Roland Schmidt
Hoffmann-La Roche
ParticleSignalAnalytical chemistryBiological activityOpticsPhysicsBiophysicsSample size determinationDifferential centrifugationParticle densityResonance (particle physics)Genetically modified mouseMicroscopyNanoparticleVirologyNanotechnologyBiochemical engineeringChemistryParticle sizeMicrosphereMaterials scienceNew product developmentProcess engineeringAnticonvulsantTryptophanMuscle relaxantForced degradationImmune toleranceBenzodiazepineCharacterization (materials science)ImmunogenicityMethionineTherapeutic proteinPharmaceutical SolutionsPrefilled SyringeStress conditionsCritical assessmentProtein oxidationPhysical stabilityFuture studiesProtein particlesFlow imagingRoutine testingTherapeutic antibodyParticle analysisSources of errorComparative evaluationMeasurement methodCharacterization methodsAntibodies monoclonalLight obscurationDrug productPharmacology toxicologyVolume concentrationEnvironmental scienceReagentComputer scienceChromatographyProtein structureAmino acidHydrogen peroxideBiochemistryMicrochannelStereochemistryBovine serum albuminImmune systemResonatorFractionation
10Publications
8H-index
328Citations
Publications 10
Newest
#1Björn Boll (University of Basel)H-Index: 6
#2Juliana Bessa (Hoffmann-La Roche)H-Index: 3
Last. Atanas KoulovH-Index: 13
view all 11 authors...
A current concern with the use of therapeutic proteins is the likely presence of aggregates and submicrometer, subvisible, and visible particles. It has been proposed that aggregates and particles may lead to unwanted increases in the immune response with a possible impact on safety or efficacy. The aim of this study was thus to evaluate the ability of subvisible particles of a therapeutic antibody to break immune tolerance in an IgG1 transgenic mouse model and to understand the particle attribu...
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#1Anacelia Ríos Quiroz (University of Basel)H-Index: 3
#2Christof Finkler (Hoffmann-La Roche)H-Index: 11
Last. Atanas Koulov (Hoffmann-La Roche)H-Index: 13
view all 6 authors...
Abstract A number of new techniques for subvisible particle characterization in biotechnological products have emerged in the last decade. Although the pharmaceutical community is actively using them, the current knowledge about the analytical performance of some of these tools is still inadequate to support their routine use in the development of biopharmaceuticals (especially in the case of submicron methods). With the aim of increasing this knowledge and our understanding of the most prominen...
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#1Anacelia Ríos Quiroz (University of Basel)H-Index: 3
#2Jens Lamerz (Hoffmann-La Roche)H-Index: 12
Last. Atanas Koulov (Hoffmann-La Roche)H-Index: 13
view all 10 authors...
Purpose The current study was performed to assess the precision of the principal subvisible particle measurement methods available today. Special attention was given to identifying the sources of error and the factors governing analytical performance.
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#1Emilien Folzer (University of Basel)H-Index: 4
#2Tarik A. Khan (University of Basel)H-Index: 14
Last. Atanas Koulov (Hoffmann-La Roche)H-Index: 13
view all 7 authors...
One of the analytical tools for characterization of subvisible particles, which gained popularity over the last years because of its unique capabilities, is the resonance mass measurement technique. However, a challenge that this technique presents is the need to know the exact density of the measured particles in order to obtain accurate size calculations. The density of proteinaceous subvisible particles has not been measured experimentally yet and to date researchers have been using estimated...
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#1Emilien Folzer (University of Basel)H-Index: 4
#2Katharina Diepold (Hoffmann-La Roche)H-Index: 5
Last. Atanas Koulov (Hoffmann-La Roche)H-Index: 13
view all 9 authors...
Oxidation of methionine and tryptophan are common degradation pathways for monoclonal antibodies and present major analytical challenges in biotechnology. Generally, protein oxidation is detectable in stability and/or stressed samples (e.g., exposed to hydrogen peroxide, UV light, or metal ions). The induced chemical modifications may impact the biological activity of antibodies and may have biological consequences. However, these effects and the contribution of individual protein modifications ...
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#1Vincent Corvari (Eli Lilly and Company)H-Index: 4
#2Linda O. Narhi (Amgen)H-Index: 56
Last. Klaus Wuchner (Janssen Pharmaceutica)H-Index: 9
view all 23 authors...
Measurement and characterization of subvisible particles (including proteinaceous and non-proteinaceous particulate matter) is an important aspect of the pharmaceutical development process for biotherapeutics. Health authorities have increased expectations for subvisible particle data beyond criteria specified in the pharmacopeia and covering a wider size range. In addition, subvisible particle data is being requested for samples exposed to various stress conditions and to support process/produc...
Source
#1Björn Boll (University of Basel)H-Index: 6
#2Emilien Folzer (University of Basel)H-Index: 4
Last. Atanas Koulov (Hoffmann-La Roche)H-Index: 13
view all 7 authors...
Purpose The goal of this study was to compare and evaluate two preparative techniques for fractionation of proteinaceous subvisible particles. This work enables future studies to address the potential biological consequences of proteinaceous subvisible particles in protein therapeutic products.
Source
#1Anacelia Ríos Quiroz (University of Basel)H-Index: 1
#2Gabriela Québatte (University of Basel)H-Index: 6
Last. Michael AdlerH-Index: 10
view all 9 authors...
Although light obscuration is the “gold standard” for subvisible particle measurements in biopharmaceutical products, the current technology has limitations with respect to the detection of translucent proteinaceous particles and particles of sizes smaller and around 2 μm. Here, we describe the evaluation of a modified light obscuration sensor utilizing a novel measuring mode. Whereas standard light obscuration methodology monitors the height (amplitude) of the signal, the new approach monitors ...
Source
#1Linda O. Narhi (Amgen)H-Index: 56
#2Vincent Corvari (Eli Lilly and Company)H-Index: 4
Last. Klaus Wuchner (Janssen Pharmaceutica)H-Index: 9
view all 22 authors...
ABSTRACT Measurement and characterization of subvisible particles (defined here as those ranging in size from 2 to 100 μm), including proteinaceous and nonproteinaceous particles, is an important part of every stage of protein therapeutic development. The tools used and the ways in which the information generated is applied depends on the particular product development stage, the amount of material, and the time available for the analysis. In order to compare results across laboratories and prod...
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#1R. Ian Fryer (Hoffmann-La Roche)H-Index: 13
#2Roland Schmidt (Hoffmann-La Roche)H-Index: 8
Last. Leo H. Sternbach (Hoffmann-La Roche)H-Index: 19
view all 3 authors...
The synthesis of a series of 5-pyridyl analogus of the psychopharmacologically active class of compounds, 1,4-benzodiazepines, is described. These compounds are being screened for psychosedative, muscle relaxant, and anticonvulsant activity.
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