Search results for "Gene Therapies"
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Tools and Processes for Mature and Emerging Therapies
While technology advances for more traditional biologic-based drugs such as monoclonal antibodies are evolutionary, the processing requirements for emerging cell therapies and gene therapies may requi…
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Transformative Medicines Challenge FDA and Manufacturers
Combos crucial
The process of developing and delivering cutting-edge gene therapies also involves ensuring reliable and accurate delivery and dosing for patients, objectives that increasingl…
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Flexible Facilities for Viral Vector Manufacturing
…d to be placed inside a new or repurposed space or shell-building—tailored for viral-vector-based gene therapies (3).
“Speed to market is critical for most, if not all, biologics. This is quite r…
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Maximum Output Starts with Optimized Upstream Processing
In the meantime, companies developing new biologics, and in particular vaccines, oncolytic viruses, and gene therapies based on viral vectors, need to identify and access manufacturing capacity as ear…
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Single-Use Technologies Prove Effective for Viral Vector Process Development
Need for higher commercial capacity
Many viral-vector manufacturing processes for gene therapies were initially developed in academic laboratories using traditional plasticware systems such as m…
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GMP Challenges for Advanced Therapy Medicinal Products
Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.
By Sean Milmo
A consultation period…
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Downstream Processing for Cell-Based Therapies
Rafiq, Fernanda Masri
With increasing numbers of advanced therapies—including cell and gene therapies—entering early- and late-stage clinical development, significant focus has been directed towar…
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Best Practices for Selecting a Top-Quality Cell Line
Irina Shi - Stock.Adobe.com
Leveraging automation and a step-by-step approach are keys to success.
By Cynthia A. Challener
Cell lines determine the performanc…
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Scalable Viral Vector Manufacturing
The interest for robust and scalable viral vector manufacturing is rapidly increasing, with the recent developments of both cell and gene therapy and oncolytic virus-based therapies. As cost pressur…
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Milestones and Moderate Progress in 2012 Drug Approvals
First gene therapy and plant-based expression vector products approved in 2012.
In terms of product approvals, the past year can be considered reasonably successful. Twelve biopharm…