Search results for " gene therapy"
Article
Top Process Development Trends for 2021 and a Look into 2022
AAV is quickly becoming the most flexible and useful vector in gene therapy. But, according to Anki Magnusson, staff research engineer, protein and viral production, and Åsa Hagner-McWhirter, Ph…
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Akron Bio Will Install a Cytiva FlexFactory to Manufacture Plasmid DNA
Materials for cell and gene therapy manufacturing, such as pDNA, have been experiencing capacity constraints, and the platform will enable rapid scale-up to address supply chain bottlenecks.
“With…
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Production of Recombinant Adeno-associated Virus Vectors Using Microcarrier Culture of HEK293T Cells
As the gene therapy projects enter clinical Phase III or get market approval, large-scale production of viruses has become a limiting factor in the industrialization of gene therapy.
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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
The learning curve for process analytical technology has slowed widespread adoption.
By Cynthia A. Challener
alexlmx a- Stock.Adobe.com
Process analytical technology (P…
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A Look at the Affinity Chromatography Landscape
Affinity columns with specific antigens to each AAV serotype had been used for purification of AAV-based gene therapy products, and more recently a new resin has been introduced that binds all AAV ser…
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Ensuring Viral Safety of Viral Vaccines and Vectors
This article outlines the risks and challenges associated with managing viral safety in virus vaccines and vectors for gene therapy, and highlights a holistic risk-mitigation approach of testing and c…
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3rd BioProcessing Asia Preview: Q&A with John Curling
Given approvals of gene and cell therapy treatments in 2016-2017 and recent reports of positive clinical trial outcomes for the AAV-FVIII gene therapy treatment of Hemophilia A, I believe that develop…
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Early Communication with Regulators is Essential for SMEs
The agency’s SME Office has been disappointed with the low uptake of services from SMEs involved in the development of advanced therapy medicinal products (ATMPs)—such as gene therapy, somatic-cell th…
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The Outlook for CMO Outsourcing in 2019
By Eric Langer and Ronald A. Rader
Biopharmaceutical industry-related indicators and trends are supporting continued incremental increases in outsourcing of pre- and commercial AP…