EPPENDORF_Nov2021_UpstreamBioprocessingImprovingEfficiency - 6

People Are Key to the Digital Evolution of Biopharma
This new found willingness to invest in innovative
manufacturing technologies reflects the emergence
of a new generation of executives who understand
their benefits, Chotteau says.
" Manufacturing of biologics relies on cells, nowadays
often mammalian cells, which are both complex
and have an inherent variability. Facing this complexity,
the field has traditionally relied on human surveillance
supported by redundancy. However, due to a combination
of improved technology and generation shift,
this is now changing, " she points out.
" Two or three decades ago, today's leaders deciding
on investments and technical focus in companies,
were PhD students either working with sensors,
mathematical models, and feedback control, which
became Process Analytical Technology (PAT), or AI.
" These technologies have also evolved a lot, which
makes them attractive today and near to offering
solutions. "
Chotteau, who is also director of the KTH's
Competence Centre for Advanced Bioproduction by
Continuous Processing (AdBIOPRO), says the move
away from batch-mode production is another factor.
" Continuous bioprocesses, not to mention perfusion
process, are obviously now a rising interest, with
support from FDA and EMA, " she tells GEN. The need
for on/in-line monitoring, mathematical models, and
feedback control for these processes is much larger
than legacy batch operation, which is also a motor
for increased PAT and this type of approach. "
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Expertise
Staff with experience will also play a role in helping
industry maintain its digital momentum, according
to Johan Rockberg, PhD, associate professor in antibody
engineering and directed evolution at the KTH
Royal Institute of Technology. Currently, Rockberg
says, there is a shortage of digital manufacturing
expertise with knowledge often siloed rather than
being shared between different scientific
disciplines.
" This means that industry is struggling to find
talent and needs also to arrange a puzzle of disciplines
to cover all its needs. There is greater need
mobility between the sectors, in particular for
addressing needs in manufacturing of cell and gene
therapy products, " he explains.
Addressing the shortfall will require support from
academia, according to Rockberg, who suggests that
universities are yet to fully adapt education programs
to the digital needs of the industry.
" To date the volume of students [seeking education
in digital biopharmaceutical manufacturing] has
not been large, which means as well that it is not
often prioritized, " he continues. " Another aspect is
that academic research in bioprocessing worldwide
is rather limited due to funding policies, although
this has been slightly better the last couple of years,
and this means as well that the number of highly
educated people in bioprocessing is rather low. "
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EPPENDORF_Nov2021_UpstreamBioprocessingImprovingEfficiency

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EPPENDORF_Nov2021_UpstreamBioprocessingImprovingEfficiency - Contents
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