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Rapid Contamination Detection in Short Shelf-Life Biopharmaceuticals

Detecting Contamination in Biopharmaceuticals
credit: iStock

In recent years, the biopharmaceutical industry has shifted towards personalized cell and gene therapy products. This has led to the introduction of new quality control requirements and the development of several rapid microbial detection methods. 

Regulatory guideline USP <1071> emphasizes the importance of real-time contamination detection prior to the administration of short-life products, and digital PCR (dPCR) allows a new level of precise quantification.

This poster explores state-of-the-art nucleic acid detection, the critical steps and the advantages of this approach.

Download this poster to learn more about: 

  • The benefits of rapid microbial detection
  • Real-time PCR-based sterile testing solutions
  • The challenges of a real-time PCR test

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