Search results for " CAR-T"
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA is considering at least three CAR-T applications, and more are on the way. An FDA advisory committee voted unanimously to recommend approval of Novartis’ new CAR-T, despite concerns about the firm…
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Best Practices for Selecting a Top-Quality Cell Line
Selecting cell lines for CAR-T therapies
As opposed to a synthetic drug, chimeric antigen receptor (CAR)-T cells are living therapies that are sensitive to manipulation and difficult to manufactur…
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Emerging Therapies Test Existing Bioanalytical Methods
High sensitivity methods are required especially when evaluating the expansion and persistence of the CAR-T cells. When considering the development of flow cytometry methods to detect expression of th…
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Science Focus Fuels Successful Process Development for Startups
…countries served as a basis for our decision to keep internal all process development activities for CAR-T cell products,” notes Jean-Pierre Latere, chief operating officer of Celyad.
BriaCell, m…
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FDA Framework Spurs Advanced Therapies
According to the International Society for Cellular Therapy (ISCT), the approval of the first CAR T-cell therapies is “direct evidence of the commercializing potential of CAR-T therapies” and indicate…
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Transformative Medicines Challenge FDA and Manufacturers
Recent months have witnessed the emergence of truly breakthrough therapies, led by Novartis’ CAR-T therapy Kymriah (tisagenlecleucel) for patients with relapsed acute lymphoblastic leukemia; this appr…
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Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
This article will explore the traditional path from the laboratory to the clinic and how the fixed-bed technology provides an alternative solution to meet commercial demands.
By Alex Chatel and …
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Getting Ahead of the Game in Cell and Gene Therapy
Successes in the clinic have placed many cell and gene therapies on an accelerated route to market. But unless developers consider, at an early stage, how they might produce their product at scale, th…
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Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
By establishing effective management of data and knowledge, it will be possible to employ advances, such as artificial intelligence and synthetic biology, to their full potential in upstream bioproc…
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
While there is great excitement over the potential of CAR-T (chimeric antigen receptor) cell therapy to target and activate T cells to eliminate a cancerous or other undesirable cell type, Marks cauti…