Experimental validation of a parenteral permitted daily exposure value for cleaning-induced degradants from recombinant therapeutic proteins with in vitro immunogenicity assays.

Multiproduct manufacturing of biotherapeutic proteins generate cleaning-induced protein degradants because of extreme pH and temperature conditions during the cleaning process. Cleaning Acceptance limits are calculated based on the maximum allowable carryover (MAC) assessment of the previously manufactured active pharmaceutical ingredient (API) - or drug product - based on the permitted daily exposure (PDE) of the previously manufactured API into the dose of subsequent product. In this study, we tested a previously determined PDE value for cleaning-induced protein degradants of 650 µg/dose.

Estimating averted illnesses from influenza vaccination for children and pregnant women - El Salvador, Panama, and Peru, 2011-2018.

Background: Estimating the burden of disease averted by vaccination can assist policymakers to implement, adjust, and communicate the value of vaccination programs. Demonstrating the use of a newly available modeling tool, we estimated the burden of influenza illnesses averted by seasonal influenza vaccination in El Salvador, Panama, and Peru during 2011-2018 among two influenza vaccine target populations: children aged 6-23 months and pregnant women.

Methods: We derived model inputs, including incidence, vaccine coverage, vaccine effectiveness, and multipliers from publicly available country-level influenza surveillance data and cohort studies.

A High Threshold of Biotherapeutic Aggregate Numbers is Needed to Induce an Immunogenic Response In Vitro, In Vivo, and in the Clinic.

Background And Purpose: There is concern that subvisible aggregates in biotherapeutic drug products pose a risk to patient safety. We investigated the threshold of biotherapeutic aggregates needed to induce immunogenic responses.

Methods And Results: Highly aggregated samples were tested in cell-based assays and induced cellular responses in a manner that depended on the number of particles.

Waveform load analysis for fatigue in the printed PLA.

Additive manufacturing is fast becoming a key process to manufacture a customized design with complex geometry and one process usually employed is based on the fused filament fabrication. Up to now this method is typically employed for rapid prototyping, it is therefore their mechanical strength is lower than the components manufactured using conventional casting process. It is well known that most failures are happened under repeated loads; therefore, a functional component mandatory needs to reach endurance strength under cyclic loads.

The Social Impacts of Circular Strategies in the Apparel Value Chain; a Comparative Study Between Three Countries.

Unlabelled: The apparel value chain is essential for the livelihood of millions of workers around the globe. However, human rights violations and the lack of a sustained income by apparel workers demonstrate the poor working conditions present in this sector. Circular economy (CE) has been used by incumbent businesses and startups as a framework to achieve sustainability, thus contributing to its economic, environmental and social dimensions.