Presentation made at the PDA Advanced Therapy Medicinal Products introducing an integrated equipment based on the Closed Vial to scale-up the manufacturing of an allogeneic product or deploy/scale-out for an autologus.

1. PDA: A Global
Association
Scaling-up for
Commercial
Manufacturing of an
Allogeneic Product
PDA ATMP, VU Amsterdam
June 2, 2015
Jean-Sébastien Parisse

2. Agenda
2
Aseptic Technologies’ Overview
Position in ATMPs
Requests from users
Scaling up with AT Box

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Created in 2002 as a spin-out of GSK Biologicals
Developped and industrialized the concept of a ‘pharmaceutical closed
container, filled through the septum, which is resealed by heat’
Since 2011, SKAN A.G. as main share-holder
COMPANY
AT Overview

4. 4
CLOSED VIALS
CLOSED VIAL FILLING LINES
Produced in ISO5 clean room with the stopper in
place and secured
Sterilized by gamma irradiation prior release and
delivery
Filling performed by a specific needle piercing the
stopper
Stopper immediately re-sealed by laser
Capping (snap-fit) inside the barrier
AT Overview
CONCEPT OF THE CLOSED VIAL TECHNOLOGY

5. 5
AT Overview
CLOSED VIAL
Particularly suitable for :
- toxic products and high value products
- very low temperature storage
- products sensitive to alkali and/or
metal ions
Vial body made of COC
Stopper made of TPE
Hydrophobic material preventing from
electrostatic interactions
Specially designed stopper minimizing
loss of residual volume
Unbreakable vial
Sizes from 1 to 50 ml

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AT Overview
CLOSED VIAL FILLING LINES
Lean manufacturing eliminates most
complex steps of aseptic filling:
no WFI washing
no hot-air tunnel
no siliconization
no stoppering
no crimping
Limits risk of batch rejection thanks to
lean manufacturing
Secures potent and high-value products
Easily scalable, from manual to fully
automated high-speed fillers
Closed Vial Technology drastically
simplifies aseptic filling operations

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ATMP USERS
2009 2010 2011 2012 2013 2014 2015
Position in ATMPs

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ATMP STORAGE CONTAINERS
Opaque materials (no visual inspection)
Intrinsic particles
Difficult to scale up (no automation)
Subject to breakage during
handling/transportation
Important dead volume
Position in ATMPs

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ATMP STORAGE CONTAINERS
Container Closure Integrity
Position in ATMPs

10. 10
ATMP STORAGE CONTAINERS
Container Closure Integrity
Position in ATMPs

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ATMP CLOSED VIAL USERS
Closed and scalable
vpLN2 resistant container
Enables visual inspection
Cell viability and recovery
Autologus and Allogeneic
In Phase II or Phase III
Position in ATMPs
DRIVERS
CHARACTERISTICS

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GENERAL REQUESTS FROM USERS
Solution for bulk product homogenization
Limited product loss in the process
Closed system, rapid operations to minimize contact time with DMSO
Visual inspection (not blood, reach pharma?)
Track&Trace solution
Easy to scale-up for allogeneic or deploy (scale-out) for autologus
Position in ATMPs

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SCALING-UP (OUT) WITH AN INTEGRATED PROCESSING EQUIPMENT
Simple isolator, in positive
pressure with HEPA filters
Air from/to the room
<20 min cycles
Catalitic converter to capture
H2O2
Robotic L1 equipment for up to
600 Closed Vials per hour
www.aseptictech.com
Scaling up with AT Box

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UPSTREAM INTEGRATION
The α/β connection system for liquid
transfer across the isolator enables to
remove the agitation system (wave-
induced or mechanical) and pump out
of the critical area
Using smart filling kit allowing in-line
measurements
viability
morphology
clusters
and cell-count
Scaling up with AT Box

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DOWNSTREAM INTEGRATION
Using RFID-embedded caps, vials can
be individually identified and tracked
Direct information (product name,
batch number, expiry date) and link
pointing to any file stored in the cloud
vpLN2 resistant tag allows tracking and
inventory management in the
Controlled Rate Freezer, storage
dewar and during shipping to the
patient
Scaling up with AT Box

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TRACK AND TRACE FROM MANUFACTURING TO THE BED SIDE
Secured data logged in the RFID tag
Readable any time thanks to Near
Field Communication (NFC) devices
Real-time indication of use available
at the Point Of Care (POC) during the
thawing and injection
Scaling up with AT Box

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changes to the technology, features, specifications, and design of the equipment
without notice.
Status: June 2015, Aseptic Technologies S.A., Gembloux, Belgium