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1.4 Compendial vs Alternative Methods

Biomerieux

Created on July 19, 2024

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Transcript

is compendial in EUROPE for cell-based preparation ONLY cf. EP 2.6.27

BACT/ALERT 3D

is compendial in EUROPE cf. EP 2.6.32

ENDONEXT (rFC)

and

BACT/ALERT 3D

is compendial in CHINA for cellular therapies ONLY. cf. Chinese Pharmacopoeia 9406

Applicable since March 2024

is soon compendial in US for short life product cf. USP<72>

BACT/ALERT 3D

is compendial in US cf. USP <86>

ENDONEXT (rFC)

and

Published in Nov.2024 and Applicable in May 2025

No foreseeable date