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A simple, rapid, and robust “on‐the‐go” identity testing of biotherapeutics using FTIR spectroscopy
Author(s) -
Afzal Mohammad A.,
Bhojane Purva P.,
Rathore Anurag S.
Publication year - 2021
Publication title -
electrophoresis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.666
H-Index - 158
eISSN - 1522-2683
pISSN - 0173-0835
DOI - 10.1002/elps.202100045
Subject(s) - fourier transform infrared spectroscopy , computer science , food and drug administration , biochemical engineering , innovator , biosimilar , product (mathematics) , process engineering , business , mathematics , microbiology and biotechnology , risk analysis (engineering) , engineering , biology , chemical engineering , geometry , intellectual property , operating system
The stunning rise of biotherapeutics as successful treatments of complex and hard‐to‐treat diseases, in particular cancer, has necessitated the development of a rapid analytical method capable of differentiating these otherwise significantly similar antibody‐based products. The existing methods for product identification pose significant drawbacks in terms of the consumption of time and labor. Here, we present an FTIR spectroscopy‐based simple, rapid, and robust method that is capable of differentiating between the biotherapeutics (both innovator products and biosimilars). The proposed approach uses partial least‐squares‐discriminant analysis to pinpoint subtle differences in the FTIR spectra of the samples, enabling us to not only identify the product but also calculate its concentration. This FTIR‐based method can be used to fulfill the identity testing requirement of a pharmaceutical drug in its final packaged form set by the US Food and Drug Administration. Along with this, identity testing can also be deployed at multiple steps in the manufacturing process and can also be used by the appropriate regulatory or government agency for tackling counterfeits of biotherapeutic products.