Protein and peptide formulation analysis is a critical step in drug development to ensure their quality, safety, and effectiveness for clinical use. As the world's leading pharmaceutical company in formulation development and analysis, CD Formulation is committed to providing high-quality protein and peptide formulation analysis services to support customers around the world. We have advanced technical equipment and an experienced team to customize the most optimized formulation solutions for customers to ensure that drug products meet regulatory requirements and have maximum stability, solubility, and efficacy.

About Proteins & Peptides Formulation Analysis

Protein and peptide formulation analysis is critical to developing safe, effective and stable products. One of the key aspects of protein and peptide formulation analysis is determining the optimal delivery formulation. This involves determining the most appropriate excipients, delivery systems and processing techniques to ensure the stability and bioavailability of the protein or peptide. Factors such as pH, temperature, and compatibility with other ingredients must be carefully considered to prevent degradation or loss of activity. Additionally, another important aspect of formulation analysis is the assessment of protein and peptide stability and allergenic potential. Proteins and peptides are easily degraded by factors such as temperature, pH, and oxidation. Stability testing helps determine a product's shelf life and ensures it remains safe and effective throughout its intended use.

Explore Our Proteins & Peptides Formulation Analysis Services

Formulation development is a critical step for the successful clinical application of therapeutic proteins and peptides. To support the successful implementation of formulation development, CD Formulation provides a variety of supporting formulation analysis services for various therapeutic proteins and peptides to characterize their physicochemical properties and stability.

We have extensive experience and advanced equipment to provide customers with high-quality, fast, and accurate analytical services for therapeutic protein and peptide formulations. Our formulation analysis services include but are not limited to:

• Nanoparticle Characterization for Proteins & Peptides Formulation
• In Vitro Release Testing for Proteins & Peptides Formulation
• In Vitro Penetration Testing for Proteins & Peptides Formulation
• Sterility Testing for Proteins & Peptides Formulation

Importantly, we will operate in strict accordance with international standards and specifications to ensure that the data is accurate and reliable while protecting your intellectual property rights and commercial secrets.

Our Expertise and Technologies

Thanks to the continuous exploration and discovery of therapeutic proteins and peptides, our professional knowledge and technical capabilities have continued to improve, and we have made important achievements in nanoformulations, transdermal formulations, oral formulations, injections, and other therapeutic drug formulations. Our experienced team of experts supports you in the following areas:

Cutting-edge analytical equipment and testing capabilities for characterizing protein and peptide nanoformulation products.

Our analytical laboratories are equipped with advanced equipment to support the development of a wide range of nanoformulations, such as liposomes, microspheres, nanoparticles, and hydrogels, and characterize your products using:

• Size Distribution Testing
• Zeta Potential Testing
• Efficiency (EE%) Testing
• Drug Loading Testing
• Dynamic Light Scattering
• Nanoparticle Tracking Analysis
• Infrared and UV Spectroscopy

IVRT and IVPT studies for characterizing protein and peptide transdermal formulations.

Transdermal formulations require rigorous IVRT and IVPT studies to ensure the safety and effectiveness of the product. We have extensive experience in transdermal formulation characterization and can support a variety of characterization and analytical testing projects for transdermal formulations of therapeutic proteins and peptides, including:

• New IVRT/TVPT analytical methods development and validation.
• IVRT/TVPT analysis methods adaptation study.
• Skin integrity testing.
• Franz diffusion cell.

In addition, we also provide corresponding TVRT testing services for other formulations, including:

• Therapeutic proteins and peptides liquid formulations: Shaker method
• Therapeutic proteins and peptides nanoformulation: sample separation (SS) method, dialysis membrane (DM) method, and continuous flow (CF) method.

ICH stability studies of protein and peptide formulations.

ICH stability studies are at the heart of any pharmaceutical formulation development program. We perform ICH stability studies of protein and peptide formulations for our clients to address changes in their physicochemical or microbial properties and ensure that the products remain safe, effective, and of high quality throughout their shelf life, including:

• ICH stability testing analytical method development and validation.
• Long-term stability testing
• Intermediate stability test.
• Accelerated stability testing.
• In-use stability testing.
• Forced degradation testing.

Microbial limit testing for characterizing the safety of protein and peptide formulations.

Microbial limit testing is an important tool to ensure that protein and peptide formulation products are safe and effective. Our laboratory is equipped with advanced equipment and technology to test samples accurately and quickly and provide detailed test reports, including:

• Sterility testing.
• bacteria testing.
• Mildew testing.
• Mycoplasma testing.

Why Choose Us for Proteins & Peptides Formulation Analysis?

• Our expert team has extensive experience in performing protein and peptide formulation analysis, ensuring that your samples are handled with precision and accuracy.
• We have the most advanced equipment and technology to test any protein and peptide formulations, including but limited to oral formulations, transdermal formulations, injections, as well as innovative nanoformulations and sustained-release formulations.
• Flexible, tailor-made solutions to meet the specific needs of our clients across different clients.
• Strict quality assurance protocols ensure that all analyses are performed to the highest standards and comply with industry standards.
• Fast and efficient service ensures that customers' projects can be delivered on time.

Publication

With state-of-the-art analytical equipment and professional knowledge, CD Formulation remains at the forefront of the development and analysis of therapeutic protein and peptide formulations. Please feel free to contact us if you are interested in our services. We will provide you with the best solutions and support.