Search results for " therapeutic"
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Jefferson Institute for Bioprocessing Opens Near Philadelphia, PA
“Biomanufacturing is going through an unprecedented period of innovation in new products and growth in legacy therapeutics that promise many new jobs over the next decade and beyond,” JIB executive di…
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Are You in Control of the Quality of Your mAbs?
…technology has been adopted to develop and qualify assays for monoclonal antibodies (mAbs) and other therapeutic proteins to ensure drug quality.
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Biomanufacturing: The Cost of Unskilled Workers
First, a 2018 report from BioPlan Associates estimates there are well over 10,000 therapeutics in R&D, both drugs (chemical substance pharmaceuticals) and biopharmaceuticals (biotechnology-derived pha…
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Ensure SEC Column Reproducibility in Protein Drug Analysis
Size exclusion chromatography (SEC) is the go-to analytical method in the analysis of therapeutic protein drugs. This article describes the factors affecting the reproducibility of columns and how you…
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A Look at the Affinity Chromatography Landscape
… with high binding capacity and productivity, resulting in a final sc pDNA product suitably pure for therapeutic applications,” he explains.
Cytiva has increased the window of operation for th…
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Scalable Viral Vector Manufacturing
In the last couple of years, there have been several new approved therapeutics based on viral vectors and many more are in the development pipeline. This results in a large demand for viral vector pro…
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Scaling Up Novel Therapies
Although these treatments are in early stages of development, gene therapy has already become a reality, with companies such as Spark Therapeutics. The company received “breakthrough therapy” status f…
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Manufacturing of Viral Vectors
Viral vectors are also explored for use in gene and cell therapy and as the basis for prophylactic and therapeutic vaccines. In gene therapy, viral vectors can be used for the delivery of functional g…
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
…l type, Marks cautioned that the use of genetically modified cellular therapies to achieve a durable therapeutic effect requires a consistent process for producing and characterizing cells.
Ma…
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Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
Also, during this period, the number of FDA-approved recombinant therapeutics has increased by approximately 400% (6,7). In 2017, FDA set a record for the number (31 approvals) and percent (93%) of ap…