A3P ENDOTOXINS & PYROGENS
Regulatory - LAL Test - rFC - MAT - LPS - Depyrogenation

Place

Mercure Château Perrache Hotel

Date

5 & 6 June 2019

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Format

Conferences, Round Table, Exhibition

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La search for endotoxins is a critical test for pharmaceutical companies developing injectables and medical devices, throughout the manufacturing process until batch release. The BET test (Bacterial Endotoxin Test) LAL is currently a harmonized method in the USA, Europe and Japan.

Given the diversity of products involved, from traditional chemical assets to the complex formulation of products derived from biotechnology and lipid products, a wide range of endotoxin and pyrogen tests have been developed in recent years, to meet the different needs of industry and ensure patient safety. The scientific and regulatory debates around the phenomena LER and holding time samples, theautomation of classical tests or miniaturized, alternative tests based on the recombinant factor C and MAT test demonstrate the growing interest and evolution around the mastery of pyrogen tests and endotoxins in the pharmaceutical industry.

During 2 days, industry and suppliers will share their respective approaches and experiences during conferences and a roundtable to cover and debate these themes.

The topics discussed and developed will be the following

  • Endotoxins and Pyrogens: historical and retrospective to define the basics
  • State of the regulatory and referential sites (US, Europe, Japan) : new texts in progress
  • The challenges of the classic LAL test: complex product validation, holding time, interference, LER masking effect and leading causes of disability
  • Alternative tests or pharmacopoeias, rFC (recombinant factor C) and MAT tests (Monocyte Activation Test)
  • The physicochemical structure of LPS
  • Depyrogenization
Official language of conferences: Français
Simultaneous translation of conferences: French <-> English

Mercredi juin 5 2019

Welcome of participants
13:30
History and regulatory texts around endotoxin tests. The pyrogen test on rabbit (RPT)
Thierry BONNEVAY & Emmanuelle COPPENS - SANOFI PASTEUR & Sylvie GUYOMARD DEVANLAY - MICROBIOPHARMA
14:00
Endotoxin Assay Automation with the PyroTecTM PRO System
Sunniva FÖRSTER - LONZA VISP
15:30
Coffee break & Exhibition visit
16:00
(1-3) -β-D-Glucan: Properties, Sources, Bacterial Endotoxin Test Interference and Mitigation Strategies
David GUY - ASSOCIATES OF CAPE COD
17:00
How to avoid disability during a bacterial endotoxin test?
Gilles GOY - CHARLES RIVER
17:30
Existing relationships between bioburden evaluation and pyrogens
Alexandre MURA - CONFARMA
18:00
Cocktail aperitif on the exhibition
18:30

Thursday June 6 2019

Welcome of participants
08:00
Feedback from experiments on the qualification tests of the depyrogenisation tunnels
Philippe BOURBON - INTERTEK
09:00
LPS structure and understanding of LER effect
Johannes REICH - MICROCOAT
09:30
Coffee break & Exhibition visit
10:00
Holistic approach to LER studies for our new vaccines: a practical example
Marine MARIUS - SANOFI PASTEUR
11:00
Physicochemical Structure of LPS: Diversity and Heterogeneity
Martine CAROFF - LPS BIOSCIENCES
11:30
Lunch on the exhibition
12:00
Pyrogen detection with MM6 line-based cell MAT: validation and case study
Mathilde ARNAULT - MERCK
13:30
MAT strategy at Sanofi Pasteur
Stéphanie RICHARD - SANOFI PASTEUR
14:00
Setup of the recombinant Factor C rFC, an alternative endotoxin method in a QC microbiological laboratory
Tony DINIS - CEVA ANIMAL HEALTH
14:30
Coffee break & Visit the exhibition
15:00
Round table
15:30
End of the event
16:30

If you wish to reserve a stand, please fill in the form below

Exhibition form

Plan of the exhibition

CompanyNo. StandCompanyNo. Stand
CHARLES RIVER1 CARSO-LSEHL9
2 Albhades10
BiiON3 CONFARMA11
SUEZ WATER TECHNOLOGIES SOLUTIONS4 ASSOCIATES OF CAPE COD12
MERCK5 NELSON LABS13
BIOMERIEUX6 Lonza COLOGNE GMBH14
ICARE LABORATORY7 CONTEC INC15
Sidji8

Services included with the Table Top stand

  • A dedicated exhibition space on which you can install your products and communication tools: umbrella stand, roll-up, display, product, ... A basic equipment including a table, 2 chairs and 1 electrical connection (2kw) without circuit breaker protection, the loan of a Nespresso coffee machine with pods
  • Breaks and meals indicated in the program
  • Unlimited WiFi
  • A badge that allows you free access to the entire technical and scientific program
  • List of participants in the event
  • Ability to register an additional person at the special rate "accompanying" (590 € HT)
[Form inscriptionendotoxinspyrogenes not found!]

Contact

According to your requirements and your preferences, you can contact Ludivine BAYLE:

Phone: +33 (0)4 37 28 30 46
Fax: +33 (0)4 37 28 30 60
E-mail : lbayle@a3pservices.com
Mail: A3P, 30 rue Pré-Gaudry - Lyon 69007

Accessibility

Mercure Lyon Center Chateau Perrache Hotel
12 Course of Verdun Rambaud, 69002 Lyon.

Parking nearby (Fee)
Parking Mercure Hotel: by appointment
Perrache Station: Esplanade Street, 69002 Lyon
EFFIA Lyon Perrache station: 30 Cours de Verdun Gensoul, 69002 Lyon
Q-Park Lyon Perrache Carnot: Cours Verdun, 69002 Lyon

Hotel reservation

Mercure Hotel - Lyon Château Perrache
12 Course of Verdun Rambaud,
69002 Lyon
Tel: 04 72 77 15 00


Hotel Ibis - Lyon Center Perrache

28 Cours de Verdun Perrache,
69002 Lyon
Tel: 04 78 37 56 55

Hotel Campanile - Lyon Perrache
17 Place Carnot,
69002 Lyon
Tel: 04 78 37 48 47


Kyriad Hotel - Lyon Perrache
26 Cours de Verdun Perrache,
69002 Lyon
Tel: 04 78 71 17 47

Hotel des Savoies
80 Rue de la Charité,
69002 Lyon
Tel: 04 78 37 66 94

Endotoxin research is a critical test for pharmaceutical manufacturers of injectable products and medical devices, throughout the manufacturing process until the release of batches. The BET test (Bacterial Endotoxin Test) LAL is to date, a harmonized method USA, Europe and Japan.

Faced with the diversity of the products concerned, which range from traditional chemical active ingredients to the complex formulation of products derived from biotechnology, lipid products, a wide range of tests, endotoxins and pyrogens, have been developed in recent years, to meet the different needs of industry and ensure patient safety. Scientific and regulatory debates on LER phenomena and sample holding time, the automation of classical or miniaturized tests, alternative tests based on the recombinant factor C and the MAT test demonstrate the growing interest and evolution around the mastery of pyrogen and endotoxin tests in the pharmaceutical industry.

A day and a half, combining conferences and a round table at the end of 2st will take place under the auspices of the A3P to cover and discuss these themes.

Industrial and suppliers will share their respective experience and approach.

The topics discussed and developed during these days will be:

  • Endotoxins and Pyrogens, historical and retrospective to define the basics
  • State of play, US standards - Europe - Japan, New texts in progress
  • The challenges of the classic LAL test, Complex product validation, holding time, interference, LER masking effect and leading causes of disability
  • Alternative tests or pharmacopoeias, rFC (recombinant factor C) and test MAT (Monocyte Activation Test)
  • Physicochemical structure of LPS
  • Depyrogenization