Roche’s MycoTOOL Receives Acceptance from Canadian Authorities
News Jun 14, 2013
Roche has announced that the Canadian Health Authority has accepted the use of its PCR based mycoplasma detection test MycoTOOL for release testing of one of Roche’s biological products.
The test can replace conventional and time-consuming mycoplasma detection assays based on culture methods and was also accepted by the FDA end of last year.
Mycoplasms are frequent causes of contamination in biopharmaceutical production, cell therapy, tissue engineering and vaccine manufacturing.
Traditional detection methods, required by Pharmacopoeias and drug regulating agencies worldwide, use growth on culture media and in vitro assays to detect contaminating organisms.
Requiring as much as 28 days to complete, these growth-based methods are time-consuming, making them laborious and difficult to interpret.
“Mycoplasma contamination represents a significant issue during biological drug production,” commented Ruedi Stoffel, Head of Custom Biotech at Roche. “Fast methods, like our new MycoTOOL test, will greatly enhance the efficiency, quality and safety in the manufacturing process of pharmaceutical and biological products.”
A lecture about the MycoTOOL test will be offered at the Rapid Microbiological Methods Conference taking place on 11 and 12 December 2013 in Munich.
Previous work by the International Multiple Sclerosis Genetics Consortium (IMSGC) has identified 233 genetic risk variants. However, these only account for about 20% of overall disease risk, with the remaining genetic culprits proving elusive. A new study has tracked down four of these hard-to-find genes.READ MORE
14th World Congress on Medicinal Chemistry and Drug Design
Jun 10 - Jun 11, 2019
International Conference on e-Health and Healthcare Innovations
May 08 - May 09, 2019
4th Annual Congress on Nanomedicine and Drug Delivery
Apr 04 - Apr 06, 2019