Tianhe received the validation of mycoplasma testing for GMP production

In Jan. 3rd and 4th, ThermoFisher offered an onsite training at Tianhe GMP lab for the detection of mycoplasma by using the MycoSEQ Mycoplasma Real-Time PCR Detection Kit. This detection was conducted according to U.S. FDA Current Good Manufacturing Practice regulations (FDA 21 CFR Parts 210, 211) and Electronic Records and Signatures (FDA 21 CFR Part 11). After mycoplasma detection training and validations into manufacturing operations, Tianhe Stem Cell Biotechnologies (Tianhe) has been qualified and ready to provide clinical manufacturing.