Search results for "Gene Therapies"
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Top Process Development Trends for 2021 and a Look into 2022
The COVID-19 pandemic continues to shape bioprocess development trends, and many lessons have been learned from industry’s response to and preparedness for dealing with a public health crisis. Howev…
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Akron Bio Will Install a Cytiva FlexFactory to Manufacture Plasmid DNA
“With this partnership, Akron demonstrates its continued commitment to supporting the advancement of cell and gene therapies with cGMP [current good manufacturing practice]-compliant solutions at indu…
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Production of Recombinant Adeno-associated Virus Vectors Using Microcarrier Culture of HEK293T Cells
As of March 2020, more than 4310 gene therapy clinical trials have been performed worldwide, with only 518 of them in Phase III and Phase IV. As the gene therapy projects enter clinical Phase III or g…
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2019’s Top Bioprocessing Trends and What to Expect in 2020
FDA approvals announced during the year for cell and gene therapies prompted the need to consider manufacturing facility designs specific to cell and gene therapy workflows, as well as the need to exp…
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Moving PAT from Concept to Reality
PAT can also help overcome the analytical challenges presented by viral vectors for novel vaccines and gene therapies. These products are not well-characterized molecules like monoclonal antibodies, b…
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A Look at the Affinity Chromatography Landscape
Affinity chromatography for viral vectors
Viral vectors are required for the production of gene therapies and the gene modification of cells used in various cell therapies. The greatest demand is …
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Ensuring Viral Safety of Viral Vaccines and Vectors
Ensuring Viral Safety of Viral Vaccines and Vectors
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
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3rd BioProcessing Asia Preview: Q&A with John Curling
The 3rd BioProcessing Asia conference will take place November 12-15, 2018 on Langkawi, Malaysia. This week, Bioprocess Development Forum talks with John Curling, Conference Chair, about the upcomin…
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Early Communication with Regulators is Essential for SMEs
With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process.
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The Outlook for CMO Outsourcing in 2019
…expertise or capacity remain limited, will also be outsourced more frequently, such as cellular and gene therapies. Most innovator drug companies continue to retain manufacturing and development of t…