Rapid Identification of Counterfeit Biopharmaceuticals using Portable Fourier Transform Infrared Spectroscopy.

Biopharmaceuticals are expensive due to their sophisticated manufacturing processes, challenges in analytical characterization, and stringent storage and transportation conditions. Due to the high cost and increasing demand, they have emerged as a desirable target for counterfeiters. Challenges in the identification of counterfeits originate from the fact that biological products are extremely complex, requiring complex analytical tools and tedious sample preparations. These sophisticated techniques and operational expertise are not available in all regions of low-income nations, hence exacerbating the incidence of counterfeit pharmaceuticals. This study proposes a simple FTIR spectroscopy method to rapidly identify counterfeits from original biopharmaceuticals. The dataset comprises curated FTIR spectra from 43 monoclonal antibodies(mAbs) and 42 non-mAb products., pre-processed for noise reduction and baseline correction. The study was structured into three case studies: (1) Assessing biosimilarity, (2) Detection of counterfeits, and (3) Detection of products with compromised potency. The proposed method reliably identified deviations in both mAbs and non-mAb therapeutics. Biosimilars that were outliers in PCA score plots were flagged as counterfeits across multiple analytical approaches, and mAbs diluted to 70% concentration were effectively distinguished using PCA and K-means clustering. Counterfeit detection was validated by RP-HPLC analysis. This integrated pipeline offers a rapid, label-free, and non-destructive solution for ensuring product integrity in biopharmaceutical manufacturing and distribution. These findings underscore that Fourier-Transform Infrared (FTIR) spectroscopy, paired with statistical and machine learning approaches, can be used for rapid, easy, real-world counterfeit detection and quality assurance of biopharmaceuticals.