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2022 EMERSONGLOBALUSERS
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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.

NEW SMALL-BATCH
GENENTECH PLANT RELIESON EMERSON CONTROLS
By Jim MontagueIt’s never simple to build new pharmaceutical manufacturing and support plants, but as you might imagine,
it was even trickier during the COVID-19 pandemic.
Despite epic challenges, Genentech broke ground in February 2020 on its new Clinical Supply Center (CSC) at
its headquarters in South San Francisco—where it basically invented biopharmaceutical manufacturing just afew decades earlier.

do more small-volume production of more personalized
medicines in disposable containers. This allows quicker
turnover, which is especially helpful when our scientists
have a new molecule they want to try,” said Tiffany Button,quality chapter lead for computer systems validation atGenentech. “Of course, quick turnover was also essential
during the pandemic, when vaccines had to be developed
and delivered with unprecedented speed.”

The CSC uses several types of advanced manufacturing technologies, and employs a modular, agile design
to enable on-demand delivery of Genentech’s medicinal
pipeline to patients in clinical trials. It was also designed
for easy reconfiguration and future technology implementation. Naturally, all of these quicker and more variable
operations must be performed by personnel that are justas agile and adaptable at operating its lab, quality andcontrol systems.

Button and Nimit Amipara, validation engineer andengineering supervisor at Valspec, presented “Commissioning and qualification of Genentech’s International Society
for Pharmaceutical Engineering (ISPE) Facility of the YearAward (FOYA) 2023 Winner for Pharma 4.0” this weekat the Emerson Exchange Immerse in Anaheim, Calif.

Genentech and its partners integrated several Emerson
platforms at CSC to meet these requirements, including
DeltaV DCS, Syncade MES and Fluxa PKM, along witha range of software platforms from third-party vendors.
Genentech and Valspec, a provider of system validation and lifecycle services, implemented an innovative
commissioning and qualification strategy based on theirdetailed knowledge of Emerson’s solutions and industry
best practices.
“The world of biopharma is changing. Where we previously used large-capacity, stainless-steel reactors, we now

The automation objectives for the CSC’s single-use
technologies included having a highly integrated andfully paperless automation solution.” Valspec’s Nimit
Amipara, together with Genentech’s Tiffany Button,
discussed the ambitious new validation processes thattrimmed plant completion from five or more years to
only two and a half.

Live from Emerson Exchange Immerse 2023

Small but mighty automation

To produce a greater variety of smaller batches, such as
gene therapies and other medicines with widely variable
costs, Button reported that CSC must:• Enable rapid and seamless transfer of products fromresearch to its clinical and commercial departments,• Maintain colocation of CSC with Genentech’s R&D
partners for speedy interactions and problem solving,• Exploit the benefits of technical advances in single-use
technology and digital manufacturing,• Provide a design template for facility, equipment andautomation for rapid and cost-effective, copy-and-paste
deployment at Genentech’s future commercial, smallvolume facilities, and• Accommodate a range of known and unknown future
process platforms and therapeutic modalities.
“The automation objectives for the CSC’s single-use
technologies (SUT) included having a highly integrated
and fully paperless automation solution,” said Amipara.
“It would also need built-in flexibility for clinical, ad hocactivities and be enabled for commercial launches. We alsoneed to be able to introduce new technologies as simplified standards for functions, such as review by exception(RBE), process and knowledge management (PKM), datavisualization, analytics and collection (DVAC). All ofthese requirements meant we needed to create a standard
automation platform to minimize customization, as wellas support rapid deployment of future sites.”
Consequently, Amipara added that Valspec and Genentech envisioned implementing a four-layer automation
landscape with controllers and I/O points at Level 1;
HMIs, batch management and SCADA system at Level2; historian and manufacturing execution system (MES)at Level 3; and corporate applications at Level 4.

Innovative testing and commissioning

To achieve the speed and flexibility its new facility required,
Button added that Genentech also adopted an innovative
procedure for testing and validating new equipment. This
involved more testing of high-priority devices with lesscertain performance, and less testing for common devices
with well-known performance characteristics.
“We used the ASTM E2500 risk-based approach that’s
highly driven by subject matter experts, integrates quality

into the team early, and leverages as much vendor qualification as possible,” explained Button.
“We sought agreement and approval of acceptance criteria with our quality department during design phase.
We employed quality approvals at planning and releasestages only, and focused on the value-add in the compliance. We also conducted forward-looking verification
planning with the SMEs and sought quality department
feedback and approval.”
Button added that Genentech’s team minimized risk
assessments to complex systems only, and applied standards to simple and well-understood systems. “Standardsystems received streamlined testing without gating
requirements,” said Button. “We also performed endto-end, development run tests as a main operational
qualification activity. Most importantly, we used aminimal-viable-product approach that accepted theMES and DCS systems with a known list of punch
items that were determined to be low-risk to good
manufacturing practice (GMP) operations. Our project
mantra was to isolate high-risks and fix them immediately, and accept low-risk or items with acceptableworkarounds to be fixed later.
“Instead of doing the same old testing, we looked where
we could add the most value. Once we devised that list,
Valspec did the testing and streamlined the process. Quality also wasn’t held up because I was able to do it for 12systems. We did ‘pulse checks’ to make sure we were still
adhering to the guardrails we agreed to earlier, so we didn’t
need as much traditional oversight, and we still had all
the documents and reports we might need at the end.”

Future cookie cutting

Button reported that DeltaV DCS, Syncade MES andFluxa PKM all worked well together at the CSC as Genentech and Valspec implemented their new processes. They’ll
serve as a pilot plant and template for a fleet management
strategy for other upcoming facilities. In fact, Genentech
conducted the groundbreaking for a second iteration inOceanside, Calif (OSUT) this past February.
“From breaking ground to going live, the CSC took
two years and eight months, instead of the five to 10 years
that similar projects usually require,” concluded Button.

Live from Emerson Exchange Immerse 2023