MilliporeSigma - Viral Safety - 8

Viral Safety

Advances in Upstream Technologies Reduce Viral-Contamination Risks

Survey by the CAACB
"Viral contamination events may cause
significant impact on a bioproduction
facility," according to Paul W. Barone, Ph.D.,
director of the Consortium on Adventitious
Agent Contamination in Biomanufacturing
(CAACB) at MIT. "For this reason, our consortium focuses on collective learning to
prevent these events in biopharmaceutical
manufacturing."
The CAACB provides a forum for networking, sharing experiences, collaborating on
projects and promoting new technology
to mitigate the risk of a contamination.
According to Dr. Barone, viral contamination
of mammalian cell lines is hardly an academic exercise. From a survey performed
by the consortium, the group is aware of
26 contamination events, the majority of
which occurred in the CHO cell line.
"Given its ubiquitous presence in bioproduction protocols, this is not surprising.
The consequences of these events affect all
aspects of a company's production facility,
and can be catastrophic, costing millions of
dollars and causing shutdowns for months,"
he explained. "Moreover, contamination
events have been reported in all stages
of development, from preclinical through
commercial, with the cost of their mitigation rising astronomically in the late stages."

| October 1, 2017

It is noteworthy that for the CHO cell
cultures, even though all virus contaminants were suspected to have come from
culture-media components, testing did
not eliminate the risk of contamination-
an observation highlighting the difficulty
of detecting very low levels of contamination." In at least one instance, a non-animal
raw material was directly identified as the
source of the virus contamination.
"As a way to reduce the risk from different
media components, the consortium has
evaluated the effectiveness of different
technologies to remove or inactivate
viruses in media," Dr. Barone explained.
"UV-C irradiation, physical separation using
filtering devices, and heat treatment were
all, in general, found to be effective."
On the other hand, for human and primate
cell culture, the source of virus contaminants was attributed to human sources.

the biosafety triangle: prevention, detection and removal," explained
Darren Verlenden, Vice President of Bioprocessing at MilliporeSigma.
"Because we monitor the guidelines of regulatory bodies worldwide,
we can assist customers in the interpretation of directives established
by different countries."
Verlenden expanded on the comments of the other interviewees. "We
have been developing this pathway over the last few years," he noted.
"We recognize that newly emerging companies might not have the
level of resources of more established clients, so we have to tailor our
responses to match the client's individual situation. The approach is
really holistic in which we assist the customer to understand and
quantify risk. We help evaluate different risk mitigation approaches
dependent on customers risk perception."
To prevent virus entry into production processes, Verlenden stresses
that it is essential to carefully monitor extraneous input, as contaminants are invariably introduced through outside sources. "This means
we have to look very closely at suppliers, and be assured that they have
a long-standing pattern of mature quality control, and tight warehouse

A Tailored Approach
to Viral Safety

Dr. Barone said he is proud of the
bioindustry's long-term record.
"In 30-plus years of cell culture-based
biopharmaceutical manufacturing, no
recombinant DNA-derived product has
been shown to transmit a viral safety
problem," he pointed out. n

Listen Now

Darren Verlenden
Vice President
Bioprocessing,
MilliporeSigma

http://www.GENengnews.com

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