The ebioplant. Implementation of an Integrated MES-DCS solution in a new biotech plant. 10 th April 2014

Transcription

1 The ebioplant Implementation of an Integrated MES-DCS solution in a new biotech plant 10 th April 2014

2 Agenda 2 ן UCB UCB at a Glance Focus on Cimzia ן The Edelweiss Project Project Objective Process Description ן The ebioplant Requirements & context MES Systems integration Challenges Roadmap

3 UCB in a Glance

4 UCB: A patient-centric Biopharma leader Focusing on severe diseases in Immunology and the Central Nervous System 4 FY 2012 revenue: million About employees globally Operations in close to 40 countries R&D Spend: ~25% of revenue Listed on Euronext Stephanie, living with rheumatoid arthritis

5 UCB s vision and strategies 5

6 UCB s top products Three core medicines for patients with severe diseases 6 Rheumatoid arthritis & Crohn s disease Epilepsy adjunctive therapy Parkinson s disease Restless legs syndrome

7 Cimzia 7 Cimzia (certolizumab pegol) The only PEGylated anti-tnf Available in 34 countries * More than ** patients on Cimzia worldwide Expected peak sales of at least 1.5 billion *** Audrey, living with rheumatoid arthritis * FY ** Second half of the decade - *** US, Argentina, Brazil, Chili, Mexico, Russia, Switzerland

8 The Edelweiss Project

9 The Edelweiss Project 9 Location Bulle (FR) Switzerland Area is mostly known for its world famous

10 The Edelweiss Project 10 Project Objective Goal To build a commercial production facility for CIMZIA Drug Substance that ensures projected market supply beyond 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.

11 The Edelweiss Project 11 Facts & Project Timelines 5 levels m2 of surface 7000 m3 of concrete 1500 t of steel 22 km of pipes 50 km of cables Fast Track project

12 Manufacturing process Fermentation & primary isolation Production in bioreactors(2 x liters) Bioreactors amplification Flasks amplification Working cell bank (2ml vial) 12

13 Manufacturing process - Purification Harvest Ultrafiltration & Diafiltration Chromatography & pegylation Final bulk product (5.5kg) 13

14 Project

15 15 Manufacturing Operations Released PO PO BOM & Batch Record BOM Masters MRP Batch Record preparation Warehouse (Picking) Training Lab Batch Record Picking List Released Batch Batch Record Dispensed ingredients Recipe SOP Logbook Batch release Manufacturing Weighing & Dispensing

16 16 Manufacturing Operations Actual plant Input materials End Product Hidden plant QC results Master Batch Record MSDS Equipment Logs SOPs Batch Record Deviations

17 17 Vision The plant of the future

18 18 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 PAPERLESS MANUFACTURING EBR & RELEASE ON EXCEPTION TOTAL INTEGRATION WITH AUTOMATION

19 19 IT context Local implementation in a global context SAP ERP deployed globally (Kernel) LIMS being deployed globally (OIL) No automation harmonization No MES harmonization UCB US (Seymour, IN & Rochester, NY): SAP PI sheets Materials trackaing in packaging & PP Belgium & Switzerland: XFP Full EBR in packaging Operations & materials tracking in PP Materials tracking in CP

20 20 MES selection What UCB was looking for 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 1. Resources with good biotech expertise 2. Ability to deliver fast

21 21 Implemented Syncade Functions Material Management Information Management Weigh& Dispense Equipment Logbook Document Management Electronic Batch Record

22 22 What UCB liked in EBR / Recipes Authoring Structured module (ISA88 & 95) Collaborative recipe authoring Recipe simulation ERP LIMS Unified recipe for MES & DCS Control DCS / PLC

23 23 Unified Recipe for MES and DCS

24 24 What UCB liked in Electronic Workflow Ergonomic application - Go to current step - Playback function Manufacturing review - Easy and readable EBR Native EBR with exceptions review

25 25 What UCB liked in Equipment Management Electronic logbook Track equipment usage & status Workflows (used for CIP & SIP)

26 26 EBR Lifecycle EBR EBR EBR Recipe Authoring / Simulation RecipeDocument Review/ Approval Recipe Execution Manufacturing Review MBR EBR

27 27 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. Automatic equipment tracking Hygienic states checked in the recipes, mirrored with DeltaV. Quality Work Orders

28 28 Integration

29 29 Integration & Material Master Inventory Batch Quality Goods Issues & Goods Receipt Production Orders & BOMS & Launch Phases Send set points Get parameters values Get critical parameters alarms Hygienic states mirroring & Send IPC analysis requests Get IPC analysis results

30 30 Challenges & constraints MANUFACTURING PROCESS 1st biotech commercial manufacturing UCB 2 USP streams pooled to 1 DSP (exception handling in case of contamination ) Process Support (Media, Buffers & Stock Solutions) SCHEDULE Automation deployed and version moving everyday Limited slots for MES deployment «I want it all and I want it now»

31 31 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.

32 32 Roadmap

33 Thanks! Vincent Delobel IT Manager UCB Vincent.Delobel@ucb.com Johan Zebib Sr. MES Consultant Emerson Johan.Zebib@emerson.com

34 Disclaimer 34 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.