Protein-based medicines analysis by Raman spectroscopy for the detection of counterfeits

Area of Science:

• Analytical Chemistry
• Pharmaceutical Sciences
• Spectroscopy

Background:

• Protein-based medicines offer advanced treatments for diseases like cancer and hepatitis.
• Their high value makes them targets for counterfeiters.
• Analyzing these complex molecules for authenticity is challenging.

Purpose of the Study:

• To demonstrate the efficacy of Raman spectroscopy and microscopy for rapid counterfeit detection of protein-based medicines.
• To analyze both liquid and lyophilized protein-based medicines.
• To identify characteristic spectral features for authentication.

Main Methods:

• Analysis of twelve protein-based medicines (liquid and lyophilized) using Raman spectroscopy through glass packaging.
• Analysis of ten medicines using Raman microscopy with drop deposition on a gold plate.
• Optimization of spectral acquisition parameters and band attribution.

Main Results:

• Successful identification of genuine protein-based medicines based on their unique spectral profiles.
• Detection of seven counterfeit products by analyzing their chemical composition.
• Identification of counterfeit indicators: altered excipient profiles, absence of proteins, or significant dilution.

Conclusions:

• Raman spectroscopy and microscopy are efficient tools for the rapid analysis and detection of counterfeit protein-based medicines.
• These methods can differentiate genuine products from counterfeits based on spectral signatures.
• The techniques offer a viable solution for ensuring the authenticity of high-value protein therapeutics.