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.
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.
For lab research only, cannot be used for any clinical use.