Search results for " therapeutic" in Articles / App Notes
Article
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…
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Miniaturization to Become Even More Successful
Industrial bioprocess development has changed significantly in the last decade, driven primarily by two major factors: ever-rising R&D costs of developing therapeutic candidates with simultaneous de…
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Developing an Efficient Adenovirus Downstream Purification Process
Adenovirus is one of the most frequently used viral vectors in the development of therapeutic vaccines and adenovirus is evaluated as vaccine delivery system in many preclinical and clinical studies…
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Automation Trend in Fill/Finish Reduces Contamination Risk
outsourced) fill/finish operations for recombinant therapeutics, including industry capacity and capacity utilization. These current trends include the increased use of isolator/RAB technologies, more…
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Putting Viral Clearance Capabilities to the Test
Bergmann concurs and notes that while these guidance documents work well for monoclonal antibodies and therapeutic proteins, “use of the guidelines for novel types of products can be challenging” and …