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Sökning: WFRF:(Paulsson Jonas)

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  • Cappelletto, Elia, et al. (författare)
  • Impact of Post Manufacturing Handling of Protein-Based Biologic Drugs on Product Quality and User Centricity
  • 2024
  • Ingår i: Journal of Pharmaceutical Sciences. - : Elsevier B.V.. - 0022-3549 .- 1520-6017.
  • Forskningsöversikt (refereegranskat)abstract
    • This article evaluates the current gaps around the impact of post-manufacturing processes on the product qualities of protein-based biologics, with a focus on user centricity. It includes the evaluation of the regulatory guidance available, describes a collection of scientific literature and case studies to showcase the impact of post-manufacturing stresses on product and dosing solution quality. It also outlines the complexity of clinical handling and the need for communication, and alignment between drug providers, healthcare professionals, users, and patients. Regulatory agencies provide clear expectations for drug manufacturing processes, however, guidance supporting post-product manufacturing handling is less defined and often misaligned. This is problematic as the pharmaceutical products experience numerous stresses and processes which can potentially impact drug quality, safety and efficacy. This article aims to stimulate discussion amongst pharmaceutical developers, health care providers, device manufacturers, and public researchers to improve these processes. Patients and caregivers' awareness can be achieved by providing relevant educational material on pharmaceutical product handling.
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5.
  • Cappelletto, Elia, et al. (författare)
  • Impact of Post Manufacturing Handling of Protein-Based Biologic Drugs on Product Quality and User Centricity
  • 2024
  • Ingår i: Journal of Pharmaceutical Sciences. - : Elsevier. - 0022-3549 .- 1520-6017.
  • Tidskriftsartikel (refereegranskat)abstract
    • This article evaluates the current gaps around the impact of post-manufacturing processes on the product qualities of protein-based biologics, with a focus on user centricity. It includes the evaluation of the regulatory guidance available, describes a collection of scientific literature and case studies to showcase the impact of post-manufacturing stresses on product and dosing solution quality. It also outlines the complexity of clinical handling and the need for communication, and alignment between drug providers, healthcare professionals, users, and patients. Regulatory agencies provide clear expectations for drug manufacturing processes, however, guidance supporting post-product manufacturing handling is less defined and often misaligned. This is problematic as the pharmaceutical products experience numerous stresses and processes which can potentially impact drug quality, safety and efficacy. This article aims to stimulate discussion amongst pharmaceutical developers, health care providers, device manufacturers, and public researchers to improve these processes. Patients and caregivers' awareness can be achieved by providing relevant educational material on pharmaceutical product handling.
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  • Edén, Jonas, et al. (författare)
  • The influence of serum phase on the whipping time of unhomogenised cream
  • 2015
  • Ingår i: International Dairy Journal. - : Elsevier BV. - 0958-6946. ; 49, s. 56-61
  • Tidskriftsartikel (refereegranskat)abstract
    • The objective of this study was to investigate how the properties of the serum phase, including ionic strength, protein content and specific milk salts, influence the whipping time of unhomogenised cream. This study showed that decreasing the protein content of the serum phase in cream resulted in shorter whipping time. However, addition of UF permeate to both deproteinated and proteinated creams indicated that other components than the protein fraction also influence whipping time of unhomogenised cream. Increasing the ionic strength by addition of NaCl, KCl and CaCl2 decreased whipping time, with the largest effect being found for CaCl2. A further increase in ionic strength by addition of NaCl and KCl resulted in an unfavourable effect on whipping time, whereas a pronounced effect, with shorter whipping times, was found for addition of CaCl2. (C) 2015 Elsevier Ltd. All rights reserved.
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  • Fjertorp, Jonas, et al. (författare)
  • Infrastruktur och tillväxt
  • 2010
  • Ingår i: En referensram för studier av kommuner i förändring. ; , s. 47-55
  • Bokkapitel (övrigt vetenskapligt/konstnärligt)
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  • Frings, Oliver, et al. (författare)
  • Prognostic Significance in Breast Cancer of a Gene Signature Capturing Stromal PDGF Signaling
  • 2013
  • Ingår i: American Journal of Pathology. - : Elsevier BV. - 0002-9440 .- 1525-2191. ; 182:6, s. 2037-2047
  • Tidskriftsartikel (refereegranskat)abstract
    • In this study, we describe a novel gene expression signature of platelet-derived growth factor (PDGF) activated fibroblasts, which is able to identify breast cancers with a PDGF-stimulated fibroblast stroma and displays an independent and strong prognostic significance. Global gene expression was compared between PDGF-stimulated human fibroblasts and cultured resting fibroblasts. The most differentially expressed genes were reduced to a gene expression signature of 113 genes. The biological significance and prognostic capacity of this signature were investigated using four independent clinical breast cancer data sets. Concomitant high expression of PDGF beta receptor and its cognate Ligands is associated with a high PDGF signature score. This supports the notion that the signature detects tumors with PDGF-activated stroma. Subsequent analyses indicated significant associations between high PDGF signature score and clinical characteristics, including human epidermal growth factor receptor 2 positivity, estrogen receptor negativity, high tumor grade, and large tumor size. A high PDGF signature score is associated with shorter survival in univariate analysis. Furthermore, the high PDGF signature score acts as a significant marker of poor prognosis in multivariate survival analyses, including classic prognostic markers, Ki-67 status, a proliferation gene signature, or other recently described stroma-derived gene expression signatures.
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  • Fyrestam, Jonas, 1981-, et al. (författare)
  • Determination of porphyrins in oral bacteria by liquid chromatography electrospray ionization tandem mass spectrometry
  • 2015
  • Ingår i: Analytical and Bioanalytical Chemistry. - : Springer Science and Business Media LLC. - 1618-2642 .- 1618-2650. ; 407:23, s. 7013-7023
  • Tidskriftsartikel (refereegranskat)abstract
    • Biofilms in the oral cavity can be visualized by fluorescence and a common assumption is that the endogenously produced porphyrins in certain bacteria give rise to this fluorescence. Porphyrin content in oral bacteria has been sparingly investigated, and non-selective detection techniques such as utilizing the Soret fluorescence band of porphyrins are often used. In the present study, a quantitative and selective method for the determination of porphyrins in oral bacteria has been developed and validated using high performance liquid chromatography-tandem mass spectrometry. Lysis of bacteria using Tris-EDTA buffer together with ultrasonication showed high microbial killing efficiency ≥99.98 %, and sample clean-up using C18-solid phase extraction resulted in low matrix effects ≤14 % for all analytes. Using this method, the porphyrin content was determined in the two oral pathogens Aggregatibacter actinomycetemcomitans and Porphyromonas gingivalis, as well as for baker’s yeast, Saccharomyces cerevisiae. Uroporphyrin, 7-carboxylporphyrin, 6-carboxylporphyrin, coproporphyrin, and protoporphyrin IX were identified in the investigated microorganisms, and it was shown that the porphyrin profile differs between the two bacteria, as well as for S. cerevisiae. To our knowledge, this is the first time the porphyrin profile has been determined for the bacterium A. actinomycetemcomitans.
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