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Werum: The Leading Manufacturing IT (MIT) Partner for Life Sciences
490 Employees
MES in Single-use Biomanufacturing Facilities 2 21-Sep-15
Comprehensive offer for fast & efficient MES projects
PAS-X market approach: more than software
21-Sep-15 MES in Single-use Biomanufacturing Facilities 3
The growth of Single-use Systems has been slow but steady in GMP Plants:
MES in Single-use Biomanufacturing Facilities 4
$0.00
$2.00
$4.00
$6.00
$8.00
$10.00
$12.00
$14.00
2011 2018
Bil.
Upstream Equipment Market1,2
GMP Single-use Systems
R&D Single-use Systems
Stainless Steel
• More growth in GMP vs.
R&D (23 to 64% of SUS
market)
• Increased
cannibalization of
stainless market (from
10 to 20% of spending)
• ⅔ of new small / mid
size facilities are Single-
use3
21-Sep-15
Dramatic growth also expect for Downstream as new technologies become available:
MES in Single-use Biomanufacturing Facilities 5
• > 100% growth in the
downstream market
• Still a fraction of the
traditional stainless
market
$0.00
$2.00
$4.00
$6.00
$8.00
$10.00
$12.00
$14.00
2013 2018
Bil.
Downstream Equipment Market1,2
GMP Single-use Systems
R&D Single-use Systems
Stainless Steel
21-Sep-15
What is driving Single Use trend…and what is the impact?
6 MES in Single-use Biomanufacturing Facilities
• Small Sites
• Lower
Staffing
Levels /
Skills
• Contract
Staff
• IT “Cloud”
21-Sep-15
7 MES in Single-use Biomanufacturing Facilities
This drives certain operational behaviors
Increased Manual
Activities
Increased Complexity of
Consumables
Designed for Increased
Flexibility
More Material “in space”
Risk: Human Error
Risks:
•Genealogy
•Material Tracking
Risk:
•Human Error
•IT Efficiency
Risk: Material Tracking
…and risks
21-Sep-15
Systems supporting BioPharmacutical Manufacturing have made progress
8 MES in Single-use Biomanufacturing Facilities
Can automation mitigate these risks?
Purpose built software with content designed to support BioPharmaceuticals
Mature philosophies on organization of IT systems in the architecture
New technologies will improve access to IT at smaller sites
Integration standards (i.e. OPC) and APIs simplify integration across systems
Regulators acceptance of and, in some cases, encouragement of shop-floor technology
21-Sep-15
ISA S95 IT Concept Level 4
Level 1
Level 2
Level 3
ERP (SAP) Source, Plan,
Manage Inventory, Delivery, etc
MES Dispatch Production,
Detailed Scheduling, Make product, Manage events/exceptions
DCS
Batch
Control
Discrete
Control Continuous
Control What?
Sensing the production process, manipulating the production process
Time Frame: Milliseconds
What? Monitoring, supervisory control and automated control of the production process
Time Frame: Milliseconds
What? Work flow / recipe control, stepping the process through states to produce the desired end products. Maintaining batch records and optimizing the production process.
Time Frame: Shifts, hours, minutes, seconds
What? Managing the end-to-end supply chain Establishing plans -
production, material use, delivery, and shipping. Maintaining costs of operations
Time Frame: Months, weeks, days
MES in Single-use Biomanufacturing Facilities 9 21-Sep-15
Growth of MES has been steady in life sciences
10 MES in Single-use Biomanufacturing Facilities
Time
% MES @
Top 25
1990 2015
More than 70% of top
companies have
established global
MES programs Growth driven by:
• Compliance
• Visibility
• Efficiency
• Control
• Complexity
21-Sep-15
Level 1/2
SCADA /
DCS
Where we were
11
Level 4- ERP
Level 3- MES
EBR
Challenge:
• Many point- to-
point
connections
• Expensive and
time
consuming to
validate and
maintain
• Importing lots
of Raw Data
into MES
Challenge:
• Chance for
transcription
error or “missed
value” by
operator
• Inefficient, with
lots of human
interaction
Down:
• Process
Parameters
• Recipe
start/end
Up:
• Tag Structures
• Process Data
• Alarms/Events
MES in Single-use Biomanufacturing Facilities
Historian
21-Sep-15
Level 2/1
SCADA /
DCS
A Better Approach
12
Level 3- MES
EBR
Benefits:
• Leverages existing historian connections
• Reduced validation / maintenance efforts
• Easier management of statistical data
Down:
• Process
Parameters
• Recipe
start/end
Up:
• Tag Structures
• Process Data
• Alarms/Events
MES in Single-use Biomanufacturing Facilities
Historian
21-Sep-15
The Electronic Batch Record is often seen as the single
source of production information for a produced product.
Scales
DCS LIMS
Learning
Management
Weights Control Recipe
Tags/Attributes Sample Results
Sample Request
Operator Qualifications
Electronic
Batch
Record
Historian
eDMS CAPA Maintenance
Management
Calibration Status
Equipment Usage
Display SOP
Batch Record
Dev. Status
Generate Dev.
ERP BMS
Environmental Status
Process Data
Trends
Control
Electronic Execution
MES in Single-use Biomanufacturing Facilities 13 21-Sep-15
14 MES in Single-use Biomanufacturing Facilities
This drives certain operational behaviors
Increased Manual
Activities
Increased Complexity of
Consumables
Designed for Increased
Flexibility
More Material “in space”
Risk: Human Error
Risks:
•Genealogy
•Material Tracking
Risk:
•Human Error
•IT Efficiency
Risk: Material Tracking
…and risks
21-Sep-15
15 MES in Single-use Biomanufacturing Facilities
Increased Manual
Activities
Paperless Production drives “Right First Time”
Electronic Work Instructions Strong User Guidance
Launch visual guides for operators (video, photographs)
Optimized User Interface for Shop Floor Environment
21-Sep-15
16 MES in Single-use Biomanufacturing Facilities
Increased Complexity of
Consumables
Source
Target
HU/SU ID: 123
Source: WB01
Dest: BL05
Label
Material verification by barcode scan checking material number, batch number, expiry date
Can be performed with stock material and with WIP materials
Automatic population of batch record triggered by scan
Full genealogy assembled real-time
Materials can be managed as equipment
21-Sep-15
17 MES in Single-use Biomanufacturing Facilities
Designed for Increased
Flexibility
Libraries: Pre-defined, process specific building blocks to rapidly build recipes (by Unit Operation)
Generic Recipes: Eliminates needs to re-build recipe for each new SKU
Plug / Play with Equipment Integration: Pre-defined tags in MES for specific process equipment
21-Sep-15
18 MES in Single-use Biomanufacturing Facilities
More Material “in space”
Real-time tracking of material / container movements and location
Storage condition monitoring to prevent expiration of critical materials
“Intelligent” containers and equipment that can move process relevant information between orders and areas
21-Sep-15
Case Study 1: Traditional Large Molecule
20 MES in Single-use Biomanufacturing Facilities
Background
• Top Biopharma Company
• New, single-use facility
• New technology and approach for company
• Multi-product
• Low cost basis
• New manufacturing model moving forward
Scope
• COTS Software Model
• Architecture:
• ERP (Global)
• MES (EBR, Mat., W/D)
• DCS
• Historian
• Multi-variate monitoring
• Plug and Play Equipment
• Clinical and Commercial
• 5 to 10x reduction in construction cost
Key Learnings
• Parallel development of recipes on Level 2/3
• Generic recipes apply to some areas, but not all, for BioPharma
• Need proper modularity of recipe structures to achieve “plug-n-play” goal
• Lots of change in early plant -> recipe changes…
• Simulation systems for each level of architecture critical for testing and minimizing timeline risk
21-Sep-15
Case Study 2: Autologous Therapy
21 MES in Single-use Biomanufacturing Facilities
Background
• Autologous Therapy
• Table-top manufacturing with fully SU technology
• Expecting huge growth, with specific challenges:
• Batch sizes of one
• Material tracking failures can have fatal consequences
• High tracking requirements for raw materials
• Global alignment of processes across multiple sites
Scope
• Focus on Scale-Out vs. Scale-Up5
• Chain of Identity (CoI) from outside -> inside four walls
• Architecture:
• ERP (Global)
• Scheduling / Clinics
• MES (EBR, Mat.)
Key Learnings
• MES requirements not unique to the industry
• Guidance and electronic control for operators key to maintaining quality at volume
• Future of automated Level 2 is murky
• MES provides a platform for harmonizing recipe across sites via central deployment
21-Sep-15
Thank you for your attention.
MES in Single-use Biomanufacturing Facilities 22
Marc Puich Vice President
Strategic Program Management
San Francisco, CA, USA
Phone: +1-415-738-7990 EXT105
21-Sep-15
References
23 MES in Single-use Biomanufacturing Facilities
1. Radar, R. A., Langer, E. S., Single-use technologies in biopharmaceutical manufacturing: A 10-year review of trends and the
future, Engineering in Life Sciences 2014, 14, 238-243
2. Radar, R. A., Langer, E. S., Upstream Single-Use Bioprocessing Systems, BioProcess International 10(2), February 2012
3. Radar, R. A., Langer, E. S., Innovation In Stainless-Steel Bioprocessing, Life Science Leader, November 2013
4. Situa E-strategties, http://www.situaestrategias.com/internet-of-things-iot-enables-3-88-trillion-in-potential-value-to-
manufacturers-2648
5. Monesmith, Tamara T., Meeting the Challenges in Manufacturing Autologous Cellular Therapies, BioProcess International,
March 2011
21-Sep-15