RSS Newsfeed  Your shopping cart.
home
SEARCH

Search in

Keyword

GMP News
21/11/2012
 

FDA-approval for Roche’s nucleic acid based (PCR) Rapid Mycoplasma Test (MycoTOOL® PCR Mycoplasma Detection Kit)

  
On November 1st, 2012, the MycoTOOL® PCR Mycoplasma Detection Kit-based test from Roche Applied Science was approved by the U.S. Food and Drug Administration (FDA) for release testing of a  Roche biopharmaceutical product. It is the first commercially available Mycoplasma PCR test approved by FDA that can replace conventional and time-consuming mycoplasma detection assays (culture method as well as indicator cell culture method) for the testing of biologics and biopharmaceuticals.

In the past three years Roche’s nucleic acid based (PCR) rapid mycoplasma test has been approved by the European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and more than 100 additional Health Authorities worldwide as a Mycoplasma PCR test for release testing of several biopharmaceutical products. The MycoTOOL® PCR Mycoplasma Detection Kit providing all critical reagents for performing an easy to use sample preparation and PCR is globally available for use.

On this occasion, an additional lecture about the MycoTool and the way to get the approval was added to the agenda of the Rapid Microbiological Methods Conference on 11 and 12 December 2013 in Munich.


Conference Recommendations

Related GMP News
22/10/2014EDQM revises 5.1.10. Guidelines for using the Test for Bacterial Endotoxins
08/10/2014New FDA Interim Guidance for Human Drug Compounding Outsourcing Facilities
02/09/2014RMM Homepage - Update and new Structure of Literature List
02/09/2014RMM Working Group announces Changes on its Board
02/09/2014Draft USP Chapter 1223 Validation of Alternative Microbiological Methods published

 

 GMP News by Topics
 Analytical QC
 APIs and Excipients
 Computer Validation
 Counterfeit Medicines
 Good Distribution Practices
 GMP Inspections/Audits
 Pharma Technology
 Quality Assurance
 Sterile / Aseptic / Microbiology
 Validation
 Medical Devices
 Pharmaceutical/Clinical
 Development
 Regulatory Affairs