Friday, February 27, 2015

Determination of critical quality attributes (CQA) of the final product and critical intermediates

Morphology under phase contrast microscopy
Morphology by cell pellet (HE, PAS, immunocytochemistry by the yellow antibodies)
Viability by Countes after trypan blue stain.
qRT-PCR (Alb, AFP, OTC, CPS1)
Implantation into the subcapsular tissue of the kidney

Ammonia metabolism in vitro
Ammonia metabolism in vivo

Morphology by cell pellet (Oil Red O)
ICG test
qRT-PCR (Cyp 1A2, 2B6, 3A4)

Genomics

Will not do:
Flow cytometry






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