NOVA BIOMEDICAL BIOPROFILE FLEX2 - Intended Use and Tests Performed; Operation Overview

1-4
BioProfile FLEX2 ESM Instructions for Use Manual
1.4 Intended Use and Tests Performed
The BioProle FLEX2 External Sampling Module is intended for automatic delivery of cell
culture or media samples to the BioProle FLEX2 Analyzer from a uid handling device
that is capable of both delivering samples to the ESM Sample Cup and communicating
with the FLEX2 Host application software, such as the ambr® 15 or ambr® 250 automated
bioreactor systems from Sartorius Stedim Biotech. Integration of the BioProle FLEX2
analyzer and any applicable external uid handling device via the ESM enables an
automated “online” analysis for quantitative determination of the 16 key cell culture
parameters offered by the BioProle FLEX2 system (depending on module conguration),
including: pH, pO
2
, pCO
2
, glutamine (Gln), glutamate (Glu), glucose (Gluc), lactate (Lac),
ammonium (NH
4
+
), sodium (Na
+
), potassium (K
+
), calcium (Ca
2+
), Total Cell Density
(TCD), Viable Cell Density (VCD), Viability (%), Live Cell Diameter, and Osmolality (Osm).
Using the directly measured results and the vessel temperature entered by the operator,
the BioProle FLEX2 + ESM offers the following calculated parameters:
• Temperature Corrected pH (for entered values other than 37°C)
• Temperature Corrected pO
2
(for entered values other than 37°C)
• Temperature Corrected pCO
2
(for entered values other than 37°C)
• Air Saturation
• CO
2
Saturation
• HCO
3
-
(Bicarbonate) Concentration
NOTE: The BioProle FLEX2 ESM Module is an accessory sample delivery system for
the BioProle FLEX2 Analyzer, not an analytical device.
1.5 Operation Overview
Sampling is performed by the ambr® liquid handler robot arm, which draws a sample
from a selected ambr® vessel and deposits it into the ESM sample cup. The ESM
automatically transfers the sample from the cup to the BioProle FLEX2 Analyzer for
analysis. Sample assay panels are congured on the FLEX2 and made available for
selection when scheduling analyses from the ambr® user interface. The FLEX2
communicates with ambr® over TCP/IP to allow for sample scheduling, data transfer,
and feedback control. The initialization and maintenance of the ESM is predominantly
facilitated through the BioProle FLEX2 user interface, but some functions may also be
performed through the ambr® user interface. All control schemes based on FLEX2 results
such as feedback control are managed in the ambr® software.
NOTE: Integration of the FLEX2 with ESM
requires an ESM top plate in place
of the 96-well plate sampling deck.
The ESM top plate houses the
ESM sample port, pinch valve,
and air detector. Once an ESM is
installed, the FLEX2 will no longer
offer 96-well plate sampling,
but Manual and Load-and-Go
Carousel sampling will still be
available.
Figure 1.1. FLEX2 + ESM integrated with ambr® 15 system