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Artikel: Detection of hepatitis C virus and parvovirus B19 in human plasma pools by nucleic-acid amplification techniques – Trends in results of EDQM proficiency testing studies from 2004 to 2018

Taconet, Laure / Seifner, Alexandra / Baylis, Sally A / Chudy, Michael / Kreβ, Julia / Mathys, Esther / Wirz, Maria / Buchheit, Karl-Heinz / Behr-Gross, Marie-Emmanuelle

Biologicals. 2021 June, v. 71

2021

Abstract: The European Directorate for the Quality of Medicines & HealthCare (EDQM) has run proficiency testing schemes on the detection of viral contaminants in human plasma pools by nucleic-acid amplification techniques since 1999 for hepatitis C virus and since ...

Abstract	The European Directorate for the Quality of Medicines & HealthCare (EDQM) has run proficiency testing schemes on the detection of viral contaminants in human plasma pools by nucleic-acid amplification techniques since 1999 for hepatitis C virus and since 2004 for parvovirus B19. A retrospective analysis was performed to assess their impact and identify trends and progress in the results obtained by participating laboratories over a 15-year span, from 2004 to 2018. The results demonstrate that overall performance improved over that time, especially among the regular participants. Participation in these proficiency testing schemes is therefore recommended for all interested control laboratories. This analysis also shows that hepatitis C virus detection now seems well established compared to that of parvovirus B19, which still appears more challenging.
Schlagwörter	Hepatitis C virus ; governance ; health services ; humans ; retrospective studies ; viral contamination
Sprache	Englisch
Erscheinungsverlauf	2021-06
Umfang	p. 9-19.
Erscheinungsort	Elsevier Ltd
Dokumenttyp	Artikel
Anmerkung	NAL-AP-2-clean
ZDB-ID	1017370-5
ISSN	1095-8320 ; 1045-1056
ISSN (online)	1095-8320
ISSN	1045-1056
DOI	10.1016/j.biologicals.2021.04.004
Datenquelle	NAL Katalog (AGRICOLA)

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Artikel ; Online: Detection of hepatitis C virus and parvovirus B19 in human plasma pools by nucleic-acid amplification techniques - Trends in results of EDQM proficiency testing studies from 2004 to 2018.

Taconet, Laure / Seifner, Alexandra / Baylis, Sally A / Chudy, Michael / Kreβ, Julia / Mathys, Esther / Wirz, Maria / Buchheit, Karl-Heinz / Behr-Gross, Marie-Emmanuelle

Biologicals : journal of the International Association of Biological Standardization

2021 Band 71, Seite(n) 9–19

Abstract	The European Directorate for the Quality of Medicines & HealthCare (EDQM) has run proficiency testing schemes on the detection of viral contaminants in human plasma pools by nucleic-acid amplification techniques since 1999 for hepatitis C virus and since 2004 for parvovirus B19. A retrospective analysis was performed to assess their impact and identify trends and progress in the results obtained by participating laboratories over a 15-year span, from 2004 to 2018. The results demonstrate that overall performance improved over that time, especially among the regular participants. Participation in these proficiency testing schemes is therefore recommended for all interested control laboratories. This analysis also shows that hepatitis C virus detection now seems well established compared to that of parvovirus B19, which still appears more challenging.
Mesh-Begriff(e)	Blood Donors ; DNA, Viral/isolation & purification ; Hepacivirus/genetics ; Hepacivirus/isolation & purification ; Humans ; Parvovirus B19, Human/genetics ; Parvovirus B19, Human/isolation & purification ; Plasma/virology ; Retrospective Studies
Chemische Substanzen	DNA, Viral
Sprache	Englisch
Erscheinungsdatum	2021-05-15
Erscheinungsland	England
Dokumenttyp	Journal Article
ZDB-ID	1017370-5
ISSN	1095-8320 ; 1045-1056
ISSN (online)	1095-8320
ISSN	1045-1056
DOI	10.1016/j.biologicals.2021.04.004
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: The first World Health Organization International Standard for infliximab products: A step towards maintaining harmonized biological activity.

Metcalfe, Clive / Dougall, Thomas / Bird, Chris / Rigsby, Peter / Behr-Gross, Marie-Emmanuelle / Wadhwa, Meenu / Study, Participants Of The

mAbs

2018 Band 11, Heft 1, Seite(n) 13–25

Abstract: Due to the increase in the number of infliximab products, the need for global harmonization of the bioactivity of this monoclonal antibody was recognized by the World Health Organization (WHO). In response, the National Institute for Biological Standards ...

Abstract	Due to the increase in the number of infliximab products, the need for global harmonization of the bioactivity of this monoclonal antibody was recognized by the World Health Organization (WHO). In response, the National Institute for Biological Standards and Control (NIBSC) developed the first international standard (IS) for infliximab, which targets tumour necrosis factor (TNF). Each ampoule is assigned values of 500 IU of TNF neutralizing activity and 500 IU of binding activity. Two preparations of infliximab were formulated and lyophilized at NIBSC prior to evaluation in a collaborative study for their suitability to serve as an IS for the in vitro biological activity of infliximab. The study involved participants using in vitro cell-based bioassays (TNF neutralization, antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity) and binding assays. The results of this study showed that the candidate preparation, coded 16/170, is suitable as an IS for infliximab bioactivity. This infliximab IS from NIBSC, is intended to support in vitro bioassay calibration and validation by defining international units of bioactivity. The proposed unitages, however, are not intended to revise product labelling or dosing requirements, as any decisions regarding this relies solely with the regulatory authorities. Furthermore, the infliximab IS is not intended for determining the specific activity of products, nor to serve any regulatory role in defining biosimilarity. We briefly discuss the future use of WHO international standards in supporting the global harmonisation of biosimilar infliximab products.
Mesh-Begriff(e)	Biological Products/chemistry ; Biopharmaceutics/standards ; Biosimilar Pharmaceuticals/chemistry ; Humans ; Infliximab/chemistry ; Reference Standards ; World Health Organization
Chemische Substanzen	Biological Products ; Biosimilar Pharmaceuticals ; Infliximab (B72HH48FLU)
Sprache	Englisch
Erscheinungsdatum	2018-11-05
Erscheinungsland	United States
Dokumenttyp	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	1942-0870
ISSN (online)	1942-0870
DOI	10.1080/19420862.2018.1532766
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel: Conséquences réglementaires de l'utilisation des anticorps monoclonaux.

Lackner, Friedrich / Behr-Gross, Marie-Emmanuelle

Medecine sciences : M/S

2009 Band 25, Heft 12, Seite(n) 1183–1188

Abstract: Köhler and Milstein published a method for the manufacture of mouse monoclonal antibodies of predefined specificity 1975 [1], a work rewarded with the Nobel Prize 1984. Since then, the field has developed rapidly with new production methods such as ... ...

Titelübersetzung	Regulatory consequences for the use of monoclonal antibodies.
Abstract	Köhler and Milstein published a method for the manufacture of mouse monoclonal antibodies of predefined specificity 1975 [1], a work rewarded with the Nobel Prize 1984. Since then, the field has developed rapidly with new production methods such as recombinant DNA technology, phage display and genetically engineered animals. Following the first clinical applications with a mouse monoclonal antibody, new classes as chimaeric, humanized and human monoclonal antibodies appeared, with the advantages of less adverse reactions and better efficacy. The development over more than 30 years resulted in more than 25 approved products on the market for various therapeutic applications, e.g. for the treatment of cancer, inflammatory diseases, heart disease and transplantation, and medicines for many more applications are currently under development.
Mesh-Begriff(e)	Animals ; Antibodies, Monoclonal/adverse effects ; Antibodies, Monoclonal/classification ; Antibodies, Monoclonal/therapeutic use ; Antibodies, Monoclonal, Humanized ; Clinical Trials as Topic ; Drug Approval/legislation & jurisprudence ; Drug Evaluation, Preclinical ; Drug Industry/legislation & jurisprudence ; European Union ; Forecasting ; Humans ; International Agencies/legislation & jurisprudence ; International Agencies/standards ; Mice ; Quality Assurance, Health Care ; Risk ; Safety-Based Drug Withdrawals ; Technology, Pharmaceutical/legislation & jurisprudence ; United States ; United States Food and Drug Administration
Chemische Substanzen	Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; TGN-1412 monoclonal antibody
Sprache	Französisch
Erscheinungsdatum	2009-12
Erscheinungsland	France
Dokumenttyp	English Abstract ; Journal Article ; Review
ZDB-ID	632733-3
ISSN	1958-5381 ; 0767-0974
ISSN (online)	1958-5381
ISSN	0767-0974
DOI	10.1051/medsci/200925121183
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: European consensus proposal for immunoglobulin therapies.

Sewell, W A Carrock / Kerr, Jacqueline / Behr-Gross, Marie-Emmanuelle / Peter, Hans-Hartmut

European journal of immunology

2014 Band 44, Heft 8, Seite(n) 2207–2214

Abstract: The use of immunoglobulin (Ig) preparations (intravenous, IVIg, subcutaneous, SCIg) for replacement and immunomodulation therapy worldwide has tripled in the past 20 years and represents an ever-increasing cost factor for healthcare organizations. The ... ...

Abstract	The use of immunoglobulin (Ig) preparations (intravenous, IVIg, subcutaneous, SCIg) for replacement and immunomodulation therapy worldwide has tripled in the past 20 years and represents an ever-increasing cost factor for healthcare organizations. The limited access to the starting material of this essential medicinal product is currently the driving force for human plasma collection. Increasing awareness and improved diagnosis of human primary immunodeficiencies and a broadening of immunomodulatory indications are responsible for this development, and on a longer run might lead to plasma supply shortages. Consensus recommendations for the optimal use of Ig in clinical practice, including priority rankings for the most urgent indications, are therefore urgently needed. During a recent meeting in Kreuth, Germany, expert nominees from 36 Council of Europe states, together with colleagues from observer countries and regulatory agencies came up with this consensus statement.
Mesh-Begriff(e)	Consensus ; Europe ; Humans ; Immunization, Passive/methods ; Immunization, Passive/standards ; Immunoglobulins/therapeutic use
Chemische Substanzen	Immunoglobulins
Sprache	Englisch
Erscheinungsdatum	2014-08
Erscheinungsland	Germany
Dokumenttyp	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	120108-6
ISSN	1521-4141 ; 0014-2980
ISSN (online)	1521-4141
ISSN	0014-2980
DOI	10.1002/eji.201444700
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: Recommendations of the VAC2VAC workshop on the design of multi-centre validation studies.

Halder, Marlies / Depraetere, Hilde / Delannois, Frédérique / Akkermans, Arnoud / Behr-Gross, Marie-Emmanuelle / Bruysters, Martijn / Dierick, Jean-François / Jungbäck, Carmen / Kross, Imke / Metz, Bernard / Pennings, Jeroen / Rigsby, Peter / Riou, Patrice / Balks, Elisabeth / Dobly, Alexandre / Leroy, Odile / Stirling, Catrina

Biologicals : journal of the International Association of Biological Standardization

2018 Band 52, Seite(n) 78–82

Abstract: Within the Innovative Medicines Initiative 2 (IMI 2) project VAC2VAC (Vaccine batch to vaccine batch comparison by consistency testing), a workshop has been organised to discuss ways of improving the design of multi-centre validation studies and use the ... ...

Abstract	Within the Innovative Medicines Initiative 2 (IMI 2) project VAC2VAC (Vaccine batch to vaccine batch comparison by consistency testing), a workshop has been organised to discuss ways of improving the design of multi-centre validation studies and use the data generated for product-specific validation purposes. Moreover, aspects of validation within the consistency approach context were addressed. This report summarises the discussions and outlines the conclusions and recommendations agreed on by the workshop participants.
Mesh-Begriff(e)	Consensus Development Conferences as Topic ; Humans ; Multicenter Studies as Topic ; Practice Guidelines as Topic ; Vaccines/therapeutic use ; Validation Studies as Topic
Chemische Substanzen	Vaccines
Sprache	Englisch
Erscheinungsdatum	2018-02-01
Erscheinungsland	England
Dokumenttyp	Journal Article
ZDB-ID	1017370-5
ISSN	1095-8320 ; 1045-1056
ISSN (online)	1095-8320
ISSN	1045-1056
DOI	10.1016/j.biologicals.2018.01.003
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Buch: Collaborative study to establish the 2nd WHO international standard for low molecular weight heparin and the low-molecular-mass heparin for assay European Pharmacopoeia biological reference preparation

Gray, Elaine / Rigsby, Peter / Behr-Gross, Marie-Emmanuelle

2003

Körperschaft	WHO Expert Committee on Biological Standardization
Verfasserangabe	Elaine Gray, Peter Rigsby, and Marie-Emmanuelle Behr-Gross
Mesh-Begriff(e)	Heparin, Low-Molecular-Weight/standards ; Biological Assay/methods ; Reference Standards
Sprache	Englisch
Umfang	43 p. :, ill.
Verlag	World Health Organization
Erscheinungsort	Geneva
Dokumenttyp	Buch
Anmerkung	Caption title. ; At head of title: Expert Committee on Biological Standardization, Geneva, 17 to 21 November 2003. ; "WHO/BS/03.1986."
Datenquelle	Katalog der US National Library of Medicine (NLM)

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Artikel: International collaborative study to assess candidate reference preparations to control the level of anti-D in IVIG for use in Europe and the United States.

Thorpe, Susan J / Fox, Bernard / Heath, Alan / Behr-Gross, Marie-Emmanuelle / Virata, Maria L / Yu, Mei-Ying W

Biologicals : journal of the International Association of Biological Standardization

2006 Band 34, Heft 3, Seite(n) 209–212

Abstract: Regulatory requirements to control the level of anti-D in intravenous immunoglobulin (IVIG) products with European and United States (US) licences are to be introduced. A reference preparation of IVIG containing anti-D at 0.0475 IU/ml and having a ... ...

Abstract	Regulatory requirements to control the level of anti-D in intravenous immunoglobulin (IVIG) products with European and United States (US) licences are to be introduced. A reference preparation of IVIG containing anti-D at 0.0475 IU/ml and having a nominal titre of 8 using the proposed direct haemagglutination reference method was deemed suitable to define the anti-D limit. This preparation, code 02/228, and a negative control IVIG preparation, code 02/226, were established by the World Health Organization as International Reference Reagents (IRRs). As stocks of the IRRs are limited, new larger fill stocks of positive and negative reference preparations, codes 04/132 and 04/140, respectively, were produced. The results from an international collaborative study involving 16 laboratories showed that preparations 04/132 and 04/140 are indistinguishable from the corresponding IRRs 02/228 and 02/226, respectively, using the proposed direct haemagglutination reference method. Stocks of 04/132 and 04/140 have been shared with the European Directorate for the Quality of Medicines (re-coded as 23613 and 23614, respectively) and with the Center for Biologics Evaluation and Research of the United States Food and Drug Administration (re-coded as CBER Lots 1B and 1N-b, respectively) for use as European and US Biological Reference Preparations, respectively.
Mesh-Begriff(e)	Europe ; Evaluation Studies as Topic ; Hemagglutination Tests ; Humans ; Immunoglobulins, Intravenous/standards ; International Cooperation ; Isoantibodies/analysis ; Reference Standards ; Rho(D) Immune Globulin ; United States ; United States Food and Drug Administration ; World Health Organization
Chemische Substanzen	Immunoglobulins, Intravenous ; Isoantibodies ; RHO(D) antibody ; Rho(D) Immune Globulin
Sprache	Englisch
Erscheinungsdatum	2006-09
Erscheinungsland	England
Dokumenttyp	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1017370-5
ISSN	1095-8320 ; 1045-1056
ISSN (online)	1095-8320
ISSN	1045-1056
DOI	10.1016/j.biologicals.2005.11.001
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel: Collaborative study for the establishment of a European Phamacopoeia Biological reference preparation for Bordetella pertussis mouse antiserum for serological potency testing of acellular pertussis vaccines.

Poirier, Bertrand / Bornstein, Nicole / Andre, Murielle / Marmonier, Denis / Pares, Monique / Vanhooren, Gerard / Rautmann, Guy / Behr-Gross, Marie-Emmanuelle / Dobbelaer, Roland / Fuchs, Florence

Biologicals : journal of the International Association of Biological Standardization

2003 Band 31, Heft 1, Seite(n) 25–38

Abstract: A collaborative study was organised by the European Directorate For the Quality of Medicines (EDQM) to assess the suitability of a candidate mouse antiserum as a European Pharmacopoeia Biological reference preparation (BRP) for acellular pertussis ... ...

Abstract	A collaborative study was organised by the European Directorate For the Quality of Medicines (EDQM) to assess the suitability of a candidate mouse antiserum as a European Pharmacopoeia Biological reference preparation (BRP) for acellular pertussis vaccine potency testing. The candidate antiserum was obtained by immunising mice with a five-component acellular pertussis vaccine: pertussis toxin (PT), filamentous haemagglutinin (FHA), pertactin (PRN) and Fimbrial 2/Fimbrial 3 (Fim 2&3). The study has been divided into two separate phases. Phase I was a pre-qualification study including three laboratories. This phase was aimed at pre-qualifying the candidate BRP (cBRP) and at documenting the impact of differences in the antibody detection methodology enzyme linked immunosorbent assay (ELISA) procedures on results of pertussis antisera calibration versus the currently used standard US standard pertussis antiserum (mouse) Lot 1 (SPAM-1) (United States Food and Drug Administration (USFDA) reference serum) and the cBRP. As no significant difference between the antibody titres determined by using the different ELISA methodologies was found, a large-scale study enrolling 13 laboratories (Phase II) was carried out, each participant performing its in-house methodology. Its aim was to calibrate the cBRP (in terms of the SPAM-1 reference) and to demonstrate its equivalence or superiority to internal references. The study showed that there was no difference in positive sera titres expressed relative to their corresponding internal reference (homologous situation) or the proposed standard (heterologous situation) reference. The cBRP can, therefore, reliably act as replacement for the in-house reference preparations. Further analysis of the outcome of this study enabled to assign to the cBRP a potency of 39, 138, 34 and 56 ELISA unit per millilitre, respectively, to its anti-PT, anti-FHA, anti-PRN and anti-Fim 2&3 antibody contents. The cBRP has been adopted by the European Pharmacopoeia Commission at its June 2000 session as Bordetella pertussis mouse anti-serum Ph Eur. BRP batch 1.
Mesh-Begriff(e)	Animals ; Bordetella pertussis/immunology ; Cooperative Behavior ; Immune Sera/immunology ; Mice ; Pertussis Vaccine/immunology ; Pharmacopoeias as Topic ; Reference Standards
Chemische Substanzen	Immune Sera ; Pertussis Vaccine
Sprache	Englisch
Erscheinungsdatum	2003-02-20
Erscheinungsland	England
Dokumenttyp	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1017370-5
ISSN	1095-8320 ; 1045-1056
ISSN (online)	1095-8320
ISSN	1045-1056
DOI	10.1016/s1045-1056(02)00075-1
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Buch ; Online: WHO reference reagents to standardise haemagglutination testing for anti-A and anti-B in normal intravenous immunoglobulin products / by Susan J. Thorpe, Bernard Fox, Giles Sharp, Alan B. Heath, Mei-Ying W. Yu, Maria L. Virata-Theimer, Marie-Emmanuelle Behr-Gross, and Eriko Terao

Thorpe, Susan J / Fox, Bernard / Sharp, Giles / Heath, Alan B / Yu, Mei-Ying W / Virata-Theimer, Maria L / Behr-Gross, Marie-Emmanuelle / Terao, Eriko / World Health Organization. Biologicals Unit / WHO Expert Committee on Biological Standardization (2008 : Geneva, Switzerland)

2008

Abstract: WHO/BS/08.2091 ... 43 p. ... English ... ...

Abstract	WHO/BS/08.2091 43 p. English only
Schlagwörter	Pharmaceuticals and Biologicals
Sprache	Englisch
Verlag	Geneva : World Health Organization
Dokumenttyp	Buch ; Online
Datenquelle	BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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