Quartic.

ai
Smart Industry. Delivered.

Bringing
Artificial Intelligence
to the Pharmaceutical
Industry
(c) Copyright Quartic.ai 2018-2020 All rights reserved
Who we are
Quartic.ai was founded by a veteran team of process manufacturing and reliability
experts, in conjunction with data scientists to make AI deployment easy and sustainable.

Team of 42 people (and

growing!) ready to help you
through every step of your
digital transformation journey

Recent News
•Featured, Most Innovative Company, Interphex Annual Exhibition N.Y., Innophex Event, April 2019
•Most Innovative Company July 15, 2019 by Pharmaceutical Manufacturing Magazine Oakville, ON, CANADA
•Featured by Genetic Engineering News, Aug 2, 2019
•Featured in Biopharm International, Aug 7, 2019 Plainfield, IN, USA
•FDA Invited Quartic.ai to speak at Annual PDA-FDA Conf Sept 2019 San Jose, CA, USA

(c) Copyright Quartic.ai 2018-2020 All rights reserved

 Manufacturing Focus Smart Manufacturing Enterprise

Process manufacturing creates value by converting raw

materials and energy into finished goods with complex
chemical and bio-chemical processes

18 Trillion Industry

Pharmaceuticals
Food & Beverage
Mineral Processing
Chemicals
Pulp & Paper
Petrochemicals Our full stack AI and Industrial IoT platform connects to
Oil & Gas manufacturing data, creates context and lets industrial users
build AI applications for real-time and predictive monitoring
to increase operational efficiency output.
Building the OT1 of the future!
1 OT: Operational Technology – Automation systems that run manufacturing
High Demand for Smart Manufacturing Technology

12% average gain in efficiency over 5 years expected from

Smart Manufacturing
pwc Di gital Factories Ma rch 2020

A 10% efficiency increase in process manufacturing increases

pwc Di gital Factories Ma rch 2020

margin up to 83% Dow Chemicals i nternal study

Digital manufacturing is a high priority for 70% McKi ns ey&Company 2018

Supply chain agility needs cannot be met with current state of automation

© Copyright Quartic.ai 2017-2020 All rights reserved

Slow Adoption: Technology has failed to deliver

91% of AI projects failed to meet expectations 1

80 – 85% of manufacturing companies are “Proof of Concept Factories” 2

Key barriers and friction points:

• Current technology does not address the right user personas
• Technology limits rapid experimentation
• Legacy automation and existing workflows are not embraced
• No IT-OT stack to embrace edge and cloud in common workflow
[1] 2019 Deloitte Survey on AI adoption in manufacturing [2] 2020 Accenture survey

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❖ Full-stack Edge-to-cloud platform
❖ Manufacturing focus
❖ Zero-code deployment
❖ Real-time streaming analytics
❖ Cloud (Azure, AWS), hybrid or on-premise
❖ GxP compliant
❖ CFR21 Part 11 compliance
❖ Hardware agnostic
❖ ISA99, IEC62443 security
❖ Built on IIRA and RAMI4.

(c) Copyright Quartic.ai 2018-2020 All rights reserved

Breaking Down the Barriers to AI Adoption with the Quartic Platform™

Lack of Lack of
Clear
Necessary Business
Talent IT-OT Case
gaps Lack of
Concerns Courage Data
About Data Integration
Concerns Ownership
about Challenge
Cyber
Security

Source: McKinsey Industry 4.0 Global Expert Survey 2016

© Copyright Quartic.ai 2017-2020 All rights reserved

The future of Industrial AI success

The existing gaps between IT and OT

technology, personas and workflows are the
biggest challenge and the biggest opportunity
for smart manufacturing success

Digital SME
OT and Manufacturing operations Digital Manufacturing operations
IT and Data Science

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A Smart Manufacturing Enterprise with the Quartic Platform

Easy to customize workflows

CEP

Closing the gap between the art-of-the-possible and value realization!

© Copyright Quartic.ai 2017-2020 All rights reserved

 • Accelerate pipeline of drugs – speed to market post clinical trials

Addressing key • Reduce WIP inventory – a drag on the balance sheet

Life Sciences • Reduce Compliance risk when scaling

Challenges with
• Position existing infrastructure to the new therapeutic modalities - delivery, personalization
AI & IIOT
• Lower footprint for scaling – more continuous manufacturing technology

(c) Copyright Quartic.ai 2018-2020 All rights reserved

Practical, high ROI Pharma 4.0 AI and Big Data applications
Contracting Maintenance
Process Tech Production Quality
Pilot Plant (CDMO, and
Development Transfer Operations Assurance
CMO) Reliability

• Dynamic DoEs
• Create and manage your design space in real time with
operational data
• Support for AutoML PAT modelling
• Capture Process Development knowledge in models
for next stage acceleration

(c) Copyright Quartic.ai 2018-2020 All rights reserved

Practical, high ROI Pharma 4.0 AI and Big Data applications
Contracting Maintenance
Process Tech Production Quality
Pilot Plant (CDMO, and
Development Transfer Operations Assurance
CMO) Reliability

• Big data MVDA • Transfer Learning for pipeline acceleration

• A modern MVDA for big data & ML
• Superior performance on non-linear models compared
to PCA & PLS
• Realtime streaming MVDA on-prem, cloud & hybrid
• Easiest on-line deployment of MVDA
• Automation of PAT
• Quicker value from ILM PAT investments for RTR
• Cycle time reduction between unit operations
• Predictive models with automated PAT analysis
• Optimization
• Closed loop control of concentration (with PAT)
• AI augmented Recipe orchestration
• Continuously improving batches instead of “Golden”
batch
(c) Copyright Quartic.ai 2018-2020 All rights reserved
• Expedited Tech Transfers
• Faster Process compliances after change
• Transfer of product improvements across
CMO network
• Reduce Consistency and engineering runs
• Digital Twin for autonomous control
• Accelerated reinforcement learning
• AI Control based on hybrid model
• Media/Buffer Prep with the assistance of
PATs
Practical, high ROI Pharma 4.0 AI and Big Data applications
Contracting Maintenance
Process Tech Production Quality
Pilot Plant (CDMO, and
Development Transfer Operations Assurance
CMO) Reliability

Cognitive Asset Health Monitoring

• Baselining of health for multi-product/recipe assets and
unit operations equipment
• Continuous risk monitoring of critical failure modes
• Early detection of process induced incipient faults Condition
• Realtime root-cause detection with severity rating Data

Abnormal Situation Prediction

• Turning past alarm “floods” into proactive insights
Process
• Downstream event propagation prediction Data
• Making Safety Instrumented Systems predictive and
responsive

(c) Copyright Quartic.ai 2018-2020 All rights reserved

Practical, high ROI Pharma 4.0 AI and Big Data applications
Contracting Maintenance
Process Tech Production Quality
Pilot Plant (CDMO, and
Development Transfer Operations Assurance
CMO) Reliability

Proactive EQMS Dynamic, on-line Qbd

• Augmenting quality with AI-enabled anomaly detection • Real-time risk-based implementation of CPV
• Improving product disposition - Review by Exception • Machine learning enabled
• Improving resource utilization - Automate Periodic Reporting • Product control through journey of molecule

LIMS
Improve Product Disposition by
connecting to contextualized data
EQMS
Document/ Quality
EBR Training Mgmt Processes Reduce Investigation Time optimizes
use of in-demand resources
Manufacturing /
Shop Floor Enriched Analytics and Reporting
leading to better decisions
ERP
Feedback
ERP / Proactive
Insights Reports &
Analytics
(c) Copyright Quartic.ai 2018-2020 All rights reserved
From process
From Processcontrol
Controlsystems …to –
Systems product control
to Value systems
Control Systems

Unit # Unit # Unit # n

1 2

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Life Sciences Use cases
Process Development, tech transfer and scale-up (Speed, agility and time-to-market improvement)
• Digital capture of product & process understanding from Phase IV to process development
• Reduce the number of consistency batch runs for process development with modelling
• Reduce the number of robustness and compliance batch runs for PQ & commercialization with transfer learning
• Digital tech transfer to CMO or internal manufacturing scale-up – reduce time to compliant manufacturing

Production optimization (Increase return on assets, reduce cost of production)

• Achieve optimized state faster after initial commercial manufacture using base models from PQ runs
• Reduce cycle time between unit operations by converting offline assays to soft sensors
• Turn batch manufacturing into contiguous manufacturing and RTR with soft sensor based ILM of unit CQAs & CPAs – increase utilization of
high demand production assets
• Remove performance variability in identical processes - transfer optimization effort and knowledge from one high performance unit
operation to other identical poor performance unit operation
• Yield increase with consistency, beyond SPC – operate in tighter set point limits (within PARs) with AI augmented recipe orchestration

PQ: Process Qualification; RTR: Real-time Release, ILM: Inline monitoring; CQA: Critical Quality Attributes; CPA: Critical Process Attributes

(c) Copyright Quartic.ai 2018-2020 All rights reserved

Life Sciences Use cases
Critical Equipment Reliability
• Digitalize RCM (Reliability Centered Maintenance) with predictive monitoring of asset performance capability
• Reduce MTTR (Mean-time-to-repair) with predictive root cause indication
• Reduce MRO spares inventory with continuous and predictive asset health risk monitoring
• Accelerate value from CBM (Condition based monitoring) investment with automated CBM across products and recipes on the same asset

Facilities and utilities optimization

• Reduce high purity utility costs by optimizing CIP and SIP cycle times
• Reduce primary drying costs on freeze dryers with optimized cycle times

Product Control Strategy and CPV (Continued Process Verification) and Quality
• Continuous monitoring of variability and risk to robustness through the lifecycle of the molecule – dynamic CPV & Qbd
• Reduce cost of quality with predictive exception based deviation monitoring
• Reduce APR cost and effort with evidence based deviation management
• Automate assay analytics from LIMS

(c) Copyright Quartic.ai 2018-2020 All rights reserved

 Sterilization Autoclave – Vaccine Production
Fortune 100 Global Vaccine Pharmaceutical Company

Customer Challenges
▪ Repeat and frequent failure of critical components leads to unacceptable level of unplanned downtime and production loss.
▪ Multiple recipe (product) types on same asset made baselining of condition impossible with logic based system
▪ Identified as a high-risk equipment in the vaccine production process.
▪ Autoclaves are a bottleneck of the manufacturing process, everything in and out of the sterile production area must flow thro ugh an autoclave.
▪ High use for six days a week, with a planned downtime every seventh day for maintenance, leaving limited time for troubleshoo ting and failure avoidance.
Scope
• Define all potential and current failure modes of the entire system.
• Identify what failure modes can be identified early using existing data and what additional sensors were
required.
• Develop AI models to learn baseline operations and identify abnormal conditions on critical components.
• Deploy real-time monitoring and alerting system to identify, notify and avoid failure conditions.

Results
▪ Reduced Mean Time Between Failure (MTBF) from seven days to ninety days.
▪ Eliminated time-based replacement of critical components.
▪ Reduced spares inventory
▪ Increase equipment availability
 Continuous Reactor | Autonomous Control and Optimization
Emerging Continuous Manufacturing Technology Supplier

1st Autonomous continuous Reactor undergoing FDA-

ETT approval Review

Customer Challenges
• Continuous flow (tube-in-tube) reactor
• Low residence time reaction, multiple pathways
• Multiple chemistries and molecules on same reactor – require fast
on-line compliance using spectroscopy

Solution
• The Quartic platform uses process and ILM spectroscopy data to
model setpoints for different chemistries
• New molecule changes use on-line models and ILM for “Dial-a-
molecule” control strategy in conjunction with a Rockwell PLC

(c) Copyright Quartic.ai 2018-2020 All rights reserved

(c) Copyright Quartic.ai 2018-2020 All rights reserved
Bioreactor | Fermentation Yield Improvement
Fortune 100 Global Pharmaceutical Company

Customer Challenges
• High batch-to-batch variability in yield from fermentation process
• High variability in phase times
• Poor visibility and late notification to operators of actual phase state
• Limited success from offline multi-variate analytics experiments (SIMCA-PCA)
Solution
• Robust, repeatable model for phase identification from historical batch classification
• Developed composite batch performance index model from high yield/low cycle time batches
• Developed ideal baseline models for CPP’s in each phase
• Connected real-time process and equipment condition data to online model
• Realtime indication of overall performance index in each phase with influencing factors
• Realtime equipment health index score indication
Results
• Consistency of yield across batches
• Overall improvement in yield (1.7%)
• Early warning of impact of equipment health on batch performance, previously not available

(c) Copyright Quartic.ai 2018-2020 All rights reserved

Bioreactor | Fermentation Yield Improvement

Real-time and
predictive
Batch
Performance Realtime
Index) Component
Health Index

Variables Variables
(CPP) impacting
impacting Component
Batch Health
Performance

Batch/campaign
digital thread
(CQA/CPP trend
over batches)

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