Building Confidence in Regulatory Validation of Cell-Based Products

While rapid microbial methods drive quick delivery for most medical products, advanced medicinal therapies are emerging as a new challenge in quality control testing. These evolving products, often derived from mammalian- or human-cellular tissues or cell lines, present unique interferences with bioanalytical assays. These advanced therapies often contain their own cellular matrices, including many of the same metabolic markers rapid detection technologies are based on. 

In this expert-led industry article, Labors LS and Charles River share a detailed account of implementing ATP-bioluminescence for rapid microbial detection in complex, cell-based matrices. 

With the recent compendial recognition of ATP-bioluminescence under USP <73>, this case study offers timely insights into: 

  • Applying validated methods that meet regulatory expectations 
  • Navigating high-background ATP challenges in cell therapy products 
  • Achieving statistically equivalent results to compendial sterility tests 
  • Streamlining validation with transferable primary data 

Labor LS, one of Europe’s largest independent pharmaceutical contract laboratories, has relied on the Celsis® system since 2008. Its high level of alignment with the compendial method makes it very easy for employees to use and significantly increases authority acceptance. The Celsis Adapt™ System, which represents the latest development of the Celsis® platform for cell-based samples, has also proven itself in practice and provides indispensable services in microbial testing of cell-based preparations.”

Stefan Gärtner, Head of Department, Test for Sterility, Labor LS

Authors:

 

Stefan Gärtner
Head of Department, Test for Sterility
Labor LS

 

Stacey Ramsey, MS
Senior Manager, Celsis® & Microbial Applications Lab
Charles River