Further cost savings are possible during downstream processing of the product. Owing to the high concentration of the produced
MAb, concentrating it prior to purification is not necessary. Depending on the application of the MAb, purification might
be omitted as well, because the MAb purity, i.e., the ratio of MAb to contaminants, is much higher than the purity of MAbs
produced with conventional systems. According to the analysis presented here, total production costs are lowest when CELLine is used (€1.5/mg MAb, or approximately
$1.85/mg MAb), and they increase by 60 percent when using roller bottles (€2.4/mg MAb, or approximately $2.96/mg MAb), primarily
resulting from higher expenses for serum and labor. The production with a stirred bioreactor further augments the costs, due
to additional labor and to equipment amortization. It should be noted, however, that costs depend on the amount of MAb produced:
for small amounts (less than 50 mg) the difference between roller bottles and CELLine is small and economic considerations
are less relevant. For larger amounts (greater than 1 g), the use of a stirred bioreactor becomes competitive and represents
an alternative to CELLine. CONCLUSION The CELLine bioreactor combines the advantages of high cell densities achieved in two-compartment systems with the ease of
use typical of a standard tissue culture flask, resulting in economically efficient biomanufacturing on a small to medium
scale. The presented benefits of MAb production with CELLine also apply to the manufacturing of other biological products
such as recombinant proteins and viral vectors, so that any laboratory with basic cell culture expertise can produce highly
concentrated, high-quality proteins for research or diagnostic purposes in a cost-efficient way.5-7Fabrizio Baumann is product manager for cell cultivation at INTEGRA Biosciences AG, Schonbühlstr. 8, CH - 7000 Chur, Switzerland, phone: +41 (0)81.286.95.30, Fax: +41(0)81.286.95.33,
fabrizio.baumann@integra-biosciences.com
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