Physicochemical characterization of biopharmaceuticals

Area of Science:

• Biopharmaceutical analysis
• Protein therapeutics characterization
• Biotechnology

Background:

• Biopharmaceuticals offer high target selectivity in therapy.
• Recombinant DNA technology is key for producing modern protein therapeutics.
• Patent expirations are driving demand for biosimilar development.

Purpose of the Study:

• To review analytical methods for characterizing protein biopharmaceuticals.
• To compare analytical requirements for originator and biosimilar products.
• To discuss quality assurance challenges in biopharmaceutical manufacturing.

Main Methods:

• Overview of classical methods: gel electrophoresis and liquid chromatography.
• Inclusion of state-of-the-art mass spectrometry techniques.
• Discussion of middle-down and bottom-up mass spectrometry approaches.

Main Results:

• Biopharmaceutical quality assurance requires extensive analytical effort.
• Variations in production processes significantly impact protein therapeutics.
• Glycoprotein analysis methods include glycopeptide, released glycan, and monosaccharide analysis.

Conclusions:

• Comprehensive analytical characterization is crucial for biopharmaceutical safety and efficacy.
• Advanced analytical techniques are essential for distinguishing biosimilars from originator products.
• This review provides a foundation for understanding biopharmaceutical analytical strategies.