During therapeutic protein and peptide development, detailed and thorough characterization should be performed in accordance with ICH Guideline Q6B. CD Formulation uses state-of-the-art instrumentation and groundbreaking technical methods to characterize your therapeutic proteins and peptides to the highest technical standards. Whether you need detailed characterization of newly developed proteins and peptides, or quality control and validation of existing products, we can provide you with comprehensive support and customized solutions.

About Therapeutic Proteins & Peptides Characterization

Therapeutic proteins and peptides are an important class of drugs used to treat a variety of diseases. However, these drugs are not as stable as traditional drugs. Due to their complex molecular structure, successfully developing them can be challenging. Proteins and peptide are much more complex than small molecule drugs, and in-depth characterization of the biophysical and biochemical characteristics of protein and peptide biomolecules is critical to identify critical quality attributes (CQAs) to ensure consistent safety and efficacy. Proteins are formed from long chains of amino acids that interact with each other, forming secondary and tertiary molecular structures that may affect protein molecular potency and function. Protein and peptide characterization tests help understand their physical and chemical properties that may have an impact on product performance, stability, appearance, and other critical quality attributes during processing and drug development, advancing drug candidates into development and into the market.

Fig. 1 Different analytical techniques that are currently applied for characterization of protein and peptide drugs. (Akbarian M, et al., 2022)

Explore Our Therapeutic Proteins & Peptides Characterization Services

At CD Formulation, we understand the importance of protein and peptide characterization in the biologics development process. Our highly qualified protein chemists specialize in a variety of analytical testing techniques and methods to help your therapeutic proteins and peptides succeed.

Our clients are attracted by the fact that our comprehensive protein and peptide characterization services meet global regulatory requirements for biopharmaceuticals. With our continuous exploration and rich experience in biological products analysis methods and technologies, we can provide key information and support for your project development, and ensure that your protein and peptide characterization project is delivered within the budget and in the fastest time.

Available therapeutic protein & peptide characterization projects include:

• Protein & Peptide Structure Characterization
• Higher-Order Protein Structures Characterization
• Peptide Mapping Analysis
• Protein & Peptide Particle and Aggregation State Characterization
• Protein & Peptide Viscosity Analysis
• Protein & Peptide Quantitative Analysis
• Protein & Peptide Sequencing Analysis
• Amino Acid Analysis
• Post-translational Modification Analysis
• Protein & Peptide Stability and Thermal Denaturation Analysis
• Protein & Peptide Crystallization Analysis
• Proteins & Peptides PH Titration Testing
• Protein & Peptide Druggability Assessment

Our Expertise and Technologies

With our advantages in protein and peptide quantification, protein structure analysis, and physical and chemical property determination, we can help you obtain high-standard protein and peptide active pharmaceutical ingredients (APIs) or finished products. Our pharmaceutical team and team of protein chemists often combine multiple strategies for protein and peptide characterization, including multiple mass spectrometry techniques such as Orbitrap, and QToF, and other biochemical analysis methods such as X-ray crystallography and nuclear magnetic resonance techniques.

In addition, we use bioinformatics tools to analyze protein sequences and predict their structures.

Supporting Services for Therapeutic Proteins & Peptides Characterization

Apart from physical and chemical characterization and quantitative analysis, we also provide impurity and biological activity analysis services for protein & peptide biological products. In addition, we have the ability to evaluate formulation-related critical quality attributes to offer comprehensive quality control and quality assurance support for your project. Our supporting services include:

• Biosimilarity Study
• Comparability Study
• Stability Study
• Forced Degradation Study
• Impurity Detection and Quantitative Analysis
• Host Cell Protein (HCP) Residue Analysis
• Cell-based Potency Assay
• Ligand Receptor Binding Assay
• Immunogenicity Assay

Why Choose Us for Therapeutic Proteins & Peptides Characterization?

• We have extensive experience in the characterization and testing of various therapeutic proteins and peptides.
• Our laboratories are equipped with state-of-the-art instruments.
• Our team has decades of experience supporting biopharmaceutical product development using protein and peptide characterization methods.
• Comprehensive characterization testing capabilities, including but not limited to protein and peptide physicochemical characterization, primary structure and post-translational modification analysis, advanced structure analysis, aggregation analysis, particle analysis, peptide map analysis, etc.
• Flexible experimental design and testing options can meet any customer's specific needs.

Publication

At CD Formulation, we understand the importance of protein and peptide characterization in the biologics development and manufacturing process. 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.