Search results for "Gene Therapies"
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Cytiva and 4Tune Engineering Collaborate on Cell Therapy Quality Risk Management
“Our collaboration with Cytiva will provide their customers with an automated, systematic, and user-friendly approach to risk management that will improve lifecycle management of cell and gene therapi…
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A Closer Look at Affinity Ligands
Affinity ligands play an exciting role in the ever-growing sphere of downstream processing. In speaking with BioPharm International®, Phillip Elliott, PhD, associate director of Process Development,…
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Manufacturing of Viral Vectors
Viruses are infectious agents that can only replicate inside of living cells. This trait is used by molecular biologists for the delivery of genetic materials into cells. Viral vectors are also explor…
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State of the Biopharmaceutical Industry: Lessons from 2018 Survey Data
But, we have documented that there is currently a “capacity crunch” in cellular and gene therapies areas, and this will get much worse.
4) Capacity utilization is also in a “good place,” now in th…
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Single-use Bioreactors Have Reached the Big Time
…s (reducing the scale for more precise therapies), fits well together with the thinking around cell/gene therapies, according to Norris. “[Cytiva] is taking its experience in single-use bioreactor te…
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Updating Viral Clearance for New Biologic Modalities
However, demonstrating viral clearance is even more difficult with the newer biotherapeutic modalities being developed today such as viral vector-based gene therapies. Many of these new and evolving b…
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Process Development: 2020 Reflections and 2021 Possibilities
…duction of therapeutics is process chromatography, particularly for monoclonal antibodies (mAb) and gene therapies. This makes knowing the current status of process chromatography and what the future…
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Virus-like Particles as Therapeutic Moieties of the Future
Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency.
By Ramesh Kumar, Manidipa Banerjee, Anurag S. Rathore
Virus-like…
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Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…
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Drug Quality Key to Innovation and Access
Similarly, modern, agile, and reliable production systems that adhere to standards and ensure data integrity are vital for development and access to biosimilars, cellular and gene therapies, complex d…