Peptide Drug Impurity Detection

Peptide-based drugs are a special type of drugs that fall between traditional chemical drugs and large molecule drugs. In recent years, due to their features such as low toxic side effects, strong biological activity, no metabolic heterogeneity, and low dosage, they are receiving increasing attention in the medical field. The production of peptide drugs primarily adopts three methods: chemical synthesis, animal tissue extraction, and gene recombination expression. However, during these production processes, some impurities are inevitably generated, posing potential threats to the efficacy and safety of the drugs. In order to ensure the quality and safety of peptide drugs, the strict detection and control of these impurities are particularly important.

 

Sources of Impurities in Peptide Drugs

Impurities related to peptide drugs can be categorized into four types:

 

1. Process Impurities Introduced During Synthesis

peptide-related impurities such as missing peptides, fragmented peptides, inserted peptides, and unprotected peptides.

 

2. Degradation Impurities

degradation products produced by unstable factors such as peptide deamidation, oxidation, reduction, hydrolysis, mismatched disulfide bonds, and β-elimination.

 

3. Polymers

dimers and polymers.

 

4. Optical Impurities

racemization, non-enantiomeric impurity.

 

Common Techniques for Impurity Detection in Peptide Drugs

1. High-Performance Liquid Chromatography (HPLC)

HPLC has become the most commonly used method in drug quality analysis. The separation principle is based on the interaction between peptides and the stationary phase. Peptides are composed of multiple amino acids connected by peptide bonds, which have a certain hydrophobicity. By selecting the appropriate chromatographic column, mobile phase, and detector, the separation and detection of peptide drugs and their impurities can be achieved.

 

Features: high resolution and sensitivity, can be used online with other techniques; however, the sample processing process is cumbersome, the sample consumption is large, and the equipment cost is high.

 

2. Capillary Electrophoresis (CE)

Different from the hydrophobic separation mechanism of HPLC, CE is based on the difference in the migration speed of peptides in an electric field to achieve separation of peptides and impurities. Different peptides have different migration speeds in an electric field due to differences in charge, size, and shape.

 

Features: efficient, fast, economical, and consumes less sample; however, electroosmosis may affect the composition of the sample, the reproducibility is poor, the throughput is low, and it is not suitable for the preparation of large amounts of samples.

 

3. High-Performance Liquid Chromatography-Mass Spectrometry (HPLC-MS)

Liquid chromatography-mass spectrometry has become an important means of separating and identifying various compounds. When using liquid chromatography-mass spectrometry to analyze peptide drug impurities, it can give the impurity's primary and even multi-level mass spectrometry information without obtaining pure impurities, thus obtaining the molecular weight and sequence information of the impurity, providing a basis for the qualitative and structural analysis of the related peptides.

 

Features: High sensitivity and resolution, able to accurately identify and quantitatively analyze impurities in peptide drugs; however, the equipment cost is high and operation and maintenance are relatively complex.

 

Importance of Peptide Drug Impurity Analysis in Drug Development

1. Ensure Drug Quality

By analyzing the impurities in peptide drugs, the quality and purity of drugs can be ensured, guaranteeing their safe and effective therapeutic effects.

 

2. Monitor Production Process

Impurity analysis can help monitor impurities that may be produced during the production process, adjust production parameters in time, and reduce the generation of impurities.

 

3. Guide Drug Improvement

In-depth analysis of impurities in peptide drugs can provide important references for drug improvement and optimization, further improving the stability and efficacy of the drug.

 

Impurity analysis of peptide drugs is an indispensable part of drug development. By identifying and analyzing various impurities in peptide drugs, we can ensure the quality and safety of drugs, guide the production and improvement of drugs, and provide important support for drug development. MtoZ Biolabs has established seven detection platforms, combining high-resolution mass spectrometry, MALDI TOF, high-performance chromatography, capillary electrophoresis, and other analytical techniques to efficiently and accurately analyze various impurities in peptide drugs. In addition, MtoZ Biolabs also provides other related services for bio-product characterization, you can click related services to learn more.