The measurement of a therapeutic protein or peptide release from a given dosage form is fundamental to protein or peptide drug development and quality control. In vitro release testing provides a robust and reproducible method to assess the batch-to-batch quality of protein or peptide biopharmaceuticals while maintaining consistent drug release profiles. This plays a vital role in formulation development, quality control, and stability studies. Thanks to decades of experience in protein and peptide drug analysis and testing, CD Formulation has established a complete, advanced in vitro release testing technology platform to support the testing and bioequivalence (BE) research of different protein or peptide dosage forms.

Why Conduct In Vitro Release Testing?

In vitro release testing (IVRT) is a key step in the development and evaluation of protein and peptide biopharmaceuticals, involving the study of the release of therapeutic proteins or peptides from different dosage forms,such as sustained-release formulations, nanoparticles, gels, etc., into suitable media in a controlled laboratory environment. The results of IVRT provide important information on the release rate and release mechanism of therapeutic proteins or peptides, and help evaluate the stability, solubility and absorption properties of the drug. Specifically, it involves 1) evaluating the performance of different formulations under standardized conditions to identify any potential problems with formulation changes, manufacturing processes or long-term stability, 2) demonstrating the safety, efficacy and quality of their products through IVRT, 3) optimizing drug formulations by studying factors that affect drug release, such as dosage form type, excipients, manufacturing process, etc., 4) providing valuable insights into the in vivo performance of protein or peptide products by simulating drug release in a controlled laboratory environment.

Explore Our In Vitro Release Testing Services for Proteins & Peptides Formulation

As experts in protein and peptide formulation development, analytical testing, and quality control, we provide unparalleled in vitro release testing services to the pharmaceutical industry. Our in vitro release testing services for protein and peptide formulations can comprehensively evaluate drug release profiles, ensure that the release rate and stability of drugs are effectively monitored, and provide important references for drug formulation optimization.

Our laboratory team has extensive experience and expertise to provide customized solutions based on the characteristics of your protein and peptide formulations. Our IVRT services obtain data on drug release in vivo or in vitro skin permeability by evaluating the rate and extent of release of proteins or peptides from drug products under simulated human physiological conditions. This can help you predict drug absorption in the human body and provide important reference information for the drug development process.

Our protein and peptide analytical testing experts can perform the following operations, including but not limited to:

• IVRT analysis methods development and optimization for protein and peptide drug.
• IVRT analytical methods validation and transfer for protein and peptide drug.
• Perform IVRT of protein and peptide drugs according to GLP guidelines.
• Analysis of release profiles to evaluate drug release kinetics and behavior.
• Comparison of release profiles between different formulations or manufacturing processes.
• Customized testing services based on specific customer needs and requirements.
• Technical support and consulting to optimize in vitro release testing protocols.
• Regulatory support to ensure compliance with relevant guidelines and standards.
• Bioequivalence studies.
• IVRT analytical testing of multiple dosage forms of proteins or peptides, including solid, liquid, transdermal, nanoformulations, etc.

Our Solutions for Proteins & Peptides Drug In Vitro Release Testing Services

According to FDA industry guidance, oral solid or liquid dosage forms are subject to in vitro dissolution testing or in vitro disintegration testing, which is equivalent to in vitro release testing for transdermal dosage forms. Our laboratory team uses advanced technology and equipment to perform IVRT testing on different types of protein or peptide drugs to obtain the rate and extent of release of the relevant proteins or peptides from drug formulations in vivo.

Fig. 1 Proteins or peptides in vitro release testing services.(CD Formulation)

Applications

Protein or peptide in vitro release testing is an essential element of quality control. Our in vitro release testing services help ensure the consistent quality and performance of your products, including:

• Therapeutic protein or peptide release testing: This is a mandatory test that determines the efficacy of the product by measuring the amount of drug released in a given time.
• Batch consistency: In vitro release testing analytical method parameters such as accuracy, precision, and repeatability are used to measure the effectiveness of IVRT equipment and the overall robustness of the test, ensuring similar results and batch consistency under different conditions.
• System suitability testing: In vitro release testing helps evaluate whether the IVRT system is operating as expected and meets acceptable variability limits.

Why Choose Us for Proteins & Peptides Drug In Vitro Release Testing?

• We have extensive expertise and successful experience in performing IVRT analysis of proteins or peptides.
• Innovative technologies and equipment can test any protein or peptide drug formulation, including nanoformulations, and liquid and solid formulations.
• Strict quality assurance protocols ensure that all analyses are performed to the highest standards and in compliance with industry standards.
• Provides flexible and tailor-made solutions.
• Fast and efficient service ensures that customers' projects can be delivered on time.

Publication

IVRT is a key component of the analysis and characterization of protein and peptide formulations, providing predictive information about the in vivo release of the formulation. CD Formulation offers unparalleled protein/peptide IVRT services to help you design and improve the preparation process and storage conditions of the formulation. Please feel free to contact us if you are interested in our services. We will provide you with the best solutions and support.