eln as collaborative r&d tool within lonza's exclusive synthesis business

ELN as collaborative R&D tool within Lonza's Exclusive Synthesis business

ELECTRONIC LABORATORY NOTEBOOKS27th of March 2007, Frankfurt, Germany

Dr. Matthieu GiraudELN Project Leader, R&D Exclusive Synthesis, Lonza Ltd, Visp (Switzerland)

Content

Lonza Brief DescriptionR&D Exclusive SynthesisObjectives and MilestonesE-Lab journal LifecycleIntegration of LIMSIntegration of CDSSummary and future

Lonza Brief Description

Lonza is a Custom Manufacturing OrganizationPredominantly life sciences driven company headquartered in Basel (Switzerland)Sales of CHF 2.91 billion in 2006 Lonza operates 26 production and R&D facilities around the world and employs over 7100 people

Lonza Group 2007Business Portfolio Composition

46%

9%

45%

Exclusive Synthesis &Biopharmaceuticals

Bioscience

Organic Fine &PerformanceChemicals

2007 Estimated Sales: CHF 2.8 billionLife sciences portfolio now nearly 90% of sales

Lonzas Life Science Plattform

Organic Fine & Performance

ChemicalsExclusive synthesis & Biopharmaceutical

Nutrition

Hygiene /Personal Care /

Preservation

IndustrialSpecialties

Small Molecules

Peptides

Biotransformation

Bioscience

Mediaand Sera

Rapid MicrobialDetection

Cell Therapy

Research Products

MammalianOperations

BiopharmaServices

MicrobialOperations

Pharma Sales and Marketing

Lonza Global Sites

R&D Environment definition

Current R&D Characteristics:Multidisciplinary inter-dependence of research Several geographic sitesHard copy and digital dataCritical R&D data is in paper lab notebooks

Generate new requirement for:Faster, more effective information accessAdded security levels Increased inter- and intra-departmental collaborationGlobal system

Infrastru

cture

LONZA System Architecture

Lonza

Business SectorsCorporate

Functions / S

ervices

ERP

ERP (SAP R/3) DMS

Documentum Management System (Documentum) LIMS

LIMS (Labsystems, QM) Microsoft

Office Automation (MS-Office, MS-Exchange)

Definition of further Lonza wide Information systems

Businessand Site

specific IS

Businessand Site

specific IS

Businessand Site

specific IS

Businessand Site

specific IS

Businessand Site

specific IS

Business

and Site

specific IS

Business

and Site

specific IS

ObjectivesIdentical across companyGlobal collaborative solutionSmooth transition when people change/leave projectsEnhances collaborationImprove quality of dataNew employee ramp time

For all users

Management

Compatible with our CISWeb / databaseEasy to install, maintain and upgradeAudit trailInformation retrieval from the desktop

IT

Intuitive, easy-to-learnImproves efficiencySave timeProfessional working environmentPerforming calculationImporting data

CISWeb: Web-based Chemical Information System

Contains the collection of chemical substances used at Lonza Each substance has a CIS-Nr (number ID)Contains substance information like structure, abbreviation, names, synonyms Shows which documents contains information concerning these substances Enables full document access as appropriate depending on reading rights

ELN: The 3rd database

Document Database Substance Database

Reaction Database(ELN)

CIS Nr

CISWeb

CISWeb is based on ORACLE for the chemistry and text data Three types of Databases

Substance DatabasesReaction DatabasesDocument Databases with / without CIS numbers

Each Database of each type can be searched solely or in any combination together with other databases (multiple database search).

What are the Options?

Stay with Lab notebook (kg’s of paper)How to search/share information

Acquisition of Commercial ELNs systemFlexibility, integration in our system?

In-House DevelopmentSupport/capacity?Time/Cost?

Outsource DevelopmentSupport?

Time/Cost?

LONZA IT

ELN team

LCM Chem

ists

LCM Chem

ists Sopheon

Sopheon

M. G

iraud

M. G

iraud

J.C. J.C. PerlbergerPerlberger

T. T. W

yerW

yer

EE--LabjournalLabjournal

ELN project with Sopheon

Phase 1Definition of user requirement with our partners

Phase 2Evaluate customization effort of in-house toolsUser feedbackConfiguration, local installation and evaluation of Pilot

Phase 3Installation, distribution, documentation and trainingFeedback

Criteria for ELN Success

Using internet web pages

Using ISIS* Draw for chemical data entry

Using InfoChem Cartridge

Using CISWeb application for entries of chemical reaction with CIS Nr

Security level (Administrator / Chemist / technicians)

Administrator / SuperUser

Chemists

Technicians* MDL®

Criteria for ELN Success phase 1

Hybrid Approach (Attached scanned documents signed by witness)Accommodates daily research and experiment changes All experiments are globally accessible (even if not finished)Preparation of experiment:

planed mode (preparation of the reaction by the chemist)Input of the data

Effective mode (filled by the technicians)Copy existing experiment as template (cloning mode for the optimization work) Export data from reaction to Excel (overview, reporting…)

InfoChem Products

InfoChem Chemistry Cartridge for Oracle (ICCARTRIDGE)

• Integrates chemical structureand reaction retrieval intorelational databases

• Extended SQL commands foraccess to chemistry data

• Proprietary specific operators asXSS, SSS, RSS, MSIMFP (forsimilarity searches), etc.

• Outstanding indexing performancefor millions of structures/reactions

Results Phase 1

Feb-2002. Main functions defined (similar to paper-notebooks, maximum freedom, ability to include objects (chromatograms, photos, excel-sheets etc…)Standard within Lonza: Oracle, CISWeb, ISIS*Full chemical search capabilitiesFast search on experiment propertiesFree text searchAgreed on the interfaceTeam involvedSchedule in place

* MDL®

E-Lab journal Lifecycle: Phase 2 & 3

Entry Creation

Control & Check outShare

Archive

CIS Web: Document Search

CIS Web: Substance Search

Input of new experiment

Input of Effective Data

RCT 1 + RCT 2 - ELN Prod.

Availability to import various data types from many sources/disciplines

Experimental protocols (in Word or scanned doc.)Analysis (HPLC, NMR, GC)Pictures / draw of the installationLiterature reviewsCertificate of AnalysisRelease sheet

External documents could be easily added

Legal requirements(no e-signature)

External documents

Search with the new interface

All versions of ELN entries are safely stored and searchable in the “original form” in read only mode

Full incorporation into our LONZA CISWeb system:

All other documents stored in the CISWeb such as call

report, R&D report, protocols, analytical methods, etc are

safely stored and searchableDocument Database Substance Database

Reaction Database(ELN)

CIS Nr

ELN health

0

5000

10000

15000

20000

25000

2004 2005 2006 2007 2008 2009

New reactions New variations

Trend 2004 - 2007

4572373 700

48081622

13818

2714

26508

0

5000

10000

15000

20000

25000

30000

2004 2005 2006 2007

ReactionsVariations

Integration of LIMS in ELN

ELECTRONIC LABORATORY NOTEBOOKS

LIMS: SampleManager 2002

How to retrieve LIMS results


205480

Lonza ELNRCT 1 + RCT 2 ELN Prod.

Intermediate step(s)

?

LIMS ID

Expectations β-version of the CISWeb tool

LIMS integration - status

Change request released by the Global LIMS officeTool developed by LONZA IT is working on the test serverTest script passedShould be in production in Q2 2007If for each variation a ELN user access

once to a LIMS results via the LIMS Web tool, we anticipate a ROI of ca 15’000 € per year.In some cases, LIMS ID are easily checked up to 10 times: ROI ☺

Integration of CDS in ELN


External QC documents


What is CDS?

A Chromatography Data System (CDS) is used to control HPLC & GC instruments, chromatography data creation, evaluation and managementThe CDS can be accessed via Internet in a secure way through the Terminalserver making it possible to fully control and administer the system from anywhere Instrument control, administration or data evaluation can be performed from any PC with access to the LONZA net (user must have appropriate application user privileges)

What can be retrieved from Empower Webserver?

Step #1

Step #2

Step #3

Step #4

Step #5

Goal: Should be similar to LIMS tool


Capture results from Empower in CISWeb

For one single LIMS ID, the user chooses the release results he wants to display

Status

Discussion started with Waters in March 06First quotation received in Mai 06

Search in custom fieldsConversion of Empower data into JCAMP

In September, initial offer was killed by Waters (new policy)No new solution/proposal received as of today by Waters Project on hold

How to remove remaining paper?


Hardware support

Crystal View Extender is a KVM extending systemThe CPU (of the office pc) is ‘shared’ by Crystal View box300m can separate the cpu and the screen, keyboard

and mouseExisting network infrastructure used to share, keyboard, video and mouse signals

Desktop remoteAcquisition of a cheap cpu unit / screen, keyboard

and mouseUse intranet

Washable (water/ethanol) keyboard are commercially available

Step to full electronic record

Summary and future

2002 First discussions of an ELN2003 First version in pilot in LCM (Lonza Custom Manufacturing)2004 Release in Chemistry in LCM2004 - 2005 Major upgrade released – 200 users2005 Release in LOC (Lonza Organic Chemicals)2005 Release in China2006 Release in Belgium2007 Q2 Integration to LIMS2007 Q3 Product Sheet exported directly from ELN2008-2009 Step to full electronic, integration of CDS?

The team

Théo WyerJean-Claude PerlbergerDetlev WorschAdolar ZimmermannMatthieu Giraud

Contact: [email protected]

Stefan PotthastRalf SchulzeAndreas FiebigUwe MüllerJörg HochheimerSittichai Promma

Greetings

eln as collaborative r&d tool within lonza's exclusive synthesis business

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