Search results for " control"
Article
Process Chromatography Selection for Downstream Processing Applications
Also, the ability to use concentrated buffer components and mixing them in-line under controlled conditions (in-line conditioning) has simplified the chromatographic operation. Other simplifications a…
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Microbiological Testing: Time is of the Essence
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods.
By Cynthia A. Challener
Effective microbiological testing during biopharmace…
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A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
Demand for custom formulations and packaging have increased, as has customer demand for quality control reports.
Several suppliers reported facility expansions to increase capacity for these vital…
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Innovative Therapies Require Modern Manufacturing Systems
The development of new antibiotics gained from several spending provisions: in addition to $100 million to NIH for that purpose, the Centers for Disease Control and Prevention (CDC) received $160 mill…
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Antibody Production in Microbial Hosts
Further, mAb production in microbial hosts such as bacterial cells completely abrogates the nuisance of glycosylation control and speeds up production timelines, further simplifying bioprocessing. The…
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Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
Cell lines are cultured, passaged, and processed in and among laboratories with widely varying quality control (QC) procedures, while sharing cell lines is endemic--particularly in academia. For these…
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Taking a “Development-by-Design” Approach to Cell Therapies
QC is quality control.
Regulations evolve
Cell therapy is still a new area for regulators, and, as Preti says, some guidelines are clear and others aren’t. “Development by design is need…
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Ensuring the Quality of Biologicals
The use of materials of biological origin in medicine has a long history, and the quality control of biologicals has been in place for many years.
The Ph. Eur. began elaborating monographs on biol…
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Drug Discovery and Development in India
In December 2014, however, the NPPA announced that it will bring an additional 52 new drugs under price control. Consequently, drug makers have cut back on the number of medicines launched; data from …
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Labeling of Biosimilars
The laying of the legal foundations for the control of biosimilars over the past 14 years has given the EU global leadership in the regulation on the products, of which it had approved 19, including t…