Search results for " biopharms" in Articles / App Notes

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…

Article 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…

Article 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 |…

Article 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…

Article 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…

Article 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…

Article 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…

Article Quality Systems Key to Lifecycle Drug Management
Jun 01, 2015 By Jill Wechsler BioPharm International Volume 28, Issue 6 The submission and review of manufacturing supplements is costly and time consuming for biopharmaceutical comp…

Show All Results

Previous PageNext Page