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

100

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.

All rights reserved. All text, images, graphics, animation, videos, and other materials on

this document are subject to the copyright and other intellectual property rights of

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