Implementing an ELN

An Electronic Laboratory Notebook
to Biotherapeutics Pharmaceutical Sciences
Julie Spirk Spry
1
2012
Topics of Discussion
2

Acknowledgements

Overview of the Landscape

Configuring the LabWare eLN

Adding R&D eLN users to a QC-centric LIMS

Next Steps & Future Direction
Acknowledgements
3

James Bauer

Michael Parker

Charles Demarest

Paula Pyrchla

John Henrikson

Robert Njoroge

Justin Kenagy

Russell Robins

Tim Landewe

Arnaud Sartre

Franco Pagone

Richard Wu

Overview of the landscape
 Pfizer
 BioTherapeutics
4
 The
Options
 The
Choice
Pharm Sci eLN Needs

Configuring the LabWare eLN

Adding R&D eLN users to a QC-centric LIMS

Next Steps & Future Direction
Acknowledgements
5

Justin Kenagy

Charles Demarest

Russell Robins


Yingping
ZhangTogether for a Healthier World
Working
Franco Pagone

Paula Pyrchla
An Aggregation of 25+ Companies!
1990
+
1997
1998
1999
+
+
+
Hickson
Int’l Plc
Gene/Networks
Agouron
+
Plaistow
Institute Farmaco
Biologico Pagni
Pharmacia AB
1993
1995
+
+
2000
Sugen, 1999
+
1990 +
2003
Kabi Pharmacia
Kabi Vitrum
+
Kelco Chemicals
(1994)
Upjohn Company
(1985)
American Home
Products
6
1987–
1987
–88
1989
1992
1994
+
+
+
+
Animal divisions of:
A.H Robbins
American
Cyanamid
– SmithKline Beecham Animal Health (1995)
– Restivo Italiana (1994 – through Roerig)
– Koshin Medical KK (1992)
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.
2009
– Vicuron Pharmaceuticals Ltd (2005)
– Idun Pharma (2005) — Apoptech (1994)
– CSL Ltd Animal Health Unit (2004)
BioTherapeutics Pharm Sci Functions


7
Bioprocess R&D

Analytical R&D

Bioprocess Characterization
and Assay Support
Purification Process
D
Development
l
t

Assay Development and
Biochemical Characterization

Conjugation and Polytide
Process Development

Bioassay and Impurity
Testing

Clinical Drug Substance
Manufacturing

Quality
Q
lit Control,
C t l Stability,
St bilit
Microbiology

Mass Spec & Biophysical
Characterization and
Analysis

Pharmaceutical
Characterization and Assay
Support

Cell Line Development

Culture Process Development

Pharmaceutical R&D

Formulations

Novel Drug Delivery

Clinical Drug Product
Manufacturing
BioTherapeutics Pharm Sci eLN Needs

8
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,
Samples Test,
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
The Options
9
1.
Global Pharm Sci traditional eLN
2.
LIMS / eLN single system
Global Pharm Sci eLN
Pros


10
Shared
Sh
d validation
lid ti & supportt
across both BTx & PTx Pharm
Sci organizations
Traditional eLN provides a great
User Interface for unstructured
data (journaling, attaching files)
Cons

Duall d
D
data
t entry
t into
i t eLN
LN & LIMS
or eLN & BCD

Waiting on Work Request
system

Waiting on Stability functionality

Waiting for queries & reports
across experiments

Waiting for parsing tool
LIMS / eLN Single System
Pros
11
Cons

Capture structured &
unstructured data

Not sharing eLN validation &
support across Pharm Sci lines

Manage work requests


Reduce transcription by parsing
instrument data into structured
worksheets
Less advanced user interface for
(j
g,
unstructured data (journaling,
attaching files)

Worksheet
o s eet data ttransparently
a spa e t y
mapped to LIMS: Samples,
Test, Results

Ability to query and report data
across experiments
i
t

Stability functionality for GMP &
non-GMP

Established avenue for CRO
data entry
System Platform Options
Single Platform
ELN vendor – LabWare LIMS – BCD
Single system provides
ELN / LIMS / BCD functionality
f
ti
lit
Significant cost & time to integrate and
i t i
maintain
ELN
LIMS
12
BCD
ELN
LIMS
BCD
1
The Choice
13

Overview of the landscape

Configuring the LabWare eLN
 The
Team
 The
Plan
 LabWare
14
eLN Functionality

Adding R&D eLN users to a QC-centric LIMS

Next Steps & Future Direction
Our ImplementationTeam
1.
LabWare Developer
 Configuring
 Developing
LabWare eLN Module
code to tailor functionality to meet our needs
 Troubleshooting
2.
User Engagement Lead
 Early
Adopter Coordinator
 Super
 User
3
3.
functionality issues
User Trainer
Support Lead
Business Lead
 Requirements
 Preparation
/ Harmonization Engagement
g g
Leader
 Management
15
Engagement & Contracting
The ImplementationTeam
4.
5.
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
Validation / Workbook Design Team
 Validation
Team
 Workgroup
 Support
Workbook Building Team
Team
Validation
16
Workbook Development
Support
BTxPS eLN Activities
Q2 2011

2012
Configure
Vanilla eLN
Early
Adopters
2013
Vanilla eLN
Deployment
ARD Assay Workbook
Development
17
Deploy
Work
Request
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
 Recording
 File
materials and equipment
attachments and journaling
 Routing
experiments for review
 Experimental
18
write ups
searching
PS LIMS eLN Navigation (Visual Workflow)
19
Metadata Overview, Journaling, File Attachments
20
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
Workbook Building Responsibilities

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
P
id
modification
difi ti suggestions
ti
to workbook team
22

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 LIMS
 Advantages
 Logistics

23
Next Steps & Future Direction
Advantages

Advantages achieved from building eLN on LIMS
platform
 Single
database housing all BTxPS data
 Existing
 Existing
internal knowledgebase
hardware (Servers, Citrix)
 Pre-existing
validated functionality
– Sample Management
– Stability Management
– Environmental Monitoring
 Pre-existing
Pre existing
Contract Research Organization (CRO) Interface
– direct input via the eLN or traditional LIMS interface
 Reporting
24
data from early to late stage project data
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
 QC
eLN users only see eLN functionality
eLN users have both eLN and LIMS
functionality
25
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

The addition of Workbooks to
the experiment allow for capture
of structured data
 Mapping
 Parsed
26
data capture
data to samples, tests, results
in from instrument files
Workbook defines flexibility vs. structure
Non-GMP Users
l ti M
 F
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
27
GMP Users
 P
Products
d t with
ith P
Product
d t
Specifications are used
to define Lots > Samples >
T t > Results
Tests
R
lt

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
2012 Current eLN Activities
Q4 2011

2012
Early
Adopter
2013
Standard eLN
Deployment
ARD Assay Workbook
Development
29
Deploy
Work
Request
What’s next?
30

Connect with our global instrumentation management
software to auto-populate
p p
instrument info &
calibration data.

Add workgroup specific workbooks for each line to
iimprove efficiencies
ffi i
i & entry
t off d
data
t iinto
t d
database
t b

Create reporting and search queries to
assimilate data into meaningful
comparisons & trending for our users

Implement the electronic
b h record
batch
d functionality
f
i
li

and the like…
Questions
31