Stability Analysis

Drug stability studies are an important part of the drug development and life cycle, especially in support of development and IND submission activities. The stability test assesses how the quality of the drug substance or drug product or its packaging changes over time under the influence of environmental factors including temperature, humidity and light. This process determines if any physical, chemical or microbiological changes affect the efficiency and integrity of the final products. These studies also help determine the optimal storage conditions, product quality and expiration date of the finished drug.

With a stable team providing a professionally managed Good Manufacturing Practice (cGMP) stability program, Creative Biolabs offers a wide range of capacities and conditions, including climate walk-in rooms, cabinets and refrigerators, and frozen storage. Even the most complex dosage forms, APIs or product types, including Oral Inhalation and Nasal Drug Products (OINDP), biopharmaceuticals or vaccines, are guaranteed to provide responsive and customized stability emergency and disaster recovery storage services to help you reduce the risks associated with expensive stability testing.

One-Stop Stability Testing Services

• ■ GMP Analytical Chemistry and Microbiology Laboratory
• ■ Development and verification of stability indication methods
• ■ API, clinical trial materials, stability testing of formulated products
• ■ All ICH conditional storage (ICH Guide Recommended Conditions Q1A & Q1B)
• ■ Photostability (ICH Q1B Options 1 & 2)
• ■ Temperature cycling, freeze-thaw and transportation studies
• ■ Custom storage and management
• ■ Stable emergency and disaster recovery storage
• ■ Continuous electronic monitoring and backup power
• ■ Custom temperature and humidity settings
• ■ Customizable conditions to meet multiple needs
• ■ Tailored reports

Highlights from Creative Biolabs

• ✔ Fast turnaround times - Very fast turnaround time is one of our main strengths.
• ✔ Quality standard - Our laboratories are GMP certified to meet the rigorous standard required for the supply of analytical services for QC and product release.
• ✔ Cutting-edge equipment - Automated balancing systems, such as pipetting or DNA extraction robots, work hand-in-hand with professionals to achieve maximum flexibility and optimal reproducibility.

To help you meet the quality, safety and regulatory standards you expect from drugs, our common tests cover impurity analysis, dissolution, moisture, hardness, friability and disintegration to ensure complete products and packaging systems show sufficient stability throughout the product lifecycle.

Based on the expertise of OINDP testing and the extensive stability studies experience, Creative Biolabs’ scientists provide the development and validation of stability study methods through state-of-the-art technology in our stability analytical laboratories. With a comprehensive understanding of the latest developments in regional, national and ICH stability research guidelines, we aim at providing truly flexible and stable outsourcing partnerships, integrated storage and testing capabilities that allow you to focus on your core business objectives, bringing quality and safety to manufacture.

To find out more about our lot release testing services, please contact us.