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Article The Affordable Care Act's Impact on Innovation in Biopharma
Despite this spending increase, Americans’ average life expectancy and the efficiency of the US healthcare system are ranked near the bottom of countries with advanced economies (2). These cost increa…

Article State of Quality and Compliance in the Biopharmaceutical Industry
As a result of these efforts, new standards and guidelines have been published and numerous conferences held regarding quality systems, product quality, and regulatory compliance. However, after more …

Article Addressing the Challenges in Downstream Processing Today and Tomorrow
In addition to high cell density mammalian expression, expanded utilization of other expression systems such as microbial and yeast will support these newer biotherapeutics (BioTx). The diversity of B…

Article Nurturing Knowledge from Disparate Data Streams
For many of these techniques, however, the inevitable evolution from paper-based data collection procedures to electronic systems has not been without difficulties. “It may be argued, for example, tha…

Article Reducing Cross-Contamination Risks in Process Chromatography
Single-use solutions for process chromatography are no exception and offer distinct advantages over permanent, stainless-steel systems in many circumstances. Reducing risk Manufacturer…

Article Fermentation for the Future
Soluble expression One of the drawbacks of many bacterial expression systems, particularly E. coli, is the formation of insoluble aggregates of the overexpressed recombinant protein, referred to a…

Article Challenges and Trends in Biopharma Facility Design
Decreasing the time for batch production via single-use systems intensifies the value derived from smaller batches. The reduced capital investment required for single-use facilities can be as much as …

Article Automated Concentration and Diafiltration of Multiple siRNA Samples
Automation of the production and screening processes has the inherent advantage of rapidly and systematically analyzing large sample quantities.  A team of scientists from Cytiva collaborated w…

Article Improving Upstream Predictability
Using real-time data from these sensors has improved decision making, while automating data transcription between systems has minimized risk. Lonza is also moving to the use of electronic batch record…

Article Tools and Processes for Mature and Emerging Therapies
In April 2019, at the INTERPHEX trade show in New York City, vendors of bioprocessing equipment and materials announced improvements to existing platforms, added options for upstream and downstream sy…

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