Search results for "Gene Therapies"

Article FDA Framework Spurs Advanced Therapies
Markets and Markets estimates the value of the regenerative medicine market (including cell and gene therapies, immunotherapies, and tissue engineering) will grow at a compound annual growth rate of 2…

Article Patenting Prospects for Cell-Based Therapies
Cell-based therapies are moving medical treatments forward, but intellectual property uncertainties may delay progress. By Kevin Noonan Treatment using cell-based therapies is a rapidl…

Article Scaling Up Novel Therapies
Developers are exploring how these platforms might be used in novel therapies such as cell and gene therapies. Although these treatments are in early stages of development, gene therapy has already be…

Article Science Focus Fuels Successful Process Development for Startups
For Krystal Biotech, which is developing gene therapies for skin diseases using a new vector for delivery, process development has involved cell-line engineering as well as determination of the optimu…

Article Biopharma Seeks Balance
New paradigm: Gene and cell therapies FDA’s approval of the first cell and gene therapies in 2017 created new dynamics in the biopharma industry as well as new science, technology, business, and e…

Article 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…

Article 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…

Article 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…

Article 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…

Article 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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