PROVIDING CHEMISTS WITH THE RIGHT ELN USING A CUSTOM DEVELOPED TOOL

Transcription

1 ELECTRONIC LABORATORY NOTEBOOKS SMI, 30th of January 2008, London PROVIDING CHEMISTS WITH THE RIGHT ELN USING A CUSTOM DEVELOPED TOOL Preliminary rolling out of biologists users: Lessons from LONZA Dr. Matthieu Giraud ELN Project Leader, R&D Exclusive Synthesis, Lonza Ltd, Visp (Switzerland)

2 Content Lonza Brief Description ELN: Global tool Environment Definition Objectives and Milestones Legal aspects Integration of LIMS Sharing best practice with our customers Preliminary Rolling Out in Microbio-Department 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 2.87 billion in 2007 Lonza operates 26 production and R&D facilities around the world and employs over people slide 3

4 Our global production sites enable us to serve customers worldwide Williamsport Mapleton Rockland Portsmouth Verviers, BE Slough, UK Braine, BE Porriño, SP Copenhagen, DK Kouřim, CZ Visp, CH Walkersville Hopkinton Conshohocken Saint-Beauzire, FR Liyang Guangzhou / Nansha Singapore Key Custom Manufacturing Life Science Ingredients Bioscience Custom Manufacturing & Life Science Ingredients slide 4

5 Chemical and biotech synergies create innovative manufacturing pathways Chemistry Biochemicals Biotechnology Advanced Chemical Synthesis Biosynthesis Biotransformation Biocatalysis Therapeutic proteins Monoclonal antibodies Fine Chemicals (LSI) Small Molecules Peptides & Oligonucleotides Microbial Fermentation Microbial Biopharma Mammalian Cell Culture Cell Therapy (LBS) Need for inter- and intra-departmental collaboration tool slide 5

6 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 6

7 ELN 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 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 CISWeb: Web-based Chemical Information System CISWeb is based on ORACLE for the chemistry and text data 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 9

10 ELN: The 3 rd database Document Database Substance Database CIS Nr Reaction Database (ELN) slide 10

11 What were 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 (CIS Web databases)? In-House Development IT support / capacity? Time / Cost? Outsource Development Support? Time/Cost? LONZA IT slide 11

12 ELN team slide 12 M. Giraud M. Giraud Sopheon Sopheon E-LabNotebook A. Dietz A. Dietz Super Super-Users Users D. Rohr

13 ELN project with Sopheon Phase 1 Definition of user requirements with our partners Phase 2 Evaluate customization effort of in-house tools Users feedback Configuration, local installation and evaluation of Pilot Phase 3 Installation, distribution, documentation and training Feedback ( ) slide 13

14 ELECTRONIC LABORATORY NOTEBOOKS Legal Environment of ELN See Dr. Michael Kompter, Boehringer Ingelheim GmbH IQPC Frankfurt 2007

15 IP Protection First to invent United States First to invent The Rest of the World First to file United States awards patent rights to the first to invent. Other countries award to the first to file their patent application slide 15

16 Legal Approach at LONZA We have chosen the hybrid approach. No electronic signature! Several cases are possible: The experiment will be potentially involved in a patent. It is recommended that hard copies of electronic records be printed out and the printouts signed and dated by the technician / a non-inventor witness The experiment is involved in qualification work (LONZA SOP: each document should be signed e.g. procedures, chromatograms ) Others: no signatures, but strongly recommended! slide 16

17 Criteria for ELN Success Web pages ISIS* Draw for chemical data entry CISWeb application for entries of chemical reaction with CIS Nr InfoChem Chemistry Cartridge for Oracle (ICCARTRIDGE) Need additional development for the display of peptides * MDL slide 17

18 Owner Co-owner - Operator Security level (Administrator / Chemist / technicians) Owner all right Co-owner similar right as Owner can not delete a reaction Operators can not delete a reaction can not add/delete condition parameters can assign other operators can create/clone new variation slide 18

19 Criteria for ELN Success phase 1 Hybrid Approach 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 19

20 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 Local team involved (Visp / Switzerland) * MDL slide 20

21 CIS Web: Doc and Substance Search slide 21

22 Input of new experiment slide 22

23 Create New Reaction We recommend to fulfill the mass balance 2 options: A + B C Option A Option B slide 23

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

25 Planned - Effective Planned material: Are entered to prepare the daily experiments. Data exported to create the Product Sheet Request from our customers to receive process description in English. Our Master Batch Records (MBRs) are in German, Chinese, French, ) How?: ELN allows mapping of data into MS-office documents (Excel ): Avoid redundant work. Time saved Product sheet slide 25

26 Planned - Effective Effective: The amount effectively weighed at the balance Are needed for the yield calculation All electronic data from ELN within a reaction are ready to be exported in excel (extremely useful for optimization work) slide 26

27 External Documents could be easily added Availability to import various data types from many sources / disciplines Experimental protocols (Word, scanned doc, directly in ELN) Analysis (HPLC, NMR, GC) Pictures / draw of the installation Literature Reviews Certificate of Analysis Release sheet slide 27

28 External Documents Legal requirements (no e-signature) slide 28

29 Electronic Procedure slide 29

30 Electronic Procedure slide 30

31 ELN Health 15'000 New reactions each year New variations each year 10'000 5' slide 31

32 Trend LONZA Reactions LONZA Variations Average of 10 variations (experiments) per reaction slide 32

33 Optimization Work What are the options if I want to repeat an experiment: Only the reactants (e.g. A & B) are identical Use new reaction A + B C Reactants /reagents /solvents are identical, only physical parameters are changed (e.g. temperature, ph ) Use clone slide 33

34 ELECTRONIC LABORATORY NOTEBOOKS Integration of LIMS in ELN

35 LIMS: SampleManager 2002 slide 35

36 How to retrieve LIMS results slide 36

37 How to retrieve LIMS results slide 37

38 Expectations LIMS Web Access LIMS ID slide 38

39 Lonza ELN RCT 1 + RCT 2 ELN Prod. slide 39

40 LIMS integration - status Change request released by the Global LIMS office Tool developed by LONZA IT Test script passed If for each new 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 Sharing Best Practice

42 We work with some of the most influential businesses in the world slide 42

43 ELECTRONIC LABORATORY NOTEBOOKS Preliminary Rolling Out in Microbio-Department

44 Expectations Faster, more effective information access Save time Retrieval from the desktop Increased inter- and intra-departmental collaboration Global system Enhances collaboration Improve quality of data Flexibility slide 44

45 ELN Developed for Chemist: a Good Start? First quick answer: No way, too far away from our needs! Strategy: Play around with LONZA ELN and come back with feedback and custom field requirements. Define way forward. After 2 month trials: only few add-on on the table Addition of new fields (customer, conclusion, hyperlinks) but no need for real IT development All new project are now using ELN New Bio-Super-User on board slide 45

46 Example slide 46

47 Example slide 47

48 Way Forward Expand ELN to Microbio Down Stream Process team in Visp (CH) Share best practice with Slough (UK, mammalian production and development). Implementation of ELN? Define new add-on to have a more user friendly interface SOPs Go full electronic slide 48

49 Summary 2002 First discussions 2003 Piloting in LCM (Lonza Custom Manufacturing) 2004 Release in LCM - Chemistry Major upgrade 200 users 2005 Release in China & LOC (Lonza Organic Chemicals) 2006 Release in Belgium 2007 Connection with LIMS 2006 Release in Riverside (US) 2007 Rolling out in Microbio-Department slide 49

50 The ELN Team Denise Rohr Andreas Wietz Detlev Worsch Adolar Zimmermann Matthieu Giraud Super-Users Belgium: G. Sommen, T. Happaerts US: L. Rhyne China: L. Song, X. Liu Switzerland K. Meilert, O. Krebs, E. Vogel, S. Eyer Biotec: C. Jungo ORD: W. Wenger Stefan Potthast Ralf Schulze Andreas Fiebig Uwe Müller Jörg Hochheimer Sittichai Promma Contact: slide 50

51 Questions slide 51

52 Greetings slide 52

53 ELECTRONIC LABORATORY NOTEBOOKS Backup slides

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 Digital pen (Destiny) slide 54

55 Step to full electronic record slide 55