Hanns-Christian Mahler
Goethe University Frankfurt
ParticleAnalytical chemistryViscosityProtein aggregationComposite materialNanotechnologyNatural rubberChemistryParticle sizeMaterials scienceIn vivoExcipientPolysorbatePolysorbatesLight obscurationDrug productComputer scienceChromatographyMonoclonal antibodyBiochemistryMedicineVialPharmacology
117Publications
31H-index
4,105Citations
Publications 116
Newest
#1Ariane Schröter (University of Basel)H-Index: 1
#2Hanns-Christian Mahler (Goethe University Frankfurt)H-Index: 31
Last. Michael JahnH-Index: 3
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Abstract null null Introduction: The migration of chemicals from processing materials into biopharmaceuticals can lead to various problems. Leachables from administration materials, with no possibility of further clearance, are of particular concern. Released chemicals can be toxic or react with formulation components, thereby impacting product safety. Therapeutic proteins, which are susceptible to chemical modifications, have highest risk to be affected. null Aim: The aim of this study was to i...
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#1Ariane Schröter (University of Basel)H-Index: 1
#2Sonja Peter (ETH Zurich)
Last. Michael JahnH-Index: 3
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Abstract null null Leaching of toxic or reactive chemicals from polymeric materials can adversely affect the quality and safety of biopharmaceuticals. null It was therefore the aim of the present study to analyze leachables from a disposable clinical administration syringe using a polysorbate-containing surrogate solution and to assess their chemical reactivity. null Analytical methods did include (headspace) GC-MS, Fourier-transform-infrared spectroscopy, a ferrous oxidation-xylenol orange assa...
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#1Joachim Schuster (University of Basel)H-Index: 3
Last. Roman MathaesH-Index: 10
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Abstract Changes in the environment from the drug product to the human physiology might lead to physical and/or chemical modifications of the protein drug, such as in vivo aggregation and fragmentation. Although subcutaneous (SC) injection is a common route of administration for therapeutic proteins, knowledge on in vivo stability in the SC tissue is limited. In this study, we developed a physiologic in vitro model simulating the SC environment in patients. We assessed the stability of two monoc...
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Abstract Advanced therapy medicinal products (ATMPs), such as somatic cell-therapy medicinal products or tissue-engineered products for human use, offer new and potentially curative opportunities to treat yet untreatable diseases or disorders. For cell-therapy medicinal products (CBMPs), multiple stability and quality challenges exist and relate to the cellular composition and unstable nature of these parenteral preparations. It is the aim of this review to discuss open questions and problems as...
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#1Joachim Schuster (University of Basel)H-Index: 3
Last. Roman MathaesH-Index: 10
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Abstract Therapeutic proteins are administered by injection or infusion. After administration, the physiologic environment in the desired body compartment - fluid or tissue - can impact protein stability and lead to changes in the safety and/or efficacy profile. For example, protein aggregation and fragmentation are critical quality attributes of the drug product and can occur after administration to patients. In this context, the in vivo stability of therapeutic proteins has gained increasing a...
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#1Joachim Schuster (University of Basel)H-Index: 3
#2Christine Probst (Luminex Corporation)H-Index: 7
Last. Roman MathaesH-Index: 10
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The stability of therapeutic proteins can be impacted in vivo after administration, which may affect patient safety or treatment efficacy, or both. Stability testing of therapeutic proteins using models representing physiologic conditions may guide preclinical development strategy; however, to date only a few studies assessing the physical stability are available in the public domain. In this manuscript, the stability of seven fluorescently labeled monoclonal antibodies (mAbs) was evaluated in h...
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#1Ariane Schröter (University of Basel)H-Index: 1
#2Atanas KoulovH-Index: 13
Last. Michael JahnH-Index: 3
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Abstract Introduction Polysorbates (PS) are used in biopharmaceuticals to stabilize therapeutic proteins. Oxidative degradation of (poly)unsaturated fatty acids (PUFAs) contained in PS was shown to lead to α,β-unsaturated carbonyls. Aim The n-6-PUFA linoleic acid accounts for up to 18% of all FAs contained in multi-compendial grade PS80. 4-hydroxynonenal (HNE) is highly reactive towards nucleophilic amino acids, potentially leading to covalent protein modifications. This study tests whether HNE ...
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#1Christian WeinmannH-Index: 1
#2Ahmad S. SediqH-Index: 8
Last. Dhananjay JereH-Index: 15
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Evaluation of product viscosity, density and aeration on the dose delivery and accuracy for intravitreal injections with commonly used commercially available hypodermic 1 mL syringes. Six commercially available hypodermic 1 mL syringes with different specifications were used for the study. Syringes were filled with the test solutions with different densities and viscosities. Syringes were also subjected to shaking stress to introduce aeration in the test solutions in the presence of different su...
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Abstract Intravitreal (IVT) injection is currently the state of the art for drug delivery to the back of the eye. Drug Products (DP) intended for IVT injections usually pose challenges such as a very low injection volume (e.g. 50 μL) and high injection forces. DPs in vials are typically transferred and injected using disposable polymer syringes, which can feature a silicone oil (SO) coating. In our syringe in-use study, we compared dead volume, total SO content and SO layer distributions of thre...
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