The eBioPlant

10th April 2014

Implementation of an Integrated MES-DCS solution in a new biotech plant

ן UCB• UCB at a Glance• Focus on Cimzia

ן The Edelweiss Project• Project Objective• Process Description

ן The eBioPlant• Requirements & context

Agenda2

• Requirements & context• MES• Systems integration• Challenges• Roadmap

UCB in a Glance

UCB: A patient-centric Biopharma leader

� FY 2012 revenue: €3 462 million

� About 9 000 employees globally

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Focusing on severe diseases inImmunology and the Central Nervous System

� About 9 000 employees globally

� Operations in close to 40 countries

� R&D Spend: ~25% of revenue

� Listed on Euronext

Stephanie, living with rheumatoid arthritis

UCB’s vision and strategies5

UCB’s top products

Rheumatoid arthritis & Crohn’sdisease

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Three core medicines for patients with severe diseases

Epilepsy adjunctive therapy

Parkinson’s disease Restless legs syndrome

Cimzia ®

• The only PEGylated anti-TNF

• Available in 34 countries *

• More than 41.000** patients on

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Cimzia ® (certolizumab pegol)

• More than 41.000** patients on Cimzia ® worldwide

• Expected peak sales of at least € 1.5 billion ***

* FY 2012 - ** Second half of the decade - *** US, Argentina, Brazil, Chili, Mexico, Russia, Switzerland

Audrey, living with rheumatoid arthritis

The Edelweiss Project

The Edelweiss Project

Bulle (FR) – Switzerland

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Location

Area is mostly known for its world famous…

The Edelweiss Project

Goal

• To build a commercial production facility for CIMZIA Drug Substance that ensures projected market supply beyond 2014.

Objectives

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Project Objective

Objectives

• Design and construct a facility delivering the wanted amounts, timely and with flexibility (2 phases).

• Implement state-of-the art process, capitalizing on expertise gained at CMOs, with minimal regulatory risk.

The Edelweiss Project11

Facts & Project Timelines

• 5 levels• 18500 m2 of surface• 7000 m3 of concrete• 1500 t of steel• 22 km of pipes• 50 km of cables• 50 km of cables

Fast Track project

Production in bioreactors (2 x 15’000 liters)

Manufacturing process – Fermentation & primary isolation

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Working cell bank

(2ml vial)

Flasks amplification

Bioreactors

amplification

Manufacturing process - Purification

Harvest

Ultrafiltration & Diafiltration

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Chromatography & pegylation

Final bulkproduct (5.5kg)

eBioPlant Project

eBioPlant15

Manufacturing Operations

MRP

Released PO

Warehouse (Picking)

Masters

POBOM & Batch Record

Batch Record preparation

Batch

BOM

Batch release Weighing & Dispensing

Released Batch

Recipe Logbook

SOP

Manufacturing

Dispensedingredients

Lab

PickingListTraining

Batch Record

BatchRecord

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Actual plant

Input materials

End Product

Manufacturing Operations

Hidden plant

Master Batch Record

Equipment Logs

Deviations

Batch Record

SOPs

MSDS

QC results

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Vision – The plant of the future

eBioPlant18

Requirements

MAXIMIZE USE OF ELECTRONIC SOLUTIONS IN ORDER TO

■ Increase the core processes performance

■ Ensure full control of operations

■ Ensure high data availability

■ Integrate the new plant in the existing global UCB IT landscapes■ Integrate the new plant in the existing global UCB IT landscapes

PAPERLESS MANUFACTURING

EBR & RELEASE ON EXCEPTION

TOTAL INTEGRATION WITH AUTOMATION

eBioPlant19

Local implementation in a global context

■ MES @ UCB

■ US (Seymour, IN & Rochester, NY): SAP PI sheets

• Materials trackaing in packaging & PP

■ MES @ UCB

■ US (Seymour, IN & Rochester, NY): SAP PI sheets

• Materials trackaing in packaging & PP

IT context

■ SAP ERP deployed globally (Kernel)

■ LIMS being deployed globally (OIL)

■ No automation harmonization

■ No MES harmonization • Materials trackaing in packaging & PP

■ Belgium & Switzerland: XFP

• Full EBR in packaging

• Operations & materials tracking in PP

• Materials tracking in CP

• Materials trackaing in packaging & PP

■ Belgium & Switzerland: XFP

• Full EBR in packaging

• Operations & materials tracking in PP

• Materials tracking in CP

■ No MES harmonization

eBioPlant20

MES selection

■ Integrated Automation & MES package

■ Cover the needs with a minimum of development effort - within budget

■ System which allows relatively easy change/improvement of recipes

■ A partner who could deliver a fast track project

What UCB was looking for…

■ A partner who could deliver a fast track project

1. Resources with good biotech expertise

2. Ability to deliver fast

eBioPlant21

Implemented Syncade Functions

MaterialManagement

Information Management

Weigh & Dispense

Document Management

Electronic Batch Record

Equipment Logbook

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What UCB liked in EBR / Recipes Authoring

ERPLIMS

• Structured module (ISA88 & 95)

• Collaborative recipeauthoring

• Recipe simulation

• Unified recipe for MES & DCS

• Structured module (ISA88 & 95)

• Collaborative recipeauthoring

• Recipe simulation

• Unified recipe for MES & DCS

ControlDCS / PLC

LIMS DCSDCS

eBioPlant23

Unified Recipe for MES and DCS

eBioPlant24

• Ergonomic application

• - Go to current step

• - Playback function

• Manufacturing review

• Ergonomic application

• - Go to current step

• - Playback function

• Manufacturing review

What UCB liked in Electronic Workflow

• - Easy and readable EBR

• Native EBR withexceptions review

• - Easy and readable EBR

• Native EBR withexceptions review

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• Electronic logbook

• Track equipment usage & status

• Workflows (used for CIP &

• Electronic logbook

• Track equipment usage & status

• Workflows (used for CIP &

What UCB liked in Equipment Management

• Workflows (used for CIP & SIP)

• Workflows (used for CIP & SIP)

eBioPlant26

EBR Lifecycle

EBR

EBR

Recipe Document

Review / Approval

Recipe

Execution

Recipe

Authoring / Simulation

MBR EBR

EBR

Manufacturing

Review

eBioPlant27

Implementation

RECIPES & EQUIPMENT

22 recipes & 17 equipment classes.

■ Manual and automated operations tracked in the recipes.

■ Materials addition with quality check tracked in the recipes.

■ IPC operations triggered from the recipes.

■ DeltaV phases started from the recipes.■ DeltaV phases started from the recipes.

■ Automatic equipment tracking

■ Hygienic states checked in the recipes, mirrored with DeltaV.

■ Quality Work Orders

eBioPlant28

Integration

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Integration

� Material Master

� Inventory

� Batch Quality

� Goods Issues & Goods

&

� Launch Phases

� Send set points

&

� Goods Issues & Goods Receipt

� Production Orders & BOMS

� Send set points

� Get parameters values

� Get critical parameters alarms

� Hygienic states mirroring

� Send IPC analysis requests

� Get IPC analysis results

&

eBioPlant30

Challenges & constraints

MANUFACTURING PROCESS

■ 1st biotech commercial manufacturing plant @ UCB

■ 2 USP streams pooled to 1 DSP (exception handling in case of contamination…)

■ Process Support (Media, Buffers & Stock Solutions)

SCHEDULESCHEDULE

■ Automation deployed and version moving everyday

■ Limited slots for MES deployment

■ «I want it all and I want it now»

eBioPlant31

Challenges & constraints

INTERNAL RESOURCES

■ Biotech team new to UCB (different background & culture)

■ Unclear understanding of what EBR is.

■ Low availability (same people doing everything)

■ IT: new system

EXTERNAL RESOURCES

■ Resources not located onsite. A distributed team of 22 people located in France, India, Romania, US, and Belgium.

eBioPlant32

Roadmap

Thanks!Vincent DelobelVincent Delobel

IT Manager – UCB

Email : Vincent.Delobel@ucb.com

Johan Zebib

Sr. MES Consultant – Emerson

Email : Johan.Zebib@emerson.com

Disclaimer34

This presentation is meant for a general audience, and is not intended for healthcare professionals, patients or patients associations.

This presentation includes “forward-looking statements” relating to UCB group of companies (“UCB”) that are subject to known and unknown risks and uncertainties, many of which are outside of UCB’s control and are difficult to predict, that may cause actual results to differ materially from any future results expressed or implied from the forward-looking statements. In this presentation, the words “anticipates,” “believes,” “estimates,” “seeks,” “expects,” “plans,” “intends” and similar expressions, as they relate to UCB, are intended to identify forward-looking statements. Important factors that could cause actual results to differ materially from such expectations include, without limitation: the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms; the economic environment of the industries in which UCB operates; costs associated with research and development; changes in the prospects for products in the pipeline or under development by UCB; dependence on the existing management of UCB; changes or uncertainties in tax laws or the administration of such laws; changes or uncertainties in the laws or regulations applicable to the markets in which UCB operates. All written and oral forward-looking statements attributable to UCB or persons acting on its behalf are expressly qualified in their entirety by the cautionary statements above. UCB does not intend, or undertake any obligation, to update these forward-looking statements.