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Article ; Online: Introduction of General Chapters on standard methods for allergen quantification in the European Pharmacopoeia.

Zimmer, Julia / Bonertz, Andreas / Kaul, Susanne / Vieths, Stefan

2023 Volume 78, Issue 4, Page(s) 923–927

Abstract: The Biological Standardization Project BSP090 has been successfully concluded in 2021. As a result, two standard methods for quantification of the major allergens Bet v 1 and Phl p 5 will be implemented in the European Pharmacopoeia (Ph. Eur.). The ... ...

Abstract	The Biological Standardization Project BSP090 has been successfully concluded in 2021. As a result, two standard methods for quantification of the major allergens Bet v 1 and Phl p 5 will be implemented in the European Pharmacopoeia (Ph. Eur.). The General Chapter describing the protocol of the respective Bet v 1-specific ELISA has already been adopted by the Ph. Eur. Commission and will become an official part of the Ph. Eur. in the beginning of 2023. As this will be the first allergen-specific standard method in the EU, this paper intends to summarize the preceding process and outline the measures necessary to comply with the new regulatory requirement.
MeSH term(s)	Humans ; Allergens/analysis ; Enzyme-Linked Immunosorbent Assay/methods
Chemical Substances	Allergens
Language	English
Publishing date	2023-01-06
Publishing country	Denmark
Document type	Journal Article ; Review ; Research Support, Non-U.S. Gov't
ZDB-ID	391933-x
ISSN	1398-9995 ; 0105-4538
ISSN (online)	1398-9995
ISSN	0105-4538
DOI	10.1111/all.15631
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Article ; Online: Introduction of General Chapters on standard methods for allergen quantification in the European Pharmacopoeia

Zimmer, Julia / Bonertz, Andreas / Kaul, Susanne / Vieths, Stefan

Allergy. 2023 Apr., v. 78, no. 4, p. 923-927

2023 , Page(s) 923–927

Abstract	The Biological Standardization Project BSP090 has been successfully concluded in 2021. As a result, two standard methods for quantification of the major allergens Bet v 1 and Phl p 5 will be implemented in the European Pharmacopoeia (Ph. Eur.). The General Chapter describing the protocol of the respective Bet v 1‐specific ELISA has already been adopted by the Ph. Eur. Commission and will become an official part of the Ph. Eur. in the beginning of 2023. As this will be the first allergen‐specific standard method in the EU, this paper intends to summarize the preceding process and outline the measures necessary to comply with the new regulatory requirement.
Keywords	Europeans ; allergens ; hypersensitivity ; methodology ; wills
Language	English
Dates of publication	2023-04
Size	p. 923-927
Publishing place	John Wiley & Sons, Inc.
Document type	Article ; Online
Note	REVIEW
ZDB-ID	391933-x
ISSN	1398-9995 ; 0105-4538
ISSN (online)	1398-9995
ISSN	0105-4538
DOI	10.1111/all.15631
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Quality control of allergen products with mass spectrometry part I: Positioning within the EU regulatory framework.

Spiric, Jelena / Schulenborg, Thomas / Holzhauser, Thomas / Schuler, Frank / Bonertz, Andreas / Lauer, Iris / Bartel, Detlef / Vieths, Stefan / Mahler, Vera / Reuter, Andreas

Allergy

2024

Abstract: Mass spectrometry (MS) has advanced greatly and many of its applications are ready for utilization within regulatory procedures and could significantly contribute to overcome challenges in standardization of allergen products. It seems sensible to ... ...

Abstract	Mass spectrometry (MS) has advanced greatly and many of its applications are ready for utilization within regulatory procedures and could significantly contribute to overcome challenges in standardization of allergen products. It seems sensible to discuss MS within the regulatory framework, before addressing technical questions. While the application to purified proteins is well established from product development to manufacturer's release analytics, its application to complex products such as allergen products is still under development. It needs to be determined where it can complement or replace established methods or where MS offers limited improvement. Despite its technical appeal and versatility, currently MS is mentioned in regulatory guidelines only as one possible measurement method. For example, no specific MS method is given in the European Pharmacopoeia. We discuss applications of MS within the EU regulatory framework. This includes their advantages and disadvantages and their positioning between research, characterization, manufacturer's release analytics and official batch testing. We discuss the qualitative detection of single and multiple allergens as proof of identity, qualitative to semi-quantitative protein profiles for batch to batch consistency testing, and quantification of allergens to state mass units of allergens. MS may also facilitate standardization of allergen products, reference products and reference standards.
Language	English
Publishing date	2024-02-29
Publishing country	Denmark
Document type	Journal Article
ZDB-ID	391933-x
ISSN	1398-9995 ; 0105-4538
ISSN (online)	1398-9995
ISSN	0105-4538
DOI	10.1111/all.16080
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Article ; Online: Regulatory Requirements for the Quality of Allergen Products for Allergen Immunotherapy of Food Allergy.

Englert, Lisa / Mahler, Vera / Bonertz, Andreas

Current allergy and asthma reports

2021 Volume 21, Issue 5, Page(s) 32

Abstract: Purpose of review: Medicinal products for allergen immunotherapy (AIT) of food allergies have gained enormous momentum in recent years. With this new class of products entering marketing authorization procedures, compliance to regulatory requirements ... ...

Abstract	Purpose of review: Medicinal products for allergen immunotherapy (AIT) of food allergies have gained enormous momentum in recent years. With this new class of products entering marketing authorization procedures, compliance to regulatory requirements becomes a critical element. Here, an overview is provided on specific requirements and aspects concerning the quality control and manufacturing of these products. Recent findings: Recent developments in the field of AIT for food allergies are divers, including products for oral, epicutaneous, and subcutaneous application, most notably targeting egg, milk, and peanut allergy. As the source materials for food AIT product are typically produced for food consumption and not for medicinal purposes, unique challenges arise in the manufacturing processes and controls of these medicinal products. Individual approaches are needed to assure acceptable quality, including control of relevant quantitative and qualitative characteristics. Major characteristics for quality verification include determination of protein content, total allergenic activity, and major allergen content. The applied manufacturing processes need to be established such that relevant process parameters are kept within justified limits and consistency of produced batches is assured. Allergen products for food AIT present specific challenges with respect to quality aspects that differentiate them from other commonly available AIT products. While established regulation is available and provides clear guidance for most aspects, other issues require consideration of new and individual settings relevant here. Consequently, as experience grows, respective amendments to currently available guidance may be needed.
MeSH term(s)	Allergens/therapeutic use ; Desensitization, Immunologic/standards ; Drug Industry/legislation & jurisprudence ; Drug Industry/standards ; Drug and Narcotic Control/legislation & jurisprudence ; European Union ; Food/adverse effects ; Food Hypersensitivity/immunology ; Food Hypersensitivity/therapy ; Government Regulation ; Humans ; Peanut Hypersensitivity/immunology ; Peanut Hypersensitivity/therapy ; Quality Control
Chemical Substances	Allergens
Language	English
Publishing date	2021-05-10
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2057370-4
ISSN	1534-6315 ; 1529-7322
ISSN (online)	1534-6315
ISSN	1529-7322
DOI	10.1007/s11882-021-01008-9
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: New guidance on the regulation of allergen products: key aspects and outcomes.

Bonertz, Andreas / Mahler, Vera / Vieths, Stefan

Current opinion in allergy and clinical immunology

2020 Volume 20, Issue 6, Page(s) 624–630

Abstract: Purpose of review: Key aspects and outcomes from the recently published guidance on the regulation of allergen products are summarized.: Recent findings: A new regulatory guideline has been published to enhance harmonized national approaches on the ... ...

Abstract	Purpose of review: Key aspects and outcomes from the recently published guidance on the regulation of allergen products are summarized. Recent findings: A new regulatory guideline has been published to enhance harmonized national approaches on the regulation of allergen products and thereby strengthen the availability of high-quality products across the European Union (EU). As the guideline was developed, critical aspects for allergen products regulation were identified and are discussed in the document, including recommendations on the regulatory procedures to be applied for diagnostics, allergen immunotherapy products and named-patient products. Summary: The new guidance is expected to provide clarifications on and support harmonization of the regulation of allergen products in the EU.
MeSH term(s)	Allergens/chemistry ; Allergens/immunology ; Animals ; Desensitization, Immunologic/methods ; European Union ; Humans ; Practice Guidelines as Topic ; Social Control, Formal/methods
Chemical Substances	Allergens
Language	English
Publishing date	2020-08-28
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2088710-3
ISSN	1473-6322 ; 1528-4050
ISSN (online)	1473-6322
ISSN	1528-4050
DOI	10.1097/ACI.0000000000000687
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Article ; Online: Manufacturing and quality assessment of allergenic extracts for immunotherapy: state of the art.

Bonertz, Andreas / Mahler, Vera / Vieths, Stefan

Current opinion in allergy and clinical immunology

2019 Volume 19, Issue 6, Page(s) 640–645

Abstract: Purpose of review: The recent developments in the manufacturing and quality assessment of allergenic extracts in Europe are summarized.: Recent findings: Quality assessment has always been a fundamental part of allergen product evaluation. New ... ...

Abstract	Purpose of review: The recent developments in the manufacturing and quality assessment of allergenic extracts in Europe are summarized. Recent findings: Quality assessment has always been a fundamental part of allergen product evaluation. New analytical methods have been reported that fill currently existing gaps in the characterization of commonly used allergen products. New types of products require innovative considerations and concepts for their assessment. Advanced standardization efforts aim at increasing reliability and comparability of analytical tools applied for allergen product characterization. In consequence, regulatory requirements are updated in line with such developments. Summary: Current demands on the quality of allergen products ensure production of well characterized products of consistent quality. While experience with manufacturing processes and successful product characterization approaches increase, accompanying and continuous re-evaluation of underlying quality control and assessment concepts is being performed.
MeSH term(s)	Allergens/immunology ; Cell Extracts/standards ; Desensitization, Immunologic ; Europe ; Humans ; Quality Assurance, Health Care ; Reproducibility of Results
Chemical Substances	Allergens ; Cell Extracts
Language	English
Publishing date	2019-08-26
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2088710-3
ISSN	1473-6322 ; 1528-4050
ISSN (online)	1473-6322
ISSN	1528-4050
DOI	10.1097/ACI.0000000000000579
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Article ; Online: A regulator's view on AIT clinical trials in the United States and Europe: Why successful studies fail to support licensure.

Bonertz, Andreas / Tripathi, Anubha / Zimmer, Julia / Reeb, Christina / Kaul, Susanne / Bridgewater, Jennifer / Rabin, Ronald L / Slater, Jay E / Vieths, Stefan

The Journal of allergy and clinical immunology

2022 Volume 149, Issue 3, Page(s) 812–818

Abstract: Clinical studies demonstrate that efficacy and safety in allergen immunotherapy (AIT) are linked to a multiplicity of factors decisively influencing success or failure. In recent years, numerous trials were performed with correspondent study results ... ...

Abstract	Clinical studies demonstrate that efficacy and safety in allergen immunotherapy (AIT) are linked to a multiplicity of factors decisively influencing success or failure. In recent years, numerous trials were performed with correspondent study results published. Yet, the number of AIT products successfully obtaining licensure in the analogous time frame is comparably limited. Essential for licensure is that the AIT product investigated remains comparable in its qualitative and quantitative composition throughout the clinical development. Verification of efficacy is not solely demonstrated by a statistically significant difference between the test and control populations; it must also be shown to be clinically relevant. Choice of meaningful inclusion and end-point criteria is critical. Post hoc or subgroup analysis can be supportive but needs verification as predefined criteria in additional studies. Data analysis may be presented on varying analysis populations, while it should be based on the intention-to-treat population for regulatory review to allow objective assessment of the treatment effect on the overall study population. Apparently conflicting interpretations of clinical data between publications and regulatory review are frequently based on their inherently different objectives, with regulatory review taking into considerations the full data sets of all relevant clinical studies for the concerned AIT product to allow an informed decision on licensure.
MeSH term(s)	Allergens/therapeutic use ; Desensitization, Immunologic/methods ; Europe ; Humans ; United States
Chemical Substances	Allergens
Language	English
Publishing date	2022-03-06
Publishing country	United States
Document type	Journal Article
ZDB-ID	121011-7
ISSN	1097-6825 ; 1085-8725 ; 0091-6749
ISSN (online)	1097-6825 ; 1085-8725
ISSN	0091-6749
DOI	10.1016/j.jaci.2022.01.004
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Article ; Online: DGAKI and PEI in dialogue 2023: Diagnostics and allergen immunotherapy.

Pfaar, Oliver / Hamelmann, Eckard / Taube, Christian / Wagenmann, Martin / Wedi, Bettina / Werfel, Thomas / Bartel, Detlef / Bonertz, Andreas / Hartenstein, Diana / Kaul, Susanne / Mahler, Vera / Worm, Margitta

Allergologie select

2023 Volume 7, Page(s) 229–235

Abstract: A roundtable discussion on February 10, 2023 between the German Society for Allergology and Clinical Immunology (DGAKI) and the Paul-Ehrlich-Institut (PEI) aimed to discuss in detail current aspects of allergen immunotherapy (AIT), its regulatory ... ...

Abstract	A roundtable discussion on February 10, 2023 between the German Society for Allergology and Clinical Immunology (DGAKI) and the Paul-Ehrlich-Institut (PEI) aimed to discuss in detail current aspects of allergen immunotherapy (AIT), its regulatory framework under the transitional provision of the Therapy Allergen Ordinance (TAO), and the consequences for the planned guideline work of the DGAKI, regulatory challenges in the approval of AIT products for children and adolescents as well as allergy diagnostics. The content and discussion points of this dialogue are summarized and are set in context with the current literature.
Language	English
Publishing date	2023-12-12
Publishing country	Germany
Document type	Journal Article
ZDB-ID	2893503-2
ISSN	2512-8957 ; 2512-8957
ISSN (online)	2512-8957
ISSN	2512-8957
DOI	10.5414/ALX02450E
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Article ; Online: Allergen-specific immunotherapy and evidence: A European regulatory perspective.

Bartel, Detlef / Bonertz, Andreas / Hartenstein, Diana / Kaul, Stefan / Lauer, Iris / Reeb, Christina / Rösner-Friese, Karen / Sliva, Katja / Zimmer, Julia / Vieths, Stefan / Mahler, Vera

Allergologie select

2023 Volume 7, Page(s) 198–210

Abstract: Allergen immunotherapy (AIT) has been performed for 112 years. In this article we summarize regulatory standards and challenges based on scientific evidence on AIT. Most crucial and timely aspects concerning AIT are addressed from the regulatory ... ...

Abstract	Allergen immunotherapy (AIT) has been performed for 112 years. In this article we summarize regulatory standards and challenges based on scientific evidence on AIT. Most crucial and timely aspects concerning AIT are addressed from the regulatory perspective of the authors as employees of a national competent authority in Europe: (1) product specificity; (2) clinical efficacy; (3) treatment for adults and children (needs for extrapolation); (4) allergen exposure chambers; (5) biomarkers; (6) standardization; (7) real-world evidence; (8) independent official batch release (benefit and challenges); (9) harmonization on the EU level. The Paul-Ehrlich-Institut (PEI), the Federal Institute for Vaccines and Biomedicines, in Langen near Frankfurt/Main in Germany, examines and evaluates the benefits and risks of AIT products within the course of clinical development, marketing authorization, and subsequently throughout their entire life cycle to ensure high-quality, safe, and effective AIT products.
Language	English
Publishing date	2023-12-12
Publishing country	Germany
Document type	Journal Article ; Review
ZDB-ID	2893503-2
ISSN	2512-8957 ; 2512-8957
ISSN (online)	2512-8957
ISSN	2512-8957
DOI	10.5414/ALX02413E
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Current developments with peptide-based human tumor vaccines.

Khazaie, Khashayarsha / Bonertz, Andreas / Beckhove, Philipp

Current opinion in oncology

2009 Volume 21, Issue 6, Page(s) 524–530

Abstract: Purpose of review: Cancer immunology became scientifically credible only some 20 years ago with the demonstration of the existence of human tumor antigens. In this short time span, outcomes of cancer vaccine trials have raised hopes and also surfaced ... ...

Abstract	Purpose of review: Cancer immunology became scientifically credible only some 20 years ago with the demonstration of the existence of human tumor antigens. In this short time span, outcomes of cancer vaccine trials have raised hopes and also surfaced disappointments. This review focuses on the prospects of peptide-based vaccines in cancer immunotherapy. Recent findings: Accurate descriptions of the natural immune responses to cancer allow for a more precise targeting of such tumors by boosting preexisting antitumor immune responses in patients. The development of synthetic long-peptide vaccines avoids many of the pitfalls of previous vaccination trials through the presence of multiple epitopes that may elicit memory antitumor immune responses. Furthermore, the combination of standard therapy with newly developed immunomodulating agents, such as antibodies blocking cytotoxic T lymphocyte-associated antigen-4 or programmed death receptor-1, and more efficient immune adjuvants has shown promising results. Summary: Immunotherapy is becoming an effective means of targeting human cancers, and the application of such approaches in combination with current standard schemes of treatment can lead to a significant benefit in survival and quality of life for cancer patients.
MeSH term(s)	Antigens, CD/immunology ; Antigens, Neoplasm/immunology ; CTLA-4 Antigen ; Cancer Vaccines/administration & dosage ; Cancer Vaccines/immunology ; Humans ; Immunotherapy/methods ; Immunotherapy/trends ; Neoplasms/immunology ; Neoplasms/therapy ; Treatment Outcome ; Vaccines, Subunit/administration & dosage ; Vaccines, Subunit/immunology
Chemical Substances	Antigens, CD ; Antigens, Neoplasm ; CTLA-4 Antigen ; CTLA4 protein, human ; Cancer Vaccines ; Vaccines, Subunit
Language	English
Publishing date	2009-11
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	1049384-0
ISSN	1531-703X ; 1040-8746
ISSN (online)	1531-703X
ISSN	1040-8746
DOI	10.1097/CCO.0b013e328331a78e
Database	MEDical Literature Analysis and Retrieval System OnLINE

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