SHARE:
Modernizing Life Science Manufacturing: How
analytics, IoT and the cloud are rewriting drug production
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need a partner, such as AWS, that has tailored its
cloud offering to the pressures and requirements of
good manufacturing practice (GMP) environments.
THE VALUE OF AUTOMATED AND
CONTINUOUS COMPLIANCE IN THE CLOUD
Manu f a c tu re rs t hat r u n t he i r re g u l ate d G x P
workloads on the AWS Cloud are realizing a range
of unique benefits, including enhanced traceability
and trackability of what's occurring in their IT
environment, near real-time testing and enhanced
speed of setup.
The pharmaceutical company Merck is one of many
companies that run regulated workloads on the AWS
Cloud, benefiting from the automated and continuous
compliance this provides. Utilizing AWS CloudTrail,
Merck has the capability to log every change to its
system, enabling it to provide auditors with details
of all revisions. Similarly, AWS Config is used to
show auditors how its environment was configured
on any day in the past, improving on the point-in-
time approach to compliance that was common in
the industry
1
.
Similarly, Moderna Therapeutics runs day-to-day
drug manufacturing GxP workloads in the AWS
Cloud to maximize cost savings and agility. From
Moderna's inception in 2010, the company embraced
a cloud-first strategy
2
. Traditionally, a biotech would
establish an on-premises infrastructure when it needed
to run regulated workloads. Moderna believed running
GxP workloads using SAP on the AWS Cloud could
be done more quickly and at less cost than setting up
on-premise hardware. That belief has been validated
by Moderna's ability to construct a 200,000-square-
1 AWS re:Invent 2016: Continuous Compliance in the AWS Cloud
(LFS302). (2016).
2 Damiani, M. & Johnson, D. Moderna Therapeutics Case Study – Amazon
Web Services (AWS). Amazon Web Services, Inc. Available at: https://aws.
amazon.com/solutions/case-studies/moderna-therapeutics/. (Accessed:
7th August 2018)
foot GMP facility whose supply chain and processes
are driven by a GxP cloud IT environment. The AWS
Cloud-based system enables a fully integrated ecosystem
of applications.
"For us, it doesn't make sense to see any company
going into the old way of doing things, with the
agility, flexibility and the integration that you can
bring using AWS and SAP," Marcello Damiani, Chief
Digital Officer at Moderna, said. "It's been flexible
enough to allow us to build in a very fast fashion
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."
Companies including Merck and Moderna are using
the cloud to enable a new level of manufacturing
agility and compliance to enhance their operational
performance. By working with industry members
and regulatory consultancy Lachman Consultant
Services, AWS created a white paper to outline how
the AWS Cloud platform can be used in a manner
that is consistent with GxP compliance guidelines,
creating valuable information to guide companies
interested in adopting the cloud for regulated life
science workloads.
UNLOCKING THE VALUE OF EXISTING
MANUFACTURING DATA WITH
ANALYTICS AND MACHINE LEARNING
Seeing an opportunity to significantly lower costs
while increasing output reliability and quality, some
manufacturers are integrating data analytics into
existing production environments to gain insights
into process parameters that determine critical quality
metrics, enabling them to identify and resolve issues
faster. The capability to glean fresh insights from
existing data is made possible by the ability for
manufacturers to store and analyze vast amounts of
information in an efficient manner in the AWS Cloud.
3 [Whitepaper] AWS and SAP: How and Why Companies Run Regulated
Workloads in the Cloud. Available at: https://pages.questexweb.com/
AWSandSAP-December2017-Registration.html?source=meta. (Accessed:
29th June 2018)
