FDA allows Mycoplasma release testing of a biopharmaceutical product using MycoTOOL®
In November 2012, the US Food and Drug Administration accepted…
In November 2012, the US Food and Drug Administration accepted the use of the MycoTOOL® PCR Mycoplasma Detection Kit as a release method for a biopharmaceutical product manufactured by Roche Applied Science intended for distribution in the United States.