Implementation of ELN within Synthon ... - PerkinElmer
Implementation of ELN within Synthon ... - PerkinElmer
Implementation of ELN within Synthon ... - PerkinElmer
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CROSS-DISCIPLINE<br />
IMPLEMENTATION OF <strong>ELN</strong> FOR<br />
SYNTHON<br />
BIOPHARMACEUTICALS.
CONTENTS<br />
• A short introduction<br />
• History <strong>of</strong> <strong>ELN</strong> <strong>within</strong> <strong>Synthon</strong><br />
• <strong>ELN</strong> configuration <strong>within</strong> <strong>Synthon</strong><br />
• <strong>Implementation</strong> <strong>of</strong> <strong>ELN</strong> <strong>within</strong> <strong>Synthon</strong> Biopharmaceuticals<br />
• The future<br />
<strong>Synthon</strong>
A SHORT INTRODUCTION<br />
• Bonnie Schutte, 35 years old<br />
• Living together with wife and 5 month old son in Ede,<br />
The Netherlands<br />
1991<br />
<strong>Synthon</strong>
A SHORT INTRODUCTION<br />
• Started in May 2010 as Laboratory Support Officer IT at<br />
<strong>Synthon</strong>.<br />
• Responsible for all lab-related IT <strong>within</strong> <strong>Synthon</strong><br />
Biopharmaceuticals.<br />
1991<br />
<strong>Synthon</strong>
SYNTHON IS WELL ESTABLISHED WITH A STRONG<br />
HISTORY OF SUCCESS<br />
1991 Founded in<br />
The Netherlands<br />
1997 Opened <strong>of</strong>fice in<br />
North Carolina, USA<br />
2001 Acquired API<br />
facility in Argentina<br />
2003 Introduced<br />
simvastatin<br />
2006 Introduced<br />
tamsulosin<br />
2009<br />
• Opened new R&D<br />
and production unit in<br />
the Czech Republic<br />
• Opened <strong>of</strong>fice in<br />
Moscow, Russia<br />
2011<br />
• Acquired Syntarga<br />
and its ADC technology<br />
in The Netherlands<br />
• Opened new<br />
biopharmaceutical lab<br />
in The Netherlands<br />
1991 1993 1995 1997 1999 2001 2003 2005 2007 2009 2011<br />
2013<br />
<strong>Synthon</strong><br />
1993 Launched first<br />
product generic<br />
dobutamine<br />
1994 Opened R&D<br />
facility in Prague,<br />
Czech Republic<br />
1998<br />
2000 Acquired<br />
API production<br />
facility in Blansko,<br />
Czech Republic<br />
• Acquired drug product<br />
manufacturing facility in<br />
Spain<br />
• Opened <strong>of</strong>fice in<br />
Australia<br />
2007<br />
• Acquired<br />
Laboratorios<br />
Rider in Chile<br />
• Launched<br />
Biopharmaceuticals<br />
business<br />
2010<br />
2012 Acquisition <strong>of</strong><br />
LEX System, a biologics<br />
manufacturing platform<br />
• Acquired Laboratorios<br />
Nafar in Mexico<br />
• Opened <strong>of</strong>fice in Jordan<br />
• Opened <strong>of</strong>fice in South<br />
Korea
SYNTHON’S STRATEGIC DIRECTION IS TOWARD SPECIALTY<br />
PHARMACEUTICALS<br />
<strong>Synthon</strong> is on a path toward becoming a recognized global leader in specialty<br />
pharmaceuticals for auto-immune diseases / multiple sclerosis and oncology.<br />
<strong>Synthon</strong>
SYNTHON COMPLETED NEW WORLD CLASS<br />
BIOPHARMACEUTICAL LABS<br />
Located at <strong>Synthon</strong> Headquarters in Nijmegen, Netherlands<br />
New Labs opened in April, 2011<br />
• 6850m 2 gross area<br />
• 2x 1000m 2 lab floor<br />
• 131 working places<br />
• 2400 m 2 <strong>of</strong>fices<br />
• 800 m 2 GMP warehouse<br />
<strong>Synthon</strong>
CONTENTS<br />
• A short introduction<br />
• History <strong>of</strong> <strong>ELN</strong> <strong>within</strong> <strong>Synthon</strong><br />
• <strong>ELN</strong> configuration <strong>within</strong> <strong>Synthon</strong><br />
• <strong>Implementation</strong> <strong>of</strong> <strong>ELN</strong> <strong>within</strong> <strong>Synthon</strong> Biopharmaceuticals<br />
• The future<br />
<strong>Synthon</strong>
HISTORY OF <strong>ELN</strong> WITHIN SYNTHON<br />
Situation in 2006 (pré-<strong>ELN</strong> time)<br />
laboratory journals…<br />
database…<br />
• Project transfers were very time consuming<br />
• No search possibilities<br />
<strong>Synthon</strong>
HISTORY OF <strong>ELN</strong> WITHIN SYNTHON (2)<br />
September 2007:<br />
demonstration<br />
CambridgeS<strong>of</strong>t <strong>ELN</strong><br />
January 2008:<br />
follow-up<br />
discussions and<br />
start setting<br />
requirements<br />
June 2008: pilot<br />
study and<br />
additional<br />
requirements<br />
May 2007:<br />
presentation<br />
Cambridge-S<strong>of</strong>t<br />
<strong>ELN</strong><br />
<strong>Synthon</strong>
HISTORY OF <strong>ELN</strong> WITHIN SYNTHON (3)<br />
June 2009:<br />
Production<br />
candidate for Chem<br />
R&D available<br />
Jul-Dec 2009:<br />
I/OQ for Chem<br />
R&D<br />
Jan 2010: Chem<br />
R&D Live<br />
In 2009 Bio R&D<br />
joined the <strong>ELN</strong><br />
discussions<br />
<strong>Synthon</strong>
HISTORY OF <strong>ELN</strong> WITHIN SYNTHON (4)<br />
July 2010: Final<br />
version for Bio<br />
R&D<br />
Oct 2010-July<br />
2011 IOPQ for<br />
Bio R&D<br />
July 2011: Bio<br />
R&D Live<br />
March 2010:<br />
<strong>Synthon</strong> CZ<br />
joined (Chem<br />
config)<br />
<strong>Synthon</strong>
CONTENTS<br />
• A short introduction<br />
• History <strong>of</strong> <strong>ELN</strong> <strong>within</strong> <strong>Synthon</strong><br />
• <strong>ELN</strong> configuration <strong>within</strong> <strong>Synthon</strong><br />
• <strong>Implementation</strong> <strong>of</strong> <strong>ELN</strong> <strong>within</strong> <strong>Synthon</strong> Biopharmaceuticals<br />
• The future<br />
<strong>Synthon</strong>
<strong>ELN</strong> CONFIGURATION WITHIN SYNTHON<br />
• <strong>ELN</strong> runs on Citrix<br />
- No <strong>of</strong>fline functionality anymore<br />
- Reliable Citrix environment crucial<br />
• Oracle standard with additional Oracle<br />
fail safe<br />
<strong>Synthon</strong>
<strong>ELN</strong> CONFIGURATION WITHIN SYNTHON (2)<br />
Chemical R&D<br />
Nijmegen<br />
Prague<br />
Chem R&D<br />
Blansko<br />
Technology<br />
Blansko<br />
Bio R&D<br />
Bio-analytical<br />
Downstream<br />
Processing<br />
Upstream<br />
Processing<br />
Cell-line<br />
development<br />
<strong>Synthon</strong>
<strong>ELN</strong> CONFIGURATION WITHIN SYNTHON (3)<br />
• Completely separated the configuration <strong>of</strong> the Bio and<br />
Chem departments<br />
• Chem: one configuration is used in four departments on<br />
three different locations<br />
• Bio: each department has its own configuration(s)<br />
<strong>Synthon</strong>
<strong>ELN</strong> CONFIGURATION WITHIN SYNTHON (4)<br />
<strong>Synthon</strong>
HISTORY OF <strong>ELN</strong> WITHIN SYNTHON (5)<br />
<strong>Synthon</strong>
CONTENTS<br />
• A short introduction<br />
• History <strong>of</strong> <strong>ELN</strong> <strong>within</strong> <strong>Synthon</strong><br />
• <strong>ELN</strong> configuration <strong>within</strong> <strong>Synthon</strong><br />
• <strong>Implementation</strong> <strong>of</strong> <strong>ELN</strong> <strong>within</strong> <strong>Synthon</strong> Biopharmaceuticals<br />
• The future<br />
<strong>Synthon</strong>
IMPLEMENTATION OF <strong>ELN</strong> WITHIN SYNTHON<br />
BIOPHARMACEUTICALS<br />
• Reasons for Bio to use the chemical focussed E-<br />
notebook:<br />
- Rapid implementation<br />
- <strong>Synthon</strong> wide harmonization <strong>of</strong> <strong>ELN</strong> s<strong>of</strong>tware<br />
- Use <strong>of</strong> in-place validation documentation.<br />
• For Bio a more biological oriented configuration was<br />
developed.<br />
<strong>Synthon</strong>
IMPLEMENTATION OF <strong>ELN</strong> WITHIN SYNTHON<br />
BIOPHARMACEUTICALS (2)<br />
Testing, piloting<br />
Users start to work in the final pilot<br />
version<br />
IOQ at validation server<br />
IOQ at production server<br />
<strong>Synthon</strong>
IMPLEMENTATION OF <strong>ELN</strong> WITHIN SYNTHON<br />
BIOPHARMACEUTICALS (3)<br />
Migration <strong>of</strong> closed experiments to<br />
production server<br />
PQ1 at production server<br />
Release and go live production Bio<br />
PQ2 and migration <strong>of</strong> open<br />
experiments<br />
<strong>Synthon</strong>
IMPLEMENTATION OF <strong>ELN</strong> WITHIN SYNTHON<br />
BIOPHARMACEUTICALS (4)<br />
2009 Bio joined <strong>ELN</strong><br />
implementation, testing<br />
and piloting<br />
December 2010,<br />
patching validation<br />
server for Simple E-sign<br />
and fixing issues.<br />
Oct 2010 Bio starts with<br />
the I/OQ at validation<br />
server<br />
<strong>Synthon</strong>
IMPLEMENTATION OF <strong>ELN</strong> WITHIN SYNTHON<br />
BIOPHARMACEUTICALS (5)<br />
April 2011:<br />
Start I/OQ at<br />
production server<br />
July 2011:<br />
Restricted release<br />
<strong>ELN</strong><br />
PQ-2<br />
Migration <strong>of</strong> open<br />
experiments<br />
June 2011:<br />
Migration <strong>of</strong><br />
closed<br />
experiments to<br />
production server.<br />
PQ-1.<br />
August 2011<br />
Closure <strong>of</strong> PQ-2<br />
<strong>Synthon</strong>
IMPLEMENTATION OF <strong>ELN</strong> WITHIN SYNTHON<br />
BIOPHARMACEUTICALS (6)<br />
• Delaying factors<br />
• <strong>Implementation</strong> <strong>of</strong> Simple E-sign<br />
• Issues observed during IQ validation server<br />
• Migration <strong>of</strong> a significant number <strong>of</strong> experiments<br />
• Issues and incident during IQ production server<br />
<strong>Synthon</strong>
IMPLEMENTATION OF <strong>ELN</strong> WITHIN SYNTHON<br />
BIOPHARMACEUTICALS (7)<br />
• User experience in validated system:<br />
• The production server is faster than prior sytem<br />
• Simple E-sign got rid <strong>of</strong> rendering during signing<br />
• Users completely want to go paperless<br />
• Some small improvements and issues were suggested and/or<br />
observed.<br />
<strong>Synthon</strong>
IMPLEMENTATION OF <strong>ELN</strong> WITHIN SYNTHON<br />
BIOPHARMACEUTICALS (8)<br />
• Lessons learned:<br />
• Be clear about the objectives <strong>of</strong> the project and do not introduce<br />
“Nice to have” items; instead, try to make optimal use <strong>of</strong> the<br />
functionality <strong>of</strong>fered by the supplier<br />
• Time spent on demo versions should be limited and geared<br />
towards identification <strong>of</strong> pitfalls, bugs and necessary adjustments.<br />
• Move quicly to a validated <strong>ELN</strong> system, e.g. To avoid large<br />
migration events.<br />
<strong>Synthon</strong>
CONTENTS<br />
• A short introduction<br />
• History <strong>of</strong> <strong>ELN</strong> <strong>within</strong> <strong>Synthon</strong><br />
• <strong>ELN</strong> configuration <strong>within</strong> <strong>Synthon</strong><br />
• <strong>Implementation</strong> <strong>of</strong> <strong>ELN</strong> <strong>within</strong> <strong>Synthon</strong> Biopharmaceuticals<br />
• The future<br />
<strong>Synthon</strong>
THE FUTURE<br />
• On short term:<br />
• Solving the small issues and implementing some suggestions <strong>of</strong><br />
users<br />
• On longer term:<br />
• Working on more paperless laboratory by eg tablets, screens in<br />
biosafety cabinets<br />
• Newer version <strong>ELN</strong> with R&D Lims and Bio-assay?<br />
<strong>Synthon</strong>
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