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Stability testing is used to demonstrate short and long term stability of a biologic or therapeutic after exposure to a variety of environmental factors. We have the expertise to apply stability testing methods to detect compound changes in identity, purity and potency. We also meet all the requirements outlined in ICH guidelines.

BioReliance stability testing services include:

• Alarmed monitoring systems
• Secured storage areas
• Temperature, humidity, and light variability
• Labeling, handling, and storage
• Computerized entry and reporting
• Long term stability testing
• Accelerated stability testing

BioReliance offers stability testing for small molecule drugs, peptides, biologics, and therapeutics with well-documented sampling strategies. Contact us to talk about specific stability testing issues.

What are the ICH guidelines for stability testing?

Document ICH topic Q1A outlines the regulatory requirements for stability testing of new drug substances and products. BioReliance stability testing services meet all of these requirements. The purpose of stability testing is to provide evidence on how the quality of a drug product varies with time in response to environmental changes, in order to establish a shelf life and recommended storage conditions. Test conditions are defined by a region’s mean kinetic temperature derived from climatic data. The guidelines outline the following conditions for testing a regulatory approval:

• Stress testing – this identifies likely degradation of products and is done on a single batch of drugs. It includes temperature, humidity, oxidation, and photolysis testing. Details for each of these testing conditions can be found in the ICH Q1A regulatory document
• Batch selection – data should be provided for at least 3 primary batches
• Container closure system – this should simulate the packaging proposed for storage and distribution
• Specification – testing should cover the physical, chemical, biological, and microbiological attributes. Validated stability indicating analytical procedures should be applied
• Testing frequency –
  • Long term studies - depend on the proposed re-test period (every 3 months for the first year, 6 months for the second year)
  • Accelerated storage – minimum 3 time points for a 6-month study
  • Intermediate storage – minimum 4 time points for a 12-month study (0, 6, 9, 12  months)
• Storage conditions – conditions and length of studies chosen should cover storage, shipment and subsequent use
• Evaluation – usually data is analyzed quantitatively on an attribute that is expected to change over time
• Statements and labeling – this should accord with relevant national/regional requirements. Specific instructions on storage should be provided

Results from all of these studies form an integral part of the information provided for regulatory authorities.

Contact us to find out how BioReliance scientists can help you with your analytical needs.