Advances and Applications in Biopharmaceutical Analysis Techniques
Biopharmaceuticals, derived from biotechnology and bioengineering, are primarily composed of biological macromolecules. These include protein drugs, nucleic acid drugs, gene therapy drugs, and cell therapy drugs. Due to their distinct advantages, biopharmaceuticals are increasingly capturing a significant share of the global pharmaceutical market. Consequently, analytical techniques specific to biopharmaceuticals are also evolving and improving.
Advancements in Biopharmaceutical Analytical Techniques
With the ongoing development of biopharmaceuticals, corresponding analytical methods are being refined. Key techniques currently employed include:
1. Protein Mass Spectrometry Analysis
Mass spectrometry serves as a fundamental tool for analyzing protein drugs, incorporating methods such as liquid chromatography-mass spectrometry (LC-MS) and matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS).
2. High-Performance Liquid Chromatography (HPLC)
HPLC is a standard technique used to assess the purity and concentration of protein drugs.
3. Electrophoresis Analysis
Electrophoresis is another prevalent method for analyzing protein drugs and includes techniques like isoelectric focusing electrophoresis (IEF) and two-dimensional gel electrophoresis (2-DE).
Applications of Biopharmaceutical Analytical Techniques
Biopharmaceutical analytical methods are crucial in various stages of drug development and quality assurance:
1. Drug Development Phase
These techniques are employed to evaluate drug purity, stability, and biological activity, providing a scientific foundation for drug development.
2. Drug Manufacturing and Quality Control Phase
Analytical techniques are utilized for monitoring the production process and ensuring product quality, thereby safeguarding drug safety and efficacy.
MtoZ Biolabs, an integrated chromatography and mass spectrometry (MS) services provider.
Related Services
How to order?
