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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...

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Qualification of a LC-HRMS platform method for biosimilar development using NISTmab as a model.

Paresh Tank1, Shruti Vora1, Sarita Tripathi1

  • 1Analytical Chemistry Division of Zelle Biotechnology Research and Analytical Services, Zelle Biotechnology Pvt. Ltd., A-7 M.I.D.C., Mira Industrial Area, Western Express Highway, Mira Road, Thane, 401 104, India.

Analytical Biochemistry
|February 9, 2024
PubMed
Summary

A validated LC-HRMS peptide mapping method ensures biosimilar quality by accurately characterizing monoclonal antibodies. This robust analytical technique provides high precision and accuracy for critical quality attributes, supporting biosimilar development.

Keywords:
BiosimilarsLC-HRMS based peptide mappingMethod qualificationNISTmabTherapeutic protein analysis

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Area of Science:

  • Analytical Chemistry
  • Biopharmaceutical Analysis
  • Quality Control

Background:

  • Biosimilars offer cost-effective alternatives to biopharmaceuticals.
  • Rigorous analytical methods are crucial for ensuring biosimilar consistency and regulatory compliance.
  • Liquid chromatography coupled with high-resolution mass spectrometry (LC-HRMS) is a powerful technique for characterizing complex biologics.

Purpose of the Study:

  • To validate an LC-HRMS based peptide mapping method for biosimilar characterization.
  • To assess the method's performance according to ICH Q2R1 guidelines using NISTmAb as a reference.
  • To ensure the method's suitability for identifying and characterizing monoclonal antibodies in biosimilar development.

Main Methods:

  • Peptide mapping using Liquid Chromatography-High Resolution Mass Spectrometry (LC-HRMS).
  • Method validation following International Council for Harmonisation (ICH) Q2R1 guidelines.
  • Assessment of system suitability, specificity, accuracy, precision, robustness, and carryover using NISTmAb.

Main Results:

  • The validated LC-HRMS method demonstrated high accuracy (mass error < 2.42 ppm) and precision (%RSD < 0.000219%) for NISTmAb peptides.
  • The method successfully differentiated NISTmAb from similar molecules and spiked conditions, confirming specificity.
  • Robustness was confirmed across varying storage conditions, column temperatures, and mobile phase compositions, with negligible carryover.

Conclusions:

  • The validated LC-HRMS peptide mapping method is a versatile and reliable tool for biosimilar characterization.
  • This method effectively assesses critical quality attributes, including sequence coverage and post-translational modifications (PTMs).
  • The established method supports the development and quality assurance of biosimilar monoclonal antibodies.