20. Process Technologies
Please define what your
sensors need to measure
- - Product quality
- - media
Before Continuous,
need full
automation of unit
ops
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5
Scenario 2 + 3
2k Batch/Perfusion
Upstream
Does PD have
impact on pdt
quality – start &
end?
+ intensified
------------
Perfusion
[10 days]
+ perfusion
------------
Continuous
Harvest
Media
Seed Train
Production
Bioreactors
Harvest
Facility/
Automation
Consumables
RM
Regulatory
Personal exchange between
Biopharma/Medium vendor to
develop customised medium
Host cell line
development
for Rolling Seed
technology
Closed
Scale-up
Foam-sensing
vision system
for automated
controll
ATF 2k
Fully disposable;
Robustness
Improved
Shaken & Stirred
bioreactor for
high turnaround
- one bioreactor
Improved
filter for
venting
Media most
input on ACQA
Improved media
sterilization
-improved filters
- alternate tech.
2k Batch
Disposable HTST for
media
Other treatments
(virusfilter)
Alternate CO2
removal strategy
to enable O2 only
gassing & no foam
Standard seed
train
1:10 split
More robust
tech.
Better weldevs
½-1”
Improved
foam
reduction
technology
Design product for
high perf mfg
Increase bag
customize speed by
vendor
(ie <2 months)
Number of
ports in bag
Bag reliability;
Lot-to-lot
variability
Minimal bag material
concern (leachables) &
proper control/defect
strategy
Robust bag
packaging &
delivery from
vendor
Economical
single-use
centrifuge
Ergonomic but smallest
possible layout
configurations for lowest
cost facilities
Supporting data for
fully closed
‘connectors’ for use in
non-classified space
EoL
Consolidated list of
compounds/test could lower
cost for academia to research
5g/L
10 day
Seed train &
prod
Closed processing
- Production bioreactor unclassified
- including scale-up
- Downstream bioreacto Class D or E
Process
Automation;
Reduced
intervention
Harvest to
support high
density
Faster
changeover
‘limited’
changeover
Reduce or
eliminate IP
sampling
Implement
disposable
probes
Faster, robust
RM testing /
release
Faster cycle
times
<10d Prod. Brx
Reduced lot-
to-lot
varibaility
Media High
concentrations
Liq-liquid reduced
components
Improved mass
transfer
matches cell
type/density
Robotic cell
scale-up in
isolator
Proper gassing
strategy for high
density process
Reduced cost
of filter for cell
sep.
Improved inline
disp. Sensors
-DO, cell density
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5
Large cell bags
-Robust
-Low temp
-P/T
-automatic dispensing
R-T stable
Media
Microbial
media?
Storage of high
vol. cell bags
Reliable bio-mass
probes (wide
dynamic range)
pH
measurement
w/o offline
correction
Single-use
harvest
technology
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5
Improved
filtration (body
feed)
Acoustic
separator
blank
Robustness
bag film - leaks
Ballroom Concept
- No segregation
classified in F
Reliability of
bag ‘integrity’
Reliability of
bag film
(leachables)
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5
Real-time
release –
1 day
High potency
products
Managing data &
using it to inform
process with
enhanced PAT
tools
Inline
characterization
of product quality
Sensors for
BM+
metabolite
ATF
Disposable
PAT
20 yrs
Sensor
do all-in-1
Ballroom
-closed system
upstream &
downstream
Single
bioreactor
scale-up
100ml-500L
Need simple in-
line conditioning
(not a chromo
skid)
Single use of
ATF for N-1
perfusion
Robust
disposable
pump, not
peristaltic
Real-time
reconstitution
of medium
(powder) -
liquid
Microbial
fermentation/
synthetic biologics
not detailed
Single use, robust,
low cost harvest
tech
10-20g/L
10 day
process
Max. seed
expansion efficiency
(high density cell
bank w/ good vol.)
Multi-product
Parallel
streams
Interchangeable
bags
Not Vendor
Specific
Target MAB
$1/gm
No
changeover
Online
sensors
Raw
materials –
electronic
cofa
Min testing
Same-day
release
Mnimal / No. release
testing
-Qdb, well controlled,
well characterized
process
TOP
5
Minimal
tech
transfer
<1 month
Upstream
Team
20