Search results for "virus" in Articles / App Notes
Article
Scaling Up Novel Therapies
Great improvements have been seen so far in delivering adeno-associated virus (AAV) vectors. These results demonstrate the inextricable link between clinical work and process development, said Kathy H…
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State of the Biopharmaceutical Industry: Lessons from 2018 Survey Data
• The downstream areas seen as needing the most improvements are now single-use purification, continuous downstream purification, and virus filtration. Again, desires for single-use technology took th…
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
He cited a lack of capacity for manufacture of lentiviral and adeno-associated virus (AAV) vectors for limiting clinical development and noted that the process of production in current cell lines is n…
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The Challenge of Disruptive Technologies in Bioprocessing
Thermo Fisher Scientific has commercialized three POROS CaptureSelect AAV affinity resins to establish industrialized platforms for the purification of adeno-associated virus (AAV). The move is meant …
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Developing an Efficient Adenovirus Downstream Purification Process
Adenovirus is also explored as a potential viral vector for gene therapy and as an oncolytic virus. This application note describes the development of downstream chromatography steps for purification …
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Achieving Efficient Adenovirus Upstream Production
Adenovirus has also been explored as a viral vector for gene therapy and as an oncolytic virus. This application note describes the production of adenovirus in HEK293 suspension cells in a bioreactor …
Article
Modern Manufacturing Key to More Effective Vaccines
Rumors of health risks continue to discourage vaccination of teens against human papillomavirus (HPV) despite evidence that it can prevent cancer.
FDA Commissioner Scott Gottlieb, MD, voiced s…
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Industry Adoption of Single-Use Systems Remains Low
Now we have a complete portfolio of single-use upstream and downstream systems for bioprocessing, including rocking and stirred tank bioreactors, sensors, smart mixers, filtration pump skids, virus in…
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FDA Framework Spurs Advanced Therapies
Kolata, “Gene Therapy Hits a Peculiar Roadblock: A Virus Shortage [4],” New York Times, Nov. 27, 2017.
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Process Development: What May Lie Ahead in 2018?
In addition, the agency approved Luxturna (voretigene neparvovec-rzyl), the first FDA-approved gene therapy for a genetic disease and the first adeno-associated virus vector gene therapy approved in t…