The Need for MES in Single-use Biomanufacturing Facilities · 21-Sep-15 MES in Single-use...

The Need for MES in Single-use

Biomanufacturing Facilities CellWorld 2015 21 September 2015

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:


• > 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


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


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


Growth of MES has been steady in life sciences


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



This drives certain operational behaviors

Increased Manual

Activities


Consumables


Flexibility


Risk: Human Error

Risks:

•Genealogy

•Material Tracking

Risk:

•Human Error

•IT Efficiency

Risk: Material Tracking

…and risks

21-Sep-15


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



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



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



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

What more is on the horizon?

19 MES in Single-use Biomanufacturing Facilities 21-Sep-15

4

Case Study 1: Traditional Large Molecule


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


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.


Marc Puich Vice President

Strategic Program Management

San Francisco, CA, USA

Phone: +1-415-738-7990 EXT105

[email protected]

21-Sep-15

References


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

http://www.situaestrategias.com/internet-of-things-iot-enables-3-88-trillion-in-potential-value-to-manufacturers-2648




























Date post:	16-Apr-2018
Category:	Documents
Upload:	vuongkhuong
View:	220 times
Download:	2 times

The Need for MES in Single-use Biomanufacturing Facilities · 21-Sep-15 MES in Single-use...

Documents