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Advanced Cell Therapies
Challenges and Solutions
for GMP manufacturing
Topics
Advanced Cell Therapies:
Trends and Challenges
Manufacturing Options:
Isolator or Clean Room?
Comecer Isolation Technology
Trends and Challenges
Advanced Cell Therapies
ACT Trends
ACT Challenges
Compliance Safety
Reproducibility Effectiveness
ACT Challenges
Compliance
GMP
Guidelines
Directive
2003/94/EC
Safety
Risk
Elimination
Sterility
assurance
Cross-
contamination
avoidance
Reproducibility
Minimize
operator tasks
Eliminate
unexpected
situations
Reduce
workload
Effectiveness
Easy
scalability
Manufacturing Options
Advanced Cell Therapies
Isolator or Clean Room?
Isolation Technology is well known in
pharmaceutical industry
• To manage HAPI (Highly Active Pharmaceutical
Ingredients)
• To test batch sterility in pharma preparations
• To aseptically dispense ingredients among different
preparations
• To aseptically prepare non sterilizable formulations
• To conduct Research & Development
Isolation Technology is a path from user
requirements to validation
UNDERSTAND SHARE SKETCH DISCUSS
GENERAL
DESIGN
DISCUSS
DETAILED
DESIGN
DISCUSS
MANUFACTURE FAT INSTALL
SAT –
IQ/OQ
Asepsis and containment can coexist
with isolation technology
ASEPSIS:
protect product
from operator’s environment
• Physical and Aerodynamic
Barrier (positive pressure)
• Clean ability
• Special attention to critical
areas
• Powerful Decontamination
• Environmental Monitoring for
Class A
CONTAINMENT:
protect operator
from product
• Physical and Aerodynamic
Barrier (negative pressure)
• Clean ability
• Precautions for filter
replacements
• Powder handling
• Explosion proof
Layout differences
Isolator:
all-in-one approach
Clean Room:
cascade approach
Space occupancy
Isolator
• Lower footprint
• Less classified area
• Lower investment per square
meter of classified area
• No airlocks
Clean Room
• Higher footprint and
space requirement
• Larger classified area
• High investment per square
meter of classified area
• Needs airlocks
Time management
Isolator
• Fast access
• Faster personnel
• Modularity provides higher
throughput
Clean Room
• Slow access
• Slower personnel
• Fixed configuration gives
lower throughput
Control Management
Isolator
• Easy validation given
small space
• Easy microbio control
• Reduced number of SOP
and training needs
Clean Room
• Complex validation of large
and different spaces
• Complex microbio control
• Huge SOP and training needs
Sanitization management
Isolator
• One product strategy:
H2O2 vapour sterilization
• Easy pass-through sterilization
with H2O2
• Largely automated process
Clean Room
• Complex cleaning procedures
for A and B areas
• Uses many products
• Fully manual process
Operational costs of an isolator are
significantly lower than a clean room
Running costs of an isolator are
one-third of those of a clean room
0 10000 20000 30000
Gowning
Micro Bio Control
Sanitization
Electricity
Hepa Filters
Gloves
Validation
Isolator Clean Room
(Cost estimates expressed in Euro)
Isolation technology is mentioned
in GMP Annex I, 21
“The utilization of isolator technology to minimize
human interventions in processing areas may result
in a significant decrease in the risk of microbiological
contamination of aseptically manufactured products.”
Our isolation technology
ACT manufacturing with a Comecer Isolator
Custom
design
Flexibility Incubator
Lab
in a box
Custom design
Flexible configurations
2, 3 and 4 glove modules
Flexible combinations
An incubator module in grade A environment
Entire volume
(up to 400 l)
accessible from
the interior of
the isolator
through 8 small
doors.
Each door
contains two
extractable
trays.
“Lab in a box”
Storage
Refrigerator
Microscope
Centrifuge
Transfer
Hatch
Viable &
Non-Viable
Monitoring
Integration of all critical areas under
isolation technology for ACT
Acceptable
Convenient
Beneficial to procedure
Cost effective
A revolution for GMP manufacturing
Isolators can be installed in a class D environment,
while being validated internally as Class A.
This fundamental ability is what primarily constitutes
the revolution of this technology compared to the
classical clean room approach.
Advanced Cell Therapies - GMP Manufacturing
Advanced Cell Therapies - GMP Manufacturing
Advanced Cell Therapies - GMP Manufacturing

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