Rapid Identification of Biotherapeutics with Label-Free Raman Spectroscopy
| Autor: | Christopher Larkin, Santosh Kumar Paidi, James B. McGivney, Ishan Barman, Soumik Siddhanta, Robert Strouse |
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| Rok vydání: | 2016 |
| Předmět: |
Chemistry
010401 analytical chemistry Discriminant Analysis Nanotechnology 02 engineering and technology Identity testing Spectrum Analysis Raman 021001 nanoscience & nanotechnology 01 natural sciences 0104 chemical sciences Analytical Chemistry Biological Therapy Rapid identification Pharmaceutical Preparations Identity (object-oriented programming) Biochemical engineering Least-Squares Analysis 0210 nano-technology Drug identification Product identification Algorithms Label free |
| Zdroj: | Analytical Chemistry. 88:4361-4368 |
| ISSN: | 1520-6882 0003-2700 |
| Popis: | Product identification is a critical and required analysis for biotheraputics. In addition to regulatory requirements for identity testing on final drug products, in-process identity testing is implemented to reduce business risks associated with fill operations and can also be used as a tool against counterfeiting. Biotherapeutics, in particular monoclonal antibodies, represent a challenging cohort for identity determination because of their similarity in chemical structure. Traditional methods used for product identification can be time and labor intensive, creating a need for quick, inexpensive and reliable methods of drug identification. Here, driven by its molecular-specific and nonperturbative nature, we present Raman spectroscopy as an alternate analytical tool for identity testing. By exploiting subtle differences in vibrational modes of the biologics, we have developed partial least-squares-discriminant analysis derived decision algorithms that offer excellent differentiation capability using spontaneous Raman spectra as well as label-free plasmon-enhanced Raman spectra. Coupled with the robustness to spurious correlations due to its high information content, our results highlight the potential of Raman spectroscopy as a powerful method for rapid, on-site biotherapeutic product identification. |
| Databáze: | OpenAIRE |
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