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Article: Routine Epstein-Barr virus diagnostics from the laboratory perspective: still challenging after 35 years.

Hess, Ralf D

2004 Volume 42, Issue 8, Page(s) 3381–3387

MeSH term(s)	Diagnosis, Differential ; Epstein-Barr Virus Infections/diagnosis ; Epstein-Barr Virus Infections/epidemiology ; Herpesvirus 4, Human/genetics ; Herpesvirus 4, Human/growth & development ; Humans ; Prevalence
Language	English
Publishing date	2004-08
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	390499-4
ISSN	1098-660X ; 0095-1137
ISSN (online)	1098-660X
ISSN	0095-1137
DOI	10.1128/JCM.42.8.3381-3387.2004
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Article: The neurosurgical benefit of contactless

Kuppler, Patrick / Strenge, Paul / Lange, Birgit / Spahr-Hess, Sonja / Draxinger, Wolfgang / Hagel, Christian / Theisen-Kunde, Dirk / Brinkmann, Ralf / Huber, Robert / Tronnier, Volker / Bonsanto, Matteo Mario

Frontiers in oncology

2023 Volume 13, Page(s) 1151149

Abstract: Purpose: In brain tumor surgery, it is crucial to achieve complete tumor resection while conserving adjacent noncancerous brain tissue. Several groups have demonstrated that optical coherence tomography (OCT) has the potential of identifying tumorous ... ...

Abstract	Purpose: In brain tumor surgery, it is crucial to achieve complete tumor resection while conserving adjacent noncancerous brain tissue. Several groups have demonstrated that optical coherence tomography (OCT) has the potential of identifying tumorous brain tissue. However, there is little evidence on human Experimental design: Multiple 3-dimensional Results: Visual OCT-scan classification correlated well with histopathological findings. Classification with measured OCT image-properties achieved a balanced accuracy of 85%. A neuronal network approach for scan feature recognition achieved 82% and an auto-encoder approach 85% balanced accuracy. Overall applicability showed need for improvement. Conclusion: Contactless
Language	English
Publishing date	2023-04-13
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2649216-7
ISSN	2234-943X
ISSN	2234-943X
DOI	10.3389/fonc.2023.1151149
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Article ; Online: Regulatory, biosafety and safety challenges for novel cells as substrates for human vaccines.

Hess, Ralf D / Weber, Friedemann / Watson, Keith / Schmitt, Siegfried

Vaccine

2012 Volume 30, Issue 17, Page(s) 2715–2727

Abstract: In the development of novel substrates used for production of human vaccines there has been significant progress made in recent years. Emerging and re-emerging infectious diseases like the recent porcine Influenza A virus (H1N1) pandemic necessitated the ...

Abstract	In the development of novel substrates used for production of human vaccines there has been significant progress made in recent years. Emerging and re-emerging infectious diseases like the recent porcine Influenza A virus (H1N1) pandemic necessitated the availability of unprecedented amounts of vaccines. In addition, the high demand for vaccines in the industrialised countries has also been paralleled by a steep increase in demand in developing countries. The manufacturing capability for viral vaccines produced in embryonated hen eggs and conventional/classical cell substrates, such as chicken embryo fibroblasts, has now reached its capacity limit. This constraint may be overcome by utilising other recognised cell substrates such as Madin Darby Canine Kidney (MDCK) (dog origin), Chinese Hamster Ovary (CHO) (hamster cells) or Vero cells (monkey origin) or as an alternative, introduce new cell substrates of human or avian origin. Using new cell substrates may prove to be a highly replication-proficient way of producing live viral vaccines such as Influenza A viruses. Despite some advantages, cell substrates may pose a small residual risk to humans since some of them are known to be tumourigenic in immunosuppressed animals. However, this residual risk should be considered acceptable by regulators. Safety testing requirements for cell substrates used in the manufacture of vaccines is mandated by published guidance from organisations such as World Health Organization (WHO), United States Food and Drug Administration (FDA), European Medicines Agency (EMA) and International Conferences on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use (ICH) as well as requirements laid down in compendial monographs (Ph. Eur. and USP). This paper considers the guidance contained in these regulatory documents. In addition, the safety challenges and almost arbitrary risk-based classification of cell substrates used in the production of human vaccines together with compliance to GCCP (Good Cell Culture Practice) are discussed. Even though there has been tremendous progress in the last few years, reflected mainly by revisions and updates to regulatory guidance documents, there still is still no consensus between regulators nor significant harmonisation of the guidance documents or monographs.
MeSH term(s)	Animals ; Cell Culture Techniques ; Cell Line ; Humans ; Vaccination/legislation & jurisprudence ; Vaccines/adverse effects ; Vaccines/standards
Chemical Substances	Vaccines
Language	English
Publishing date	2012-04-05
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2012.02.015
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Article: Progressive Liver Disease in Patients With Ataxia Telangiectasia.

Donath, Helena / Woelke, Sandra / Theis, Marius / Heß, Ursula / Knop, Viola / Herrmann, Eva / Krauskopf, Dorothea / Kieslich, Matthias / Schubert, Ralf / Zielen, Stefan

Frontiers in pediatrics

2019 Volume 7, Page(s) 458

Abstract: Ataxia telangiectasia (A-T) is a devastating multi-system disorder characterized by progressive cerebellar ataxia, immunodeficiency, genetic instability, premature aging and growth retardation. Due to better care the patients get older than in the past ... ...

Abstract	Ataxia telangiectasia (A-T) is a devastating multi-system disorder characterized by progressive cerebellar ataxia, immunodeficiency, genetic instability, premature aging and growth retardation. Due to better care the patients get older than in the past and new disease entities like disturbed glucose tolerance and liver disease emerge. The objective of the present investigation is to determine the evolution of liver disease and its relation to age and neurological deterioration. The study included 67 patients aged 1 to 38 years with classical A-T. At least two measurements of liver enzymes were performed within a minimum interval of 6 months in 56 patients. The median follow-up period was 4 years (1-16 years). A total of 316 liver enzyme measurements were performed. For analysis, patients were divided into two age groups (Group 1: <12 years; group 2: ≥12 years). In addition, ultrasound of the liver and Klockgether Ataxia Score (KAS) were analyzed. We found significantly higher levels of alpha-fetoprotein (AFP) (226,8 ± 20.87 ng/ml vs. 565,1 ± 24.3 ng/ml,
Language	English
Publishing date	2019-11-07
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2711999-3
ISSN	2296-2360
ISSN	2296-2360
DOI	10.3389/fped.2019.00458
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Article: Differentiation of different stages of brain tumor infiltration using optical coherence tomography: Comparison of two systems and histology.

Strenge, Paul / Lange, Birgit / Draxinger, Wolfgang / Grill, Christin / Danicke, Veit / Theisen-Kunde, Dirk / Hagel, Christian / Spahr-Hess, Sonja / Bonsanto, Matteo M / Handels, Heinz / Huber, Robert / Brinkmann, Ralf

Frontiers in oncology

2022 Volume 12, Page(s) 896060

Abstract: The discrimination of tumor-infiltrated tissue from non-tumorous brain tissue during neurosurgical tumor excision is a major challenge in neurosurgery. It is critical to achieve full tumor removal since it directly correlates with the survival rate of ... ...

Abstract	The discrimination of tumor-infiltrated tissue from non-tumorous brain tissue during neurosurgical tumor excision is a major challenge in neurosurgery. It is critical to achieve full tumor removal since it directly correlates with the survival rate of the patient. Optical coherence tomography (OCT) might be an additional imaging method in the field of neurosurgery that enables the classification of different levels of tumor infiltration and non-tumorous tissue. This work investigated two OCT systems with different imaging wavelengths (930 nm/1310 nm) and different resolutions (axial (air): 4.9 μm/16 μm, lateral: 5.2 μm/22 μm) in their ability to identify different levels of tumor infiltration based on freshly excised
Language	English
Publishing date	2022-08-30
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2649216-7
ISSN	2234-943X
ISSN	2234-943X
DOI	10.3389/fonc.2022.896060
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Article ; Online: Registration of histological brain images onto optical coherence tomography images based on shape information.

Strenge, Paul / Lange, Birgit / Grill, Christin / Draxinger, Wolfgang / Danicke, Veit / Theisen-Kunde, Dirk / Hagel, Christian / Spahr-Hess, Sonja / Bonsanto, Matteo M / Huber, Robert / Handels, Heinz / Brinkmann, Ralf

Physics in medicine and biology

2022 Volume 67, Issue 13

Abstract: Identifying tumour infiltration zones during tumour resection in order to excise as much tumour tissue as possible without damaging healthy brain tissue is still a major challenge in neurosurgery. The detection of tumour infiltrated regions so far ... ...

Abstract	Identifying tumour infiltration zones during tumour resection in order to excise as much tumour tissue as possible without damaging healthy brain tissue is still a major challenge in neurosurgery. The detection of tumour infiltrated regions so far requires histological analysis of biopsies taken from at expected tumour boundaries. The gold standard for histological analysis is the staining of thin cut specimen and the evaluation by a neuropathologist. This work presents a way to transfer the histological evaluation of a neuropathologist onto optical coherence tomography (OCT) images. OCT is a method suitable for real time
MeSH term(s)	Biopsy ; Brain/diagnostic imaging ; Neurosurgical Procedures ; Staining and Labeling ; Tomography, Optical Coherence/methods
Language	English
Publishing date	2022-06-24
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	208857-5
ISSN	1361-6560 ; 0031-9155
ISSN (online)	1361-6560
ISSN	0031-9155
DOI	10.1088/1361-6560/ac6d9d
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Article: Regulatory, biosafety and safety challenges for novel cells as substrates for human vaccines

Hess, Ralf D / Weber, Friedemann / Watson, Keith / Schmitt, Siegfried

Vaccine. 2012 Apr. 5, v. 30, no. 17

2012

Abstract	In the development of novel substrates used for production of human vaccines there has been significant progress made in recent years. Emerging and re-emerging infectious diseases like the recent porcine Influenza A virus (H1N1) pandemic necessitated the availability of unprecedented amounts of vaccines. In addition, the high demand for vaccines in the industrialised countries has also been paralleled by a steep increase in demand in developing countries. The manufacturing capability for viral vaccines produced in embryonated hen eggs and conventional/classical cell substrates, such as chicken embryo fibroblasts, has now reached its capacity limit. This constraint may be overcome by utilising other recognised cell substrates such as Madin Darby Canine Kidney (MDCK) (dog origin), Chinese Hamster Ovary (CHO) (hamster cells) or Vero cells (monkey origin) or as an alternative, introduce new cell substrates of human or avian origin. Using new cell substrates may prove to be a highly replication-proficient way of producing live viral vaccines such as Influenza A viruses. Despite some advantages, cell substrates may pose a small residual risk to humans since some of them are known to be tumourigenic in immunosuppressed animals. However, this residual risk should be considered acceptable by regulators. Safety testing requirements for cell substrates used in the manufacture of vaccines is mandated by published guidance from organisations such as World Health Organization (WHO), United States Food and Drug Administration (FDA), European Medicines Agency (EMA) and International Conferences on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use (ICH) as well as requirements laid down in compendial monographs (Ph. Eur. and USP). This paper considers the guidance contained in these regulatory documents. In addition, the safety challenges and almost arbitrary risk-based classification of cell substrates used in the production of human vaccines together with compliance to GCCP (Good Cell Culture Practice) are discussed. Even though there has been tremendous progress in the last few years, reflected mainly by revisions and updates to regulatory guidance documents, there still is still no consensus between regulators nor significant harmonisation of the guidance documents or monographs.
Keywords	Chinese hamsters ; Food and Drug Administration ; Orthomyxoviridae ; World Health Organization ; biosafety ; cell culture ; compliance ; developed countries ; developing countries ; dogs ; eggs ; fibroblasts ; hens ; humans ; kidneys ; manufacturing ; monkeys ; pandemic ; risk ; safety testing ; swine influenza ; viral vaccines
Language	English
Dates of publication	2012-0405
Size	p. 2715-2727.
Publishing place	Elsevier Ltd
Document type	Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2012.02.015
Database	NAL-Catalogue (AGRICOLA)

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Article: Meeting report: Part 1. Notes from the Molecular Virology Workshop, 23-24 April 2004, Clearwater Beach, Florida, USA.

Hess, Ralf D / Gärtner, Barbara C / Garrett, Patricia E

Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology

2005 Volume 32, Issue 3, Page(s) 259–262

MeSH term(s)	Animals ; DNA, Viral/analysis ; Humans ; Virology/methods ; Virus Diseases/diagnosis ; Viruses/genetics ; Viruses/isolation & purification
Chemical Substances	DNA, Viral
Keywords	covid19
Language	English
Publishing date	2005-08-03
Publishing country	Netherlands
Document type	Congress
ZDB-ID	1446080-4
ISSN	1873-5967 ; 1386-6532
ISSN (online)	1873-5967
ISSN	1386-6532
DOI	10.1016/j.jcv.2004.08.012
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Article: Meeting report: Part II. Notes from the Twentieth Annual Clinical Virology Symposium.

Hess, Ralf D / Gärtner, Barbara C / Garrett, Patricia E

Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology

2005 Volume 32, Issue 4, Page(s) 342–346

MeSH term(s)	Animals ; Blood Donors ; Humans ; Monkeypox virus/isolation & purification ; Monkeypox virus/physiology ; Norovirus/pathogenicity ; Norovirus/physiology ; SARS Virus/isolation & purification ; SARS Virus/physiology ; Teaching ; Virology/education ; Virology/methods ; Virus Diseases/diagnosis ; Virus Diseases/epidemiology ; Virus Diseases/prevention & control
Keywords	covid19
Language	English
Publishing date	2005-01-08
Publishing country	Netherlands
Document type	Congress
ZDB-ID	1446080-4
ISSN	1873-5967 ; 1386-6532
ISSN (online)	1873-5967
ISSN	1386-6532
DOI	10.1016/j.jcv.2004.11.005
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Article ; Online: Phase 2 study of the bispecific T-cell engager (BiTE) antibody blinatumomab in relapsed/refractory diffuse large B-cell lymphoma.

Viardot, Andreas / Goebeler, Marie-Elisabeth / Hess, Georg / Neumann, Svenja / Pfreundschuh, Michael / Adrian, Nicole / Zettl, Florian / Libicher, Martin / Sayehli, Cyrus / Stieglmaier, Julia / Zhang, Alicia / Nagorsen, Dirk / Bargou, Ralf C

Blood

2016 Volume 127, Issue 11, Page(s) 1410–1416

Abstract: ... T cells to CD19-positive B cells. This phase 2 study evaluated stepwise (9-28-112 μg/d with weekly dose ... increases; n = 23) or flat (112 μg/d; n = 2) dosing of blinatumomab by continuous infusion ...

Abstract	Few patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) achieve prolonged disease-free survival. Blinatumomab, a bispecific T-cell engaging antibody construct, transiently links CD3-positive T cells to CD19-positive B cells. This phase 2 study evaluated stepwise (9-28-112 μg/d with weekly dose increases; n = 23) or flat (112 μg/d; n = 2) dosing of blinatumomab by continuous infusion, with dexamethasone prophylaxis, in patients with relapsed/refractory DLBCL. Patients received a median of 3 prior lines of therapy. Median time since last regimen was 1.5 months. Seventeen patients ended treatment in cycle 1 (induction), 7 in cycle 2 (consolidation), and 1 in retreatment. Among 21 evaluable patients, the overall response rate after 1 blinatumomab cycle was 43%, including complete responses (CRs) in 19%. Three patients had late CR in follow-up without other treatment. The most common adverse events with stepwise dosing were tremor (48%), pyrexia (44%), fatigue (26%), and edema (26%). Grade 3 neurologic events with stepwise dosing were encephalopathy and aphasia (each 9%) and tremor, speech disorder, dizziness, somnolence, and disorientation (each 4%). Of 5 (22%) patients who discontinued stepwise dosing because of adverse events, 4 (17%) had neurologic events. Most neurologic events resolved. The flat-dose cohort was stopped because of grade 3 neurologic events in both patients. Blinatumomab monotherapy appears effective in patients with relapsed/refractory DLBCL, a heavily pretreated patient population with a high unmet medical need. Further studies need to define the optimal approach to achieve the target dose without early dropout. The study was registered at www.clinicaltrials.gov as #NCT01741792.
MeSH term(s)	Adult ; Aged ; Antibodies, Bispecific/administration & dosage ; Antibodies, Bispecific/adverse effects ; Antibodies, Bispecific/immunology ; Antibodies, Bispecific/therapeutic use ; Antigens, CD19/immunology ; Antigens, Neoplasm/immunology ; Antineoplastic Agents/administration & dosage ; Antineoplastic Agents/adverse effects ; Antineoplastic Agents/immunology ; Antineoplastic Agents/therapeutic use ; CD3 Complex/immunology ; Dexamethasone/therapeutic use ; Disease-Free Survival ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Fatigue/chemically induced ; Female ; Fever/chemically induced ; Humans ; Immunotherapy ; Kaplan-Meier Estimate ; Lymphoma, Large B-Cell, Diffuse/drug therapy ; Male ; Middle Aged ; Molecular Targeted Therapy ; Nervous System Diseases/chemically induced ; Recurrence ; Remission Induction ; Salvage Therapy ; Tumor Burden
Chemical Substances	Antibodies, Bispecific ; Antigens, CD19 ; Antigens, Neoplasm ; Antineoplastic Agents ; CD3 Complex ; blinatumomab (4FR53SIF3A) ; Dexamethasone (7S5I7G3JQL)
Language	English
Publishing date	2016-01-11
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Multicenter Study
ZDB-ID	80069-7
ISSN	1528-0020 ; 0006-4971
ISSN (online)	1528-0020
ISSN	0006-4971
DOI	10.1182/blood-2015-06-651380
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