Digital Manufacturing

at Amgen
Presented By:
Nicolas Costa, Juan Martinez, Nestor Rodriguez, Kamilla
Sedov, & Emilie Claire Schneider

BUS282B - Spring 2022, San Jose State University MBT

Industry Overview

● Revenue projected to increase due to fast growth of biopharma segment

● Most biopharma companies develop biologics:
○ More complex and fragile manufacturing
○ Significant time and financial investments; often fail
○ Outsource to CMOs or manufacture themselves
○ Stringent review process
○ IP rights and market exclusivity terms (12 years)

Amgen Background

● A biotechnology innovator since 1980, Amgen has grown to be one of the world's leading
independent biotechnology companies
● Worldwide presence - over 100 countries and regions
● Focus on 6 therapeutic areas - cardiovascular disease, oncology, bone health,
neuroscience, nephrology and inflammation
● Specialize in research and biomanufacturing
● Around 18 pharmaceutical products on the market

Digital Transformation

● Application of digital technologies to improve and scale operations

● ML: opportunities for deeper analysis and new insights but has flaws (FP, FN)
○ Use complex models
○ Learn from data without human’s instructions
○ When can’t isolate specific inputs → “black box” → hard to approve with FDA
● Few companies are “digitally mature”
○ Regulatory constraints, IP issues, conservative culture

Digital Transformation at Amgen

● RT-MSPM origin: monitor one variable → many variables at a time

○ Easy to use without statistical knowledge
○ Principal component analysis: see the big picture with fewer variables
○ Feed the model with RT data and use control limits
○ People resolve the issues

● Issues with RT-MSPM

○ Varied adoption: from enthusiasm to disregard
○ Alarm fatigue → ignore real problem
○ Enthusiastic employees may be too optimistic
○ Hard to measure effectiveness and estimate ROI
○ Fear of automation

Organizing for Digital Transformation

● In 2015 Amgen created the Digital Integration and Predictive

Technologies (DIPT) team
● This formalized the work that Ündey had been doing and gave
the group permission to expand beyond RT-MSPM
● To mitigate risk, experts from process development,engineering,
quality control conducted a study called the failure modes and
effects analysis (FMEA), which documented all the potential
associated risks.
● By January 2020, the DIPT team had implemented hundreds of
projects across Amgen. The team was comprised at that time
with about 30 full-time staff, plus a handful of graduate students
and interns.

Testing Automation

● In 2019, the DIPT team had begun to test more predictive

models. They had started by developing probabilistic
models for predictive bioreactor maintenance.

● The model generated recommended actions to take, but

also permitted the decision-maker to override them and
follow a different procedure if they so choose. This was
done because a fully automated process was considered
too risky the focus was on preventing failure rather
than automating.

● In 2020, the company had just started testing the

predictive model. This model saves them 12 hours per
batch, however it took three to four months building
it and then another five to six months working with the
manufacturing and quality assurance/control to integrate
it.

Two Opportunities

Partner with a team in Rhode

Partner with a team in Puerto Island to develop predictive ML
Rico to develop RT-MSPM for model to automate one step of
mAbX the manufacturing process for
a top selling product

Where should the DIPT team devote its limited time?

WOT Analysis of Digital Mfg.
Strengths:
Puerto Rico: Weaknesses:
Highly Educated Staff Hard to calculate ROI
Strong Upper Management Backing Puerto Rico:
Previous Relations with Team Limited Production Data of the Complicated
Rhode Island: Manufacturing Process
Experience with Enbrel Rhode Island:
Next-Generation, 120,000 sq ft. plant Will automation in the manufacturing
RT-MSPM started with Ündey at RI process cause fear of replacement of
human jobs in the workplace?

Opportunities: Threats:
Puerto Rico: Cost of Time, Money, Personnel to Develop
Spread Adoption of the RT-MSPM models Puerto Rico:
$4 billion on R&D → Bringing Products to Will the model stick with the mAbX team?
market more efficiently Rhode Island:
Rhode Island Is jeopardizing $5 billion annually in sales
Sustain Market Share with top products for Enbrel worth it?
Begin to integrate ML into Amgen’s
manufacturing process
Conclusions

● In conclusion, after assessing the benefits and limitations of each

opportunity, we felt that it would in the best interest of the Amgen to partner
with the Rhode Island team to develop the automation of one step in the
manufacturing process of their top selling product.