Understanding protein-excipient interactions serves as a critical step in the rational design of formulations to stabilize and deliver protein- and peptide-based therapeutics. CD Formulation provides a range of advanced technologies and solutions to help customers understand protein-excipient interactions and optimize drug performance and stability. Our team has the experience and expertise to tailor solutions to our clients that best suit their needs.

Why Conduct Priotein & Peptide-Excipients Compatibility Study?

Protein- and peptide-based drugs are increasingly popular in the pharmaceutical industry due to their specific targeting capabilities and low toxicity. However, these biologics are inherently unstable and may undergo degradation, aggregation, or denaturation during formulation and storage. Excipients are often added to protein and peptide formulations to improve their stability, solubility, and potency. Currently, a variety of excipients are used to stabilize proteins, inhibit protein aggregation, reduce surface adsorption, or simply provide physiological osmotic pressure. Stabilizers cover a wide range of molecules, including sugars, salts, polymers, surfactants, and amino acids. The effect of these excipients on protein stability in solution is mainly caused by their interaction with the protein and the container surface, most importantly with water. Some excipients stabilize proteins in solution by direct binding, while others use a number of fundamentally different mechanisms involving indirect interactions. Therefore, during formulation development, it is critical to study the multiple mechanisms by which excipients interact with proteins in solution and various interfaces and to explain how various interaction forces contribute to their observed stability effects on the protein.

Explore Our Excipients Compatibility Study of Proteins & Peptides Formulation

Similar to small molecule drugs, in the development of protein and peptide formulations, the selection, optimization and characterization of excipients are very critical. This can be achieved through the properties, compatibility, solubility, stability, and protein-excipient interactions of the excipients. Research and testing are conducted to determine the best combination of excipients and to stabilize proteins and peptides and reduce aggregation.

At CD Formulation, we offer a wide range of protein/peptides-compatibility and interaction analysis services to support the timely development of your protein and peptide drug products. Our list of available services includes but is not limited to:

• Screening and characterization of excipients
• Physical and chemical characterization, including composition, solubility, particle size, humidity, thermal performance testing, etc.
• Toxicity and safety assessment, including assessment of potential toxicity and biocompatibility properties of excipients.

• Protein & peptide-excipient interaction research, including characterizing the structure and function of proteins and peptides, studying the impact of excipients on the stability and solubility of proteins and peptides, and exploring how excipients affect the biological activities of proteins and peptides and activity.

• Excipient stability research, including evaluation of the stability of excipients under different conditions such as temperature, humidity, light, etc., as well as research on the solubility and stability of excipients in different pH values and solvents. Research methods mainly include thermal analysis methods (such as thermogravimetric analysis, differential scanning calorimetry analysis), spectroscopic methods (such as ultraviolet-visible absorption spectroscopy, fluorescence spectroscopy), chromatographic methods (such as high-performance liquid chromatography, gas chromatography), and nuclear magnetic resonance wait.

• Protein-excipient compatibility studies, including in vitro experiments, structural analysis, kinetic studies, etc., to evaluate the interaction mode, stability, and impact on protein structure and function between proteins and excipients.

Our Analytical Technologies for Excipients Compatibility

Why Choose Us for Priotein & Peptide-Excipients Compatibility Study?

• Our team of scientists and researchers have the knowledge and skills to design and execute thorough and accurate studies to evaluate the compatibility of protein and peptide with various excipient.
• We have access to state-of-the-art laboratories and equipment to provide accurate and reliable results.
• We provide comprehensive support throughout the entire study process, from study design to data interpretation. Our team is available to answer any questions or address any concerns you may have along the way.
• We provide end-to-end services for protein/peptide formulation development from excipient screening, and formulation design to the final finished product.
• We provide flexible trial design and customized solutions.

Publication

CD Formulation focuses on exploring the interaction between proteins and excipients to determine the most suitable excipients, optimizing drug stability and delivery performance. Please don't hesitate to contact us if you are looking for professional support and guidance to help you understand protein-excipient compatibility and interactions and optimize your formulation protocols.  Let us work together to advance the development and application of protein- and peptide-based therapeutics.