Search results for " analytics"
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
Article
Platform Approach Speeds Process Development
Thousands of clones per project are analyzed using a robotic platform including cell sorting, automated single-cell deposition, and high-throughput analytics for product quantity and quality. The high…
Article
A Q&A With Jeff Carter on Trends in Single-Use Technologies
Process Development Forum speaks with Jeff Carter, Strategic Projects Leader at Cytiva, and first Vice Chair on the executive board of the Bio-Process Systems Alliance (BPSA).
What general trend…
Article
Innovative Therapies Require Modern Manufacturing Systems
FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.
By Jill Wechsler
FDA set a 19-year record in 2015 in approving more new drugs and biologics, and …
Article
Biacore Concentration and Ligand-Binding Analyses
Biotherapeutic drugs including antibodies, cytokines, and hormones are used for treatment of a variety of diseases including arthritis, cancer, and diabetes. Compared to traditional small-molecule dru…
Article
CMOs Continue to Improve Overall Biomanufacturing Performance
Better process development is creating industry benchmarks for bioprocessing.
By Eric Langer
Biomanufacturing efficiency is on everyone’s minds, being the single most important area of focus…
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…
Article
Biosimilars Will Bring Significant Litigation and Patent Challenges
May 04, 2015
By Randi Hernandez
The risks involved with patent suits may become a bit more undesirable, thanks to new legislation aimed at deterring unreasonable patent suits. A senate bill…