Webinar • BIO IT: BioPharma Asia Magazine

Regulatory Approval of Three Rapid Microbiological Methods for MACI Product ReleAgéndalo en tu calendario habitual ¡en tu horario!

Jueves, 8 de noviembre de 2018, de 10.00 a 11.00 hs Horario de Virginia (US)
Webinar en inglés

Rapid detection of contaminants is essential for cell therapy products with short shelf lives. Integrating quality into the process through lot segregation, raw material qualification, environmental control, personnel training, and detailed procedures is critical because final results for conventional microbiological tests may not be available prior to product release or patient administration. EMA approval of the MACI MAA in 2013 followed by US FDA BLA approval in 2016 included three RMM product release assays for sterility, endotoxin, and mycoplasma.

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