Welcome Address to the 9th International
Paul-Ehrlich-Seminar
D. Haustein ................................................ 1
Current State of Regulation
Chairmen: M.R. Rooke, H. Rode ................................ 5
Adaptation of registration dossiers to the requirements of
the Directive 89/342/EEC (so-called „Updating")
G. Höltz ..................................................... 7
Discussion ..................................................... 11
The European guidelines regulating allergen products and the
Ph.Eur. Monograph on Allergens: transformation into everyday
practice
W. Geißler .................................................. 13
Discussion ..................................................... 17
Round-Table-Discussion:Allergen regulation in European
Countries
M.C.Annequin, J. Dayan-Kenigsberg, K. Erlandsson-Persson,
L.J. Husager, O.A. Lake, S. May, S. Mäkinen-Kiljunen,
С. Pini, Т. Schneider ....................................... 21
Status of allergen standardization in India
B.Р. Singh .................................................. 41
Discussion ..................................................... 45
Statistical consideration in the establishment of release
limits for allergen vaccines in the USA
J. Slater et al. ............................................ 47
Discussion ..................................................... 56
Formulation of therapeutic allergen mixtures: problems
associated with the number, proportion and enzymatic
activities of allergens
R.E. Esch ................................................... 57
Named patient products: interest and possible regulation
A.Saporta ................................................... 63
Named patient products: critical aspects
H.J.Malling.................................................. 67
Round-Table-Discussion:Allergen mixtures/named patient
products
R.E. Esch, A. Saporta, H.J. Mailing ......................... 73
Standardization and Quality Control of Allergen Products
Chairmen: W.M. Becker, S. Vieths ............................ 79
Quality improvements of allergenic source material
С. Bergquist ................................................ 81
Discussion ..................................................... 86
A new start for allergen references and standardization based
on purified/ recombinant allergens and monoclonal and
monospecific polyclonal antibodies
R. van Rее .................................................. 87
Discussion ..................................................... 90
Standardization in quality control of modified end-products
0. Cromwell et al. .......................................... 93
Discussion .................................................... 100
Assays for the determination of the biological activity of
allergen extracts
A. Hoffmann et al. ......................................... 101
Discussion .................................................... 108
Problems of food allergen extracts
S. Lehrer and G. Reese ..................................... 111
Discussion .................................................... 116
Clinical Trials with New and Established Allergen Products
Chairmen: K.Ch. Bergmann, H.J. Mailing ..................... 119
Local routes of immunotherapy
J. Bousquet ................................................ 121
Discussion .................................................... 128
A clinical trial with purified natural major allergens from
grass pollen
M. Fernández-Rivas et al. .................................. 131
Discussion .................................................... 136
Vaccination strategies in young children at risk for allergy
K. Duchén .................................................. 239
Discussion .................................................... 142
Requirements for demonstrating clinical efficacy: clinical
aspects
T.R. Kordash ............................................... 145
Requirements for demonstrating clinical efficacy:
statistical aspects
W. Lehmacher ............................................... 149
Discussion .................................................... 154
Recombinant versus Natural Allergens
Chairmen: D. Kraft, K. Blaser .............................. 157
Recombinant allergens expressed in E. coli: benefits and
drawbacks in the diagnosis of food allergies
S.Vieths et al. ............................................ 159
Discussion .................................................... 169
Cloning and characterization of Phi p I in different
expression systems
W.M. Becker et al. ......................................... 171
Discussion .................................................... 179
Expression of yellow-jacket and wasp venom Ag5 allergens in
bacteria and in yeast
R. Monsalve et al. ......................................... 181
Discussion .................................................... 188
Biological activity of recombinant bee venom allergens and
their mutants expressed in baculovirus-infected cells
L. Soldatova ............................................... 189
Discussion .................................................... 194
Structural and biological demands on recombinant allergens
related to their application
M. Spangfort ............................................... 197
Discussion .................................................... 201
Skin testing with wild-type recombinant birch pollen
allergens and hypoallergenic modified molecules
G.Pauli et al. ............................................. 203
Discussion .................................................... 210
Large scale production and quality criteria of recombinant
allergens for marketing
R. Valenta et al. .......................................... 211
Discussion .................................................... 224
Registration of recombinant proteins (including allergens)
in the EU
C.Pini ..................................................... 227
Discussion .................................................... 230
Expression and cloning of recombinant indoor allergens
M. Chapman ................................................. 233
Discussion .................................................... 238
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