Paul Ivor Chamberlain

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There are major structural differences between plant and mammalian N-linked glycans, with those from plants being immunogenic in most laboratory mammals and eliciting glycan-specific IgE and IgG antibodies in humans, when delivered parenterally. However, because humans are constantly exposed to plant glycoproteins in the diet, glycosylated plant-made(More)
The principles of establishing biosimilarity are to demonstrate structural and functional similarity to a reference product using the most discriminatory analytical methods. There is still considerable controversy on the scientific basis for extrapolation of indications for biosimilars, which has been strengthened by diverging global regulatory decision(More)
This article reflects on methodological limitations for interpretation of relative immunogenicity of biosimilar and reference therapeutic monoclonal antibodies, in emphasizing the relevance of correlation of bioanalytical signals with appropriate clinical end points, and the possible need for post-marketing observational studies to indicate the impact of(More)
Although mAbs present a different set of challenges from other product classes, and the pre-clinical safety evaluation may need to be more extensive than for other medicinal products to overcome the limited predictive value of conventional pre-clinical test systems, the level of risk associated with first administration to human subjects can be effectively(More)
Acknowledgements This report would not have been possible without the generous support of the George C. Metcalf Foundation and their Inclusive Local Economies program. As Program Director, Adrianna Beemans has been incredibly insightful and encouraging throughout this process of discovery. The authors would like to thank the members and Steering Committee(More)
Older people have a major part to play in the design of everyday products and environments. Often designers pay little attention to the needs of older people so their involvement can therefore ensure that designers start to think differently. Working with three groups of older people and a group of carers, the research team developed a methodology for(More)
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