全部文献期刊学位论文会议报纸专利标准年鉴图书|学者科研项目
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作者:Hanns-Christian Mahler , Hongwen Rivers ...
来源:[J].The AAPS Journal(IF 4.386), 2017, Vol.19 (6), pp.1656-1668Springer
摘要:Therapeutic breakthroughs in a number of retinal degenerative diseases have come about through the development of biotherapeutics administered directly into the eye. As a consequence of their use, we have gained more insight into the immune privileged status of the eye and the va...
作者:Hanns-Christian Mahler , Helena Reinisch ...
来源:[J].Journal of Pharmaceutical Sciences(IF 3.13), 2019, Vol.108 (7), pp.2397-2405Elsevier
摘要:Abstract(#br)Subvisible particles (SVPs) are an obligatory critical quality attribute of the product, and yet, they are found in all biopharmaceutical products intended for infusion or injection. Light obscuration (LO) is the primary pharmacopeial method used to quantify SVP...
作者:... Dieter Röthlisberger , Dhananjay Jere , Hanns-Christian Mahler
来源:[J].Regulatory Toxicology and Pharmacology(IF 2.132), 2019, Vol.101, pp.29-34Elsevier
摘要:Abstract(#br)A toxicological evaluation to determine the product specific permitted daily exposure (PDE) value is an accepted method to determine a safe limit for the carry-over of product residues in multipurpose manufacturing facilities. The PDE calculation for intravitreal (IV...
作者:Hanns-Christian Mahler , Atanas Koulov ...
来源:[J].Journal of Pharmaceutical Sciences(IF 3.13), 2019Elsevier
摘要:Abstract(#br)Glass fogging is a phenomenon occurring in lyophilized drug products and can be described as a thin product layer deposited on the inner surface of the glass container, in the area not covered by the lyo cake itself. It is often considered a cosmetic defect; how...
作者:... Susanne Jörg , Jörg Huwyler , Hanns-Christian Mahler
来源:[J].Journal of Pharmaceutical Sciences(IF 3.13), 2019Elsevier
摘要:Abstract(#br)Cell therapy products represent an exciting new class of medicinal products, which must be parenterally administered. Thus, compliance with parenteral preparation guidelines is required. One requirement for parenteral products is the characterization of particle cont...
作者:Hanns-Christian Mahler , Atanas Koulov ...
来源:[J].Journal of Pharmaceutical Sciences(IF 3.13), 2019Elsevier
摘要:Abstract(#br)Glass fogging is a phenomenon occurring in lyophilized drug products and can be described as a thin product layer deposited on the inner surface of the glass container, in the area not covered by the lyo cake itself. It is often considered a cosmetic defect; how...
作者:... Susanne Jörg , Jörg Huwyler , Hanns-Christian Mahler
来源:[J].Journal of Pharmaceutical Sciences(IF 3.13), 2019Elsevier
摘要:Abstract(#br)Cell therapy products represent an exciting new class of medicinal products, which must be parenterally administered. Thus, compliance with parenteral preparation guidelines is required. One requirement for parenteral products is the characterization of particle cont...
作者:Hanns-Christian Mahler , Philipp Metzger ...
来源:[J].European Journal of Pharmaceutics and Biopharmaceutics(IF 3.826), 2017, Vol.112, pp.177-186Elsevier
摘要:Abstract(#br)Following intravitreal (IVT) injection, therapeutic proteins get exposed to physiological pH, temperature and components in the vitreous humor (VH) for a significantly long time. Therefore, it is of interest to study the stability of the proteins in the VH. However, ...
作者:... Karoline Bechtold- Peters , Hanns-Christian Mahler , Wolfgang Friess
来源:[J].European Journal of Pharmaceutics and Biopharmaceutics(IF 3.826), 2017, Vol.112, pp.109-118Elsevier
摘要:Abstract(#br)Significant loss of preservative was observed during filling of drug products during filling line stops. This study evaluated the losses of three commonly used preservatives in protein drugs, i.e. benzyl alcohol, phenol, and m -cresol. Concentration losses durin...
作者:Hanns-Christian Mahler , Sandeep Yadav ...
来源:[J].Pharmaceutical Research(IF 4.742), 2018, Vol.35 (8), pp.1-8Springer
摘要:Abstract(#br) Purpose(#br)Polysorbates are commonly added to protein formulations and serve an important function as stabilizers. This paper reviews recent literature detailing some of the issues seen with the use of polysorbate 80 and polysorbate 20 in protein formulations. Base...

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