medicinal-chemistry-biosimilars-2019-keynote

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Der Pharmacia Sinica
ISSN: 0976-8688 Page 25
Medicinal Chemistry and Biosimilars
March 25-26, 2019 | Budapest, Hungary
Euroscicon Conference on
Medicinal Chemistry & Biosimilars 2019
Innovative cell line generation and early process development is the
cornerstone of the success of a biosimilar antibody, since costs of goods
(COGs) needs to be very low. To achieve this, high producing cell lines in
combination with a modulatory USP strategy to meet similarity to the
originator without limiting productivity are obligatory. The major strategy
generally used in USP to optimize productivity, is elevation of viable cell
density (VCD) in the fermenter. This USP solution however creates difficulties
in DSP, since clarification will be difficult and in addition host cell related
impurities will be high. Therefore, we increase specific productivity (Qp)
using our SPOT™ technology, already during cell line generation. In addition,
upstream process modulation can be used to increase Qp while at the same
time improving biosimilar product quality. The high Qp values facilitate high
volumetric productivity at low VCD, which enables an efficient DSP process.
Alongside we observed that irrespective of the VCDs, cell lines with a high
productivity had a very high demand for nutrients and oxygen. Because of the
high oxygen requirements, a high-power input is necessary in bioreactors,
resulting in hardware limitations, i.e. maximum gas flow and agitation rates.
In turn, these hardware limitations ultimately limit innovations that increase
productivity further. To avoid this issue, we applied metabolic engineering
and developed the SLIM™ technology on our CHOBC® platform. The
SLIM™ technology decreases oxygen and feed consumption and therefore
decreases gas flow and agitation rates in the bioreactors. Together, SPOT™
and SLIM™ technology in our CHOBC® platform reduce cost of goods of
biosimilars.
Using SPOT™ and SLIM™ technology and
upstream process modulation to reduce
cost of goods of biosimilars
Biography
MTDenHartogreceivedhisPhD inMolecularBiology
at the University of Amsterdam (NL). Subsequently,
he carried out a Post-doctoral Fellowship at the The
Palo Alto Institute of Molecular Medicine (Mountain
View, US). Thereafter, he was involved in the startup
of PanGenetics where he was responsible for
Molecular Biology and Protein Expression. In 2003,
he was one of the Founders of Bioceros, where he
currently holds a position of Director of Cell Line
Development. He is Author/Co-author of over 20
papers in international scientific journals in the field
of Biotechnology.
MT Den Hartog, Der Pharmacia Sinica 2019, Volume:10
DOI: 10.21767/0976-8688-C1-001
MT Den Hartog
Bioceros BV, Netherlands