BioProcess Product Guide - GE Healthcare Life Sciences

Products for process development
7
GE Healthcare supports all stages of the
drug development process, from early
discovery to the development of clinical
material and the final transfer to fullscale
production. Process development,
the design and scale-up of a process
for clinical production, is supported by
numerous products and services.
High-throughput process development
(HTPD) is a method that shortens
development time and increases
the amount of information available
during early process development.
PreDictor 96-well filter plates, prefilled
with GE Healthcare BioProcess
chromatography media, support
HTPD by allowing parallel screening of
chromatographic conditions, either in a
manual or in an automated workflow. As
a result, a large number of experimental
conditions may be evaluated
simultaneously, with minimal sample
consumption. Assist software supports
the PreDictor workflow from set-up of
experimental design to data evaluation.
PreDictor RoboColumn units are mini
columns prepacked with GE Healthcare
BioProcess chromatography media.
When used together with a robotoic
system such as Tecan, PreDictor
RoboColumn units perform automated
parallel screening of media and process
conditions with minimal sample
consumption.
There are different types of prepacked
columns containing various types of
BioProcess media. The 10 cm bed height
HiScreen columns contain media from
the Capto, Capto ImpRes, and MabSelect
families, as well as Sepharose Fast Flow
and Sepharose High Performance.
ÄKTA avant and ÄKTApilot are
members of the ÄKTA family of
chromatography systems and are
well-suited for process development.
As well as operating a wide range of
prepacked columns, ÄKTA avant can
also operate HiScale, FineLINE Pilot 35,
and AxiChrom 50 columns. FineLINE 70,
AxiChrom 50, 70, and 100, and BPG 100
can be connected to ÄKTApilot. The
control software for ÄKTA systems
is UNICORN, which can also be
used for pilot-scale systems and
full production. UNICORN combines
the flexibility needed for method
and process development with the
stringent requirements for commercial
manufacture of biopharmaceuticals.
ReadyToProcess is our platform of
ready-to-use products, engineered
for convenience and speed. The
product line is designed to meet the
biopharmaceutical industry’s need for
increased flexibility and Lean enabling
solutions – from cell culture and
fermentation to purification and final
filling. ReadyToProcess products include
WAVE Bioreactors, WAVE Mixer, fluid
handling as well
as ready-to-use
filtration and
chromatography
solutions.
For more
information on
ReadyToProcess
products, see
pages 34–72.
Process development
Lead
identification
Research
Pre-clinical testing
Process Development
Clinical phase
I
Clinical phase
II
Process Dev
Pilot Scale
Clinical phase
III
Marketing
approval
Market
introduction
GMP Production
PreDictor formats
HiTrap/HiScreen
HiScale
ReadyToProcess
AxiChrom
GE Healthcare’s formats for process development through manufacturing.
152 www.gelifesciences.com/bioprocess