies (mAbs) as a platform for biopharmaceuticals has led to the need new analytical techniques that can precisely assess physicochemical properties of these large and very complex drugs purpose correctly identifying quality attributes (QA). One QA, higher order structure (HOS), is unique essential establishing consistency biopharmaceutical manufacturing, detecting process-related variations from manufacturing changes comparability between...
Two-dimensional (2D)
Quality attributes (QAs) are measureable parameters of a biologic that impact product safety and efficacy essential characteristics linked to positive patient health outcomes. One QA, higher order structure (HOS), is directly coupled the function protein biologics, deviations in this QA may cause adverse effects. To address critical need for HOS assessment, methods analyzing structural fingerprints from 2D nuclear magnetic resonance spectroscopy (2D-NMR) spectra have been established drug...
Monoclonal antibodies (mAbs) are an important and growing class of biotherapeutic drugs. Method development for the characterization critical quality attributes, including higher-order structure (HOS), mAbs remains area active inquiry. Recently, solution-state nuclear magnetic resonance (NMR) spectroscopy has received increased attention is a means reliable, high-resolution HOS aqueous-based preparations mAbs. While predominantly formulated in solution, up to 20% prepared as solid amorphous...
The use of NMR spectroscopy has emerged as a premier tool to characterize the higher order structure protein therapeutics and in particular IgG1 monoclonal antibodies (mAbs). Due their large size, traditional 1H–15N correlation experiments have proven exceedingly difficult implement on mAbs, number alternative techniques been proposed, including one-dimensional (1D) 1H fingerprint by line shape enhancement (PROFILE) method two-dimensional (2D) 1H–13C methyl correlation-based approach. Both...
Characterization of the higher-order structure (HOS) protein therapeutics, and in particular monoclonal antibodies, by 2D 1 H-13 C methyl correlated NMR has been demonstrated as precise robust. Such characterization can be greatly enhanced when collections spectra are analyzed using multivariate approaches such principal component analysis (PCA), allowing for detection identification small structural differences drug substance that may otherwise fall below limit conventional spectral...
The successful development and regulatory approval of originator biosimilar therapeutic proteins requires a systems approach to upstream downstream processing as well product characterization quality control. Innovation in process design control, strategies, data integration represent an ecosystem whose concerted advancement may reduce time-to-market further improve comparability biosimilarity programs. biopharmaceutical community has made great strides this end, yet there currently exists...