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2022 EMERSONGLOBALUSERS
EXCHANGE
October 3-5 • Anaheim, California,
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October
24-28 • Gaylord, Texas, USA

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Live from Emerson Global Users Exchange 2022

For more information, visit Emerson’s Boundless Automation web pageTOC
and the Emerson Industrial Software Showcase on LinkedIn.

FUJIFILM FAST-TRACKS AMERICA’SLARGEST CELL CULTURE CDMO
By Len VermillionMore than 2 billion people worldwide do not haveaccess to medicine, and it’s only getting worse.
The COVID-19 pandemic showed that ramping
up the production of medicines at breakneck speed canbe of vital importance. The next time a pandemic hits,
the life sciences industry must be equipped and ready.
The good news is that they will be, thanks to efforts
such as the one being put forth by FujiFilm Diosynth
Biotechnologies, a global contract development and manufacturing organization (CDMO) and provider of cell andgene therapy and viral vaccine products. FujiFilm doesn’t
make its own products, it quickly gets them to market forothers. It offers solutions for cell line development, processdevelopment, late phase activities, clinical and commercial
manufacturing of a wide variety of biopharmaceuticals.
CDMOs can be a vital cog in a well-orchestrated effort toquickly manufacture vaccines, such as happened during
the pandemic.

“We change products, so we need to have flexibility in
our facilities,” he said.

Replicate to gain efficiency

FujiFilm has been through this process before. The Holly
Springs site is a nearly identical clone to its Hillerød facility. “We take a different approach. We want to reduce thetime to completion,” Grønnegaard said.
That’s why FujiFilm uses a cloning-across-sites systemthat is built on utilizing Drug Substance Manufacturing (DSM) modules. The modules are designed withidentical automation concepts intended to allow for fast

FujiFilm is looking ahead and building the largest
cell culture CDMO in North America, located in Holly
Springs, N.C. The 1 million-square-foot facility will beready for production in 2025. The company has additional
U.S. locations in Cambridge, Mass., College Station, Texas,and Thousand Oaks, Calif., in addition to Hillerød, Denmark, and Teesside, U.K.
Jacob Grønnegaard, director of automation for FujiFilm Diosynth Biotechnologies, was on hand at Emerson
Exchange Immerse 2023 in Anaheim, Calif., and told acaptivated audience that the company has speed and flexibility in mind as it builds its latest facility.

The ultimate goal is to deliver the completed project inless than 24 months lead time, 50% of the working hours
and 85% of the installed costs of the previous facility.”
Jacob Grønnegaard of FujiFilm Diosynth Biotechnologies
discussed how the company’s unique cloning processes
dramatically reduce project execution time, effort andexpense at this week’s Emerson Exchange Immerse.

Live from Emerson Exchange Immerse 2023

scalability for production and agility and redundancy forsupply chain management.
Grønnegaard said the company increases cloning percentage as a project progresses. “As we move from DSM
expansion to completion, we increase the percentage withthe ultimate goal of delivering the completed project inless than 24 months lead time, 50% of the working hours
and 85% of the installed costs of the previous facility.”

DSM modules

What is a DSM module? The modules are the core of thefacility, and it’s where the production takes place. Eachmodule consists of two upstream trains, four productionbioreactors, a harvest suite and a purification suite.
Such a highly sensitive environment needs a high-levelsystem architecture. Each DSM module has its own Emerson DeltaV automation system and two DSM modules
will share an Emerson Syncade manufacturing execution system (MES).
The DSM modules in Holly Springs will be the same asin the Denmark facility. Both facilities have the same layout
and process equipment. They have the same process andinstrumentation diagrams (P&IDs) and 3D engineeringmodels. Most notable is that they will have the same DeltaVand Syncade application code. The only localization,according to Grønnegaard, will be for required buildingcode differences between the U.S. and Denmark, suchas electrical standards. Both facilities will be governed by
the same standard operating procedures.

Application code process

Grønnegaard outlined FujiFilm’s DeltaV application codedevelopment process utilizing its unique cloning procedure during the session. Before the process even begins,
the application code is developed for the initial DSM andgoes through full qualification testing.
From there, FujiFilm exports the DeltaV code and design
documents. It uses a qualified tool to convert tag numbers
complete with code and graphics from the initial DSM
to the new DSM. It uses a qualified tool to update design
documents with the new DSM tag numbers.
FujiFilm then implements any changes that exist
between the new DSM and initial DSM. From there, itqualifies each change individually. Finally, the DeltaV codeis qualified ready for use during equipment commissioning.
The result is intended to be one of the top medicine
production facilities in the country. Hopefully, it won’t
have to ramp up production for a virus vaccine to combat
a worldwide pandemic, but if the time ever comes again,
it will be scalable and ready.

Live from Emerson Exchange Immerse 2023