| In this Applications Note, we describe the
processes used by our customers to validate the Guava
ViaCount assay and adopt the Guava Personal Cell
Analysis (PCATM) system into a Good Manufacturing
Process (GMP) bioproducts manufacturing setting.
After an initial evaluation of the Guava PCA system,
which indicated that the system would work with their
cells of interest, they validated the performance of the
Guava ViaCount assay, comparing results with the
standard manual hemacytometer counts using trypan
blue exclusion. They adopted the ViaCount assay and
the Guava PCA system for cell counting and viability
assessment into their manufacturing group by developing
documented procedures for: 1) instrument
monitoring and validation using Guava CheckTM; 2)
performing the ViaCount assay; and 3) training. |
