Search results for " process development"
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
…te the regulatory approval path
9:44 - The impact of filing accelerated review applications on process development
11:41 - What quality teams should do to ensure quality standards are mai…
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Evolving demands of process development services
In this interview, BioPharm International discusses how process development demands have changed for service providers with Xiaoyong Fu, PhD, chief technology officer and head of API Business, WuXi ST…
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Manufacturers Struggle with Breakthrough Drug Development
Developing breakthrough products requires a new approach to process development and commercial launch, said Earl Dye of Genentech at the CASSS forum, in describing the company’s program to develop CMC…
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Free On-Demand Webinar: Smart Process Development of Chromatography Steps
Join Peter Hagwall as he reviews three smart process development tools that enable reduced timelines and improved process outcomes:
1.
In-silico process development and data-driven decisions…
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High-Throughput Process Development Handbook
Employing high-throughput tools for process development helps address these challenges.
High-throughput process development (HTPD) shortens development time at the same time as it increases the am…
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Vaccine Development and Production Challenges Manufacturers
Mar 01, 2015
By Jill Wechsler
BioPharm International
Volume 3, Issue 28
Vaccines are front-page news these days. Researchers are advancing new vaccines for Ebola and other devastating di…
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Free eBook: Considerations for smarter and faster process development
What you will learn:
Industry drivers to go smarter and faster in process development
Strategies for more efficient upstream process development
Strategies for more efficient down…
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Accelerating CMC - The future of process development is in silico
Simulation for in silico process development is becoming a viable option to reduce the time needed for chemicals, manufacturing, and control (CMC) activities and increase process understanding. Advanc…
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Chromatography Process Development Going Smarter
Especially, he explains how methods such as raw material insights and mechanistic modeling enable accelerated process development and improve general process understanding, robustness, and performance…
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Vaccine Development Faces Urgency and Challenges
Global outbreaks energize vaccine R&D and drive production modernization.
By Jill Wechsler
The Ebola outbreak in 2015 and the current stampede to develop a new vaccine to combat the Zika vir…