Search results for " biopharms"
Article
Moving Biosimilars Forward in a Hesitant Market
The biosimilars landscape is growing as market factors, such as pricing pressure, advanced bioprocessing and analytical technologies, and upcoming patent expirations for innovator biologics dr…
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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…
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Evolving demands of process development services
Shifting demands from industry innovators is leading to an increased need for flexible and agile outsourcing partners offering broad and integrated models.
Over the years and in light o…
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Enhancing Resins Addresses Purification Concerns
Christoph Burgstedt/Stock.Adobe.com
Enhancement of resin technology can improve the ability of chromatography to purify the growing landscape of increasingly complex biomolecu…
Article
Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Advances in cell culture media technology have helped achieve safer biologics.
By Tom Fletcher, Holden Harris
Regulatory expectations for cell-culture-based biologics production processes ch…
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mAbs to Watch in 2016
By Randi Hernandez
Of the 45 new molecular entities and new therapeutic biological products approved by FDA in 2015, nine products were monoclonal antibodies (mAbs). And there may be many more o…
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Breakthrough Drugs Raise Development and Production Challenges
Manufacturers and FDA look for innovative strategies to meet accelerated timeframes.
Jul 01, 2015
By Jill Wechsler
BioPharm International
Volume 28, Issue 7, pg 8–9
The FDA pro…
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Robust Optimization, Simulation, and Effective Design Space
Jul 01, 2015
By Thomas A. Little, PhD
BioPharm International
Volume 28, Issue 7, pg 40–44
Approaches to the generation of process models, optimization techniques, and application of …
Article
Taking a “Development-by-Design” Approach to Cell Therapies
Jun 15, 2015
By Agnes Shanley
BioPharm International eBooks
Volume 28, Issue 13
Whether outsourcing or developing cell therapies in-house, success demands a focus on quality, c…