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FORUM PROGRAMME koelnmesse, Cologne, Germany 8, 9, 10 February 2011
Tuesday 8th  14:30 – 14:55
February 2011
13:30 – 13:55 Extractables and leachables
testing: strategies for practice
The session will show how to
design a reasonable extractables
and leachables (E&L) study. It
will cover the following topics:
the translation of regulatory
requirements into analytical lab
work; the evaluation of extractables
data and the consequences for
leachables studies; and how to
outsource E&L studies. Illustrative
case examples will be provided.
Dr Armin Hauk, Head of the
Trace Analysis Group, the GLP
Testing Facility, Intertek.
14:00 – 14:25 New and highly sensitive biosensors
with interferometric detection
15:00 – 15:25
The Ostendum group of companies is
developing a new biosensor platform
where the detection principle is based
on interferometry. Specific ligands are
bound in a microfluidic device with a
reference channel and, in the present
set up, three detection channels.
Specific binding of antigens is real-
time and quantitatively recorded from
analysis of the interferometric profile.
This label-free technology is at least
10 to 100 times more sensitive than
other optical detection principles such
as surface plasmon resonance. Several
applications are being developed such
as for IgE detection in human serum
and pesticide detection in cereals.
Dr Aart van Amerongen, Senior
Scientist, Biomolecular Sensing
& Diagnostics, Wageningen
UR Food & Biobased Research
(formerly known as A&F).
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NMR spectroscopy using 600
MHz cryo probe spectrometers:
a new dimension of quantitative
pharmaceutical analysis
under full GMP compliance
The presentation will provide an
overview of the pharmaceutical
relevant applications of NMR analysis
in a modern GMP laboratory. In
detail examples of multi-component
analysis, amino acids, peptides,
qNMR with internal standards,
polysaccharides and lipids will
be presented. The common NMR
spectroscopy enables a fast analysis
turnaround time. It is optimised
for the analysis of samples with
small amounts of material and
a low number of test items.
Dr Bernd Diehl, CEO, Spectral
Service, Cologne.
Rapid microbial diagnostics
enabled by microtechnology
The innovative Sieve-ID diagnostic
concept allows for an easy direct
analysis of micro-organisms in a
sample and can be performed
within minutes, even on-site. To
illustrate the possibilities of this
novel diagnostic platform in hygiene
screening, water analysis, and medical
diagnostics, several applications will
be presented, including accurate
quantification, organism-specific
detection, viability screening, cell
recovery and sample clean up.
Michel Klerks, CEO, Innosieve
Diagnostics BV.
Wednesday 9th  11:00 – 11:25
February 2011
10:00 – 10:25
Combining automated sample
preparation with UHPLC+ solutions
for shortest possible analysis times
The increasing use of UHPLC in
laboratories has led to much faster
chromatography runs, but two other
bottlenecks are still commonly found
in pharmaceutical laboratories,
namely preparation and data
processing times. This is particularly
true for methods that analyse multiple
components and require complex
calculations. This session looks at
ways of automating the sample
preparation stage, and decreasing
11:30 – 11:55
data processing times in order to
achieve the shortest possible time
from sample to result. The analytical
method used to demonstrate
this is an ICH linearity test for
UHPLC analysis of 5 components
commonly found in soft drinks.
Mr Fraser McLeod, Senior
Director LSBU Product and
Solutions Marketing, Dionex
10:30 – 10:55 Measuring the performance
characteristics of nebulizers and
liquid formulations for nebulization
This session will provide a brief
introduction on how inhalers
(metered dose and dry powder) are
tested. It will consider the nature
of nebulizers and what needs to
be considered when these devices
are tested. It will also provide
information on how nebulizer test
procedures have been developed
and what these involve.
Dr Manfred Keller, Executive
Vice-President and Chief Scientific
Officer, eFlow, PARI Pharma GmbH.
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Rapid sterility and microbial
limits testing using AK-
amplified bioluminescence
This session will provide an
explanation of how adenylate kinase
(AK) and adenosine diphosphate
(ADP) are used to increase the
sensitivity and speed the reaction
time of the ATP bioluminescence
‘firefly’ assay. The application
of amplified bioluminescence
to both microbial limits testing
and sterility testing using Celsis
AKuScreen will be considered.
Anna Mills, Technical Support
Manager, Celsis | Rapid Detection
Rapid microbial methods for
microbiological quality control
to obtain same-day results
In this presentation, Toxikon Europe
will provide an overview of the
different RMMs available on the
market and explain the method
selected by Toxikon for further
development. In addition, it will
present an approach for the conduct
of routine rapid sterility tests on
pharmaceuticals for same-day
results, using solid phase cytometry
(Scan RDI, Chemunex, France). The
tests are conducted inside a sterility
isolator to obtain the stringent
environmental conditions required
for the conduct of a sterility test.
An insight on how to validate these
methods and how regulatory
acceptance can be obtained is
also given during the session.
Peter Cornelis, Department
Supervisor Microbiology and In
Vitro Toxicology, Toxikon Europe.
 
FORUM PROGRAMME koelnmesse, Cologne, Germany 8, 9, 10 February 2011
12:00 – 12:25 Using XRF spectrometry for
quality control of drug products
This presentation will deal with using
X-ray fluorescence spectrometry
(XRF) for drug quality control. XRF is a
non-destructive technique with high
elemental sensitivity and simple or
no sample preparation. It can be used
in production and quality control to
quantify major and minor elements
in fillers, binders, lubricants, and other
excipients. Traces of toxic compounds
in excipients and final drug products
can be detected and quantified and
reported at sub ppm levels, and so
can traces of catalyst residues.  discovery and development will be
Ian Campbell, Product
Manager, PANalytical BV.
12:30 – 12:55 Practical approaches
to sterility testing
This presentation will consider
general difficulties associated with
sterility test validation and practical
approaches to products which are
difficult to test. It will also provide
an overview of those aspects of the
sterility test which are not covered
in the pharmacopoeias, as well
as the current debates about the
sterility test. Both the membrane
filtration and direct inoculation
methods will be covered.
Dr Tim Sandle, Head of
Microbiology, UK NHS Bio
Products Laboratory.
 
   
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Thursday 10th  11:00 – 11:25
February 2011
10:00 – 10:25 PLGA dynamic degradation
and mechanical properties
This session will consider PLGA
dynamic degradation and mechanical
properties. The ElectroForce®
BioDynamic® test instruments
provide precise characterisation
of biomaterials and biological
specimens within a closed saline
or cell culture media environment.
They can be used for the evaluation
of a variety of specimens, including
biomaterials, acellular scaffolds and
cell-seeded scaffolds, native tissue
samples and tissue-engineered
constructs. Their compact design
makes them suitable for incubator
use and long term experiments in a
biomaterials or cell culture laboratory.  Rita Cortvrindt, CEO, EggCentris NV.
Rainer Böhm, Bose GmbH,
Regional Account Manager,
ElectroForce Systems Group.
10:30 – 10:55 Mass spectrometry as an analytical
tool for the biotechnology and
pharmaceutical industries:
examples from microbial
identification and intact protein QC  molecular biology laboratories or
Two examples for the utilisation
of mass spectrometry as a quality
control tool will be presented.
MALDI-TOF MS can be used for the
rapid, accurate and cost-effective
identification of microbes. High
performance mass spectrometry
enables the control of intact proteins
from biopharmaceutical production.
Dr Thomas Maier, Head of
Molecular and Microbiological
Laboratory, Bruker Daltonik GmbH.
Early screening for reproductive 12:00 – 12:25 Rapid raw material verification
effects by innovative in vitro at the point of need with
bioassays is now possible: when handheld analysers
and where to fit them in during We sell handheld analysing
the drug development process  equipment for the pharmaceutical
The characteristics (organ/cell and chemical industry. Our
type, product amount, time, etc) new TruScan Raman analyser
and features (endpoints, validity, revolutionizes the identification
examples, etc) of the available in process of incoming raw materials.
vitro bioassays representing the Ursula Hentschel, Marketing,
main targets of the male and female ServanTech GmbH & Co KG.
reproductive systems and embryo
development will be presented.
Their potential use and advantages 12:30 – 12:55 Determination of residual
during the different phases of drug solvents (Class I, Class II and
Class III ) in pharmaceuticals
evaluated and discussed, for instance This session will deal with the
when to apply them, and whether determination of residual solvents by
they can help in reducing costs and a pressure balanced GC-HS technique
development time, and whether in diluents of varying polarities, as
they can be used for animals. per USP<467>; and also the use
of HS-traps to improve detection
limits and increase throughput.
Uli Meier, Application Specialist for
11:30 – 11:55 Quantitative real-time rapid
Chromatography, PerkinElmer.
PCR: economising on time
while adapting to a real-
time rapid approach
This session will consider quantitative
real-time PCR, an approach with
a highly increasing significance in
clinical diagnostics. In the future,
time and cost savings, as well as
efficiency enhancements, will
become more and more critical.
Rapid qPCR performed at high speed
and with an enormous reduction
in reagents can be reached by  
optimisation of several factors
during a qPCR run independent   
of the used real-time chemistry.
Melanie Jahn, Application
Specialist, Analytik Jena | Biometra.      
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WORKSHOP PROGRAMME koelnmesse, Cologne, Germany 8, 9, 10 February 2011
Tuesday 8th  Wednesday 9th  Thursday
February 2011
10:30 – 12:30 Evaluating the risk of
genotoxic impurities
Guidance relating to genotoxic
impurities was first formally
introduced in 2006 with the advent of
the EMA guideline.  Subsequent draft
guidelines were issued by the FDA at
the end of 2008.  This presentation
will examine the current challenges
faced by the industry with respect to
guideline interpretation, in particular
the key areas of uncertainty.  It will
seek to provide instruction on how
to evaluate GI-related risk and how
to manage areas of uncertainty,
and will use illustrative case studies
where practical.  The session will
conclude with an open forum
discussion, in which participants
will be able to raise any questions
they may have. It is hoped this
will lead to a lively debate!
Dr Andrew Teasdale, Chair of
AstraZeneca’s Genotoxic Impurities
Advisory Group, responsible for the
company’s strategy relating to GIs.
     
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February 2011
12:30 – 14:30 Safety testing of combination
products with a focus on
wound care products
Safety testing of medical devices is
a complex area, especially when the
device is combined with a therapeutic
pharmaceutical.  Using wound
care products as an example, the
session will discuss the requirements
for testing such products.
Andy Makin, Managing
Director, LAB Research A/S.
 
10th February 2011
10:30 – 12:30 New trends in life sciences relating
to the EU funded research project
DINAMICS (Diagnostic Nanotech
and Microtech Sensors)
DINAMICS is an EU funded research  
project which aims to develop
an integrated and cost-effective
nanobiological sensor for the
detection of bioterrorism and
environmental assays. Its prime
deliverables will be exploitable
prototype handheld and continuous
monitoring devices for the detection
of harmful substances in the water
supply network. DINAMICS foresees
the development of a highly sensitive
system with a short analysis time
based on DNA-hybridisation sensors
integrated into microfluids and signal
conditioning/processing systems.
For reliable and flexible surveillance
of the drinking water supply
network, a portable measuring
instrument will be developed by
DINAMICS for special assignments.
This will contribute to the security
of major public events (e.g. sports
meetings) by means of specific
surveillance of strategic points
in the water supply network.
At the development stage is a
monitoring station for the continuous
surveillance of the drinking water
supply network, which will rapidly
and reliably identify intentionally
or unintentionally released
infectious agents and thereby make
a significant contribution to the
security of the civilian population.
Rolf Boetzel, provenion
Engineering (and partners).
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 Exhibitors include
3M, Germany AES CHEMUNEX, Germany/France Alpha M.O.S., France Anecto, Ireland Applied
Biosystems, France BaseClear, The Netherlands BioControl Systems, United Kingdom biomedis
Vertriebsgesellschaft, Germany BIO-RAD, Germany Biotest AG, Germany BOSE Electroforce, Germany
Brookfield, Germany BRUKER Daltonik, Germany Carl Zeiss MicroImaging, Germany Celsis, United
Kingdom Cobalt Light Systems, United Kingdom CONGEN Biotechnologie, Germany Dionex, Germany
DSM PremiTest, The Netherlands DuPont Qualicon, Germany DYNA-MESS, Germany Hans Schnidt
& Co, Germany Harlan Laboratories, Sweden HS-Technik, Germany Hygiena International, United
Kingdom HyServe, Germany/Japan IDOS Software AG, Germany ILS (International Laboratory
Services), United Kingdom IMADA, Japan Innosieve Diagnostics, The Netherlands Instron, Germany
Intertek, Germany/UK Invitrogen, France LAB Research, Denmark Life Technologies, France Lloyd
Instruments, United Kingdom LTG, Germany Luxcel BioSciences, Ireland Mark-10, USA Mecmesin,
United Kingdom Merck, Germany MêTiS Biotechnologies, France Millipore, France Mocon, USA
Neogen Europe, Germany/UK Ocean Optics, The Netherlands Oxford Instruments, United kingdom
Oxoid, UK Pall GeneSystems, France PANalytical, Germany PerkinElmer, Germany PreSens
Precison Sensing, Germany proRheo, Germany Q-Bioanalytic, Germany QIAGEN, Germany/UK
QTS Analytical, United Kingdom R-Biopharm, Germany ServanTech, Germany SIGMA-ALDRICH,
Switzerland Smithers Rapra, United Kingdom Spectral Service, Germany Stable Micro Systems, United
Kingdom Sterigenics, Belgium TECOmedical, Switzerland Thermo Fisher, Germany Toxikon, Belgium

How to get to koelnmesse

Nearest airports Nearest train station
Cologne Bonn 12km/12min Köln Messe/Deutz 0.5km/2min
Düsseldorf 40km/40min

Exhibition opening hours

Tuesday 8th February 2011 09:30 - 17:00 hours
Wednesday 9th February 2011 09:30 - 17:00 hours
Thursday 10th February 2011 09:30 - 15:00 hours

Forums and workshops start at 10:00 hours

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