Plenary Session I

Vaccines, Animals and Man

W.M.S. Russell

Developments in the Reduction Refinement and Replacement of Animal Tests in the Quality Control of Immunobiologicals

J.G. Kreeftenberg

Session I

Current Regulations and Regulatory Policy on Alternatives

J.G. Kreeftenberg

CBER: New Approaches to Biological Product Testing

J.A. Donlon

Requirement to Consider Alternatives in the United States

R. De Haven

Alternatives to Animals in the Development and Control of Biological Products for Human and Veterinary Use. The Role of the European Pharmacopoeia

A. Artiges

Session II

Alternatives to in Vivo Immunogenicity Tests and Antibody Production

A.R. Shaw

Synthetic Peptide Vaccines: Foot-and-Mouth Disease Virus as a Model

F. Sobrino

E. Blanco

M. Garcia-Briones

V. Ley

Antibody Production Without Animals

B.M. Stadler

Use of Animal Testing for Evaluating Glycoconjugate Vaccine Immunogenicity

D.V. Madore

N. Strong

R. Eby

Membrane-based Cell Culture Systems - an Alternative to in vivo Production of Monoclonal Antibodies

A. Nagel

S. Koch

U. Valley

F. Emmrich

U. Marx

Session III

Alternatives to in Vivo Potency and Protection Tests

R. Dobbelaer

Alternatives to in Vivo Potency and Protection Tests for Veterinary Vaccines

R.N. Lucken

Viral Veterinary Vaccines

P.P. Pastoret

F. Falize

Poultry Vaccines: An Analysis of the Animal Trials Required for Vaccine Testing and the Way to Reduce or Refine these Tests

C. Jungback

B. Kuchler

E.M. Schirk

Development of Monoclonal Antibodies Suitable for Use in Antigen Quantification Potency Tests for Clostridial Veterinary Vaccines

P.J. Hauer

N.E. Clough

Development of a Nitric Oxide Induction Assay as a Potential Replacement for the Intracerebral Mouse Protection Test for Potency Assay of Pertussis Whole Cell Vaccines

C. Canthaboo

D. Xing

M. Corbel

Evaluation of Toxin Neutralisation in Test Systems for Diphtheria Antibody Assessment

J. Vandenberg

J.W. van der Gun

C.F.M. Hendriksen

Potency Testing of Anti-Lymphocyte Globulins: in Vitro Alternatives for the Monkey Skin Graft Assay

C. Conrad

O. Janssen

G. Schaffner

D. Kabelitz

Session IV

Alternatives to in Vivo Toxicity and Safety Tests

D. Sesardic

A 4R Concept for the Safety Testing of Immunobiologicals

K. Cussler

Neurovirulence

D. Wood

Detection of Endotoxins and other Pyrogens Using Human Whole Blood

S. Fennrich

M. Fischer

T. Hartung

P. Lexa

T. Montag-Lessing

H.G. Sonntag

M. Weigandt

A. Wendel

Novel Assays for the Detection of Botulinum Toxins in Foods

M. Wictome

K.A. Newton

K. Jameson

P. Dunnigan

S. Clarke

J. Gaze

A. Tauk

K.A. Foster

C.C. Shone

Toxicity Tests on Native and Recombinant Bordetella pertussis Adenylate Cyclase Toxin Preparations

K. Hormozi

R. Parton

J. Coote

Session V

Physicochemical Alternatives to Bioassays

J. van Noordwijk

Introduction

J. van Noordwijk

Hormones: The Role of the European Pharmacopoeia

E. Charton

The Development of Non-Animal Based Bioassays for Cytokines and Growth Factors

A.R. Mire-Sluis

New Methods for the Characterisation of Biopharmaceuticals: Conjugate Vaccines Against Haemophilus influenzae type b

X. Lemercinier

D. Crane

C. Gee

S. Austin

B. Bolgiano

C. Jones

Session VI

Reduction and Refinement of in Vivo Tests

C.F.M. Hendriksen

Refinement of in Vivo Tests

D.B. Morton

Reduction in Animal Use in the Production and Testing of Biologicals

M.F.W. Festing

Session VII

Validation, Acceptance and Global Harmonization of Alternative Methods

E. Griffiths

Alternatives and Developing Countries

J.B. Milstien

N. Dellepiane

The Use of Alternatives to Animal Tests in Developing Countries

H.A. Hong

J. Hendriks

Session VIII

Case Reports and Collaborative Studies

J.-M. Spieser

Validation of Test Methods in the Quality Control of Biologicals

C.F.M. Hendriksen

Use of the Single Dilution Test for the EP Tetanus Toxoid Potency Assay

B.L. McKee

Tetanus Antibodies Measured by the Toxin Binding Inhibition Test (ToBI) in Mothers and Children in the Neonatal Tetanus Program in Vietnam

N.Q. Anh

H.A. Hong

T.N. Nhon

N.D. Thinh

N.T. Van

J. Hendriks

Statistical Evaluation of Numbers of Animals to be Used in Vaccine Potency Testing: A Practical Approach

A.M. Akkermans

C.F.M. Hendriksen

Veterinary Vaccines: In-VITRO - International Veterinary Industry Test Replacement Organisation

K. Redhead

R. Lucken

A. van de Moer

S. Houghton

B. Simpson

A. Cameron

P. Monkton

K. Hennesy

C. Ellis

Validation of In Vitro Assays for Botulinum Toxin: A Case Study

R.E. Gaines Das

A.B. Heath

H. Martin

D. Sesardic

Serological Assays as Alternatives to the Ph Eur Challenge Test for Batch Release of Tetanus Vaccines for Human Use

R. Winsnes

C.F.M. Hendriksen

D. Sesardic

A. Akkermans

A. Daas

Release Potency Tests of Hepatitis Vaccines

J. Descamps

A. Mary

E. Rommel

M.L. Anhoury

R. De Neys

M. Duchene

Poster Session

Poster Presentations

Abstracts