Post on 22-Jan-2018
FILLING SOLUTIONS
ASEPTIC TECHNOLOGIES
SAFER PARENTERALS
Over the years, BioPharmaceutical companies have taken measures to provide the highest quality to their patient
Consequently, to ensure such level of quality, huge, complex and risky equipment is operated
SAFER PARENTERALS
New products and therapies have imposed new manufacturing and quality challenges
For that reason, Aseptic Technologies has been set up in 2002
SAFER PARENTERALS
For that reason, Aseptic Technologies has been set up in 2002 with the mission to bring innovative solutions to aseptic filling operations.
SAFER PARENTERALS
OUR EXPERTISE
Aseptic Filling Technology (AT-Closed Vial® Technology)
OUR EXPERTISE
Aseptic Filling Technology (AT-Closed Vial® Technology)
OUR EXPERTISE
Manufacturing of Kits and Devices for Aseptic Filling
Aseptic Filling Technology (AT-Closed Vial® Technology)
OUR EXPERTISE
Manufacturing of Kits and Devices for Aseptic Filling
Aseptic Liquid Transfer Systems
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2002 Creation of
Aseptic
Technologies
2003
Presentation of
the concept to
EMA and FDA
2005 Presentation
of validation
results to FDA
2007
Contract filling
approved at AT
by EMA
2009 1st equipment
installed in the
United States
2011 Skan group
collaboration
2013 80% of GSK
vaccines through
AT-Port™
2015
1st equipment
installed in
Japan
2016 100th equipment
installed
2010
1st equipment
installed in
Europe
ASEPTIC TECHNOLOGIES
MILESTONES
Our solutions are for years used for manufacturing of biopharmaceutical products: cell&gene theapies, vaccines, antibodies…
USERS OF OUR TECHNOLOGY
POSITION IN THE WORLD
AT-CLOSED VIAL®
TECHNOLOGY
AT-Closed Vial®
is supplied to
biopharma manufacturer
ready-to-fill and closed
AT-CLOSED VIAL® TECHNOLOGY
CONCEPT
AT-Closed Vial®
is supplied to
biopharma manufacturer
ready-to-fill and closed
And now inside grade A it will be:
1) Filled through the stopper
1
AT-CLOSED VIAL® TECHNOLOGY
CONCEPT
AT-Closed Vial®
is supplied to
biopharma manufacturer
ready-to-fill and closed
And now inside grade A it will be:
1) Filled through the stopper
2) Then re-sealed by a laser
1 2
AT-CLOSED VIAL® TECHNOLOGY
CONCEPT
And now inside grade A it will be:
1) Filled through the stopper
2) Then re-sealed by a laser
3) And capped
AT-Closed Vial®
is supplied to
biopharma manufacturer
ready-to-fill and closed
1 2
AT-Closed Vial®
is filled, capped
and ready for next
processing steps
1 2 3
AT-CLOSED VIAL® TECHNOLOGY
CONCEPT
…offering a solution easy to launch and to scale-up:
with a complete range of vials formats (1-50ml)
AT-CLOSED VIAL® TECHNOLOGY
FILL&FINISH EQUIPMENT
MANUFACTURING OF KITS
AT-FILLING KIT™
Manufacturing of ready-to-use kits and devices for aseptic filling of injectable products AT-Filling Kit™ is • clean assembly of tubing, needle and other elements • supplied in double PE bags, Gamma irradiated • standard or customized
ASEPTIC LIQUID TRANSFER
AT-PORT™
AT-PORT™ a smart connecting system allowing safe liquid transfer across a wall between two areas with different containment classifications
Combined with connector Gamma-Sart™ commercialized by
HIGHLIGHTS AND NEW HORIZONS
HIGHLIGHTS 2016
Our 100th filling equipment installed
First users of AT-Closed Vial ® Technology in Canada and Russia, Scaling-up in Japan
First application of AT-Closed Vial ® Technology in Nanomedicine by Midatech Pharma (ES)
Automated Thawing device by Biocision (US) is available
UPCOMING
…and much more.
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PARC SCIENTIFIQUE CREALYS
Rue Camille Hubert 7 | B-5032 Gembloux | Belgium
T. +32 81 409 465 | F. +32 81 409 41
www.aseptictech.com
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Copyright by Aseptic Technologies S.A., Gembloux, Belgium.
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Aseptic Technologies S.A. These materials may not be reproduced, distributed,
modified, reposted or translated in any form or by any means without the prior written
permission of Aseptic Technologies S.A.
The status of the information, specifications and illustrations in this presentation is
indicated by the date given below. Aseptic Technologies S.A. reserves the right to make
changes to the technology, features, specifications, and design of the equipment
without notice.
Status: January 2017, Aseptic Technologies S.A., Gembloux, Belgium
DISCLAIMER