Controlled polysorbate 20 hydrolysis – A new approach to assess the impact of polysorbate 20 degradation on biopharmaceutical product quality in shortened time

Hydrolysis of polysorbate in biopharmaceutical liquid formulations upon long-term storage represents a threat issue, since discount of the intact surfactant focus could compromise protein stability. Furthermore, accumulation of polysorbate degradation merchandise is related to the formation of particulates probably affecting…

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Simultaneous quantification of polysorbate 20 and poloxamer 188 in biopharmaceutical formulations using evaporative light scattering detection

Polysorbates and Poloxamer 188 represent the most typical surfactants utilized in biopharmaceutical formulations owing to their glorious protein-stabilizing properties and good security profiles. Lately, nevertheless, an enormous variety of experiences regarding potential danger components intently associated with their purposes, corresponding…

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Simulation of oral absorption from non-bioequivalent dosage forms of the salt of raltegravir, a poorly soluble acidic drug, using a physiologically based biopharmaceutical modeling (PBBM) approach

Non-bioequivalent plasma focus profiles amongst completely different dosage types of the salt of raltegravir, a poorly soluble acidic drug, have been investigated utilizing biorelevant in vitro testing mixed with the business in silico software program, Simcyp®. A suspension and a…

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Toward a Better Understanding of Bioassays for the Development of Biopharmaceuticals by Exploring the Structure-Antibody-Dependent Cellular Cytotoxicity Relationship in Human Primary Cells

Pharmaceutical manufacturing depends on rigorous strategies of high quality management of medication and particularly of the physico-chemical and purposeful characterizations of monoclonal antibodies. To that finish, strong bioassays are fairly often restricted to reporter gene assays and the usage of…

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Neospora caninum: a new class of biopharmaceuticals in the therapeutic arsenal against cancer

Background: Microorganisms that can be utilized for his or her lytic exercise towards tumor cells in addition to inducing or reactivating antitumor immune responses are a related a part of the out there immunotherapy methods. Viruses, micro organism and even protozoa…

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Antibody-mediated rejection with and without donor-specific anti-human leucocyte antigen antibodies: performance of the peripheral blood 8-gene expression assay

Following an episode of cholera, a quickly dehydrating, watery diarrhea attributable to the Gram-negative bacterium, Vibrio cholerae O1, people mount a sturdy anti-lipopolysaccharide (LPS) antibody response that’s related to immunity to subsequent re-infection. In neonatal mouse and rabbit fashions of…

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Argentina’s Local Crop Biotechnology Developments: Why Have They Not Reached the Market Yet?

Plant biotechnology in Argentina beginning within the late 1980s, resulting in the event of assorted analysis teams in public establishments and, a decade later, some native personal initiatives. Varied scientific and technological capability on this nation allowed early 1991 structure…

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Lianhua-Qingwen Displays Antiviral and Anti-Inflammatory Activity and Synergistic Effects with Oseltamivir against Influenza B Virus Infection in the Mouse Model

Influenza B virus (IBV) is among the predominant pathogens of the annual influenza epidemic, and the illness burden is important, particularly amongst kids and younger youngsters. On this examine, the antiviral and anti inflammatory results of a conventional Chinese language…

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