Search results for " advanced therapeutics"
Article
Advances in Engineering of Protein-Based APIs
Advances in Engineering of Protein-Based APIs
New platform technologies, advanced modeling tools, and addressing patient needs are important developments.
By Cynthia A. Challener
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Article
Remote Monitoring and Big Data Advance Upstream Automation
Connected, integrated bioprocessing enterprises with greater data analytics capabilities are coming.
By Cynthia A. Challener
As upstream processing drives toward higher efficiencies in meeti…
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
The Need for Advanced Process Modeling for New Therapeutic Biologics
The Need for Advanced Process Modeling for New Therapeutic BiologicsThe trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling e…
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA works with industry on strategies for assuring high-quality regenerative medicines.
By Jill Wechsler
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Article
FDA Framework Spurs Advanced Therapies
Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.
By Cynthia A. Challener
Ibreakstock/Shutterstock.co…
Article
Advanced therapeutics process development using mechanistic modeling
Guterstam
Watch the interview of Peter Guterstam and Nick Whitelock (Cytiva), and learn about
the biological background of advanced therapeutics
what mechanistic modelling …
Article
Bracing for a Future Wave of Advanced Therapies
With the help of recent investor interest, progression of advanced therapy medicinal products (ATMPs) in the clinical space continues to move forward. Buoyed by the regulatory approval of sever…
Multimedia
Using mechanistic modeling in process development for advanced therapeutics
Peter Guterstam and Nick Whitelock discuss mechanistic modeling in process developemnt of advanced therapeutics.
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Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Analytical exoglycosidases are transitioning from being largely academic tools to being s…