MycoTOOL Mycoplasma Detection from Lonza

MycoTOOL Mycoplasma Detection from Lonza

MycoTOOL Mycoplasma Detection from Lonza

Description

Lonza offers rapid mycoplasma testing kits and testing services using the MycoTOOL® PCR Mycoplasma Detection Kit from Roche. The MycoTOOL® test is a nucleic acid based (PCR) rapid mycoplasma test intended to replace conventional and time-consuming mycoplasma detection assays for the testing of biologics and biopharmaceuticals. The MycoTOOL® PCR test is a highly sensitive method for detection of mycoplasma in both cellular and noncellular samples, providing results in hours instead of days, helping improve lab efficiency, quality, and safety.

Approved by the European Medicines Agency (EMA), the MycoTOOL® PCR test is the first commercially available assay to replace traditional, time-consuming mycoplasma culture tests for release testing of several biopharmaceutical products:

For use in quality control/manufacturing process only.

Related Products

  • Detailed Specifications
  • ItemMycoTOOL Mycoplasma Detection
  • CompanyLonza
  • PriceGet Quote
  • Regulatory ComplianceProduct release testing using the MycoTOOL Test is approved by the EMA (European Medicines Agency) for several pharmaceutical products.
  • Pharmaceutical ApplicationHelps improve efficiency, quality, and safety in the manufacturing of pharmaceutical and biological products.
  • MethodPCR
  • SensitivityValidated at 1 CFU/ml at a 95% confidence interval (=23 out of 24 positive)
  • Analysis TimeInquire
Lonza
Lonza
8830 Biggs Ford Road
Walkersville, MD 21793
United States
Phone: +1 201 316 9200
Website: www.lonza.com