A Simple, Rapid and Robust "on-the-go" Identity Testing of Biotherapeutics Using FTIR Spectroscopy.

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 consumption of time and labor. Here, we present a 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 their final packaged form set by the US Food and Drug Administration (FDA). 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 the counterfeits of biotherapeutic products. This article is protected by copyright. All rights reserved.