PharmaceuticalOutsourcingQ42020 - 14

CONTRACT MANUFACTURING

Integrated Data Solutions Drive
Improved Pharma Productivity,
Yield and Cost
Amos Dor
Managing Director, Applied Materials Pharma

Abstract

Evolving from Industry 4.0 to Pharma 4.0

Digitalization of the pharmaceutical industry has been underway
for some time, with many companies looking to benefit from the
Pharma 4.0 evolution using experience gained from the automotive
and electronics/semiconductor industries. Integrated data solutions
and digital tools combined with the use of inline sensors, process
automation, advanced analytics, and model predictive control
help to optimize production processes for higher quality and
yields. Well-timed maintenance schedules and optimal workflows
deliver greater productivity and efficiency and reduce operating
costs, helping companies come closer to realizing Pharma 4.0 with
improved Overall Equipment Effectiveness (OEE) to achieve true
Operational Excellence (OE).

In the semiconductor industry, leading producers have fully
automated manufacturing processes and implemented model
predictive control to achieve optimal process performance for
multiple decades. Processes are monitored and when any changes
are detected, adjustments are quickly made in the next run.

Industry 4.0 is far from a new concept, but until the last five years or
so, the pharmaceutical industry had been hesitant to embrace the
concept. Around 2017, interest began trending in an industry specific
concept, Pharma 4.0, to enable more efficient and competitive manufacturing practices. Pharmaceutical manufacturers, academicians,
software developers and regulators started collaborating to actively
demonstrate the value of advanced data analytics and controls drawing on experience from other sectors that were seeing great success
with the concept, such as semiconductors.1
Today, Pharma 4.0, is a widely recognized topic and trend in the
pharma sector, with many manufacturers either already leveraging
pillars of Industry 4.0 and Advanced Manufacturing with a pharmaspecific focus or investigating the best ways to implement the
concepts. There are now numerous examples available to demonstrate
how integrated data solutions, digital tools and Process Analytical
Technologies (PAT) can optimize production processes for higher
quality and yields to deliver greater productivity and efficiency with
reduced operating costs, and ultimately achieve improved Overall
Equipment Effectiveness (OEE).
Pharmaceutical Outsourcing |

14

In the pharmaceutical industry, not only has a well-known resistance
to change caused a lag in the uptake of automation, but there are
different process variables that make implementing Pharma 4.0 more
complex.2 Notably, process run times are much longer (for example
two weeks for cell culture), which means that process parameters
must be monitored and adjusted in real-time during the run. And
implementing model predictive control also can be challenging due
to the need to a) obtain FDA approval and b) create an internal use
case that will show the clear return on investment over time versus
the commitment involved to implement smart solutions.
At the onset of Pharma 4.0, only a small handful of pharma
manufacturers were willing to take a chance to adopt these
concepts. But now the reports of their experiences have made the
benefits clearer, helping to ease trepidation from the wider industry.
Significant increases in productivity (30-40% at the outset) and
decreases in Quality Control (QC) costs of 50% have been reported.3
Dramatic acceleration of lead times (65-70%) and a 65% elimination
of deviations have also been shown.
With case studies and data now available to back up the claims of
improved quality and yields, and reduced product losses coupled
with the growing acceptance of continuous processing and the
increasing prevalence of personalized/precision medicine, Pharma 4.0
is arguably in full swing. Today, most pharmaceutical manufacturers
have either implemented or are in the process of exploring how
advanced technologies and automation with model predictive
| October/November/December 2020



PharmaceuticalOutsourcingQ42020

Table of Contents for the Digital Edition of PharmaceuticalOutsourcingQ42020

Editor's Message
Editorial Advisory Board
CN Perspectives
Social Media Connections
Insider Insight - Price
Insider Insight - Ventura
Contract Manufacturing
Supply Chain
Contract Manufacturing
Interview with Yourway
Supply Chain
Clinical Trials
Roundtable
Supply Chain
Analytical Testing
Supply Chain
Clinical Trials
Analytical Testing
Horizon Lines
Industry News
Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover1
PharmaceuticalOutsourcingQ42020 - Cover2
PharmaceuticalOutsourcingQ42020 - 1
PharmaceuticalOutsourcingQ42020 - Editor's Message
PharmaceuticalOutsourcingQ42020 - 3
PharmaceuticalOutsourcingQ42020 - 4
PharmaceuticalOutsourcingQ42020 - 5
PharmaceuticalOutsourcingQ42020 - Editorial Advisory Board
PharmaceuticalOutsourcingQ42020 - 7
PharmaceuticalOutsourcingQ42020 - CN Perspectives
PharmaceuticalOutsourcingQ42020 - Social Media Connections
PharmaceuticalOutsourcingQ42020 - Insider Insight - Price
PharmaceuticalOutsourcingQ42020 - 11
PharmaceuticalOutsourcingQ42020 - Insider Insight - Ventura
PharmaceuticalOutsourcingQ42020 - 13
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 15
PharmaceuticalOutsourcingQ42020 - 16
PharmaceuticalOutsourcingQ42020 - 17
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 19
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 21
PharmaceuticalOutsourcingQ42020 - Interview with Yourway
PharmaceuticalOutsourcingQ42020 - 23
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 25
PharmaceuticalOutsourcingQ42020 - 26
PharmaceuticalOutsourcingQ42020 - 27
PharmaceuticalOutsourcingQ42020 - 28
PharmaceuticalOutsourcingQ42020 - 29
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 31
PharmaceuticalOutsourcingQ42020 - 32
PharmaceuticalOutsourcingQ42020 - Roundtable
PharmaceuticalOutsourcingQ42020 - 34
PharmaceuticalOutsourcingQ42020 - 35
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 37
PharmaceuticalOutsourcingQ42020 - 38
PharmaceuticalOutsourcingQ42020 - 39
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 41
PharmaceuticalOutsourcingQ42020 - 42
PharmaceuticalOutsourcingQ42020 - 43
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 45
PharmaceuticalOutsourcingQ42020 - 46
PharmaceuticalOutsourcingQ42020 - 47
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 49
PharmaceuticalOutsourcingQ42020 - 50
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 52
PharmaceuticalOutsourcingQ42020 - 53
PharmaceuticalOutsourcingQ42020 - Horizon Lines
PharmaceuticalOutsourcingQ42020 - 55
PharmaceuticalOutsourcingQ42020 - 56
PharmaceuticalOutsourcingQ42020 - 57
PharmaceuticalOutsourcingQ42020 - Industry News
PharmaceuticalOutsourcingQ42020 - 59
PharmaceuticalOutsourcingQ42020 - 60
PharmaceuticalOutsourcingQ42020 - 61
PharmaceuticalOutsourcingQ42020 - 62
PharmaceuticalOutsourcingQ42020 - 63
PharmaceuticalOutsourcingQ42020 - Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover3
PharmaceuticalOutsourcingQ42020 - Cover4
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