Search results for "innovation"
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Optimizing Late-Stage and Commercial Cell-Culture Processes
Cell-culture process innovations include platform processes with high productivity and chemically defined culture media, which have helped to reduce process variability and complexity, improve efficie…
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Techniques for Improving Process Development for Exosome-Derived Therapeutics
Here, the Process Development Forum speaks with Aaron Noyes, Head of Downstream Processing, at Codiak BioSciences about exosomes, their potential clinical applications, and process innovations that wo…
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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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Reducing Cross-Contamination Risks in Process Chromatography
Reducing Cross-Contamination Risks in Process Chromatography
Single-use systems provide replaceable fluid paths.
By Cynthia A. Challener
…
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Best Practices for Data Integrity
Best Practices for Data Integrity
Optimize practices and meet requirements using electronic data integrity systems.
By Jennifer Markarian
Maintainin…
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Speed and Flexibility Are Dual Goals for Biopharma Operations
The Parenteral Drug Association (PDA) is investigating options to reduce barriers to innovation imposed by post-approval change requirements. The association is also investigating the harmonization of…
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What’s In a Name? For Biosimilars, A Lot
Jun 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 6
There is still some uncertainty surrounding whether a biosimilar will share the same compendial identity—or …
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Modern Manufacturing Systems Key to FDA Quality Initiative
Apr 02, 2015
By Jill Wechsler
Pharmaceutical Technology
Volume 39, Issue 4
To ensure patient access to high quality, safe, and effective medicines, FDA spends considerable time and resou…
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FDA Approves First Biosimilar
The decision by the regulatory body comes five years after the passage of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), part of the Affordable Care Act that was signed into law i…
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What Drove Biopharma Development in 2014?
PDF readers also saw continued improvements and innovations in bioprocessing equipment and consumables. In 2014, there was significant increased interest in continuous processing, both upstream and do…