(d)

Following enzymatic dissociation, deactivate all the con-

trol loops and return the bioreactor to the biosafety

cabinet.

(e)

Remove the remaining port lid as previously described

and gently resuspend the cell suspension 10 times using

a 10 mL sterile pipette, then filter the suspension through

a

70

μm

cell

strainer

(Corning®)

into

a

sterile

centrifugation tube.

(f)

Use an equal amount of fresh pre-warmed culture media

(see Note 6) to wash the interior of the bioreactor, filter it

through the strainer into the sterile centrifugation tube

containing the initial filtrate, then centrifuge at 300  g

for 5 min.

(g)

Remove the supernatant and resuspend the cells in

pre-warmed DPBS, then centrifuge the cells again at

300  g for 5 min. Repeat this washing step twice.

(h)

Finally, remove the supernatant and resuspend the cells in

the desired amount of either fresh pre-warmed culture

media (see Note 6), for direct use, or pre-cooled cryogenic

medium, for the long-term cell storage at 160 C (see

Note 15).

3.4

Sampling and

Quality Control

This section describes the sampling procedure for the two cultiva-

tion systems and their corresponding workup, as well as basic

quality control measures, which may be performed in an upstream

setting. A simplified overview of the routine sample work-up is

given in the Fig. 4.

1. Directly following the attachment phase, a 7 mL sample is

taken to determine cellular attachment efficiency, cell distribu-

tion on the MCs, as well as the prevailing substrate and metab-

olite concentrations.

(a)

Transfer the homogenous sample to a 15-mL centrifuge

tube (Corning®) for intermediate storage.

(b)

Remove 1 mL of the homogenous sample and transfer to

a 1.5-mL microtube (Eppendorf®) and allow the MCs to

sediment in both containers.

(c)

Transfer the supernatant to another 1.5-mL microtube in

such a way as to not aspirate any MCs. This sample may

then be analyzed to determine substrate and metabolite

concentrations (see Note 3).

(d)

To the pellet remaining in the 1.5-mL microtube, add

1 mL of formalin and incubate at room temperature for

30 min. Subsequently, the sample may be either used

directly

to

determine

cell

distribution

and

MC

100

Misha Teale et al.