The key to the successful development of protein and peptide pharmaceuticals depends on ensuring the safety, efficacy, purity, biological potency, and stability of active molecules in this class of drugs, which involves developing and creating a series of robust experimental conditions to analyze and verify the target ingredients. CD Formulation is an expert in the field of protein & peptide, committed to providing a full range of analytical testing services to help you deeply understand the characteristics of its biological products and overcome a series of challenges, such as the complex production process of drugs, susceptibility to heat, acid, and alkali, degradation of proteins and peptides, etc.

What Are Proteins & Peptides Characterization and Analytical Testing?

Therapeutic proteins & peptides are a class of bioactive molecules composed of amino acids that have important biological functions, including regulating cell growth, stimulating immune responses, and transmitting signals. They can enhance or inhibit physiological processes in the body by stimulating the functions of natural molecules, thereby achieving the purpose of treating diseases. Protein & peptide characterization and analytical testing are fundamental and critical steps in the development and ongoing quality control of biologics. These bioactive molecules vary in size, molecular structure, and physical and chemical properties, which require protein analysis and characterization through various isolations and identifications to ensure their safety and efficacy. Commonly used characterization and analysis techniques for proteins and peptides include mass spectrometry (including mass spectrometry, mass spectrometry quantification, and mass spectrometry imaging), gel electrophoresis, protein purification, X-ray crystallography, and biophysical techniques.

Fig. 1 The most common analytical techniques for the structural characterization of proteins in solid pharmaceutical forms. (Bolje A, et al., 2021)

Explore Our Proteins & Peptides Characterization and Analytical Testing Services

With years of experience supporting therapeutic protein and peptide development and testing assays, CD Formulation's pharmaceutical team and protein & peptide chemists are committed to providing a full range of analytical testing services to assist our customers in deeply understanding the properties of their biological products, provide key data support for new drug development and comply with regulatory requirements.

Our expert team strategically deploys therapeutic protein and peptide analysis and characterization testing services to address key biological characteristics relevant to ensuring the efficacy and safety of target products, including protein/peptide structural analysis, peptide mapping analysis, and protein/peptide quantification analysis, post-translational modification analysis, batch-to-batch consistency analysis, and biological evaluation, etc.

Our pharmaceutical analysis team has extensive experience in the development and validation of analytical methods for biological products and is able to identify possible decomposition pathways and determine the best analytical methods to detect and quantify major components and impurities in biological products to assist you with production solutions quality control issues in the process, including stability analysis, product-related impurity analysis, process-related impurity analysis, forced degradation research, etc.

• Therapeutic Proteins & Peptides Characterization

Determine the sequence, structure, and composition of proteins and peptides through atomic force microscopy, X-ray crystallography, mass spectrometry, infrared spectroscopy, nuclear magnetic resonance, gel electrophoresis, and other technologies, and evaluate the purity and impurity content.

• Proteins & Peptides Formulation Analysis

Characterize the physicochemical properties of protein & peptide formulations through size exclusion chromatography (SEC), Fourier transform infrared spectroscopy (FTIR), circular dichroism (CD) spectroscopy, differential scanning calorimetry (DSC), high-performance liquid chromatography (HPLC) and other techniques, including assessment of solubility, aggregation, conformation, in vitro release, in vitro penetration testing, and sterility testing.

• Proteins & Peptides Quality Control and Release Testing

Critical quality attributes(CQAs) of proteins and peptides, including identity, purity, potency, stability, and impurities, are evaluated through analytical techniques such as chromatography, electrophoresis, mass spectrometry, and spectroscopy to confirm that proteins or peptides meet predetermined quality standards before release or use.

• Proteins & Peptides Biological Evaluation

Understand the mechanism of action of proteins and peptides and their formulations in organisms through in vitro experiments, in vivo experiments, and computational simulations, including immunogenicity, biological efficacy, pharmacokinetics, and pharmacodynamic analysis.

Importantly, our analytical testing laboratories can help you meet authorization requirements in all regions around the world, providing compliance data every time, including the US Food and Drug Administration (FDA), European Medicines Agency (EMA), current Good Manufacturing Practices (cGMP), etc.

Our Expertise and Technologies

CD Formulation specializes in the analytical characterization of therapeutic proteins & peptides. Our expert team has a complete set of the latest analytical techniques and equipment to characterize and test your protein & peptide products to solve various possible problems and complex challenges.

Available analytical techniques:

Why Choose Us for Protein & Peptide Formulation Research and Development?

• Multiple compendial methods and in-house analytical platforms support therapeutic protein & peptide stability, batch-to-batch consistency, and biopotency determination.
• Reliable analytical method to identify and characterize proteins & peptides that can be used to verify any ingredient in your product, including protein & peptide content and possible impurities.
• Comprehensive analysis and characterization capabilities enable a thorough analysis of the high-level structure and stability of proteins and peptides.
• Robust analytical method development and testing capabilities can obtain accurate analytical results in a short time, speed up the drug development process, and save time and costs.
• A one-stop solution that provides comprehensive analytical services from analytical method development, validation, and transfer to CGMP manufacturing quality control.

CD Formulation is committed to helping our customer determine the purity, identity, and stability of your proteins and peptides assess their biological activity and potency, and provide accurate and reliable data that meets regulatory requirements and industry standards. Don't hesitate to contact us today to learn more about how our proteins & peptide characterization services can support your research and development needs.