Confirming the protein sequence and checking for end-terminal variations, as well as demonstrating that the primary protein sequence of the biosimilar is identical to the protein sequence of the innovator product, are requirements of the ICH Q6B regulatory guidelines. CD Formulation uses the most advanced instruments and breakthrough technology methods for protein/peptide sequencing and is committed to providing high-quality protein sequencing services to the biopharmaceutical and biosimilar industries to help customers ensure product quality and safety.
Protein/peptide sequencing is the process of determining the exact amino acid sequence of a protein or peptide molecule. This information is crucial for understanding the structure, function, and interactions of proteins in biological systems. The sequencing of proteins and peptides is typically carried out using techniques such as mass spectrometry, Edman degradation, and N-terminal sequencing. This information can be used in fields such as drug discovery, biomarker identification, and structural biology.
As a protein/peptide sequencing service provider, our scientists use mass spectrometry, gas chromatography, and Edman degradation to determine the complete sequence of proteins and peptides in protein/peptide biopharmaceutical products, including amino acid sequence and modification information.
Our protein/peptide sequencing expertise covers:
Fig. 1 Protein/peptide sequencing analysis. (CD Formulation)
N-terminal sequencing, also known as gas phase sequencing, is one of the more mature methods for analyzing protein N-terminal sequences, mainly used for protein sequencing under conditions where the N-terminus is not blocked or chemically modified.
This technology is performed by chemically removing, derivatizing, and analyzing the N-terminal amino acids in peptides or proteins in sequence. The released amino acid derivatives are then identified based on their relative chromatographic retention time relative to a group of identically derivatized amino acids.
Mass spectrometry sequencing refers to the use of mass spectrometry technology to quickly cleave peptides and determine the amino acid sequence of protein samples, which can be used to identify N-terminally blocked or modified protein samples.
C-terminal sequencing usually performed by mass spectrometry and other technologies. In mass spectrometry analysis, protein samples are first enzymatically digested by digestive enzymes to obtain amino acid fragments, and then these amino acid fragments are analyzed by a mass spectrometer to determine the C-terminal sequence of the protein.
Furthermore, our comprehensive protein/peptide sequencing services are also widely used in research such as protein/peptide identification and PTM analysis.
At CD Formulation, we apply mass spectrometry (LC-MS) to protein/peptide sequence identification, a technique that is able to distinguish isobaric residues.
Mass Spectrometry(MS) Sequencing Technology
Gas Phase Sequencing Technology (EdmanDegradation)
Protein/peptide sequencing is an important tool for protein/peptide biopharmaceutical development. You can choose our services for:
Published Data
Technology: Peptide and protein sequence analysis by electron transfer dissociation mass spectrometry
Journal: Proceedings of the National Academy of Sciences of the United States of America
IF: 11.1
Published: 2004
Results:
The authors successfully develop an ETD method to facilitate peptide sequence analysis by combining ion/ion chemistry and MS/MS, and use a combination of ion/ion chemistry CAD, and ETD to characterize the primary structure of intact proteins.
Schematic of steps involved in the operation are shown as follows.
Fig. 2 Schematic of steps involved in the operation of the LTQ mass spectrometer for peptide sequence analysis by ETD. (Syka JE, et al., 2004)
CD Formulation understands the importance of protein sequencing in the development and production of biologics. With our experienced team and cutting-edge analytical methods, we provide tailored solutions to drive your molecule to success. Please feel free to contact us if you are interested in our services. We will provide you with the most professional advice and support to ensure the smooth launch and implementation of your project.
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