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

Transcription

1 ELECTRONIC LABORATORY NOTEBOOKS 27th of March 2007, Frankfurt, Germany ELN as collaborative R&D tool within Lonza's Exclusive Synthesis business Dr. Matthieu Giraud ELN Project Leader, R&D Exclusive Synthesis, Lonza Ltd, Visp (Switzerland)

2 Content Lonza Brief Description R&D Exclusive Synthesis Objectives and Milestones E-Lab journal Lifecycle Integration of LIMS Integration of CDS Summary and future slide 2

3 Lonza Brief Description Lonza is a Custom Manufacturing Organization Predominantly 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 slide 3

4 Lonza Group 2007 Business Portfolio Composition 46% 45% Exclusive Synthesis & Biopharmaceuticals Bioscience Organic Fine & Performance Chemicals 9% 2007 Estimated Sales: CHF 2.8 billion Life sciences portfolio now nearly 90% of sales slide 4

5 Lonzas Life Science Plattform Organic Fine & Performance Chemicals Nutrition Hygiene / Personal Care / Preservation Industrial Specialties Exclusive synthesis & Biopharmaceutical Small Molecules Peptides Biotransformation Mammalian Operations Biopharma Services Microbial Operations Pharma Sales and Marketing Bioscience Media and Sera Rapid Microbial Detection Cell Therapy Research Products slide 5

6 Lonza Global Sites slide 6

7 R&D Environment definition Current R&D Characteristics: Multidisciplinary inter-dependence of research Several geographic sites Hard copy and digital data Critical R&D data is in paper lab notebooks Generate new requirement for: Faster, more effective information access Added security levels Increased inter- and intra-departmental collaboration Global system slide 7

8 LONZA System Architecture Business Sectors Lonza Corporate Functions / Services ERP ERP (SAP R/3) Documentum Management System (Documentum) LIMS (Labsystems, QM) Office Automation (MS-Office, MS-Exchange) Definition of further Lonza wide Information systems Business and Site specific IS Business and Site specific IS Business and Site specific IS Business and Site specific IS Business and Site specific IS DMS LIMS Microsoft Infrastructure Business and Site specific IS Business and Site specific IS slide 8

9 Objectives Management For all users Identical across company Global collaborative solution Smooth transition when people change/leave projects Enhances collaboration Improve quality of data New employee ramp time Intuitive, easy-to-learn Improves efficiency Save time Professional working environment Performing calculation Importing data IT Compatible with our CISWeb / database Easy to install, maintain and upgrade Audit trail Information retrieval from the desktop slide 9

10 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 slide 10

11 ELN: The 3 rd database Document Database Substance Database CIS Nr Reaction Database (ELN) slide 11

12 CISWeb CISWeb is based on ORACLE for the chemistry and text data Three types of Databases Substance Databases Reaction Databases Document 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). slide 12

13 What are the Options? Stay with Lab notebook (kg s of paper) How to search/share information Acquisition of Commercial ELNs system Flexibility, integration in our system? In-House Development Support/capacity? Time/Cost? Outsource Development Support? Time/Cost? LONZA IT slide 13

14 ELN team slide 14 M. Giraud M. Giraud Sopheon Sopheon LCM LCM Chemists Chemists E-Labjournal J.C. J.C. Perlberger Perlberger T. Wyer

15 ELN project with Sopheon Phase 1 Definition of user requirement with our partners Phase 2 Evaluate customization effort of in-house tools User feedback Configuration, local installation and evaluation of Pilot Phase 3 Installation, distribution, documentation and training Feedback slide 15

16 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 * MDL Technicians slide 16

17 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 ) slide 17

18 InfoChem Products InfoChem Chemistry Cartridge for Oracle (ICCARTRIDGE) Integrates chemical structure and reaction retrieval into relational databases Extended SQL commands for access to chemistry data Proprietary specific operators as XSS, SSS, RSS, MSIMFP (for similarity searches), etc. Outstanding indexing performance for millions of structures/reactions slide 18

19 Results Phase 1 Feb 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 capabilities Fast search on experiment properties Free text search Agreed on the interface Team involved Schedule in place * MDL slide 19

20 E-Lab journal Lifecycle: Phase 2 & 3 Archive Entry Creation Share Control & Check out slide 20

21 CIS Web: Document Search slide 21

22 CIS Web: Substance Search slide 22

23 Input of new experiment slide 23

24 Input of Effective Data RCT 1 + RCT 2 - ELN Prod. slide 24

25 External documents could be easily added 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 installation Literature reviews Certificate of Analysis Release sheet slide 25

26 External documents Legal requirements (no e-signature) slide 26

27 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 searchable Document Database Substance Database CIS Nr Reaction Database (ELN) slide 27

28 ELN health New reactions New variations slide 28

29 Trend Reactions Variations slide 29

30 ELECTRONIC LABORATORY NOTEBOOKS Integration of LIMS in ELN

31 LIMS: SampleManager 2002 slide 31

32 How to retrieve LIMS results slide 32

33 How to retrieve LIMS results slide 33

34 How to retrieve LIMS results slide 34

35 How to retrieve LIMS results slide 35

36 How to retrieve LIMS results slide 36

37 Lonza ELN RCT 1 + RCT 2 ELN Prod. slide 37

38 Intermediate step(s)? slide 38

39 Expectations β-version of the CISWeb tool LIMS ID slide 39

40 LIMS integration - status Change request released by the Global LIMS office Tool developed by LONZA IT is working on the test server Test script passed Should be in production in Q If for each variation a ELN user access once to a LIMS results via the LIMS Web tool, we anticipate a ROI of ca per year. In some cases, LIMS ID are easily checked up to 10 times: ROI slide 40

41 ELECTRONIC LABORATORY NOTEBOOKS Integration of CDS in ELN

42 External QC documents RCT 1 + RCT 2 - ELN Prod. slide 42

43 What is CDS? A Chromatography Data System (CDS) is used to control HPLC & GC instruments, chromatography data creation, evaluation and management The 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) slide 43

44 What can be retrieved from Empower Webserver? slide 44

45 Step #1 slide 45

46 Step #2 slide 46

47 Step #3 slide 47

48 Step #4 slide 48

49 Step #5 slide 49

50 Goal: Should be similar to LIMS tool RCT 1 + RCT 2 - ELN Prod. slide 50

51 Capture results from Empower in CISWeb For one single LIMS ID, the user chooses the release results he wants to display slide 51

52 Status Discussion started with Waters in March 06 First quotation received in Mai 06 Search in custom fields Conversion 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 slide 52

53 ELECTRONIC LABORATORY NOTEBOOKS How to remove remaining paper?

54 Hardware support Crystal View Extender is a KVM extending system The CPU (of the office pc) is shared by Crystal View box 300m can separate the cpu and the screen, keyboard and mouse Existing network infrastructure used to share, keyboard, video and mouse signals Desktop remote Acquisition of a cheap cpu unit / screen, keyboard and mouse Use intranet Washable (water/ethanol) keyboard are commercially available slide 54

55 Step to full electronic record slide 55

56 Summary and future 2002 First discussions of an ELN 2003 First version in pilot in LCM (Lonza Custom Manufacturing) 2004 Release in Chemistry in LCM Major upgrade released 200 users 2005 Release in LOC (Lonza Organic Chemicals) 2005 Release in China 2006 Release in Belgium 2007 Q2 Integration to LIMS 2007 Q3 Product Sheet exported directly from ELN Step to full electronic, integration of CDS? slide 56

57 The team Théo Wyer Jean-Claude Perlberger Detlev Worsch Adolar Zimmermann Matthieu Giraud Stefan Potthast Ralf Schulze Andreas Fiebig Uwe Müller Jörg Hochheimer Sittichai Promma Contact: slide 57

58 Greetings slide 58