Search results for " gene therapy"
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Cytiva and 4Tune Engineering Collaborate on Cell Therapy Quality Risk Management
Our customers will have peace of mind knowing they have a strong risk mitigation process in place,” said Catarina Flyborg, vice-president, Cell and Gene Therapy, Cytiva, in a company press release.
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A Closer Look at Affinity Ligands
…been developed with high selectivity for purification of, for example, recombinant viral vectors for gene therapy applications.In one example, camelid single domain antibodies that recognize adeno-as…
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Manufacturing of Viral Vectors
In gene therapy, viral vectors can be used for the delivery of functional genes to replace defective genes to cure genetic disorders. As a vaccine platform, viral vectors can be used for the expressio…
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State of the Biopharmaceutical Industry: Lessons from 2018 Survey Data
Since 2003, BioPlan Associates, Inc. of Rockville, MD, has surveyed developers of biotherapeutics and contract manufacturing organizations working in this space about current and projected capacity …
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Single-use Bioreactors Have Reached the Big Time
The iCELLis technology, for instance, can replace roller bottles for major vaccine and gene therapy processes, but also dramatically reduce the footprint required to produce the virus titers, and it r…
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Updating Viral Clearance for New Biologic Modalities
Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.
By Feliza Mirasol
Ensuring viral clearance (i.e., removal) in downstream purification has becom…
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Process Development: 2020 Reflections and 2021 Possibilities
Addressing pain points for lentiviral vectors, which are used as a common vehicle to deliver genetic material in chimeric antigen receptor (CAR) T-cell therapy and gene therapy applications, by creati…
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Virus-like Particles as Therapeutic Moieties of the Future
Gene therapy
The ability of VLPs to deliver specific genes make them attractive tools for gene therapy. Traditional tools for gene therapy, such as liposomes, have restricted packaging capacity, p…
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Understanding Validation and Technical Transfer, Part 3
A consultation document [2]published by the European Commission (3) and an FDA guidance document on human somatic cell therapy and gene therapy (4) provide useful information for developing validation…
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Drug Quality Key to Innovation and Access
FDA plans to advance initiatives for ensuring reliable production of drugs and biologics in 2017.
By Jill Wechsler
Amidst multiple challenges to the structure and governance of the US health…