Figurate

TM

automation
solutions
Control your process, control your future
Biomanufacturers face many challenges, with speed to market, risk Consider that:
mitigation, and cost control being at the top of the list. Fortunately,
• More than 80% of company time is spent collecting and
recent advancements in digital automation can help address
cleansing data sets (2) By the numbers
and overcome these challenges. As manufacturers strive to build
digital maturity with enterprise automation, Cytiva’s Figurate™
automation software offers a robust platform to streamline
• 10% to 20% of the time, biopharma data cannot be
accessed (3) 100 sites with Cytiva FlexFactory™ configurable
manufacturing operations and capture valuable data to improve manufacturing trains
• Over 300 error-prone manual interventions occur in an
process control. average 200 L monoclonal antibody (mAb) single-use process
Biomanufacturing inefficiencies still • Success of initial production runs can be as low as 47% (4) 150 Emerson DeltaV™ unit operations
implemented across Cytiva FlexFactory™ sites
exist today • High batch failure rates and manufacturing deviations often
result from human error (5)
Recent industry reports confirm the US biopharma industry’s
slower adoption rates of enterprise-wide automation (1). Luckily, multi-industry adoption of automation and digitalization 100,000 Cytiva UNICORN™ software users
Historically, high implementation costs and slow speed-to-market provides proven success factors in efficiency, operational
caused such slower adoption rates in addition to extremely high
risks associated with quality problems.
maintenance, smarter workflows, and more to help biopharma
embrace the benefits it provides. 30 years that Cytiva UNICORN™ system
control software has been helping users solve for
their research, process development (PD), and
manufacturing needs

Improved quality Optimized Increased safety, Speed and

and yields staffing reduced risk flexibility
Increased throughout Employee efficiency Reduced manual intervention Transfer processes
Consistent control Easier maintenance and training Synchronization of units Scale up and scale out
Optimized uptime Easier investigations and batch releases Minimized cybersecurity risks Verify data
Automation and Figurate™ automation
digital plant meets numerous
maturity results strategic needs
Islands of automation and centralized control both
Implementing a centralized control platform is a key building block for increasing enjoy advantages
digital plant maturity and realizing the associated advantages and benefits. Enabling
electronic data capture, storage, access, and analysis can result in:
Islands of automation run the individual control of all
• Up to 75% reduction in paper handling and storage (6) equipment
• Up to 85% reduction in batch review time (6) • Lowest up-front cost › saves capital expenses
• Up to 20% increase in employee efficiency (1) • Shortest lead time › fastest time to milestone/market
• Up to 79% reduction in batch failures (5) • Lowest implementation complexity › lowest
• Up to 38% reduction in labor (1) project risk
• Up to 67% reduction in deviations (1)
Once operational, a distributed control system (DCS) is the foundation for improved
process control and further increased digital maturity. With a modern DCS, Distributed control system is the centralized control of all
manufacturers can work toward release by exception, which will save time and reduce equipment
costs as personnel will no longer have to gather and review disparate manufacturing • Lowest cost of goods sold › improves profit margins
data and manually approve the release of a batch—a process that can take weeks or
months. • Same look and feel for all equipment › saves time,
reduces risk
• Modern advanced technology › accelerates path to
digital maturity
Figurate™ automation family of products
Standard and custom solutions available

UNICORNTM Rockwell™/ Emerson DeltaVTM Rockwell™/ Siemens SIMATIC™

7.5 software Wonderware® PlantPAx® PCS 7

Proprietary control PLC/HMI DCS DCS DCS

single unit ops single unit ops single unit ops single unit ops single unit ops
UNICORN™ online FlexFactory™ FlexFactory™ FlexFactory™ FlexFactory™
software biomanufacturing train biomanufacturing train biomanufacturing train biomanufacturing train

1992 2016 2018 2021 Future

Biomanufacturing companies are complex organizations. They have controlled unit operations generally requires additional labor, Selecting Figurate™ automation DCS solutions utilizing either the
many different goals and objectives, all of which must be supported especially to support data collection, analysis, quality investigations, Emerson DeltaV™ or Rockwell Automation PlantPAx® platform
by their automation strategy. Figurate™ automation solutions and lot release. For these reasons, many biopharma manufacturers provides several advantages as compared to working with a
address the needs of all companies, from emerging biotechs to are turning to more advanced automation and control solutions. traditional systems integrator.
established drugmakers, contract development manufacturing Centralized or distributed control is defined as an approach Cytiva automation experts can discuss your specific current and
organizations (CDMOs), and companies developing breakthrough to control multiple pieces of manufacturing equipment using future needs and determine the most appropriate approach for your
therapeutics. controllers and human-machine interfaces (HMIs) distributed unique situation.
“Islands of Automation” is a phrase used to describe an approach to throughout a manufacturing facility that are networked together to
automation in which individual unit operations are controlled locally permit remote and/or centralized supervision and administration.
in the manufacturing suite by gowned operators. Data is collected Data is collected in a central database and accessed via a
and accessed locally. Many biomanufacturers successfully deploy network login.
this approach as the equipment can be delivered, qualified, and
rapidly made operational. However, the manual nature of individually
Advancing your digital plant maturity
1 Pre-digital plant 3 Connected plant Project risk Figurate™ automation benefits
• Paper based • Vertical integration
Time to design Pre-defined standardized functionality
• Manual operations • Electronic batch records

Time to test Quality assured through pre-verification

2 Digital silo 4 Predictive plant
• Islands of automation • Enterprise integration Risks to scale-up or scale-out Scalable from discrete unit operations
• Some manual processes • Integrated PD and manufacturing
Design iterations for process change Options readily available to deploy
2.5 Integrated 5 Adaptive plant
operation • Full end-to-end and value-chain
Unknown cost Costs known upfront

• Distributed automation integration

Time to implement Enhanced speed to market
• Centralized historian • Plug-n-play everything

Limited expertise Expertise in bioprocess, automation, and integration

1 2 2.5 3 4 5
Increasing digital plant maturity, throughput, and
lower cost of goods sold Figurate TM

automation solutions
In 2016, the BioPhorum Operations Group (BPOG) developed a multi-level Digital
Plant Maturity Model (DPMM) to provide the industry with a common framework
for describing digital enablement. Cytiva embraced this model, adding a level 2.5 to
represent the short-term goal of many manufactures deploying a DCS with central
historian as an interim step to becoming a connected plant. Cytiva Figurate™
automation DCS solutions powered by either a Emerson DeltaV™ or Rockwell Control your process, control your future
Automation PlantPAx® platform help companies achieve level 2.5.
Increased digital plant maturity provides many advantages that could drive down
manufacturing costs by as much as 25% while increasing productivity by as much as Advantages Benefits
50% (1) as a result of:
• Reduced scrap
Standardized Saves time
• Reduced labor
• Reduced deviations
• Reduced batch review time
• Increased facility utilization

Additional advantages include: Process ready

• Improved regulatory compliance and audit results Saves money
• Greatly simplified and less costly manufacturing transfers
• Faster and less costly regulatory filings
• Amortized automation costs in future clinical and commercial campaigns

Scalable
Reduces risk
Accelerate speed
to market, reduce
costs and error
The FlexFactory™ configurable manufacturing train provides
access to Current Good Manufacturing Practice (cGMP)
biomanufacturing capacity in the shortest time possible by
utilizing bioprocess equipment with pre-configured and
pre-verified automation software. This approach mitigates risk
by employing proven automation software that necessarily limits
human interaction. Advantages of this approach include:
• Rapid scale-up, scale-out, or transfer production capacity
• Reduced implementation, documentation, test, and
validation effort and time
• Consistent user interfaces help reduce human error and
training time
• Flexible implementation of manufacturing execution system
(MES) and other level 3 applications due to standardized
data interface
References
1. Bremme, Darino, Parry, Teo, “Automation and the future of work in the US biopharma industry,” McKinsey & Co, 2020. Accessed August
16, 2022.

2. Hargreaves B, “AI able to ‘predict impact of minor changes’ to manufacturing.” Outsourcing-Pharma.com. Published January 9, 2019.
Accessed August 16, 2022.

3. IDBS (a Danaher company). Digital Transformation: Are You Agile Enough to Meet the R&D Challenges IDBS.com. Published September
2020. Accessed August 16, 2022.

4. Zebib J. Review by Exception: Connecting the Dots for Faster Batch Release. BioPharm International.com. Published November 12, 2019.
Accessed August 16, 2022.

5. Haigh J, Schmidt SR, Vicalvi J, Winterhalter C. 17th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and
Production, April 2020, BioPlan
Associates, Inc. 2020. Accessed August 16, 2022.

6. ,7. Ryan, Eddie, “Electronic Batch Record System (EBRS) Roll Out at Takeda Ireland Limited the road from concept to realised benefits,”
2011, Systematic I.S. Strategies Ltd.

8. BioSolve Software - Biopharm (biopharmservices.com)

cytiva.com
Cytiva and the Drop logo are trademarks of Life Sciences IP Holdings Corporation or an
affiliate doing business as Cytiva.
Figurate, FlexFactory, and UNICORN are trademarks of Global Life Sciences Solutions
USA LLC or an affiliate doing business as Cytiva.
BioSolve is a trademark of Biopharm Services Ltd. DeltaV is a trademark of the
Emerson Process Management group of companies. PlantPAx and Rockwell are
trademarks of Rockwell Automation, Inc. SIMATIC is a trademark of Siemens
Aktiengesellschaft. Wonderware is a trademark of AVEVA Software. Any other third-
party trademarks are the property of their respective owners.

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