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for the production of material for toxicological

rug Discovery Today • Volume 16, Numbers 23/24 •

ethod on the LabChip GXII for the analysis

f low molecular weight proteins when inte-

rated with the ready to use reagents not only

implifies the sample to answer paradigm but

emoves critical bottlenecks in the quality by

he design of experiments. We describe the

rotocols for a robust protein assay and show

uantitative analysis of EGF and VEGF illustrat-

ng the resolution, the speed, and ease of use

or high throughput screening in early stage

evelopment of biopharmaceuticals.

oi:10.1016/j.drudis.2011.10.015

oster 10nnovative automated small scale par-llelized biochromatography for highhroughput method development inownstream processing

im Schroeder , Jürgen Friedle

Atoll GmbH, Ettishofer Straße 10 D-88250

eingarten, Germany

A new platform technology has been devel-

ped which enables 96 array format column

hromatography. The design allows the user

o select any chromatographic material that is

acked with due consideration to individual

aterial compression requirements. Bed con-

ainment between two filter frits ensures high

fficiency and peak symmetry similar to that of

reparative and process separation columns,

nd distinguishes the system from the current

lter based systems for simple on/off sample

quilibration operation.

Liquid flow in the columns was driven by

ositive pressure liquid displacement, like

n columns individually connected to a one

hannel stand-alone chromatography system.

ight columns are operated in parallel and pre-

rogrammed buffer preparation resulting in

ast completion of 12 column rows.

Fractions from step elution were col-

ected into standard microplates, utilizing

n automated microplate transport system and

cember 2011

subsequently submitted to a next separation

step for a further chromatographic dimen-

sion or analysis like UV, ELISA, MS, HPLC or

SDS-PAGE.

This resulted in fully automated, walk-away

procedures with a drastic reduction in process-

ing time (up to 70%) and significantly increased

process security.

Applications shown were successfully

implemented for parameter elucidation and

optimization in process development of

therapeutic protein production, in-process

monitoring of fermentation broth for mAb-

production, protein drug discovery and

depletion of abundant components in screen-

ing experiments.

doi:10.1016/j.drudis.2011.10.016

Poster 11High-throughput process developmenttechnology for design of cleaning-in-place(CIP) protocols for chromatography media

Anna Grönberg , Hans J. Johansson, Kjell

Eriksson, Enrique Carredano

GE Healthcare Bio-Sciences AB, Björkgatan 30,

751 84 Uppsala, Sweden

Cleaning-in-place (CIP) of chromatography

media is important for the integrity and safety

of the final biopharmaceutical product. Efficient

and media compatible cleaning procedures

also increase the column lifetime and thereby

contribute to cost effective processes.

We have developed a methodology where

numerous cleaning agents and sequences of

cleaning steps can be evaluated in parallel

using PreDictorTM plates, i.e. 96-well filter plates

pre-filled with chromatography media. The Pre-

Dictor plates were cycled repeatedly with feed

and the cleaning efficiency of a large number of

different chemicals and sequences of cleaning

steps were evaluated by analyzing the residual

amount of proteins on the beads after cleaning.

POSTER ABSTRACTS

The throughput of the method was maximized

by implementing the workflow on a robotic

system and by using high-throughput analysis.

The correlation between the scale-down

screening format and traditional column life-

time studies will be discussed. Process economy

calculations comparing different resins and

cleaning regimes will also be presented.

doi:10.1016/j.drudis.2011.10.017

Poster 12High throughput screening and optimiza-tion of intermediate wash conditions fora protein A chromatography step using aDesign of Experiment (DoE) approach

Kristina Nilsson-Välimaa , Gustav Rodrigo,

Tuomo Frigård, Hans Johansson

GE Healthcare Bio-Sciences AB, Björkgatan 30,

751 84 Uppsala, Sweden

Purification of monoclonal antibodies using

protein A affinity chromatography results in

high purity and yield. By including an addi-

tional intermediate wash step the purity of the

product can increase even further.

Here, optimal intermediate wash conditions

were investigated using 96-well filter plates.

Using a DoE approach in combination with

a high throughput Host Cell Protein (HCP)

analysis method, a large experimental space

could be explored. Factors such as pH, type of

salt, concentration and the effect of different

additives were studied. Conditions that lead to

significantly reduced HCP content in the prod-

uct pool were identified quickly and effectively.

Data obtained using the 96-well format was

verified using a traditional column format with

excellent correlation. The optimized condition

was then further scaled up to a scale suitable

studies.

doi:10.1016/j.drudis.2011.10.018

www.drugdiscoverytoday.com 3

• Posterabstracts