Regulatory control and standardization of allergenic extracts. Bd. 94 (Frankfurt am Main, 2003) - ОГЛАВЛЕНИЕ / CONTENTS
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ОбложкаRegulatory control and standardization of allergenic extracts. 10th International Paul-Ehrlich-Seminar, Oktober 2-5, 2002. Bd. 94 / ed. by Löwer J., Becker W.-M., Vieths S. - Frankfurt am Main: GIT Verlag, 2003. - 340 S. - ISBN 3-00-012888-3
 

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Оглавление / Contents
 
Opening Remarks to the 10th International
Paul-Ehrlich-Seminar
   Wolf-Meinhard Becker, Borstel, Germany ....................... 1

Welcome Address
   Klaus Cichutek, Vice President of the
   Paul-Ehrlich-Institut
   Ernst Th. Rietschel, Acting Director of the
   Forschungszentrum Borstel .................................... 1

Current State of Regulation
   Chairmen: Samuel B. Lehrer, Oliver Cromwell .................. 5

The EAMG position on the regulation of existing products
for treatment with special reference to named patient
products (NPPs)
   Albert M. Kroon .............................................. 7
Discussion ..................................................... 14

Specific immunotherapy in the USA: General concept and recent
initiatives
   Robert E. Esch .............................................. 17
Discussion ..................................................... 23

Sample size considerations for establishing clinical
bioequivalence of allergen formulations
   Ronald L. Rabin, J.E. Slater, P. Lachenbruch,
   R.W. Pastor ................................................. 24
Discussion ..................................................... 33

Future aspects of regulation
   Jay E. Slater ............................................... 34
Discussion ..................................................... 39

General Discussion ............................................. 42

Round Table Discussion
   Chairman: Albert M. Kroon

The manufacturers' perspective: Regulation of allergen
products in European countries
   B. Kristensen ............................................... 45
   C. Garcia Carbonell ......................................... 47
   O. Cromwell ................................................. 50
   L. Champion ................................................. 53
Discussion ..................................................... 54

Standardization and Quality Control of Allergen Products
   Chairmen: Martin Chapman, Stefan Vieths ..................... 65

Overview: Biological standardization in Europe and the USA
   Henning Løwenstein .......................................... 67
Discussion ..................................................... 69

The CREATE project: A new beginning of allergen
standardization based on mass units of major allergens
   Ronald van Ree .............................................. 70
Discussion ..................................................... 74

Mediator release assays based on human and murine IgE:
Potential and limitations in allergen standardization
   Andreas Hoffmann, S. Kaul, K. Fötisch, N. Danz, D.
   Lüttkopf, L. Hatahet, B. Kastner, L. Vogel, G. Höltz,
   S. Vieths ................................................... 76
Discussion ..................................................... 85

In vitro and in vivo characterization of hazelnut skin prick
test extracts
   Jaap H. Akkerdaas, M. Wensing, A.C. Knulst, R.С. Aalberse,
   S.L. Hefle, R. van Ree ...................................... 87
Discussion ..................................................... 96

Immunochemical and biological quantification of peanut
extract
   Lars K. Poulsen, M.H. Pedersen, M. Platzer, N. Madsen,
   E. Sten, С. Bindslev-Jensen, С.G. Dircks, P. Stahl Skov ..... 97
Discussion .................................................... 106

Latex: A new target for standardization
   Monika Raulf-Heimsoth, H.-P. Rihs, T. Brüning .............. 107
Discussion .................................................... 115

Experimental and Established Allergen Products for
Immunotherapy
   Chairmen: Kurt Blaser, Hans-Jórgen Mailing ................. 117

Criteria for clinical efficacy - readout and monitoring of
clinical studies
   Hans-Jórgen Mailing ........................................ 119
Discussion .................................................... 123

Oral, nasal and sublingual immunotherapy: Do they work,
are they safe?
   Giovanni Passalacqua, G. W. Canonica ....................... 126
Discussion .................................................... 130

Peptide-based immunotherapy: New developments
   Mark Larché ................................................ 133
Discussion .................................................... 139

Preventive aspects of specific immunotherapy
   Lars Jacobsen .............................................. 141
Discussion .................................................... 145

Recombinant and Natural Allergens
   Chairmen: Dietrich Kraft, Stefan Vieths .................... 147

Developing a manufacturing process and analyses for a
recombinant protein drug
   Ebba Florin-Robertsson ..................................... 149
Discussion .................................................... 150

Engineering and validation of recombinant proteins for
allergen vaccines
   Michael D. Spangfort ....................................... 151
Discussion .................................................... 155

Mechanisms of immunotherapy with allergoids: Lessons for
the development of recombinant allergens with reduced
IgE-binding activity
   Oliver Cromwell, H. Kahlert, G. Schramm, R. Suck,
   A. Nandy, B. Weber, H. Fiebig .............................. 156
Discussion .................................................... 161

Utility of pure allergen components in the continuing
development of in vitro diagnostics for inhalant and
food allergies
   Jonas Lidholm .............................................. 163
Discussion .................................................... 172

Comparison of natural grass pollen allergens and their
recombinant counterparts expressed in bacterial and
mammalian systems
   Arnd Petersen, B. Klostermann, J. Saloga, W.-M. Becker ..... 173
Discussion .................................................... 177

Expression of allergens in E.coli and plants - benefits and
drawbacks
   Heimo Breiteneder, B. Wagner ............................... 178
Discussion .................................................... 187

Approaches based on mutated or modified recombinant grass
pollen allergens - in vivo evaluation of the constructs
   Ute Lepp, F. Eberhardt, G. Schramm, P. Zabel, R. Suck,
   H. Meyer, H. Fiebig, O. Cromwell, W.-M. Becker ............. 188
Discussion .................................................... 191

Recombinant food allergens in the diagnosis of pollen-
related food allergy
   Barbara K. Ballmer-Weber, A. Wangorsch, S. Scheurer ........ 192
Discussion .................................................... 197

Hypoallergenic variants of the Parietaria judaica major
allergen Par j 1: In vitro and in vivo evaluation
   Paolo Colombo .............................................. 198
Discussion .................................................... 204

Recombinant mite allergens: Validation strategies and
clinical trials
   Martin D. Chapman .......................................... 205
Discussion .................................................... 210

General Discussion ............................................ 213

Immunomodulation and Immunotherapy - New Approaches
   Chairmen: Rudolf Valenta, Fatima Ferreira .................. 217

Mechanisms of specific immunotherapy: Current knowledge
   Cezmi A. Akdis, K. Blaser .................................. 219
Discussion .................................................... 227

Allergic rhinitis and its impact on asthma (ARIA) - what
does it mean for the future of SIT?
   Claus Bachert .............................................. 229
Discussion .................................................... 235

New perspectives for the treatment of food allergy (peanut)
   Hugh A. Sampson, K. Srivastava, X.-M. Li, A. W. Burks ...... 236
Discussion .................................................... 244

Alternative approaches to immunotherapy of allergy
   Irwin Ziment ............................................... 247
Discussion .................................................... 257

Parallels between parasite infections and specific
immunotherapy
   Ronald van Ree, M. Yazdanbakhsh ............................ 260
Discussion .................................................... 263

Immunomodulation and Immunotherapy - New Approaches
   Chairmen: Alain de Weck, Wolf-Meinhard Becker .............. 267

Anti-IgE therapy combined with specific immunotherapy: Pro
   Ulrich Wahn, E. Hamelmann .................................. 269
Anti-IgE therapy combined with specific immunotherapy:
Contra
   Mark Larché ................................................ 272
Discussion .................................................... 276

Strategies for the development of safe and effective DNA
vaccines for allergy treatment
   A. Hartl, R. Weiss, R. Hochreiter, S. Scheiblhofer,
   R. Bauer, R. Valenta, F. Ferreira, W. Leitner, Josef
   Thalhamer* ................................................. 279
Discussion .................................................... 299

Protection against infectious diseases by DNA-based
vaccination strategies -lessons for allergy treatment?
   Jörg Schneider ............................................. 300
Discussion .................................................... 303

Progress in the development of new methods of immunotherapy:
Potential application of immunostimulatory DNA conjugated to
allergens for treatment of allergic respiratory conditions
   Peter S. Creticos, L. M. Lichtenstein ...................... 304
Discussion .................................................... 312

General Discussion ............................................ 314

Closing Ceremony

History and future of allergen standardization and of
the Paul-Ehrlich-Seminar
   Alain L. de Weck ........................................... 317

Closing remarks
   Stefan Vieths .............................................. 328

List of contributors .......................................... 330

List of participants .......................................... 331


 
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