Stability Studies

data on screen

Stability studies are an essential means to determine factors that can cause protein aggregation or degradation, which in turn can impact biological activity, product safety and quality. 

We approach drug substance and drug product stability studies using a variety of methods to detect changes in protein structure following forced degradation induced by elevated temperatures, freeze-thawing, mechanical stress, oxidation, and light exposure, plus exposure to the various materials and devices used in drug delivery.  

Forced degradation studies are available to support early stages of development and more comprehensive packages are available to support late phase development.   

Our cGMP compliant stability programs adhere to: 

  • ICH guidelines Q1A (R2) “Stability Testing of New Drug Substances and Products” 
  • Q5C “Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products” 
  • ICH Q6B “Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products” 

Our comprehensive suite of cGMP biopharmaceutical analysis techniques supports the methods required for drug substance and drug product testing during development of Investigational New Drug (IND), Investigational Medicinal Product Dossier (IMPD), and New Drug Application (NDA) submissions through BLA/MAA filings and commercial programs.  

Our Services

Our stability services include:  

  • Stability testing for toxicology drug substance, drug product   
  • Stability testing for clinical drug substance, drug product   
  • cGMP registration stability programs  
  • cGMP commercial stability programs  
  • Protocol design and program management  
  • Timepoint and final reports  
  • Development and validation of stability indicating methods  
  • Photostability (ICH Q1B Options 1 & 2)  
  • Storage at all ICH conditions  
  • Specialized storage conditions  
  • Temperature cycling, freeze-thaw and shipping studies  
  • Forced degradation studies  
  • Accelerated stability testing  
  • Qualified environmental chambers with continual monitoring and back-up systems  
  • Testing for stability samples stored at other facilities, and storage for contingency and retention of samples
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Discuss Your Project

Contact us to learn more about our stability services.

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