Search results for " gene therapy"
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Tools and Processes for Mature and Emerging Therapies
Backing from the investment community in innovator companies and investments by major contract development and manufacturing organizations in cell and gene therapy capacity are strong indicators the b…
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Transformative Medicines Challenge FDA and Manufacturers
Transformative Medicines Challenge FDA and Manufacturers
New gene therapies and combination products require innovative regulatory approaches.
By Jill Wechsler …
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Flexible Facilities for Viral Vector Manufacturing
While the initial project looked at a monoclonal antibody (mAb) facility, the team plans to extend the concept to cell and gene therapy production.
Cytiva has amassed expertise in modular design a…
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Maximum Output Starts with Optimized Upstream Processing
Vaccine manufacturing in terms of capacity, according to Hitchcock, has largely been provided by CDMOs operating in the cell and gene therapy space for viral vector and plasmid DNA production. “Prior …
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Single-Use Technologies Prove Effective for Viral Vector Process Development
Notably for the manufacture of vectors based on adeno-associated virus (AAV), one of the most common vector types for gene therapy delivery and viral-vector vaccines, recent data have shown that stain…
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GMP Challenges for Advanced Therapy Medicinal Products
EDQM, Symposium Report: Raw Materials for the Production of Cell-based and Gene Therapy Products (Strasbourg, 2013).
6. Cell Therapy Catapult UK, EC Review of the ATMP Regulation—Cell Therapy Catap…
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Downstream Processing for Cell-Based Therapies
Rafiq, MEng, PhD, CEng, CSci, is associate professor of Cell & Gene Therapy Bioprocessing at the University College London, WC1E 6BT, UK.
Fernanda Masri is an account manager at Sartorius Sted…
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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
What are the main reasons for this rapid increase in viral vector manufacturing?
Viral vector platforms emerging at the crossroads of cell, gene therapy, and vaccines are becoming a promising ar…
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Milestones and Moderate Progress in 2012 Drug Approvals
Until 2012, no gene therapy-based product had gained approval for human use in the western world, although a small number of such products have been approved in China (5) and four gene therapy-based d…