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An Electronic Laboratory Notebook An Electronic Laboratory Notebook to Biotherapeutics Pharmaceutical Sciences Julie Spirk Spry 1 Julie Spirk Spry 2012
An Electronic Laboratory NotebookAn Electronic Laboratory Notebook to Biotherapeutics Pharmaceutical Sciences
Julie Spirk Spry
1
Julie Spirk Spry
2012
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
Acknowledgements
James Bauer Michael Parker
Charles Demarest Paula Pyrchla
John Henrikson Robert Njoroge
Justin Kenagy Russell Robins
Tim Landewe Arnaud Sartre
3
Franco Pagone Richard Wu
Overview of the landscapePfizerBioTherapeutics Pharm Sci eLN Needs The OptionsThe Choice
Configuring the LabWare eLNConfiguring the LabWare eLN
Adding R&D eLN users to a QC-centric LIMS
Next Steps & Future Direction
4
Acknowledgements
Justin Kenagy Charles Demarest Russell Robins Yingping Zhang Franco Pagone
Working Together for a Healthier WorldWorking Together for a Healthier World
Paula Pyrchla
5
An An Aggregation of 25+ Companies!Aggregation of 25+ Companies!
Plaistow
+ + + +
19901990 19971997 19981998 19991999+
20002000AgouronGene/NetworksHickson Int’l Plc
Institute FarmacoBiologico Pagni
Plaistow
Pharmacia AB Sugen, 19991995199519931993
Kabi Pharmacia
19901990
19951995
+
19931993+ +
+
20032003
1989198919871987––8888 19921992 19941994
Upjohn Company Kelco Chemicals (1994)(1985)
+Kabi Vitrum
American Home
A.H Robbins
+
American Cyanamid
+ + +
Animal divisions of: 20092009
– SmithKline Beecham Animal Health (1995)– Restivo Italiana (1994 – through Roerig)
– Vicuron Pharmaceuticals Ltd (2005)– Idun Pharma (2005) — Apoptech (1994)
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Products Restivo Italiana (1994 through Roerig) – Koshin Medical KK (1992)
Idun Pharma (2005) Apoptech (1994)– CSL Ltd Animal Health Unit (2004)
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.
BioTherapeutics Pharm Sci Functions
Bioprocess R&D Analytical R&D Cell Line Development Culture Process Development Purification Process
D l t
Bioprocess Characterization and Assay Support
Assay Development and Biochemical CharacterizationDevelopment
Conjugation and Polytide Process Development
Clinical Drug Substance
Biochemical Characterization Bioassay and Impurity
Testing Q lit C t l St bilit Clinical Drug Substance
Manufacturing
Pharmaceutical R&D
Quality Control, Stability, Microbiology
Mass Spec & Biophysical Characterization andPharmaceutical R&D
Formulations Novel Drug Delivery Clinical Drug Product
Characterization and Analysis
Pharmaceutical Characterization and Assay
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Clinical Drug Product Manufacturing Support
BioTherapeutics Pharm Sci eLN Needs
Capture structured & unstructured data Validated worksheets that perform method specific calculations 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 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
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ASAP deployment to facilitate collaboration & decrease recording time/scrap book exercise
The Options
1. Global Pharm Sci traditional eLN2. LIMS / eLN single system
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Global Pharm Sci eLN
ProsSh d lid ti & t
ConsD l d t t i t LN & LIMS Shared validation & support
across both BTx & PTx PharmSci organizations
Traditional eLN provides a great
Dual data entry into eLN & LIMS or eLN & BCD
Waiting on Work Request system Traditional eLN provides a great
User Interface for unstructured data (journaling, attaching files)
system Waiting on Stability functionality Waiting for queries & reports
across experimentsacross experiments Waiting for parsing tool
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LIMS / eLN Single System
Pros Capture structured &
Cons Not sharing eLN validation & Capture structured &
unstructured data Manage work requests
Reduce transcription by parsing
Not sharing eLN validation & support across Pharm Sci lines
Less advanced user interface for unstructured data (journaling,
Reduce transcription by parsing instrument data into structured worksheets
Worksheet data transparently
(j g,attaching files)
o s eet data t a spa e t ymapped to LIMS: Samples, Test, Results
Ability to query and report data i tacross experiments
Stability functionality for GMP & non-GMP
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Established avenue for CRO data entry
System Platform OptionsSingle Platform
Single system provides ELN / LIMS / BCD f ti lit
ELN vendor – LabWare LIMS – BCD
Significant cost & time to integrate and i t iELN / LIMS / BCD functionality maintain
ELN ELN
BCDLIMS BCDLIMSBCDLIMS BCDLIMS
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The Choice
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Overview of the landscape
Configuring the LabWare eLNThe TeamThe PlanLabWare eLN Functionality
Adding R&D eLN users to a QC-centric LIMS
Next Steps & Future Direction
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Our ImplementationTeam1. LabWare Developer
Configuring LabWare eLN ModuleDeveloping code to tailor functionality to meet our needsTroubleshooting functionality issues
2. User Engagement LeadEarly Adopter CoordinatorSuper User TrainerSuper User TrainerUser Support Lead
3 Business Lead3. Business LeadRequirementsPreparation / Harmonization Engagement Leader
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g gManagement Engagement & Contracting
The ImplementationTeam4. Laboratory Implementation Lead Access in the laboratory via instrument PCs and laptops Network and wireless access Instrument connections
Instrument selection within eLN experiments– Instrument selection within eLN experiments– Balance integration and the like
5. Validation / Workbook Design TeamValidation TeamWorkgroup Workbook Building TeamSupport Team
ValidationValidation Workbook DevelopmentWorkbook Development SupportSupport
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ValidationValidation Workbook DevelopmentWorkbook Development SupportSupport
BTxPS eLN Activities
Q2 2011 2012 2013Q2 2011 2012 2013
Configure Configure Vanilla eLNVanilla eLN
Vanilla eLN Vanilla eLN DeploymentDeployment
Early Early AdoptersAdopters
ARD Assay Workbook ARD Assay Workbook DevelopmentDevelopment
DeployDeployWorkWork
Request Request
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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 idsIdentifying experimental products & materials with unique idsExperimental write upsRecording materials and equipmentFile attachments and journalingRouting experiments for reviewExperimental searching
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PS LIMS eLN Navigation (Visual Workflow)
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Metadata Overview, Journaling, File Attachments
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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 requestorin their experiment.
Analyst signs up for
testing
Requestor log samples
& tests in
experiment
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Analyst completes testing in
experiment
Workbook Building Responsibilities
Workbook Team InvolvementWorkbook Team takes substrate (MS Excel worksheets) toWorkbook Team takes substrate (MS Excel worksheets) to
build the eLN workbook add parsing in data & mapping to results
Create first draft of workbookCreate first draft of workbookModify workbook as advised from SMETesting documentation and migration to Production system
SME InvolvementProvide initial worksheet substrate Review first draft of eLN workbookTest and sign-off on eLN workbookP id difi ti ti
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Provide modification suggestionsto workbook team
Expected time of SME involvement is 2-5 hours per worksheet
Overview of the landscape
Configuring the LabWare eLN
Adding R&D eLN users to a QC-centric LIMSAdvantagesLogistics
Next Steps & Future Direction
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Advantages
Advantages achieved from building eLN on LIMS platformSingle database housing all BTxPS dataExisting internal knowledgebaseExisting hardware (Servers, Citrix) Pre-existing validated functionality
– Sample ManagementSample Management– Stability Management– Environmental Monitoring
Pre existing Contract Research Organization (CRO) InterfacePre-existing Contract Research Organization (CRO) Interface– direct input via the eLN or traditional LIMS interface
Reporting data from early to late stage project data
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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 Vanilla eLN built to accommodate unstructured dataReplacement for the paper notebook scenario
Visual Workflow and Role Up RolesNew eLN users only see eLN functionalityQC eLN users have both eLN and LIMS
functionality
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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 datathe data is GMP data
Research & QC users both need the vanilla eLNUnstructured data captureUnstructured data capture
The addition of Workbooks to the experiment allow for captureof structured dataMapping data to samples, tests, results
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Parsed in from instrument files
Workbook defines flexibility vs. structure
Non-GMP UsersF l ti M
GMP UsersP d t ith P d t Formulation Manager
used to create materialMaterial named with
Products with Product Specifications are used to define Lots > Samples > T t R ltExperiment ID
Ad-hoc samples logged from Formulations >
Tests > Results
Product Specification frames the data retrieval
Samples > Tests > Results
Flexibility in data retrieval and reporting
frames the data retrieval and reportingFor example, HPLC the
product specificationretrieval and reportingFor example, HPLC the
result component Reported Names are
product specification defines the result component Reported Names and data pulled
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Reported Names are dictated by the Empower Process Method
from Empower must correspond
Overview of the landscape
Configuring the LabWare eLN
Adding R&D eLN users to a QC-centric LIMS
Next Steps & Future Direction
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2012 Current eLN Activities
Q4 2011 2012 2013Q4 2011 2012 2013
Early Early AdopterAdopter
Standard eLN Standard eLN DeploymentDeployment
ARD Assay Workbook ARD Assay Workbook DevelopmentDevelopment
DeployDeployWorkWork
Request Request
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What’s next?
Connect with our global instrumentation management software to auto-populate instrument info & p pcalibration data.
Add workgroup specific workbooks for each line to i ffi i i & t f d t i t d t bimprove efficiencies & entry of data into database
Create reporting and search queries toassimilate data into meaningfulassimilate data into meaningful comparisons & trending for our users
Implement the electronic b h d f i libatch record functionality
and the like…
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Questions
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