to Biotherapeutics Pharmaceutical Sciences Julie Spirk Spry

Transcription

1 An Electronic Laboratory Notebook to Biotherapeutics Pharmaceutical Sciences Julie Spirk Spry

2 Topics of Discussion Acknowledgements Overview of the Landscape Configuring the LabWare eln Adding R&D eln users to a QC-centric LIMS Next Steps & Future Direction 2

3 Acknowledgements James Bauer Michael Parker Charles Demarest Paula Pyrchla John Henrikson Robert Njoroge Justin Kenagy Russell Robins Tim Landewe Arnaud Sartre Franco Pagone Richard Wu 3

4 Overview of the landscape Pfizer BioTherapeutics Pharm Sci eln Needs The Options The Choice Configuring the LabWare eln Adding R&D eln users to a QC-centric LIMS Next Steps & Future Direction 4

5 Acknowledgements Justin Kenagy Charles Demarest Russell Robins Yingping Working Zhang Together for a Healthier World Franco Pagone Paula Pyrchla 5

6 An Aggregation of 25+ Companies! Plaistow Institute Farmaco Biologico Pagni Hickson Int l Plc Gene/Networks Agouron 2000 Pharmacia AB Sugen, Kabi Pharmacia 2003 Kabi Vitrum American Home Products Upjohn Company (1985) Kelco Chemicals (1994) Animal divisions of: A.H Robbins American 2009 Cyanamid SmithKline Beecham Animal Health (1995) Restivo Italiana (1994 through Roerig) Koshin Medical KK (1992) + Vicuron Pharmaceuticals Ltd (2005) Idun Pharma (2005) Apoptech (1994) CSL Ltd Animal Health Unit (2004) 6 The proposals set forth in this message are subject to compliance with all local legal and regulatory obligations, including the obligation to inform and/or consult with labor organizations, works councils, trade unions and employee representatives.

7 BioTherapeutics Pharm Sci Functions Bioprocess R&D Analytical R&D Cell Line Development Culture Process Development Purification Process Development Conjugation and Polytide Process Development Clinical Drug Substance Manufacturing Pharmaceutical R&D Formulations Novel Drug Delivery Clinical Drug Product Manufacturing Bioprocess Characterization and Assay Support Assay Development and Biochemical Characterization Bioassay and Impurity Testing Quality Control, Stability, Microbiology Mass Spec & Biophysical Characterization and Analysis Pharmaceutical Characterization and Assay Support 7

8 BioTherapeutics Pharm Sci eln Needs Capture structured & unstructured data Validated worksheets that perform method specific calculations Journaling and file attachments. Replace the paper notebook. Manage work requests Reduce transcription by parsing instrument data into structured worksheets Worksheet data transparently mapped to LIMS: Samples, Test, Results Ability to query and report data across experiments Stability functionality for GMP & non-gmp Ability to interface with external vendors or CROs ASAP deployment to facilitate collaboration & decrease recording time/scrap book exercise 8

9 The Options 1. Global Pharm Sci traditional eln 2. LIMS / eln single system 9

10 Global Pharm Sci eln Pros Shared validation & support across both BTx & PTx Pharm Sci organizations Traditional eln provides a great User Interface for unstructured data (journaling, attaching files) Cons Dual ldata entry into eln LN&LIMS LIMS or eln & BCD Waiting on Work Request system Waiting on Stability functionality Waiting for queries & reports across experiments Waiting for parsing tool 10

11 LIMS / eln Single System Pros Capture structured & unstructured data Manage work requests Reduce transcription by parsing instrument data into structured worksheets Worksheet data transparently t mapped to LIMS: Samples, Test, Results Ability to query and report data across experiments Stability functionality for GMP & non-gmp Established avenue for CRO data entry Cons Not sharing eln validation & support across Pharm Sci lines Less advanced user interface for unstructured data (journaling, attaching files) 11

12 System Platform Options Single Platform Single system provides ELN / LIMS / BCD functionality ELN vendor LabWare LIMS BCD Significant cost & time to integrate and maintain i ELN ELN LIMS BCD LIMS BCD 12 1

13 13 The Choice

14 Overview of the landscape Configuring the LabWare eln The Team The Plan LabWare eln Functionality Adding R&D eln users to a QC-centric LIMS Next Steps & Future Direction 14

15 Our ImplementationTeam 1. LabWare Developer Configuring LabWare eln Module Developing code to tailor functionality to meet our needs Troubleshooting functionality issues 2. User Engagement Lead Early Adopter Coordinator Super User Trainer User Support Lead 3. Business Lead Requirements Preparation / Harmonization Engagement g Leader Management Engagement & Contracting 15

16 The ImplementationTeam 4. Laboratory Implementation Lead Access in the laboratory via instrument PCs and laptops Network and wireless access Instrument connections Instrument selection within eln experiments Balance integration and the like 5. Validation / Workbook Design Team Validation Team Workgroup Workbook Building Team Support Team Validation Workbook Development Support 16

17 BTxPS eln Activities Q Configure Vanilla eln Early Adopters Vanilla eln Deployment ARD Assay Workbook Development Deploy Work Request 17

18 Vanilla eln functionality Users are able to conveniently locate their open experiments, favorite experiments and experiments for review from the eln Navigation screen (visual workflow) Identifying experimental products & materials with unique ids Experimental write ups Recording materials and equipment File attachments and journaling Routing experiments for review Experimental searching 18

19 19 PS LIMS eln Navigation (Visual Workflow)

20 20 Metadata Overview, Journaling, File Attachments

21 Work Request Functionality t System Requester create samples & assigns testing in their experiment Analyst from supporting analytical group signs up for testing and completes testing in another experiment Results are available to original requestor in their experiment. Requestor log samples & tests in experiment Analyst signs up for testing Analyst completes testing in experiment 21

22 Workbook Building Responsibilities 22 Workbook Team Involvement Workbook Team takes substrate (MS Excel worksheets) to build the eln workbook add parsing in data & mapping to results Create first draft of workbook Modify workbook as advised from SME Testing documentation and migration to Production system SME Involvement Provide initial worksheet substrate Review first draft of eln workbook Test and sign-off on eln workbook Provide modification suggestions to workbook team Expected time of SME involvement is 2-5 hours per worksheet

23 Overview of the landscape Configuring the LabWare eln Adding R&D eln users to a QC-centric LIMS Advantages Logistics Next Steps & Future Direction 23

24 Advantages Advantages achieved from building eln on LIMS platform Single database housing all BTxPS data Existing internal knowledgebase Existing hardware (Servers, Citrix) Pre-existing validated functionality Sample Management Stability Management Environmental Monitoring Pre-existing existing Contract Research Organization (CRO) Interface direct input via the eln or traditional LIMS interface Reporting data from early to late stage project data 24

25 Logistics of adding R&D user to QC LIMS Our original LIMS implementation (prior to the eln) housed only Clinical Release & Stability data (GMP) Product Specification driven samples & tests Vanilla eln built to accommodate unstructured data Replacement for the paper notebook scenario Visual Workflow and Role Up Roles New eln users only see eln functionality QC eln users have both eln and LIMS functionality 25

26 Bringing non-gmp and GMP Worlds Together Like our other enterprise informatics systems, the PS LIMS is a validated GMP system that can now be used by both research & QC users. How the user does his work dictates whether or not the data is GMP data Research & QC users both need the vanilla eln Unstructured data capture The addition of Workbooks to the experiment allow for capture of structured data Mapping data to samples, tests, results Parsed in from instrument files 26

27 Workbook defines flexibility vs. structure 27 Non-GMP Users Formulation Manager used to create material Material named with Experiment ID Ad-hoc samples logged from Formulations > Samples > Tests > Results Flexibility in data retrieval and reporting For example, HPLC the result component Reported Names are dictated by the Empower Process Method GMP Users Products with Product Specifications are used to define Lots > Samples > Tests > Results Product Specification frames the data retrieval and reporting For example, HPLC the product specification defines the result component Reported Names and data pulled from Empower must correspond

28 Overview of the landscape Configuring the LabWare eln Adding R&D eln users to a QC-centric LIMS Next Steps & Future Direction 28

29 2012 Current eln Activities Q Early Adopter Standard eln Deployment ARD Assay Workbook Development Deploy Work Request 29

30 What s next? Connect with our global instrumentation management software to auto-populate p instrument info & calibration data. Add workgroup specific workbooks for each line to improve efficiencies i i & entry of data into database Create reporting and search queries to assimilate data into meaningful comparisons & trending for our users Implement the electronic batch record functionality and the like 30

31 31 Questions