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27th February 2024  Content supplied by: Sartorius AG

Rapid ATMP Testing Speeds Up Sterility Release

Rapid sterility and mycoplasma detection tests for Advanced Therapy Medicinal Products (ATMPs) are transforming the landscape of cell and gene therapy safety, offering unprecedented testing speeds that ensure quicker, safer patient access to life-saving treatments.

Key Advantages of the Rapid Testing Solutions:
  1. Accelerated Sterility Results: Sterility testing times are now reduced from weeks to hours, with results available in just 6 hours.
  2. Mycoplasma Detection in a Flash: The mycoplasma test delivers accurate results in only 1 hour, a significant leap from the traditional 28-day testing period.
  3. Compliance with Confidence: Tests are designed to meet the stringent requirements of EP and USP, ensuring full regulatory compliance.
  4. Ease of Use: The tests are user-friendly, requiring minimal training, and can be easily incorporated into various laboratory workflows.
  5. Technological Precision: Employing nucleic acid amplification techniques for enhanced accuracy, these tests represent the forefront of testing technology.

These rapid testing methods are a milestone for ATMP manufacturers, enabling them to expedite the release of their products while upholding the highest standards of safety. This is particularly critical for treatments with limited shelf lives, where time is of the essence.

The introduction of these rapid tests marks a significant stride forward in the commitment to improving healthcare outcomes. By facilitating the rapid development and deployment of advanced therapies, these solutions are helping to bring about a new wave of medical breakthroughs.

Download the application note.

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Date Published: 27th February 2024

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