Proteins & Peptides Stability Testing

ICH pharmaceutical stability testing is an important component of all protein/peptide biopharmaceutical development, especially in support of IND/NDA submission activities. CD Formulation offers a wide range of ICH stability testing services for large molecule protein/peptide drugs, supporting the development of efficient standard or customized storage conditions to meet your real-time, accelerated, or forced degradation stability study requirements.

Why is ICH Stability Testing Important?

ICH stability testing is designed to monitor and evaluate changes in protein/peptide APIs and finished pharmaceutical products (FPP) over a period of time under the influence of different factors such as environmental conditions (temperature, humidity, light), packaging materials, and container closure systems. Data from these studies not only determine recommended storage conditions, shipping conditions, and shelf life but also help predict their in vivo stability and efficacy.

According to international guidelines (ICH, FDA, and WHO), stability studies must be performed on drug substances (DS) and drug products (DP) to ensure the quality and efficacy of drugs throughout their life cycle in a more efficient and time-saving manner.

Fig.1 Objectives of stability testing. (González-González O, et al., 2022)

Explore Proteins & Peptides Stability Testing Services

To advance your protein/peptide drug from discovery to regulatory approval to commercial manufacturing, you must understand how your product performs under both routine and stress conditions. Following the ICH Stability Testing Guidelines, CD Formulation provides stability indicating method development and validation for protein/peptide active ingredients and final products.

Our stability testing team uses pharmacopoeial or in-house developed and validated methods to provide compliant stability testing data, including identification and quantification of possible degradation products and impurities, and routine testing of finished products such as assay, moisture, hardness, solubility, disintegration, etc.

Available Stability Testing Projects:

• Development and validation of stability-indicating methods.
• Protein/peptide active pharmaceutical ingredients (API) and finished drug product stability testing.
• Formulated product stability testing.
• Temperature cycling and freeze/thaw studies.
• Transport studies.
• Storage stability testing.
• Forced degradation testing (exposure to acid, alkalinity, oxidative stress, light, heat).
• ICH photostability (fluorescence and ultraviolet (UV)).
• Real-time stability testing.
• Long-term stability testing.
• Medium-term stability testing.
• Accelerated stability testing.
• In-use stability testing.
• Post-production stability testing.

Available ICH Stability Testing Conditions:

We have a broad range of stability testing conditions covering ICH climatic zones, while also offering custom storage capabilities:

• 21°C, 45% relative humidity.
• 25°C, 40% relative humidity.
• 25°C, 60% relative humidity.
• 30°C, 25% relative humidity.
• 30°C, 35% relative humidity.
• 30°C, 65% relative humidity.
• 30°C, 75% relative humidity.
• 40°C, 75% relative humidity.
• Storage temperature 2-8°C.
• Ultra-low temperature storage -20°C, -40°C, -80°C.

Finished Protein/Peptide Therapeutics Stability Testing

CD Formulation implements and executes pharmaceutical stability testing programs for protein and peptide biologics, with a particular focus on specialty formulations - inhaled, including nasal and pulmonary, and injectable. We provide stability testing services to help you understand how your product performs under a variety of conditions - all in compliance with ICH guidelines and compliance requirements of leading global regulatory agencies, in preparation for commercial launch.

Inhalation Product Stability Testing

Our scientists have strong expertise in stability testing of inhaled products, available testing includes:

• Particle or droplet size testing.
• Dosing uniformity.
• Spray shape/plume geometry.
• Powder and particle characterization.
• Extractables and leachable testing.

Injection Stability Testing

Our injection stability research includes influencing factor testing, accelerated testing, and long-term testing. If necessary, intermediate condition tests should be conducted. Low-temperature tests and freeze-thaw tests are recommended for injections that may be unstable at low temperatures. Available testing items include:

• pH value/acidity.
• Clarity and color.
• Loss of drying
• Weight loss on drying/moisture (powder for injection).
• Microbial limit testing (sterility).
• Bacterial endotoxin/pyrogen.
• Insoluble particles and visible foreign matter testing.
• Content (potency) determination.
• Excipient stability testing.
• Packaging material/container stability testing.
• Extractable and leachable testing.

Why Choose Us for Proteins & Peptides Stability Testing?

• We have hundreds of achievements in protein/peptide stability testing in accordance with ICH guidelines.
• We provide flexible, tailored solutions that follow stability testing guidelines in a variety of projects and environments.
• We are able to simulate all testing conditions for protein/peptide biopharmaceuticals from development, and manufacturing to final application.
• We have the expertise to handle even the most complex stability challenges.
• We adhere to strict quality standards and regulatory guidelines to ensure that all testing is conducted in accordance with industry best practices.

Publication

With over 20 years of experience in stability studies and a comprehensive understanding of the latest developments in regional, national, and ICH stability study guidelines, CD Formulation provides truly flexible, high-quality stability testing services for protein/peptide biopharmaceutical projects for clients around the world. Please feel free to contact us if you are interested in our services or have further questions. We look forward to working with you.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.