Search results for " advanced therapies" in Articles / App Notes
Article
Advancing QbD in the EU
EU authorities are stepping up their efforts to incorporate QbD principles.
The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD)…
Article
New Therapies Present Scaling Challenges
New Therapies Present Scaling Challenges
Manufacturing differences between traditional mAb therapies and newer biotherapeutics dictate whether processes should be scaled up, scaled out, or use an al…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
The Evolving Role of Starting Materials in Cell and Gene Therapy
Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting m…
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…
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Mapping a Route for Cell and Gene Therapy Process Development
While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar.
By Cynthia A. Challener
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Scaling Up Novel Therapies
Scaling Up Novel Therapies
Platform processes have improved monoclonal antibody scale-up. Can they do the same for personalized therapies?
By Agnes S…
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
More consistent and reliable production processes are critical for advancing innovative treatments.
By Jill Wechsler
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Article
Biopharma Seeks Balance
Biopharma Seeks Balance
Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.
By Rita C. Peters
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Article
Moving PAT from Concept to Reality
The learning curve for process analytical technology has slowed widespread adoption.
By Cynthia A. Challener
alexlmx a- Stock.Adobe.com
Process analytical technology (P…
Article
Maximum Output Starts with Optimized Upstream Processing
Evolution in bioprocessing
The increasing diversity of advanced therapies has driven upstream manufacturing processes to evolve, according to Philip Vanek, CTO at Gamma Biosciences. “The latest …