GMP Certification Programme

Certified Microbiological Laboratory Manager

Speakers

Low Endotoxin
Aoife Barron
Lonza Biologics
Recovery/Masking
Hands-on Laboratory Training Course
05/06 March 2024 | Munich/Bernried, Germany
Jacqueline Dünisch
Labor L+S

Dr Christian Faderl
bioMérieux Deutschland

David Guy
ACC

Dr Bernhard Illes
Microcoat

Highlights
ƒ Interpretation of interference during Endotoxin detection
ƒ Understanding Low Endotoxin Recovery (LER)
Dr Holger Kavermann ƒ Setup of hold-time studies
Roche ƒ Techniques for demasking Endotoxin

Practical Laboratory Training

Dr Michael Kracklauer in small groups – max 15 participants
Microcoat
Programme

Objective Programme
ƒ How to identify Low Endotoxin Recovery (LER) Endotoxin Detection Methods I (Focus on LAL)
ƒ How to set-up hold-time studies
ƒ Analysis of influencing factors (Sample matrices, ƒ Definition of Endotoxins
endotoxin, temperature, detection methods, etc.) ƒ Basic reaction of Limulus-based detection methods
ƒ Understanding the driving forces of LER ƒ General LAL-based detection methods
ƒ Interpretation of test results ƒ Construction and interpretation of standard curve
ƒ Dedicated sample treatment for demasking

Endotoxin Detection Methods II (Focus on rFC)

Background
ƒ General rFC-based detection methods
In the last years the LAL test has become the preferred system to ƒ Sample handling
test for endotoxins – for the in-process control as well as in the ƒ Interpretation of results
final inspection – and it is anchored in the pharmacopoeias.
However, in the recent past, the problem of low endotoxin re-
covery employs the pharmaceutical microbiology. Masking – or Test Interference I (Inhibition)
not? Evidence gaps? And how can I close them? And how to eval-
uate? ƒ Positive Product Control (PPC)
ƒ Test inhibition
These are the questions pharmaceutical microbiologists as well
as those responsible for the release have to deal with.
Test Interference II (Enhancement)
And last but not least, how can we handle the test in daily busi-
ness in a practical manner? ƒ Experiences with Interferences
ƒ Test enhancement

Target Audience
Technical Report - Guidance for LER Hold Time
ƒ Laboratory management and staff of pharmaceutical Studies
microbiology
ƒ Microbiologists and laboratory assistants from contract ƒ Endotoxin Masking
laboratories ƒ Planning and implementation of hold-time studies
ƒ Scientific staff from the Endotoxin testing area ƒ Interpretation of hold-time studies

Moderators Sample Interference/Hold Time Case Studies

Dr Johannes Reich, Microcoat ƒ Endotoxin Masking

Axel H. Schroeder, Concept Heidelberg ƒ Planning and implementation of hold-time studies
ƒ Interpretation of hold-time studies

Social Event
Mechanistic Principles of Endotoxin Masking and
In the evening of the first course day, you are cordially invited Demasking
to a social event. This is an excellent opportunity to share your
experiences with colleagues from other companies in a relaxed ƒ Mechanistic principles of masking
atmosphere. ƒ Mechanistic principles of demasking

Mitigation of LER - General Approach

ƒ General mitigation approaches

ƒ Development of dedicated mitigation protocols to
overcome LER
ƒ Case Studies

Low Endotoxin Recovery/Masking | 05/06 March 2024, Munich/Bernried, Germany

Speakers

Sample Preparation to Reverse the LER Effect Speakers

ƒ The ENDO-RS technology for endotoxin demasking Aoife Barron, Lonza Biologics
ƒ Demasking protocol development - a case study Aoife Barron is a Business Development Manager in
ƒ Application of demasking protocols Bioscience Sales at Lonza Biologics AG since July
2022. Aoife has extensive experience as a bio-
processing and QC Micro trainer at NIBRT, Dublin, and has
Validation of Demasking Method using rFC-based worked as a QC Micro Specialist for companies such as Wyeth,
Assay Pfizer and Amgen, where she developed her skills as an Endo-
toxin Testing SME. Aoife graduated from NUI Maynooth, Ireland
ƒ Demasking as sample treatment to overcome LER effect in 2007 with a Biological Sciences degree.
ƒ Validation of a rFC based method
ƒ Combination of demasking and rFC as release test for DP Jacqueline Dünisch, Labor LS
After completing her Master’s degree in Molecular
Sciences at the University of Erlangen-Nuremberg,
Jacqueline joined Labor LS in 2016 and has since
been in charge of endotoxin testing.
Practical Laboratory Work at Microcoat
Dr Christian Faderl, bioMérieux
Simulation of Contamination in Various Sample Christian Faderl joined bioMérieux in 2017. As Pro-
Matrices ject Coordinator and Manager, he is in charge of en-
dotoxin service projects like feasibility studies and
ƒ Preparation of samples affected by demasking projects.
- Test interference
- Sample interference David Guy, Associates of Cape Cod, Inc.,
David Guy is Technical Manager for Associates of
Analysis of Interference in Affected Samples Cape Cod. 2023 will see his 30th year in the field of
Bacterial Endotoxin Testing and his 10th year at As-
ƒ Application of different detection systems sociates of Cape Cod where he helped develop the endotoxin
- Limulus Amebocyte Lysate assay testing application, Pyros® eXpress. His experience covers both
- Recombinant Factor C assay Sales and Technical Support for products and methodologies
from natural lysate to recombinant reagents and manual tech-
Sample Treatment for Demasking niques to automation of the BET test.

ƒ Screening for demasking protocol Dr Bernhard Illes, Microcoat

ƒ Optimization of demasking protocol Bernhard Illes studied chemistry at LMU Munich and
ƒ Evaluation of demasking protocol did his PhD on nanoparticles and protein activation.
He is currently a project manager at Microcoat with a
focus on development projects for the mitigation of endotoxin
masking in pharmaceutical samples.

Interpretation and Comparison of Results Holger Kavermann, Roche Diagnostics

Holger Kavermann studied microbiology at the Uni-
ƒ Differentiation between test and sample interference versity of Göttingen and obtained his PhD in medical
ƒ Effects of different detection systems microbiology at the University of Munich. In 2003,
ƒ Demasking of endotoxin he joined Roche Diagnostics GmbH as Manager QC responsible
for the microbiological and cell biological analytics of QC and In-
Process-Control-samples in the production of biotechnological
derived active pharmaceutical ingredients. In 2013, he became
head of the QC Department for Environmental Monitoring and
Cleaning Validation. Since 2017, he has been the department
head for Microbiology, EM and Cleaning Analytics.

Dr Michael Kracklauer, Microcoat

Dr. Michael Kracklauer studied Biotechnologie. He
received his PhD from the RWTH Aachen University.
The research topic was the field of protein misfolding
and amyloid diseases with focus on Alzheimer’s Disease. He is
since 2018 at Microcoat in the department “Endotoxin Services”,
with responsibilities for the topics LER, rFC, method develop-
ment and validation.

Low Endotoxin Recovery/Masking | 05/06 March 2024, Munich/Bernried, Germany

If the bill-to-address deviates from the specifica- Reservation Form (Please complete in full)
tions on the right, please fill out here:
Low Endotoxin Recovery/Masking, 05/06 March 2024 , Munich/Bernried, Germany
____________________________________ Monocyte Activation Test (MAT), 07/08 March 2024, Munich/Bernried, Germany
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VAT is reclaimable.
Overnight Stay

Accommodation

CONCEPT HEIDELBERG
€ 200 discount.

organisation of this event.

Conference language
Phone +49(0)8158 - 9320

Microcoat Biotechnologie GmbH

Organisation and Contact

[email protected]

Presentations / Certificate
Hotel Marina | Am Yachthafen 1-15

Fees (per delegate, plus VAT)

Tuesday, 05 March 2024, 09.30 – 17.15 h
(Registration and coffee 09.00 – 09.30 h)

Shuttle Service from/to Munich Airport:

and back in the evening will be organised.
Venue of the Laboratory Course

Ms Isabell Helm (Organisation Manager) at

Wednesday, 06 March 2024, 08.30 – 17.00 h

Mr Axel H. Schroeder (Operations Director) at

82347 Bernried am Starnberger See, Germany

P.O.Box 10 17 64 | 69007 Heidelberg, Germany

The official conference language will be English.

ECA has entrusted Concept Heidelberg with the

For questions regarding content please contact:

ECA Members € 1,990 | APIC Members € 2,090

Or you register online at www.gmp-compliance.org.

Phone +49(0)62 21/84 44-0 | Fax +49(0)62 21/84 44 34

For questions regarding organisation etc. please contact:

+49(0)62 21/84 44 49, or at [email protected].

[email protected] | www.concept-heidelberg.de
Non-ECA Members € 2,190 | EU GMP Inspectorates € 1,095
Am Neuland 3, 82347 Bernried am Starnberger See, Germany

you will automatically receive your certificate of participation.

when you have registered for the course. Reservation should be
CONCEPT HEIDELBERG has reserved a limited number of rooms

made directly with the hotel. Early reservation is recommended.

Via the attached reservation form, by e-mail or by fax message.

+49(0)62 21/84 44 10, or at [email protected].

On 06 March at appr. 17.15 h from Microcoat to Munich Airport.

in the Hotel Marina. You will receive a room reservation form/POG

ed materials will be handed out on site and that there will not be
dinner on the first day, lunch on both days and all refreshments.

The presentations for this event will be available for you to down-
load and print before and after the event. Please note that no print-
Training Course” on 07/08 March 2024 in Bernried get a
The fee is payable in advance after receipt of invoice and includes
On 04 March at appr. 19.00 h from Munich Airport to Hotel Marina.

any opportunity to print the presentations on site. After the event,

Transfer service from Marina Hotel to Microcoat in the morning

Participants of the “Monocyte Activation Test Laboratory

WA/28092023