Search results for " development" in Articles / App Notes
Article
Analysis of Glycosylation in Biosimilars
A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.
The structures of protein drugs such as monoclonal antibodies are mad…
Article
Resolving a bottleneck in screening and characterization of recombinant antibody fragments using Biacore 4000
Techniques to screen and characterize large numbers of antibodies and provide confident selection of the best candidates for development are therefore essential. Biacore 4000 equipped with Biacore 400…
Article
Your Reliable Downstream Bioprocessing. Our Proven AxiChrom Columns
The goal for biopharmaceutical manufacturers is to develop a process that will deliver material for clinical trials quickly and smoothly, achieve success in these trials, and scale up to commercial …
Article
FDA Releases Draft Guidance on Emerging Manufacturing Technology
By Caroline Hroncich
On Dec. 23, 2015, FDA released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. The guidance discuss…
Article
Biacore Concentration and Ligand-Binding Analyses
During development and in quality control, a range of analytical technologies are used to characterize biotherapeutic drugs in terms of their structural integrity and activity. In this white
paper, …
Article
Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
The growth of the segment has necessitated development of new efficient and cost saving platforms for the preparation and analysis of early candidates for faster and better antibody selection and char…
Article
E. coli growth and Dab expression in single-use and stainless steel fermentors
This application note describes the performance of the Xcellerex™ single-use XDR-50 MO stirred-tank fermentor in an E. coli domain antibody (Dab) production process developed for a stainless steel …
Article
The Metrics of Quality Culture
FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.
By Andrew Harrison, Susan J. Schniepp
The long awaited, anxio…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
This article discusses cleaning validation of equipment dedicated to the production of a single API.
By Cristina Baccarelli, Paola Bernard, Teresa Cortellino, Oscar Cruciani, Rita Pacello, Chi…
Article
Using Single-Use Technologies in Downstream Processing
The use of single-use systems in downstream processing offers benefits in filtration and sampling and may reduce the risk of contamination.
Jul 01, 2015
By Susan Haigney
BioPharm Inter…