Proteins

The occurrence of protein aggregation during bioprocessing steps such as purification, formulation and fill-finish, impacts yield and production costs, and must be controlled throughout themanufacturing process. Understanding aggregation mechanisms and developing mitigating strategies are imperative…
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13. September 2018 The study aimed at investigating the potential of spray drying method for encapsulation of protein drugs into solid lipid microparticles (MP) and evaluating effects of excipients on encapsulation and release of protein from MP. After transformation of model protein insulin to…
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30. July 2018 Injection site reactions (ISRs) and other adverse side-effects are commonly observed during therapy with biologics. These hypersensitivity related side-effects can vary from simple rash tolife-threatening anaphylactic reaction, and may be linked to the…
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30. July 2018 Osmolytes are small organic molecules accumulated by cells in response to environmental stresses. They are represented by amino acids, sugars, polyols, tertiary sulphonium and quaternary ammoniumcompounds. These molecules present a protective behaviour and…
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25. July 2018 Concentrated monoclonal antibody (mAb) solutions can lead to high viscosity as a result of protein-protein interactions and pose challenges for manufacture. Dipicolinic acid (DPA, pyridine-2,6-dicarboxylic acid) is a potential excipient for reduction of…
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27. June 2018 In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of…
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12. June 2018 Preservatives are excipients essentially needed in pharmaceutical multi-dose formulations to prevent microbial growth. Among available substances, phenol is widely used for parenterals, however, it is known to interact with non-ionic surfactants like…
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