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Modernizing Pharma Operations

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NOVEMBER 2022

Modernizing Pharma Operations


With Process Analytical Technology

PAT for Performance Leveraging PAT in


DeltaV™ Spectral PAT
Improvements Modern Operations

This custom ebook is sponsored by Emerson and presented in


partnership with Pharmaceutical Technology.
PAT for Performance DeltaV™ Leveraging PAT in
Improvements Spectral PAT Modern Operations

Integrated Process Analytical


Technology (PAT): A Path to
Improved Performance
By Molly Firkins, DeltaV Product Marketing Manager at Emerson

Embedding process
I
t’s the same for manufacturers across industries and
across the globe; there’s a steadily increasing pressure to
analytical technology meet market demand, despite facing new challenges and
(PAT) within a control constraints. Whether it’s overcoming supply chain issues,
adapting to worker shortages, or dealing with inefficient
system simplifies a
processes and aging equipment, in essence, it all comes
traditionally complex down to that ages-old axiom of “doing more with less.” And
architecture and that means, regardless of industry, producers need to be
getting more from their existing operations.
offers pharmaceutical
manufacturers the Today’s pharmaceutical manufacturers, in particular, are
means to increase faced with a number of challenges largely stemming from
a burgeoning global population. Specifically, they’re being
their speed to market. asked to not only produce more treatments but also a wider

NOVEMBER 2022 | PHARMACEUTICAL TECHNOLOGY 2 SPONSORED CONTENT


PAT for Performance DeltaV™ Leveraging PAT in
Improvements Spectral PAT Modern Operations

variety of treatments. These dual and equally Process analytical technology, in and of itself,
important demands are the result of an isn’t new to pharmaceutical manufacturing;
ever-expanding patient base – a contingent in fact, many operations have incorporated
characterized by an increasingly diverse set PAT to some extent in an effort to achieve
of needs and requiring more personalized more control over their processes through
medicine and customized dosing. What’s closed-loop process verification. The
more, pharmaceutical manufacturers are traditional approach to achieving this,
being asked to deliver these treatments to however, has proven complex – and, at
market faster than ever – all while ensuring times, discouraging – because it requires
the quality and safety of these products. time, resources, and targeted expertise.
What’s more, personnel are often left to
To characterize this landscape as “challenging,” manage fragile systems that need significant
would be an understatement. Fortunately, upkeep throughout their lifecycle.
advancements in digital technologies are
providing incredible opportunities for
pharmaceutical manufacturers to transform
WEBSITE
their processes in ways that create new
efficiencies and propel operational DeltaV Systems and
Software for Life Sciences
performance to heretofore unseen levels.
By leveraging these new technologies,
manufacturers can, in effect, digitalize the
drug development process and create a Part of the issue arises from dealing with
clear path to consistently hitting production the vast amounts of raw data generated
goals and driving long-term profitability. The by spectral analyzers. These instruments
key, however, is identifying which of these are essential to PAT, collecting important,
technologies and approaches will actually multivariate data about a batch – usually
move the needle. 3,000-4,000 spectral variables per scan.
As you might imagine, making sense of
To that end, one of the most promising new this much data isn’t easy. Data scientists
advancements for the industry is the integration must first use multivariate data analytics
of process analytical technology (PAT) into packages to develop and validate complex
control systems. The embedding of PAT within models that convert these spectral arrays
a control system represents a paradigm shift to critical process or product attributes.
in the approach to process analytics typically These models then must run on servers
adopted by pharmaceutical manufacturers. that typically reside at Level 3 of the
And at a time when speed to market is critical, Purdue control hierarchy to translate real-
this new approach to PAT provides a path to time spectral data into useful information
significantly faster product release. before passing it to the control system, at

NOVEMBER 2022 | PHARMACEUTICAL TECHNOLOGY 3 SPONSORED CONTENT


PAT for Performance DeltaV™ Leveraging PAT in
Improvements Spectral PAT Modern Operations

which point it can be used by operators to automation system for the process and
adjust a process. hybrid industries that offers a full suite
of advanced control applications aimed
If moving large amounts of multivariate at improving plant performance. To fully
data from the lab to the plant floor leverage PAT, DeltaV makes use of well-
sounds complex, that’s because it is. Just known industry-leading chemometric model
consider the multiple, disparate systems engines such as SIMCA®-Q from Sartorius
required to make it happen: Analyzer or AspenTech’s Aspen Unscrambler™, which
instrument systems must first capture and are embedded into a standard function block
make available multivariate data in real running on the system’s application station.
time to a PAT application that can apply
the data to a model and generate results Simply put, integrated PAT offers
that must then be shared with the control
a better way. Bringing spectral
system. This layered approach creates
a complex architecture for information
signals directly into the control
technology (IT) and operational system collapses that layered
technology (OT), from implementation architecture, enabling raw
throughout the system’s lifecycle. It also spectral data to be analyzed, and
inadvertently creates a system vulnerable control decisions executed — all
to compatibility issues that could crop up
in one simplified process.
and derail production if one component in
this delicate chain is altered.
These model engines are complex tools
Simply put, integrated PAT offers a better but suffice it to say they are critical for
way. Bringing spectral signals directly into translating data into actionable information.
the control system collapses that layered Aspen Unscrambler, for example, is a
architecture, enabling raw spectral data multivariate data analysis solution that has
to be analyzed, and control decisions continued to evolve to meet the needs
executed — all in one simplified process. of the industries it serves, building upon
The result: a more stable, closed-loop and a proven, decades-long history of helping
repeatable process that enables real-time manufacturers optimize their operations.
monitoring of quality and increases speed Through numerous collaborations with
to market. analyzer providers, convenient workflows
have been developed for model build,
It’s all made possible with the right control model validation and model maintenance
system – in this instance, Emerson’s DeltaV™ for a wide range of spectroscopic PAT
distributed control system. The DeltaV instruments. Furthermore, persistent
DCS is an easy-to-use, ISASecure-certified attention to changing regulatory compliance

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PAT for Performance DeltaV™ Leveraging PAT in
Improvements Spectral PAT Modern Operations

requirements of the industry has resulted in accurate, repeatable processes. In addition,


features that support compliant and secure change control mechanisms help confirm
multivariate analysis workflows. processes are using the right model versions,
and real-time diagnostics can confirm
By embedding models from Aspen analyzers are working properly.
Unscrambler or SIMCA-Q within the control
system, the system can directly receive In today’s manufacturing landscape speed
spectral data and perform chemometric to market is everything. Pharmaceutical
model calculations on that data in real time, manufacturers no longer have the luxury
generating critical quality attributes about a of allowing a product to sit in work-in-
product. And because DeltaV Spectral PAT progress. They must be flexible, fastidious
leverages the DeltaV configuration, database and fast, and the integration of spectral
and support infrastructure used by other waveform data directly into the control
control applications, complexity is reduced, system represents a significant opportunity
process validation is simplified, and overall to increase speed to market by automating
system security is enhanced. product release and optimizing throughput –
quickly, effectively and safely.
But simply having the information is
only half the battle; ensuring actionable
information gets to the right people is
Molly Firkins
paramount. That’s why DeltaV features
a modern, intuitive operator interface DeltaV Product Marketing Manager
designed to deliver continuous insights to Emerson
operators so they stay informed and can
take action. Online measurements and
quality calculations are easily accessible,
ABOUT EMERSON
and operators can be instantly alerted
Emerson (NYSE: EMR), headquartered in St. Louis,
to deviations, allowing them to make Missouri (USA), is a global technology and software
adjustments that save batches. This company providing innovative solutions for customers
in industrial, commercial and residential markets.
means products stay on spec and get to
A leader in industrial automation, Emerson helps
market faster. process, hybrid and discrete manufacturers optimize
operations, protect personnel, reduce emissions
and achieve their sustainability goals through its
Integrated PAT systems also can establish
Automation Solutions and AspenTech businesses.
a foundation for more effective regulatory Emerson’s Commercial & Residential Solutions
management, helping ensure product business helps ensure human comfort and health,
protect food quality and safety, advance energy
safety and simplifying the audit process.
efficiency and create sustainable infrastructure. For
For example, these systems have built- more information, visit Emerson.com.
in solutions to show and document safe,

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PAT for Performance DeltaV™ Leveraging PAT in
Improvements Spectral PAT Modern Operations

Implementing Real-Time, Closed-Loop


Process Control Using Spectral PAT
Q&A with Bruce Greenwald and Molly Firkins

Embedding DeltaV Spectral PAT directly into the control


system enables life sciences manufacturers to take a
simplified approach to achieving real-time manufacturing,
Bruce Greenwald compliance with confidence, greater return on investment
Business Development
Manager,
DeltaV Distributed
(ROI), and delivery of quality treatments to market faster.
Control Systems,
Emerson
PharmTech: What factors are influencing the current landscape for life
sciences manufacturers?
Greenwald: It’s more important than ever for our pharmaceutical
manufacturers to deliver their therapies quickly and cost effectively
around the globe. With the focus on rapid results, products can’t
Molly Firkins
Product Marketing
sit in inventory for days or weeks waiting on lab testing or quality
Manager, validation. Additionally, plants are putting a massive effort into digitally
DeltaV Batch,
Emerson transforming their manufacturing process.

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PAT for Performance DeltaV™ Leveraging PAT in
Improvements Spectral PAT Modern Operations

One of the goals that the FDA first released of recent technologies like inline spectral
with their PAT (process analytical technology) analyzers, that process has introduced a slew
guidance was for manufacturers to better of new challenges.
understand the science behind their process.
By better understanding the science of the PharmTech: With those inline analyzers
process, they’d be able to fast-track the that work to automate the PAT process,
approval of those new therapies. The carrot, you mentioned the introduction of new
if you will, has now become mainstream challenges for life sciences manufacturers.
today; people have to do this. The old way Can you expand on those?
simply isn’t going to cut it. Technologies have Greenwald: With all good intentions, these
caught up and manufacturers are doing this, inline analyzers have created multiple
but it doesn’t mean it’s always been easy. execution layers, user interfaces, disparate
systems, and potentially fragile architectures.
PharmTech: What challenges are life This is the slew of challenges I mentioned
sciences manufacturers facing as a result? that ultimately make implementing,
Greenwald: The challenges really come maintaining, and validating this PAT approach
down to the execution of obtaining the difficult. Still, the need to ensure treatments
real-time quality parameter data for are thoroughly tested, using complex multi-
manufacturers to be able to release product variable data, remains a requirement.
or know if they have a problem. Process
Analytical Technology, PAT, which relies
heavily on incorporating multivariate
VIDEO
spectral analysis data, is an important part
of that process because of the tremendous Improve Speed to
Market with Real-Time,
pressure life sciences manufacturers are Closed-Loop Control
under to deliver treatments to market
quickly and efficiently.

The traditional approach to PAT PharmTech: What solutions are being


implementation has become antiquated. A brought to market by Emerson to help life
fully manual approach to sample gathering sciences manufacturers overcome these
and testing involves a lot of time-consuming challenges?
steps and introduces the risk of human Firkins: At Emerson, we have the DeltaV
error. Quality tests are often performed after distributed control system, which allows
manufacturing is complete, delaying release enhanced decision integrity with greater
and making it nearly impossible to recover insight. It also provides embedded security
from deviations. The financial impact, the with real-time delivery and transfer of data
losses, can be significant. Even with the help to run your process.

NOVEMBER 2022 | PHARMACEUTICAL TECHNOLOGY 7 SPONSORED CONTENT


PAT for Performance DeltaV™ Leveraging PAT in
Improvements Spectral PAT Modern Operations

Recently, we’ve introduced DeltaV Spectral DeltaV Spectral PAT is easier and
process analytical functionality, our DeltaV more cost effective to implement
Spectral PAT. Now DeltaV Spectral PAT
and maintain, because the users
was designed to help manufacturers meet
the FDA guidance around PAT, where the
can leverage the standard DeltaV
ultimate goal was to better understand the configuration, the database, and
science behind the process. all the support infrastructure
that are used by the other
PharmTech: Can you talk a bit more about control applications.
the DeltaV Spectral PAT, how it works,
and how that translates into value for your
customers? Unlike the traditional solutions that Bruce
Firkins: Emerson’s Spectral DeltaV mentioned with multiple layers and servers
Spectral PAT collapses that complex fragile and communication dependencies, DeltaV
architecture of the traditional PAT approach. Spectral PAT increases reliability with a
It’s become possible because DeltaV Spectral robust architecture that’s designed for
PAT runs industry-leading chemometric uninterrupted communications and closed-
models directly in the control system blocks. loop control. DeltaV Spectral PAT is easier
We use the OPC UA standard interface and more cost effective to implement and
to communicate with spectral analyzers. maintain, because the users can leverage the
Then a PAT model function block reads standard DeltaV configuration, the database,
spectral array signals and performs the and all the support infrastructure that are
quality attribute calculations for real-time used by the other control applications.
monitoring. Now, because we’re deploying Process validation is also simplified because
PAT directly in the control system, DeltaV applications are all part of the integrated
Spectral PAT provides online measurements DeltaV platform.
and quality calculations that provide
continuous data for tighter control and less PharmTech: How does taking this new
manufacturing variability all while minimizing approach of implementing embedded
human error. DeltaV Spectral PAT help life sciences
manufacturers not only drive towards fully
automating their manufacturing process,
but optimizing their process as well?
PODCAST Firkins: There are a couple of takeaways
Achieve Real-time, here. When manufacturers work in a single
Closed-Loop Control in integrated, intuitive environment, that’s
PAT Manufacturing
easy to implement and maintain. They can
monitor multivariate data from the same

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PAT for Performance DeltaV™ Leveraging PAT in
Improvements Spectral PAT Modern Operations

interface that they use to perform all their where they need to in order to optimize
other control steps. their manufacturing process and keep their
CQA in line. From that, we can also use
The system is also higher performing and model predictive control to go beyond the
it’s more secure and easier to validate. quality monitoring. We are now going to
Now the entire PAT solution is another closed-loop control.
component of the automation platform.
Secondly, it’s one thing to understand PharmTech: What’s the bottom line?
your process and to know if it’s good or Firkins: Ultimately, by using DeltaV Spectral
if it’s bad, but with embedded DeltaV PAT, our customers can help deliver quality
Spectral PAT, manufacturers have real- critical treatments to market faster by
time access to data for the CQAs (critical moving plants toward fully automated
quality attributes). production. Spectral PAT offers a simplified
approach to their operations, where
Not only is it easier to report them, it’s they can realize real-time manufacturing,
easier to take that quality, real-time data set a foundation for greater regulatory
and put it into action to make adjustments. compliance, and realize a faster return on
It can make those adjustments when and investment to their stakeholders.

NOVEMBER 2022 | PHARMACEUTICAL TECHNOLOGY 9 SPONSORED CONTENT


PAT for Performance DeltaV™ Leveraging PAT in
Improvements Spectral PAT Modern Operations

Effectively Leveraging Process


Analytical Technologies in Modern
Pharma Operations
AspenTech and Emerson are leading the way in
helping manufacturers fully integrate PAT into modern
automation systems.
Charles E. Miller The integration of process analytical technologies (PAT) into modern
Director of Solution
Consulting, automation systems represents a paradigm shift for pharmaceutical
Aspen Technology
manufacturers looking to establish a better-performing PAT architecture
that benefits their operations. We caught up with Charles E. Miller,
director of solution consulting at Aspen Technology, to help us better
understand the role of PAT in the industry.

Q1. Pharmaceutical manufacturers understand the value of


optimizing their operations, and many are wanting to go about this by
incorporating more inline monitoring capabilities with their systems.

NOVEMBER 2022 | PHARMACEUTICAL TECHNOLOGY 10 SPONSORED CONTENT


PAT for Performance DeltaV™ Leveraging PAT in
Improvements Spectral PAT Modern Operations

What do they need to consider as they look best meet their needs. They may consider
to get started? questions such as: Is this technology easy to
Well, process analytical technologies (PAT) integrate with my existing process? Is it easy
that enable inline monitoring have come to deploy and maintain? And does it give
a long way in the past few decades, but us the data we need in the way we need it?
they are not 100% cost- or risk-free, and Constraints also need to be considered when
therefore a compelling business case must scoping technologies, such as limitations of
be built. In the pharma industry, establishing on-site expertise and resources.
such a case involves a formal risk assessment
(RA) of the relevant process operation, where Q2. Traditionally, how would manufacturers
a diverse group of process stakeholders, have developed a workable solution and
including end users, management, engineers, leveraged their data?
and other subject matter experts carefully The integration and processing of analyzer
consider as many possible process failure data has a long and interesting history,
modes as possible, based on existing reflecting the unique challenges of handling
understanding of the process. The typical multivariate responses while accommodating
output of an RA is a Failure Mode and Effects instrument systems that are often complex.
Analysis (FMEA), which lists and ranks these
failure modes based on their frequency, In the early days of process analyzers, when
severity, and detectability. state-of-the art PCs used 80386 processor
technology, the processing of multivariate
In many cases, the RA identifies risks that analyzer data was strictly in the realm of the
can be mitigated using inline monitoring instrument system, with calculated process or
technologies: for example, risk of a product product attributes shared either manually, via
quality (CQA) failure or risk of a process analog (4-20 mA) signal, or via an early digital
performance (CPP) deviation. In the pharma protocol (ex., Modbus) directly to a distributed
industry, both product quality risks and control system. For the manual case, you
business risks are taken very seriously, can likely imagine all the inefficiencies and
and the nice thing about PAT is that it can risks, and even the earliest analog and digital
address both types of risks. If it’s determined approaches had their challenges. This just
that advanced analyzers are needed to wasn’t (and never could be) a scalable or
mitigate these risks, these manufacturers will sustainable approach, especially as the global
then need to scope and qualify the available demand for PAT continued to increase.
measurement technologies and supporting Moving ahead several years, analyzer
automation technologies, and work with vendors recognized the necessity of
those vendors to create a strategic plan of multivariate analysis (MVA) model build
action as they determine the technology and deployment workflows around
and automation partner whose solutions will their instruments, and they improved

NOVEMBER 2022 | PHARMACEUTICAL TECHNOLOGY 11 SPONSORED CONTENT


PAT for Performance DeltaV™ Leveraging PAT in
Improvements Spectral PAT Modern Operations

their bespoke analyzer management industry in recent years, but their extensive
software to include these functionalities. use has revealed some cases where this
Although these improved solutions did architecture is not optimal: for example,
allow end users to develop and deploy where network latency issues can affect
MVA models on these analyzers, they timely delivery of results to the DCS, or
were each typically limited to a single where site security policies limit IT/OT
instrument make and model, and in many communications. Furthermore, integration
cases had very limited model build, model and validation of these systems can be quite
optimization and management capabilities. challenging, as their communications span
As a result, these were not particularly several levels of the architecture.
scalable or sustainable solutions,
especially for end users who wanted Q3. How does AspenTech help its clients
the flexibility to use multiple analyzer with all the above?
technologies and suppliers. AspenTech brings several key elements to
address the above challenges: a legacy of
One key advantage of successfully embedding “industrial artificial
intelligence” into our clients’ operations; a
our extensive third-party
strong pedigree of MVA expertise; highly
collaborations is the presence evolved data handling and MVA modeling
of solutions that use our tools; constant attention to the ever-evolving
“low-footprint” MVA prediction cGMP regulatory expectations for PAT in
engine that executes MVA pharma; and a long history of collaboration
with third-party providers of process
models at the point of
analyzers and automation solutions. One
measurement. key advantage of our extensive third-party
collaborations is the presence of solutions
In more recent years, several suppliers that use our “low-footprint” MVA prediction
stepped up to provide more wholistic engine that executes MVA models at the
PAT management systems (PMSs) that point of measurement- whether on the
can accommodate different makes and edge, in the field, or at the shop floor level.
models of instruments, thus providing a Such solutions avoid the pitfalls associated
centralized location for all PAT functions. with model execution at higher architecture
Most deployment architectures of these levels, discussed earlier.
PMS solutions placed their key components
at the DMZ level or higher, as most of the Q4. How does Aspen Unscrambler work
management workflows resemble more with Emerson’s DeltaV DCS?
off-line “IT” type tasks. These solutions Analyzers, by themselves, produce spectral
have gained a lot of traction in the pharma intensities, which are not necessarily useful

NOVEMBER 2022 | PHARMACEUTICAL TECHNOLOGY 12 SPONSORED CONTENT


PAT for Performance DeltaV™ Leveraging PAT in
Improvements Spectral PAT Modern Operations

for process monitoring or control. AspenTech regardless of the analyzer technology that
Unscrambler is the offline tool that is used is chosen.
to create the model that converts spectral
intensities to process KPIs, which in turn It’s also very possible that this specific
gets embedded into DeltaV for real-time solution reduces the total cost of ownership
execution. DeltaV has the function block that of advanced PAT systems, in that the
can execute these models at a lower level simpler architecture is more robust, easier
in the architecture, which improves system to validate, and easier to maintain. Simply
performance and reliability, and simplifies put, implementation of the system is
system validation. easy. Maintaining the system is easy. And
operations are one step closer to fully
Just as DeltaV has well-integrated GxP automating their manufacturing.
compliance features, Unscrambler also
has GxP compliance-readiness features
supporting MVA model build, change
management and validation, as well as Charles E. (Chuck) Miller is director of solution
audit trail and security. Furthermore, as an consulting at Aspen Technology. He has more
than 30 years of experience in applying process
instrument-agnostic solution, Unscrambler
analytics and multivariate analysis to research
can be used for model build workflows and manufacturing problems in several industries,
involving a wide range of analyzer makes including chemicals, foods, materials, medical
and models, allowing end users to select the diagnostics and pharmaceuticals.
analyzer technology that is best suited for
their specific needs.

Q5. So what does this all mean for pharma ABOUT ASPEN TECHNOLOGY
manufacturers in terms of impact to their Aspen Technology, Inc. (NASDAQ: AZPN) is a
global software leader helping industries at the
operations? forefront of the world’s dual challenge meet the
On the deployment side, it provides access increasing demand for resources from a rapidly
to a simpler, more resilient, more reliable, growing population in a profitable and sustainable
manner. AspenTech solutions address complex
more secure, and better-performing PAT environments where it is critical to optimize
architecture that enables faster, smarter the asset design, operation and maintenance
decisions about your production. On lifecycle. Through our unique combination of deep
domain expertise and innovation, customers in
the development side, you have the capital-intensive industries can run their assets
benefit of a well-tested, optimized, and safer, greener, longer and faster to improve their
compliant solution for PAT model build and operational excellence.

management workflows, which works well

NOVEMBER 2022 | PHARMACEUTICAL TECHNOLOGY 13 SPONSORED CONTENT

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