GENengnews.com|MAY 19, 2019

BIOP ROCESSIN G INS I G HT S

Introducing New Bioprocessing
Technologies in the Era of COVID-19

By K. John Morrow Jr., PhD
Bioprocessing is undergoing dramaticchanges as companies develop new
manufacturing strategies; according
to Artur Miguel Arsenio, PhD, headof product management at Sartorius
Stedim Biotech. “The digitalizationof several elements of our value chain
is transforming the way we operate
and meet our customers’ needs,” hetold GEN. “With the end-to-end integration of systems and data, we are
introducing bundling and cross-sellingof multiple systems, including digitalcompanions.”
A critical feature of the Bioprocessing 4.0 concept is the reduction ofhuman error. “The increase of automation, remote diagnostics, real-time process monitoring and control can significantly reduce the need for manualtasks,” he stated, “thus decreasing therisks for an important source of contamination. Furthermore, automationand smart connected systems empower
the performance of human workers on
manual tasks, helping them to avoid
errors and reducing risks.”
The company predicts that flexible
automation integration will reduce
the project effort for installing anupstream /downstream bioprocessing

facility by 50–75% because activities
are substantially reduced during theintegration. The modular packages
allow rapid and flexible deployment orchange of various consumable configurations to allow process adaptationand quick system upgrades.
“Tailored configurations can beeasily updated with a simple softwarechange, even in a cGMP environment,” Arsenio continued. “Thesesmart modular package units allow us
to override manual set-up and runningissues, significantly reducing humanerror during set-up and process runs.”
A better process understanding also
helps to limit the number of actions
dependent on humans (and options offered), further reducing opportunities
for errors. Data analytics tools enable
process optimization, further reduc-ing the need for human intervention,and the quality by design strategy reduces the risk of failed batches due toincreased process understanding andtherefore reduces costs.
For Arsenio, Bioprocessing 4.0 is a
new concept, focusing on system anddata connectivity in the biotech industries. “We believe it to be an enabler oftransformative innovation within the industry (the way we work, our processes,our products and platforms). It brings
the potential to react flexibly and in ascalable way to changing market demands and it aligns with the industry’s
drive to significantly reduce CAPEX andOPEX associated with the manufacturing of lifesaving biopharmaceuticals toan expanding global market.”Today the overriding challenge
to the bioprocessing industry is the2 | MAY 19, 2020 | Genetic Engineering & Biotechnology News | GENengnews.com

Coronavirus COVID-19 threat and theneed to ramp of production rapidly.
“Sartorius’ Ambr systems are helping the industry to speed up process development to reach clinical trials. PAT(Process Analytical Technology) also
plays an important role,” maintains
Arsenio. “Furthermore, the market
demands of the COVID-19 pandemic
call for significant improvements, suchas time-to-clinic and time-to-facility. A
proper layout of automation can improve time-to-facility, by bringing options for faster integration. Biobrain, a
new automation platform for our biomanufactur ing systems, is a smart modular package unit, engineered to ensure
seamless integration of SU instruments
into different supervisory control anddata acquisition (SCADA) or Digital
Control System (DCS).”