1,078 research outputs found
Phaseguide assisted liquid lamination for magnetic particle-based assays
We have developed a magnetic particle-based assay platform in which functionalised magnetic particles are transferred sequentially through laminated volumes of reagents and washing buffers. Lamination of aqueous liquids is achieved via the use of phaseguide technology; microstructures that control the advancing air–liquid interface of solutions as they enter a microfluidic chamber. This allows manual filling of the device, eliminating the need for external pumping systems, and preparation of the system requires only a few minutes. Here, we apply the platform to two on-chip strategies: (i) a one-step streptavidin–biotin binding assay, and (ii) a two-step C-reactive protein immunoassay. With these, we demonstrate how condensing multiple reaction and washing processes into a single step significantly reduces procedural times, with both assay procedures requiring less than 8 seconds
The process defines the product: what really matters in biosimilar design and production?
Biologic drugs are highly complex molecules produced by living cells through a multistep manufacturing process. The key characteristics of these molecules, known as critical quality attributes (CQAs), can vary based on post-translational modifications that occur in the cellular environment or during the manufacturing process. The extent of the variation in each of the CQAs must be characterized for the originator molecule and systematically matched as closely as possible by the biosimilar developer to ensure bio-similarity. The close matching of the originator fingerprint is the foundation of the biosimilarity exercise, as the analytical tools designed to measure differences at the molecular level are far more sensitive and specific than tools available to physicians during clinical trials. Biosimilar development, therefore, has a greater focus on preclinical attributes compared with the development of an original biological agent. As changes in CQAs can occur at different stages of the manufacturing process, even small modifications to the process can alter biosimilar attributes beyond the point of similarity and impact clinical effectiveness and safety. The manufacturer's ability to provide consistent production and quality control will greatly influence the acceptance of biosimilars. To this end, preventing drift from the required specifications over time and avoiding the various implications brought by product shortage will enhance biosimilar integration into daily practice. As most prescribers are not familiar with this new drug development paradigm, educational programmes will be needed so that prescribers see biosimilars as fully equivalent, efficacious and safe medicines when compared with originator products
Simulating costs of intravenous biosimilar trastuzumab vs. Subcutaneous reference trastuzumab in adjuvant her2-positive breast cancer:A belgian case study
‘Waer vriendenmin gaet, hand aen hand, met liefde voor het Vaderland’ : het zingen van politieke liederen als verbindende praktijk in het Nederlandse revolutietijdvak (1780-1815)
In the Dutch revolutionary period of the late eighteenth century, song was often used as a political tool to construct communities that shared interests, ideologies, and feelings. Abstract feelings of unity were made concrete through the experience of collective singing. Despite being continuously employed as a unifying practice, the ways of singing and the feelings that were involved nevertheless changed in accordance with the turbulent circumstances of the time - from the emergence of the Patriots, to the Batavian Revolution, throughout the Napoleonic years, and towards the establishment of a Dutch monarchy. This essay goes beyond analysing songs as textual sources and investigates when, where, and by whom these songs were sung. By approaching the collective singing of political communities as emotional practices, we can develop a new perspective on this episode of Dutch history, in which we acknowledge the feelings and experiences of the historical actors that shaped the developments of that time
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