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The precise product quality and lower cost of goods demands of the growing biosimilars industry are driving biomanufacturing innovation. Biosimilar cell lines that produce complex glycoproteins such as monoclonal antibodies must be both highly productive and express a product with critical quality attributes closely matching those of the innovator reference. In this work, a biomanufacturing platform is described that harnesses the commercially‐established NS0 host cell in new ways to create stable, highly productive cell lines with characteristics meeting the current demands. A cholesterol metabolic selection marker and implementation strategy that can be generically applied are shown to yield high expressing cell lines as well as eliminate the need for cholesterol addition, which has been a significant barrier in both stainless steel reactors as well as in single‐use plastic systems. Additionally, for the first time, a multiplex selection strategy was implemented that served to increase NS0 cell line specific productivity >10‐fold and volumetric yields >6‐fold. The best overall performing cell line had a Qp of 28.5 picograms per cell per day was rapidly adapted to a lean production medium. Yields in L‐glutamine fed‐batch shaker cultures exceeded 500 mg/L. An initial screening of four feeding strategies resulted in a final 13‐day yield of over 1.4 g/L in small shaker culture. Overall, this work shows both the strategy to develop biosimilar cell lines and the commercial potential of a novel expression system highly suited for the manufacture of biosimilars of reference biologics currently produced in murine cells. This article is protected by copyright. All rights reserved.
Abstract The single radial immunodiffusion assay has been the accepted method for determining the potency of inactivated influenza vaccines since 1978. The world‐wide adoption of this assay for vaccine standardisation was facilitated through collaborative studies that demonstrated a high ... more
Abstract Background Whether morbidity from the 1918‐19 influenza pandemic discriminated by socioeconomic status has remained a subject of debate for 100 years. In lack of data to study this issue recent literature have hypothesized that morbidity was “socially neutral”. Objectives ... more
Smart skin that can respond to external stimuli could have important applications in medicine and robotics. Using only items found in a typical household, researchers have created multi-sensor artificial skin that's capable of sensing pressure, temperature, humidity, proximity, pH, and air ... more
Some doctors may recommend that patients with the flu take acetaminophen, or paracetemol, to relieve their symptoms; however, a new randomized clinical trial found no benefits to the over-the-counter medication in terms of fighting the influenza virus or reducing patients' temperature or ot ... more
A new study that investigated the potential of certain psychological traits for predisposing heterosexuals to have negative attitudes towards homosexual people found that psychoticism - which is present in severe psychopathological conditions but may also contribute to less severe states of ... more