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キーワード:
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要旨:
The pressure to innovate in cell-based production systems is weighting particularly strong on
the manufacturers of vaccines, as the currently used manufacturing systems do encounter
severe problems. In the case of currently used egg-based vaccine manufacturing technology
an average production campaign of e.g. influenza vaccines takes up to 6 months. In contrast
to the egg-based production technology, cell culture-based systems show the potential to
drastically shorten production cycles and improve quality of the vaccine regarding e.g.
glycosylation of immunogenic antigens and risk of animal contaminants.
CEVECs Amniocyte Production (CAP) cell technology is a versatile production platform to
generate difficult-to-express and manufacture therapeutic proteins. The generation and
development of the CAP human cell system has been fully documented according to all
relevant regulatory standards. During the past years CAP cells have been broadly used for
production of complex proteins and antibodies and thus have proved its strong potential as
new technology platform for proteins in high yields and with authentic human glycosylation
pattern.
Addressing the needs of vaccine manufacturers, we have tested the suitability of CAP cells
for the production of influenza vaccines. CAP cells growing in suspension in serum-free
medium were evaluated for their potential as host cells for different human and animal
influenza strains. The studies included extracellular metabolite concentrations during growth
and virus production in different cultivation systems, test of different commercial serum-free
media and evaluation of process conditions (trypsin concentration, multiplicity of infection,
media feeding). In addition, time-course of infection and virus adaptation was characterized,
and virus yields obtained with CAP cells were compared to those with MDCK cells.
Favorable robust process parameters and high virus yields obtained with different influenza
strains demonstrated that CAP cells are very promising candidates for large-scale
manufacturing of vaccines in serum-free medium.
