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Life Sciences
Manufacturing
Transformation
Bob Lenich
Life Sciences Marketing Director, Emerson
Presenter:
Bob Lenich
• Emerson Automation Solutions Life Sciences Marketing Director
• >35 years in the Life Sciences automation industry
• Wide experience applying technology to solve manufacturing operation problems
• B.S. in Chemical Engineering: Rose Hulman Institute of Technology
• M.B.A. University of Texas at Austin
• Contact info:
– Emerson Automation Solutions | 1100 W. Louis Henna Blvd. | Building 1 | Round Rock | TX | 78681 | USA
– T +1 512 834 7033 | C +1 512 350 4002
– www.linkedin.com/in/bob-lenich
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Emerson Confidential
Pharmaceuticals Need to Change3
“The pharmaceutical industry has been slow to adopt
approaches embraced by other industries, but I think the time
is now,”
FDA Commissioner Margaret Hamburg
touring Vertex’s continuous manufacturing line 1
1 WSJ Feb. 8, 2015 Drug Making Breaks Away from It’s Old Ways
Emerson Confidential
Pharmaceuticals Need to Change4
1 https://blogs.fda.gov/fdavoice/index.php/2018/07/fda-budget-matters-investing-in-advance... 7/13/2018
“There’s new technology that can improve drug quality, address shortages of medicines, lower
drug costs, …At the FDA, we’re focused on propelling these
innovations, collectively referred to as Advanced Manufacturing.”
FDA Commissioner Scott Gottlieb
FDA Voice July 13, 2018 1
Financial Incentives to Change
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‘Right First Time’
14%More First-Pass
Quality Yieldfor top quartile
WIP Inventory Turns
Primary Product Manufacturing Cycle Time Capacity Utilization
36 hrs
7 hrs
4th 1st
5XFaster Cycle Time
for top quartile
84%
98%
4th 1st
9
19
4th 1st
2XFaster Inventory
Turnsfor top quartile
80%
90%
4th 1st
12.5%Higher Capacity
Utilizationfor top quartile
Quartiles
Quartiles
Quartiles
Quartiles
Source American Productivity and Quality Center
Overall Life Sciences Industry Trends Driving the Transformation1
6
Cost Containment / Controls
Manufacturing Increasing in Developing Countries
World-wide Standardization of Manufacturing
• Growing protests over high pharmaceutical prices
• Drugs are curative but set records for costs
• Outside of the US, government-imposed price controls are common
• Price controls restricting innovative R&D
• New and increased manufacturing capacity is being added internationally
– Especially in China, India, and other Asian countries
• Mostly for domestic, regional, or lesser / non-regulated international commerce
• Local governments are seeking to assure domestic manufacturing
• Larger companies continue to standardize their products and manufacturing processes on a world-wide basis
• Targeting 2nd and 3rd source geographically spread facilities
– Example: major facilities in US, Ireland and Singapore
• Adoption of Single-Use and Modular systems are accelerating
Emerson Confidential1 Report and Survey of Biopharmaceutical Manufacturing and Production, April 2018
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One Path Forward:
BioPhorum
8
Member Companies
• Abbvie
• AGC Biologics
• Ajinmoto
• Aldveron
• Alexion
• Allergan
• Amgen
• Applied Materials
• Asahi Kasei
• AstraZeneca
• Avantor
• BASF
• Bayer
• Becton Dickinson
• Biogen
• BioMarin
• Bristol-Myers Squibb
• Boehringer Ingelheim
• Brammer Bio
• Catalent
• Celgene
• Chugai Pharmaceutical
• CPC
• CRB
• CSL Behring
• Dow
• Eisai
• Eli Lilly
• EMD Serono
• Emerson
• Endress+Hauser/Kaiser
• Entegris
• Ferring
• Friesland Campina
• Fujifilm Diosynth
• G-CON Manufacturing
• GE Healthcare
• Gilead
• GlaxoSmithKline
• Honeywell
• ImmunoGen
• Ipsen
• Janssen
• Juno Therapeutics
• Kyowa Hakko Kirin
• Lonza
• M&W Group
• Meissner Filtration
• Merck MSD
• Merck KGA
• Millipore Sigma
• NewAge Advantapure
• Novo Nordisk
• Pall Life Sciences
• Pfizer
• PM Group
• Regeneron
• Roche / Genentech
• Rockwell Automation
• Samsung Biologics
• Sanofi
• Sartorius Stedim
• Shire
• Siemens
• Sigma Millipore
• Takeda
• Thermo Fisher
• UCB
• Waters Corp
Emerson Confidential
>2200 Active Participants
The six Phorums Provide Benefits Across the Biopharma Supply Chain
Drug Substance, Fill Finish, Development Group, Information Technology
• Accelerating the way the industry delivers near term results, making best practice development and implementation faster, cheaper and smarter
Supply Partners
• Creating the supply chains the industry needs; defining, developing and implementing solutions for business processes, systems and culture
Technology Roadmapping
• Revolutionizing the way the industry develops longer term transformational manufacturing and technology capabilities
• Focusing on strategy and ten year time horizon, defining needs, difficult challenges and potential solutions
Regulatory Interaction
• Enable engagement and alignment with Regulatory Stakeholders in order to accelerate adoption and successful implementation of advances in manufacturing
Facilitation
• Ensures decisions are made at the right time, at the right place by the right people
• Linkages are made visible to avoid redundancy
• Synergies are leveraged through effective coordination
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Technology Roadmapping
• Dynamic and collaborative technology management process
– Accelerates innovation
– Defines future needs, difficult challenges and potential solutions
• Active participation by:
– Bio-manufacturers
– Supply partners
– Leading academics
– Regional innovation hubs
– Agencies
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Mission of the Technology Road-mapping Phorum:
To Accelerate Industry Innovation
The BPOG technology roadmapping process is a dynamic and evolving collaborative technology management process for:
• Determining precompetitive critical needs and drivers
• Identifying technology and / or manufacturing targets
• Assessing / modeling potential solutions
• Coordinating implementation projects
to
• Focus an industry community
• Provide direction
• Resolve those critical needs for a specific timeframe by consensus
• Ensure that technologies are delivered and adopted
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The First Edition Technology Roadmap was Published July 2017 and Continues
to be Accompanied by Extensive Communication
• The First Edition is freely available on the BPOG public website to maximise access & measure it’s reach.– First Edition documents are the result of two years effort by the steering
committee and the six enabling technologies roadmap teams
– Consists of 8 documents covering over 400 pages of content
• Communication within member companies continues to maximise company benefit– Increase participation levels to leverage the roadmap and further
accelerate implementation within member companies
• External communication continues to raise the profile of the roadmap, aligning industry efforts, gaining feedback and increasing number of organisations involved– Conference presentations by the steering committee and roadmap team
experts
– Regular Newsletters
– Press Releases
– Publication of articles in industry press
– Videos and webinars by the teams
– Meetings with Regulators
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http://www.biophorum.com/executive-summary/
First Edition Documents
Presentations & Articles
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Uncertainty
▪ Regulatory approvals
▪ Demand variability
▪ Competition
Cost pressure
▪ Payer pressure
▪ Biosimilars
▪ Development
Market Growth
▪ Emerging markets
▪ Global reach
▪ In region manufacture
New Product Classes
▪ Non-mAbs, ADCs
▪ Gene therapy
▪ Cell therapy
Modular and Mobile- 70% build time
- 75% CAPEX
▪ Quick to configure &
scale
▪ Standard designs
▪ Streamlined validation
Automated Facility− 50% Facility Build
Speed
− 50% OPEX costs
from current
▪ Agile, high quality, and
robust
biomanufacturing
▪ Plug and Play
▪ Open data standards
▪ Interoperability
Knowledge
Management‒ Cost of process
development
– Time to introduce a
change to an existing
process to 1 Month– Cost of Non-Quality
to 2% of operating costs
• Efficient tech. transfer
• Integrated knowledge
• Quality throughout
lifecycle
Supply Partnership
ManagementSafe, innovative supply
chains:
− Cost of quality
− Time
▪ Partnerships with
quality built in
▪ Standard working,
integration and real
time Electronic Data
Exchange
▪ Shared Planning
Market Trends & Business Drivers – The Why
Enabling Technologies & Capabilities – The How
Speed
-70% build time
-80% lead time
Cost
-90% manufacturing cost
-90% CAPEX
Flexibility
-90% changeover
Demand response
Quality
10x robustness
-90% cost of quality
Drug Product
High volume
Drug Product
Low volume
Scale Distributed
1. Large-scale Stainless Steel Fed Batch
2. Intermediate-scale Single-use Perfusion
3. Intermediate-scale Multi-product Single-use Fed Batch
4. Small-scale <500L Portable Facility
Biomanufacturing scenarios – The What
(Facility types)
5. Small-scale <50L for Personalized Medicine
First Edition Technology Roadmap Vision
Inline Monitoring and
Real time Release- Product Release
1-2 day
+ ↑ Quality, Efficiency &
Supply
▪ Enhanced In-Line
Monitoring
▪ Indirect and
Multivariate Sensors
▪ Multivariate Analysis
and Predictive
Modeling
Process Technologies- 90% CoGs
- 90% process
investment
▪ Process Intensification
& combination of unit
operations
▪ Continuous processing
technologies coupled
with advanced process
control
Roadmap Team has 12 Projects Supporting Technology Needs Identified in the
1st Edition Technology Roadmap
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8. Rapid methods for
adventitious virus &
mycoplasma.
Develop/validate new
rapid sensitive
sterility tests
4. Process
Intensification, high
cell density cell
culture processes
5. Reliable & cost
effective cell removal
options for higher
density processes in
biomanufacturing
1/7. Reduce release
testing need because
we have RTR/ILM
2/16. Managing
Product & Process
Knowledge across
the Lifecycle
6. Buffer Preparation
9/10. Data
analysis to evolve
from big data to
smart data
13/14. Robotic
technologies in
biomanufacturing
15. Standard
Facility Design
17. Reduce
suppliers internal
testing
requirements and
release efforts
20. Continuous
Downstream
Processing
Process
Technology
Inline Monitoring
& Real time
Release
Modular &
Mobile
Automated
Facility
Knowledge
Management
Supply
Partnership
Management
21. Plug and Play
1st edition
Global
Roadmap
chapter:
BPOG Technology Roadmap– 2018 ProgramFor detail of each project line, see project charter
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Jan Mar May Jul Sep Nov
4 – Upstream Process Intensification for high cell density cultures
5 - Reliable & cost effective cell removal Go / No Go decision needed
6 - On demand buffer preparation
20 - Continuous downstream processing
1/7 - Reduced release testing through in-line monitoring
15 - Standard facility design
9/10 - Big Data to Smart Data
13/14 - Robotics Technologies
21 - Plug and Play Automation
2/16 - Managing product and process knowledge across the lifecycle
17 - Relevant specifications for Raw
Materials & Single Use Components
8- Rapid methods for adventitious virus detection and sterility
assurance
1st Edition Technology Roadmap – Communications & Engagement
TR07 TR08
Process Economic Modelling
paperTechnology development
Plan with BPIT
paper
paperTechnology development PoC test
PoC test Next materialspaper
paper
paper
Model development
Technology development
Industry & regulatory strategy
2nd Edition Technology Roadmap
ILM02
F2F
CBP02
MM02
CBP01
AF01
BUFP02
MM01
KM01
BUFP03
2nd Ed Technology
RoadmapUS Roadmap component
content finalised
paper
paper
NIIMBL 1st edition US Roadmap F2FF2F
NIIMBL 2nd edition US roadmapF2F
Roadmap teamsContent generation and review
TRM SteeringProgram strategy, resolution of issues and governance.
TRM Projectso Transformational
for the industry
o Co-implementation of URS and whitepapers
o Standard frameworks
Communities of practice
Regional roadmaps
Emerson Confidential
BPOG Phorum collaboration
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Buffer Preparation
Standard Facility Design
Continuous Downstream
Processing
Process Technology
ILM & RTRModular &
MobileAutomated
FacilityKnowledge
ManagementSupply Partnership
Management
Process Development
Operations, Quality &
Compliance
Microbial ControlContamination
free process
Lean Qualification / Validation
Disposables – Change notification
Deviation management
system
Post approval supplement strategies
Human performance
Continued process verification
QC stability
Reliability
Alternatives & rapid micro
methods
Container closure integrity testing
(CCIT)
EM in a modern DP facility
Pre-post use sterilization
integrity testing
Visual inspection / particulate control
Lyophilisation
Digital plant maturity
Smart maintenance
Compliant multi-source analytics
Cloud, IaaS controls
SPITDGFFDSTR RI
Viral clearance
Formulation
Development outsourcing
CMC regulatory
Host cell proteins
How do you demonstrate
monoclonality
Qualification of scale down models
Forced degradation
studies
BioAssay
Knowledge management in
development
CMC considerations for
expedited development
programs
Analytics
Regulatory interaction
Rapid methods for adventitious
detection & assurance
Upstream Process
Intensification
Reliable & cost effective cell
removal
Rapid release testing through
inline monitoring
Knowledge Management
Big Data to Smart Data
Robotics
Relevant specifications for raw materials
Plug and Play
Disposables – Supply base reliability
Disposables – Testing, validation & release
standards
Storage & transport
Stopper quality
Supply chain digital platforms & integration
Supply Chain Mapping
Forecasting and Demand Planning
Raw material variabilityDisposables – E&L
Disposables – SUS URS
Closed systems
Multi-product facilities
Small flexible filler
Risk Mgt and Business Continuity Planning
Joint Audit Program
Industry Capacity Constraints Analysis
Microbial ControlOperational
harmonisation
Data Integrity
Cybersecurity /plant resilience,
recovery
Example Factory of the Future
Unlocking the Value of Advanced Manufacturing Requires Planning
Advanced Manufacturing
in Life Sciences are
progressing.
Assess people,
processes and
technologies within your
organization to determine
how to get the benefits
Approach requires re-thinking your
manufacturing processes and business
Technology barriers are being addressed
Secondary manufacturing is moving the fastest
but primary is also progressing
Requires people with a combination of process
and automation / data technology skills
Requires flexible and adaptable automation and
data management platforms
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