don’t need superpowers but a smart tool to detect bacteria in cell therapy products right before treatment.

Rapid Bacteria Detection Within Only 3 Hours Instead of Days: With Validated Microsart® ATMP Bacteria.

Coming 2018.

Using the proven real-time PCR method, Microsart® Bacteria enables the detection of a bacterial contamination within 3 hours. Before treatment you can be sure that only bacteria-free cell therapy products will be used. This ensures patients’ safety and reduces the need for prophylactic medication with antibiotics. A pioneering test no one else can offer you. Because real heroes deserve only the best.

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Microsart® Bacteria Kits

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Bacterial Detection | Pharmaceutical Microbiology | Sartorius

The revolution in regenerative medicine – ensure ATMPs are bacteria-free prior to treatment: 

  • qPCR methodology is used in combination with a special sequence for detecting the full range of bacterial contaminants.

Ensure patient safety and help to reduce prophylactic treatment with antibiotics:

  • Only bacteria-free cell therapy products are used for patient treatment.

Don’t worry about false positives – instead obtain reliable results within 3 hours:

  • Time-saving by avoiding lengthy 14 day cultivation protocols.
  • Ensures the highest level of qPCR specificity through use of TaqMan® probes.
  • No need to perform uncertain melting curve analysis.
Bacterial Detection | Pharmaceutical Microbiology | Sartorius

Eliminate contamination risks by using the only kit with non-infectious bacterial cells:

  • Validation standards for required bacterial species are lyophilized to render them non-infectious. 
  • Detailed step-by-step guidance for matrix-specific validation provided by Sartorius qPCR experts.

Ensure validated, quality test results in compliance with international standards:

  • Microsart® ATMP Bacteria is validated according to EP 5.1.6 and USP <1223> for sensitivity, specificity and robustness.
  • Developed in close cooperation with authorities.

Avoid the risk of cross-contamination:

  • Individually packaged patient-specific vials.
Bacterial Detection | Pharmaceutical Microbiology | Sartorius

Let the master mix do the internal control and reduce tedious pipetting steps

The DNA-sequence for internal control is included in the ready-to-use master mix.Minimize false-negative results and the number of reactions. 

Start testing right away using your existing equipment:

The kits can be used with any type of qPCR cycler able to detect the fluorescent dyes FAM® and ROX®. Clear, color-coded reagents guide through the short and simple protocol. Lyophilized reagents ensure consistent quality without the need for freezer storage.

Bacterial Detection | Pharmaceutical Microbiology | Sartorius

Choose the appropriate Microsart® Bacteria Kit based on your requirements:

  • Compendial testing and release : For testing cell-based therapeutics (ATMPs) such as autologous chondrocyte transplants or CAR-T cells: Microsart® ATMP Bacteria Kit 
  • In research & development: Microsart® RESEARCH Bacteria Kit

Microsart® RESEARCH Bacteria

Rapid detection of total bacteria within only 3 hours

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Free Trial: Bacterial Detection Solutions

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